tadalafil: package leaflet

ADCIRCA contains the active substance tadalafil.
ADCIRCA is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.

Do not take ADCIRCA
- if you are allergic to tadalafil or any of the other ingredients (see section 6).
- if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.
ADCIRCA has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- if you have ever had loss of vision – a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION).
- if you have had a heart attack in the last 3 months.
- if you have low blood pressure.
- if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking ADCIRCA.
Before taking the tablets, tell your doctor if you have:

• any heart problems other than your pulmonary hypertension
• problems with your blood pressure

• any hereditary eye disease
• an abnormality of red blood cells (sickle cell anaemia)
• cancer of the bone marrow (multiple myeloma)
• cancer of the blood cells (leukaemia)
• any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
• a serious liver problem
• a serious kidney problem.

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.

Children and adolescents
ADCIRCA is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.

Other medicines and ADCIRCA
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do NOT take these tablets if you are already taking nitrates.

Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work.
Tell your doctor or pharmacist if you are already taking:
- bosentan (another treatment for pulmonary arterial hypertension)
- nitrates (for chest pain)
- alpha blockers used to treat high blood pressure or prostate problems
- riociguat
- rifampicin (to treat bacterial infections)
- ketoconazole tablets (to treat fungal infections)
- ritonavir (for HIV treatment)
- tablets for erectile dysfunction (PDE5 inhibitors).

ADCIRCA with alcohol
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.

Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Dizziness has been reported. Check carefully how you react to this medicine before driving or using any machinery.

ADCIRCA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

ADCIRCA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

ADCIRCA is supplied as a 20 mg tablet. Swallow the tablet(s) whole with a drink of water. The tablet(s) can be taken with or without food.

Pulmonary arterial hypertension in adults
The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (age 2 years and above) weighing at least 40 kg The recommended dose is two 20 mg tablets taken once a day. Both tablets should be taken at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (age 2 years and above) weighing less than 40 kg The recommended dose is one 20 mg tablet taken once a day. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take 10 mg once per day.

Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.

If you take more ADCIRCA than you should
If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience any of the side effects described in section 4.

If you forget to take ADCIRCA
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do NOT take a double dose to make up for the one that you have forgotten.

If you stop taking ADCIRCA
Do not stop taking your tablets, unless advised otherwise by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including skin rashes (frequency common).
- chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).

• priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
• sudden loss of vision (rarely reported), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)

Other side effects have been reported:
Common (may affect up to 1 in 10 people)
- blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.

Uncommon (may affect up to 1 in 100 people)
- seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:
- Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.

Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is unknown:
- swelling of the eyelids, eye pain, red eyes, heart attack and stroke.

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What ADCIRCA contains
The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “ADCIRCA contains lactose” and “ADCIRCA contains sodium”.

Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.

What ADCIRCA looks like and contents of the pack
ADCIRCA 20 mg comes as orange film-coated tablets (tablets). They are in the shape of almonds and have "4467" marked on one side.

ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

ADCIRCA contains the active substance tadalafil.

ADCIRCA is a treatment for pulmonary arterial hypertension in adults and in children aged 2 years and above. The oral suspension is intended for paediatric patients who are not able to swallow tablets and whose dose is 20 mg.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.

Do not take ADCIRCA
- if you are allergic to tadalafil or any of the other ingredients (see section 6).
- if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.
ADCIRCA has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- if you have ever had loss of vision – a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION).
- if you have had a heart attack in the last 3 months.
- if you have low blood pressure.
- if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking ADCIRCA.
Before taking ADCIRCA, tell your doctor if you have:

• any heart problems other than your pulmonary hypertension
• problems with your blood pressure
• any hereditary eye disease
• an abnormality of red blood cells (sickle cell anaemia)
• cancer of the bone marrow (multiple myeloma)
• cancer of the blood cells (leukaemia)
• any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
• a serious liver problem
• a serious kidney problem.

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.

Children and adolescents
ADCIRCA is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.

Other medicines and ADCIRCA
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do NOT take this oral suspension if you are already taking nitrates.

Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work.
Tell your doctor or pharmacist if you are already taking:
- bosentan (another treatment for pulmonary arterial hypertension)
- nitrates (for chest pain)
- alpha blockers used to treat high blood pressure or prostate problems
- riociguat
- rifampicin (to treat bacterial infections)
- ketoconazole tablets (to treat fungal infections)
- ritonavir (for HIV treatment)
- tablets for erectile dysfunction (PDE5 inhibitors).

ADCIRCA with alcohol
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.

Do not breast-feed while taking the oral suspension as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Dizziness has been reported. Check carefully how you react to this medicine before driving or using any machinery.

ADCIRCA contains sodium benzoate (E211)
This medicine contains 2.1 mg sodium benzoate in each mL.

ADCIRCA contains sorbitol (E420)
This medicine contains 110.25 mg sorbitol in each mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

ADCIRCA contains propylene glycol (E1520)
This medicine contains 3.1 mg propylene glycol in each mL.

ADCIRCA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 1 mL, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

ADCIRCA oral suspension is supplied in a bottle. This is part of a pack which also includes a dosing device containing two 10 mL oral syringes marked in 1 mL increments and a press-in-bottle adaptor.
Read the instructions for use booklet, which is included in the carton for instructions on how to use the adaptor and the syringe.

The recommended dose is 10mL of oral suspension once daily for children aged 2 years and above and weighing less than 40 kg.

If you have a mild or moderate liver or kidney problem, your doctor may prescribe a lower dose.

The oral suspension should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.

If you take more ADCIRCA than you should
If you or anyone else takes more suspension than they should, tell your doctor or go to a hospital immediately, taking the medicine bottle with you. You may experience any of the side effects described in section 4.

If you forget to take ADCIRCA
Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do NOT take a double dose to make up for the one that you have forgotten.

If you stop taking ADCIRCA
Do not stop taking your medicine, unless advised otherwise by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including skin rashes (frequency common).
- chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).
- priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (rarely reported), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)

Other side effects have been reported:
Common (may affect up to 1 in 10 people)
- blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.

Uncommon (may affect up to 1 in 100 people)
- seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:
- Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.

Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction.
These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is unknown:
- swelling of the eyelids, eye pain, red eyes, heart attack and stroke.

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after ‘EXP’. The expiry date refers to the last day of that month.

Do not use the medicine if the bottle has been open for more than 110 days. This medicine does not require any special storage conditions.

Store in the original package. Store the bottle upright.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What ADCIRCA contains
The active substance is tadalafil. Each mL contains 2 mg of tadalafil.

The other ingredients are xanthan gum, microcrystalline cellulose, carmellose sodium, citric acid, sodium citrate, sodium benzoate (E211), silica (colloidal anhydrous), sorbitol (E420) (liquid crystallising), polysorbate 80, sucralose, simethicone emulsion (simethicone, methylcellulose, sorbic acid, purified water), artificial cherry flavour (contains propylene glycol (E1520) and water. See section 2 “ADCIRCA contains” for more information about sorbitol, sodium benzoate, propylene glycol and sodium.

What ADCIRCA looks like and contents of the pack
ADCIRCA 2 mg/mL is a white to practically white oral suspension.

ADCIRCA is packaged in a bottle containing 220 mL of oral suspension with a peelable seal and child-resistant closure, inside a carton. Each carton contains one bottle, two 10 mL graduated syringes with 1 mL graduations and a press-in-bottle adaptor.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands

Manufacturer:
- Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
- Delpharm Huningue SAS, 26 rue de la Chapelle, Huningue, 68330, France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

INSTRUCTIONS FOR USE
ADCIRCA 2mg/mL oral suspension tadalafil

Before you use ADCIRCA oral suspension, read and carefully follow all the step-by-step instructions.

This “Instructions for Use” contains information on how to use ADCIRCA oral suspension.

IMPORTANT INFORMATION YOU NEED TO KNOW BEFORE USING ADCIRCA ORAL
SUSPENSION
The adaptor represents a CHOKING HAZARD – small parts. Do not attach the oral syringe to the adaptor until the adaptor is fully inserted into the bottle. It must be inserted completely into the bottle for safe use. To be used only under adult supervision.

Do not let your child take the medicine without your help.

Do not use if bottle, seal, adaptor, or oral syringe is damaged.

Do not use the medicine if the bottle has been open for more than 110 days. See the Disposal section to find out what to do with the medicine you don’t use.

Record date of first opening of bottle here: _________________________

Do not wash the oral syringe with soap or detergent. Please see steps 4b - 4c for cleaning instructions.

Do not put the oral syringe in the dishwasher. The syringe may not work as well as it should.

Use a new oral syringe after 30 days.

It is not recommended to mix the medicine with food or water. It may affect the taste or prevent the receiving full dose.

Give ADCIRCA oral suspension only using the oral syringe supplied with the medicine.

The medicine is white. Air gaps may be difficult to see in the oral syringe when preparing the dose and may result in an incorrect dose.

In case of overdose, contact your doctor, pharmacist or nurse immediately. Quick medical attention is important for adults and children even if you do not notice any signs or symptoms.

Parts of the ADCIRCA oral suspension administration system

Medicine
Medicine bottle
Oral syringe
Plunger
Flange
Syringe tip
Adaptor
Child-resistant cap
Lift and Peel
Seal

STEP 1: PREPARE THE BOTTLE

1a
Gather the medicine bottle and adaptor.
Wash your hands with soap and water.

1b
Remove the cap from the bottle.
Firmly push the cap down while twisting it counter clockwise.
Remove the cap from the bottle.

1c
Prior to first use only, remove the lift and peel seal.
Make sure the seal is completely removed.

1d
Prior to the first use only, push the adaptor all the way down into the opening of the bottle.

The adaptor represents a CHOKING HAZARD – small parts. It must be inserted completely into the bottle for safe use.

Do not attach the oral syringe to the adaptor until the adaptor is fully inserted into the bottle.
Do not twist the adaptor.

1e
Screw the cap back on the bottle tightly.
The cap will fit over the adaptor.

STEP 2:
PREPARE THE DOSE

2a
Gather the medicine bottle with the adaptor inserted and oral syringe.
Make sure the cap is on tightly.
Wash your hands with soap and water.

2b
Shake the bottle.
Shake the medicine bottle well for at least 10 seconds before each use to fully mix the suspension.
Shake again if the bottle sits longer than 15 minutes.

2c

Remove the cap from the bottle.

2d

Firmly insert the oral syringe into the opening of the adaptor.
Make sure that the syringe tip is fully inside the adaptor and the plunger is pushed all the way to the syringe tip.

2e

Turn the bottle with the oral syringe upside down while holding the syringe in place.
Make sure that the bottle is upside down.
Make sure the oral syringe stays completely inserted in the adaptor.

2f

Draw the dose.
Slowly pull the plunger down until the mL graduation mark is visible below the bottom of the flange for the dose prescribed for your child.
The graduation mark is located on the plunger of the oral syringe.
Make sure the top edge of the graduation mark is aligned to the bottom of the flange.

2g

Turn the bottle upright and check closely for air gaps in the oral syringe.

An air gap may result in an incorrect dose.

The medicine is white, the same colour as the oral syringe. Air gaps may be difficult to see.

If there is an air gap, empty the medicine back into the bottle and repeat steps 2e through 2g.

2h

Remove the oral syringe from the bottle.

Do not touch the plunger.
STEP 3:
GIVE THE DOSE

Put the oral syringe into a corner of your child’s mouth.
Tell your child not to bite the syringe.
Do not squirt the medicine into the back of the throat.
Slowly and gently push down the plunger to the end of the syringe so that all of the medicine is in your child’s mouth.
Make sure your child swallows all of the medicine.

STEP 4:
CLEAN UP
4a
Screw the cap back on the bottle tightly.
Do not remove the adaptor. The cap will fit over it.

4b
Fill the oral syringe with clean water.
Do not wash the oral syringe with soap or detergent.
Do not remove the plunger from the oral syringe.
Fill a cup with clean water, insert the oral syringe, and pull the plunger up to fill the syringe with water.

4c
Push the plunger down and squirt the water into the cup or into the sink.
Make sure to remove the water from the oral syringe.
Shake excess water from the syringe and dry it with a paper towel.
Store the oral syringe and bottle in the original carton.
Wash your hands with soap and water.

DISPOSAL OF MEDICINE
Do not throw away any medicines via wastewater or household water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

DISPOSAL OF SYRINGE
Ask your doctor, pharmacist or nurse how to dispose of your syringe.

HOW TO STORE YOUR MEDICINE
This medicine does not require any special storage conditions
Store the bottle standing upright.
Keep the bottle and oral syringe out of sight and reach of children.

COMMONLY ASKED QUESTIONS

Q.
What if I see air gaps in my oral syringe?
A.
Do not give the medicine. Air gaps may result in an incorrect dose. Empty the medicine back into the bottle and repeat steps 2e through 2g.

Q.
What if there is too much medicine in the oral syringe?
A.
Keep the syringe tip in the bottle. Hold the bottle upright. Push the plunger down until the correct dose is in the oral syringe.

Q.
What if there is not enough medicine in the oral syringe?
A.
Keep the syringe tip in the bottle. Hold the bottle upside down. Pull the plunger down until the correct dose is in the oral syringe.

Q.
What if I get some medicine in my eye or in my child’s eye?
A.
Flush the eye immediately with water and call your doctor, pharmacist or nurse. As soon as possible, wash hands and surfaces that may have come in contact with the medicine.

Q.
How do I travel with this medicine?
A.
Make sure you have enough medicine for the entire trip. Take the oral syringe and medicine in its original container. Store the medicine in a safe place upright.

Q.
Can I mix this medicine with food or water before I give it to my child?
A.
It is not recommended to mix this medicine with food or water. This can affect the way the medicine tastes or prevent a full dose. You can give your child a glass of water to drink after he or she takes the entire dose of medicine.

Q.
What if my child spits up the medicine?
A.
Do not give additional medicine to your child. Contact your doctor, pharmacist or nurse.

Q.
What if my child does not swallow all of the medicine?
A.
Contact your doctor, pharmacist or nurse.

Q.
What if my child swallows too much medicine?
A.
Immediately contact your doctor, pharmacist or nurse.

FOR QUESTIONS OR MORE INFORMATION ABOUT ADCIRCA ORAL SUSPENSION
For questions or more information about ADCIRCA
• Call your doctor, pharmacist or nurse
• Call Lilly

Read the full package leaflet for ADCIRCA inside this box to learn more about your medicine.

For questions or more information about ADCIRCA oral suspension
If you have any questions or problems with your oral suspension syringe, contact Lilly or your doctor, pharmacist or nurse for assistance. Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to Lilly.

CIALIS is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction.

It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Do not take CIALIS if you:

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

• have serious heart disease or recently had a heart attack within the last 90 days.

• recently had a stroke within the last 6 months.

• have low blood pressure or uncontrolled high blood pressure.

• ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if CIALIS is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking CIALIS, stop taking CIALIS and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately.

CIALIS is not intended for use by women.

Children and adolescents
CIALIS is not intended for use by children and adolescents under the age of 18.

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take CIALIS if you are already taking nitrates.

Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin , clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

CIALIS with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

CIALIS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

CIALIS contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be given as a 2.5mg tablet.
Do not take CIALIS more than once a day.

Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.

When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more CIALIS than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take CIALIS
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take CIALIS more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking CIALIS (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking CIALIS. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CIALIS contains
- The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
- The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.

What Cialis looks like and contents of the pack
CIALIS 2.5 mg is a light orange-yellow film-coated tablet in the shape of an almond and has "C 2 ½" marked on one side.

CIALIS 2.5 mg is available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

CIALIS 5 mg is used to treat adult men with:
- erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function.
CIALIS will not help you if you do not have erectile dysfunction. It is important to note that CIALIS for the treatment of erectile dysfunction does not work if there is no sexual stimulation.
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

- urinary symptoms associated with a common condition called benign prostatic hyperplasia.
This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. CIALIS improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. CIALIS has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.

Do not take CIALIS if you:

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

• have serious heart disease or recently had a heart attack within the last 90 days.

• recently had a stroke within the last 6 months.

• have low blood pressure or uncontrolled high blood pressure.

• ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia.
CIALIS does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if CIALIS is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking CIALIS, stop taking CIALIS and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately.

CIALIS is not intended for use by women.

Children and adolescents
CIALIS is not intended for use by children and adolescents under the age of 18.

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take CIALIS if you are already taking nitrates.

Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin , clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

CIALIS with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

CIALIS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

CIALIS contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be given as a 2.5mg tablet.
Do not take CIALIS more than once a day.

When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.

It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection.

For the treatment benign prostatic hyperplasia
The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.
Do not take CIALIS more than once a day.

If you take more CIALIS than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take CIALIS
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take CIALIS more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking CIALIS (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking CIALIS. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CIALIS contains
- The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
- The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

What CIALIS looks like and contents of the pack
CIALIS 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side.

CIALIS 5 mg is available in blister packs containing 14, 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

CIALIS is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction.

It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Do not take CIALIS if you:

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

• have serious heart disease or recently had a heart attack within the last 90 days.

• recently had a stroke within the last 6 months.

• have low blood pressure or uncontrolled high blood pressure.

• ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if CIALIS is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking CIALIS, stop taking CIALIS and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately.

CIALIS is not intended for use by women.

Children and adolescents
CIALIS is not intended for use by children and adolescents under the age of 18.

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take CIALIS if you are already taking nitrates.

Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin , clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

CIALIS with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

CIALIS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

CIALIS contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20 mg. CIALIS tablets are for oral use.

You may take a CIALIS tablet at least 30 minutes before sexual activity.
CIALIS may still be effective up to 36 hours after taking the tablet.

Do not take CIALIS more than once a day. CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more CIALIS than you should
Contact your doctor. You may experience side effects described in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking CIALIS (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking CIALIS. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CIALIS contains
- The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
- The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
What CIALIS looks like and contents of the pack
CIALIS 10 mg is a light yellow film-coated tablet in the shape of an almond and has "C 10" marked on one side.

CIALIS 10 mg is available in blister packs containing 4 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

CIALIS is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. CIALIS has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction.

It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Do not take CIALIS if you:

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

• have serious heart disease or recently had a heart attack within the last 90 days.

• recently had a stroke within the last 6 months.

• have low blood pressure or uncontrolled high blood pressure.

• ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if CIALIS is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non- nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking CIALIS, stop taking CIALIS and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking CIALIS and contact your doctor immediately.

CIALIS is not intended for use by women.

Children and adolescents
CIALIS is not intended for use by children and adolescents under the age of 18.

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take CIALIS if you are already taking nitrates.

Some medicines may be affected by CIALIS or they may affect how well CIALIS will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin , clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

CIALIS with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well CIALIS will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking CIALIS in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

CIALIS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

CIALIS contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

CIALIS tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak.

You may take a CIALIS tablet at least 30 minutes before sexual activity.
CIALIS may still be effective up to 36 hours after taking the tablet.

Do not take CIALIS more than once a day. CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that CIALIS does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more CIALIS than you should
Contact your doctor. You may experience side effects described in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking CIALIS (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (seen in 1 to 10 in every 1,000 patients)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (seen in 1 to 10 in every 10,000 patients)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking CIALIS. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS. Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CIALIS contains
- The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
- The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
What CIALIS looks like and contents of the pack
CIALIS 20 mg is a yellow film-coated tablet in the shape of an almond and has "C 20" marked on one side.

CIALIS 20 mg is available in blister packs containing 2, 4, 8, 10 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

Tadalafil Lilly is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Lilly has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

Tadalafil Lilly contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Lilly works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Lilly will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Do not take Tadalafil Lilly if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Lilly has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- have serious heart disease or recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.
- have low blood pressure or uncontrolled high blood pressure.
- ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
- are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if Tadalafil Lilly is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Lilly and contact your doctor immediately.

Tadalafil Lilly is not intended for use by women.

Children and adolescents
Tadalafil Lilly is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil Lilly
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take Tadalafil Lilly if you are already taking nitrates.

Some medicines may be affected by Tadalafil Lilly or they may affect how well Tadalafil Lilly will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms due to a condition where prostate gland enlarges in men).
• other medicines to treat high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotic to treat bacterial infection)
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin (antibiotic to treat mycobacterial infection).
• other treatments for erectile dysfunction.

Tadalafil Lilly with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Lilly will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking Tadalafil Lilly in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Lilly contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Lilly contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Tadalafil Lilly tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Lilly. This will be given as a 2.5 mg tablet.
Do not take Tadalafil Lilly more than once a day.

Once a day dosing of Tadalafil Lilly may be useful to men who anticipate having sexual activity two or more times per week.

When taken once a day Tadalafil Lilly allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more Tadalafil Lilly than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take Tadalafil Lilly
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Tadalafil Lilly more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop taking the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking Tadalafil Lilly (frequency rare).
If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Other side effects have been reported:

Common (may affect up to 1 in 10 people)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (may affect up to 1 in 100 people)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (may affect up to 1 in 1 000 people)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking Tadalafil Lilly. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Tadalafil Lilly that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tadalafil Lilly contains
- The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
- The other ingredients are:
Tablet core: Lactose monohydrate, Croscarmellose sodium, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium laurilsulfate, Magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.
Film-coat: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Iron oxide yellow (E172), Iron oxide red (E172), Talc.

What Tadalafil Lilly looks like and contents of the pack
Tadalafil Lilly 2.5 mg is a light orange-yellow film-coated tablet in the shape of an almond and has "C 2 ½" marked on one side. The tablet is 8.58 mm by 5.23 mm.

Tadalafil Lilly 2.5 mg is available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Norge
Eli Lilly Norge A.S.

Tel: +372 6 817 280
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība
Latvijāpārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

Tadalafil Lilly contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil Lilly 5 mg is used to treat adult men with:
- erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Lilly has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation Tadalafil Lilly works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Lilly will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Lilly for the treatment of erectile dysfunction does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

- urinary symptoms associated with a common condition called benign prostatic hyperplasia.
This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. Tadalafil Lilly improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Tadalafil Lilly has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.

Do not take Tadalafil Lilly if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Lilly has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- have serious heart disease or recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.

• have low blood pressure or uncontrolled high blood pressure.
• ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with Tadalafil Lilly for benign prostatic hyperplasia. Tadalafil Lilly does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if Tadalafil Lilly is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Lilly and contact your doctor immediately.

Tadalafil Lilly is not intended for use by women.

Children and adolescents
Tadalafil Lilly is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil Lilly
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take Tadalafil Lilly if you are already taking nitrates.

Some medicines may be affected by Tadalafil Lilly or they may affect how well Tadalafil Lilly will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms due to a condition where prostate gland enlarges in men).
• other medicines to treat high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

• medicines such as ketoconazole or itraconazole (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotic to treat bacterial infection).
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin (antibiotic to treat mycobacterial infection).
• other treatments for erectile dysfunction.

Tadalafil Lilly with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Lilly will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking Tadalafil Lilly in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Lilly contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Lilly contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Tadalafil Lilly tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Lilly. This will be given as a 2.5 mg tablet.
Do not take Tadalafil Lilly more than once a day.

When taken once a day Tadalafil Lilly allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of Tadalafil Lilly may be useful to men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection.

For the treatment benign prostatic hyperplasia
The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.
Do not take Tadalafil Lilly more than once a day.

If you take more Tadalafil Lilly than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take Tadalafil Lilly
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Tadalafil Lilly more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop taking the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking Tadalafil Lilly (frequency rare).
If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Other side effects have been reported:

Common (may affect up to 1 in 10 people)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (may affect up to 1 in 100 people)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (may affect up to 1 in 1 000 people)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking Tadalafil Lilly. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Tadalafil Lilly that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tadalafil Lilly contains
- The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
- The other ingredients are:
Tablet core: Lactose monohydrate, Croscarmellose sodium, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium laurilsulfate, Magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.
Film-coat: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Iron oxide yellow (E172), Talc.

What Tadalafil Lilly looks like and contents of the pack
Tadalafil Lilly 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side. The tablet is 9.59 mm by 5.85 mm.

Tadalafil Lilly 5 mg is available in blister packs containing 14, 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība LatvijāTel:
+371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

Tadalafil Lilly is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Lilly has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

Tadalafil Lilly contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Lilly works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Lilly will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Do not take Tadalafil Lilly if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Lilly has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- have serious heart disease or recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.
- have low blood pressure or uncontrolled high blood pressure.
- ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
- are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if Tadalafil Lilly is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Lilly and contact your doctor immediately.

Tadalafil Lilly is not intended for use by women.

Children and adolescents
Tadalafil Lilly is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil Lilly
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take Tadalafil Lilly if you are already taking nitrates.

Some medicines may be affected by Tadalafil Lilly or they may affect how well Tadalafil Lilly will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms due to a condition where prostate gland enlarges in men).
• other medicines to treat high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole(to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotic to treat bacterial infection)
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin (antibiotic to treat mycobacterial infection).
• other treatments for erectile dysfunction.

Tadalafil Lilly with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Lilly will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking Tadalafil Lilly in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Lilly contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Lilly contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Tadalafil Lilly tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20 mg. Tadalafil Lilly tablets are for oral use.

You may take a Tadalafil Lilly tablet at least 30 minutes before sexual activity.
Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Lilly more than once a day. Tadalafil Lilly 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more Tadalafil Lilly than you should
Contact your doctor. You may experience side effects described in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop taking the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).

- priapism, a prolonged and possibly painful erection after taking Tadalafil Lilly (frequency rare).
If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).
Other side effects have been reported:

Common (may affect up to 1 in 10 people)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (may affect up to 1 in 100 people)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (may affect up to 1 in 1 000 people)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking Tadalafil Lilly. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Tadalafil Lilly that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tadalafil Lilly contains
- The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
- The other ingredients are:
Tablet core: Lactose monohydrate, Croscarmellose sodium, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium laurilsulfate, Magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.
Film-coat: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Iron oxide yellow (E172), Talc.
What Tadalafil Lilly looks like and contents of the pack
Tadalafil Lilly 10 mg is a light yellow film-coated tablet in the shape of an almond and has "C 10" marked on one side. The tablet is 10.81 mm by 6.59 mm.

Tadalafil Lilly 10 mg is available in blister packs containing 4 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780
España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
România

Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība LatvijāTel:
+371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu

Tadalafil Lilly is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Lilly has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.

Tadalafil Lilly contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Lilly works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil Lilly will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Do not take Tadalafil Lilly if you:
- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
- are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil Lilly has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
- have serious heart disease or recently had a heart attack within the last 90 days.
- recently had a stroke within the last 6 months.
- have low blood pressure or uncontrolled high blood pressure.
- ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
- are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.

Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Before taking the tablets, tell your doctor if you have:
- sickle cell anaemia (an abnormality of red blood cells).
- multiple myeloma (cancer of the bone marrow).
- leukaemia (cancer of the blood cells).
- any deformation of your penis.
- a serious liver problem.
- a severe kidney problem.

It is not known if Tadalafil Lilly is effective in patients who have had:
- pelvic surgery.
- removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision or your vision is distorted, dimmed while you are taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Lilly and contact your doctor immediately.

Tadalafil Lilly is not intended for use by women.

Children and adolescents
Tadalafil Lilly is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil Lilly
Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take Tadalafil Lilly if you are already taking nitrates.

Some medicines may be affected by Tadalafil Lilly or they may affect how well Tadalafil Lilly will work. Tell your doctor or pharmacist if you are already taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms due to a condition where prostate gland enlarges in men).
• other medicines to treat high blood pressure.
• riociguat.
• a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotic to treat bacterial infection)
• phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
• rifampicin (antibiotic to treat mycobacterial infection).
• other treatments for erectile dysfunction.

Tadalafil Lilly with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil Lilly will work and should be taken with caution. Talk to your doctor for further information.

Fertility
When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines
Some men taking Tadalafil Lilly in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Lilly contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Lilly contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Tadalafil Lilly tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.

You may take a Tadalafil Lilly tablet at least 30 minutes before sexual activity.
Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Lilly more than once a day. Tadalafil Lilly 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.

If you take more Tadalafil Lilly than you should
Contact your doctor. You may experience side effects described in section 4.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop taking the medicine and seek medical help immediately:
- allergic reactions including rashes (frequency uncommon).
- chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
- priapism, a prolonged and possibly painful erection after taking Tadalafil Lilly (frequency rare).
If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
- sudden loss of vision (frequency rare), distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

Other side effects have been reported:

Common (may affect up to 1 in 10 people)
- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.

Uncommon (may affect up to 1 in 100 people)
- dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare (may affect up to 1 in 1 000 people)
- fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking Tadalafil Lilly. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Tadalafil Lilly that were not seen in clinical trials. These include:
- migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
- distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.
The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Tadalafil Lilly contains
- The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
- The other ingredients are:
Tablet core: Lactose monohydrate, Croscarmellose sodium, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium laurilsulfate, Magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.
Film-coat: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Iron oxide yellow (E172), Talc.
What Tadalafil Lilly looks like and contents of the pack
Tadalafil Lilly 20 mg is a yellow film-coated tablet in the shape of an almond and has "C 20" marked on one side. The tablet is 12.09 mm by 7.37 mm.

Tadalafil Lilly 20 mg is available in blister packs containing 2, 4, 8 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600
България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100
Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00
Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500
Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222
Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800
Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280
Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00
Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600
Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00
Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Lilly France
Tél: +33-(0) 1 55 49 34 34
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600
Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000
Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10
Ísland
Icepharma hf.
Sími: + 354 540 8000
Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111
Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571
Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000
Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu