sildenafil: package leaflet

Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Revatio is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

Do not take Revatio

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

- if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”).
Revatio can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.

• if you 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 Revatio have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).

• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).

• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Revatio if you:

have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
- have a severe heart problem.
- have a problem with the pumping chambers of your heart
- have high blood pressure in the blood vessels in the lungs.
- have low blood pressure at rest.
- lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea.
- have a rare inherited eye disease (retinitis pigmentosa).
- have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
- currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
- take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Children
Revatio should not be given to children below 1 year of age.

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

Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Before you take Revatio)

Tell your doctor or pharmacist if you are already taking riociguat.

Therapies for pulmonary hypertension (e.g. bosentan, iloprost)

Medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)

Blood thinning medicines (for example warfarin) although these did not result in any side effect.

Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.

Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).

Medicines containing sacubitril/valsartan, used to treat heart failure.

Revatio with food and drink
You should not drink grapefruit juice while you are being treated with Revatio.

Pregnancy and breast-feeding
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Revatio should not be used during pregnancy unless strictly necessary.
Revatio should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.

Driving and using machines
Revatio can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines.

Revatio 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.

Revatio contains sodium
Revatio 20 mg tablets contain 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.

For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.

Use in children and adolescents
For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. Higher doses should not be used in children. This medicine should be used only in case of administration of 20 mg three times a day. Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.

If you take more Revatio than you should
You should not take more medicine than your doctor tells you to.
If you take more medicine than you have been told to take contact your doctor immediately. Taking more Revatio than you should may increase the risk of known side effects.

If you forget to take Revatio
If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Revatio
Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Do not stop taking Revatio unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

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

Like all medicines, Revatio can cause side effects, although not everybody gets them.

If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2):
- if you experience sudden decrease or loss of vision (frequency not known)
- if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults
Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.

Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.

Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in 10 people);
pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.

The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed.

Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.

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 after EXP. The expiry date refers to the last day of that month.

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

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 to protect the environment.

What Revatio contains
- The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as the citrate).
- The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium (see section 2 “Revatio contains sodium”), magnesium stearate.
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “Revatio contains lactose”), glycerol triacetate

What Revatio looks like and contents of the pack
Revatio film-coated tablets are white and round in shape. The tablets are marked with “VLE” on one side and “RVT 20” on the other. The tablets are provided in blister packs containing 90 tablets, 90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

or

Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Lietuva
Viatris
Viatris UAB
Tél/Tel: +32 (0)2 658 61 00
Tel: +370 52051288
България
Luxembourg/Luxemburg

Виатрис ЕООД
Viatris
Тел.: +359 2 44 55 400
Tél/Tel: +32 (0)2 658 61 00

(Belgique/Belgien)

Česká republika

Magyarország
Viatris CZ s.r.o.
Viatris Healthcare Kft.
Tel: +420 222 004 400
Tel.: + 36 1 465 2100

Danmark
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Viatris ApS
Tlf: +45 28 11 69 32

Deutschland
Nederland
Viatris Healthcare GmbH
Viatris Healthcare BV
Tel: +49 (0)800 0700 800
Tel: +31 (0)20 426 3300

Eesti
Norge
Viatris OÜ
Viatris AS
Tel: +372 6363 052
Tlf: +47 66 75 33 00
Ελλάδα
Österreich
Viatris Hellas Ltd
Viatris Austria GmbH
Τηλ: +30 2100 100 002
Tel: +43 1 86390
España
Polska
Viatris Pharmaceuticals, S.L.
Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712
Tel.: +48 22 546 64 00

France
Portugal
Viatris Santé
Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00
Tel: +351 21 412 72 00

Hrvatska
România
Viatris Hrvatska d.o.o.
BGP Products SRL
Tel: +385 1 23 50 599
Tel: +40 372 579 000

Ireland
Slovenija
Viatris Limited
Viatris d.o.o.
Tel: +353 1 8711600
Tel: + 386 1 236 31 80
Ísland
Slovenská republika
Icepharma hf.
Viatris Slovakia s.r.o.
Sími: +354 540 8000
Tel: +421 2 32 199 100

Italia
Suomi/Finland
Viatris Pharma S.r.l.
Viatris Oy
Tel: +39 02 612 46921
Puh/Tel: +358 20 720 9555
Κύπρος
Sverige
CPO Pharmaceuticals Limited
Viatris AB
Τηλ: +357 22863100
Tel: + 46 (0)8 630 19 00

Latvija

Viatris SIA

Tel: +371 676 055 80

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu. There are also links to other website about rare diseases and treatments.

Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Revatio is used to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.

You should not be given Revatio

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

- if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”).
Revatio can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.

• if you 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 Revatio have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (< 90/50 mmHg).

• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).

• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and Precautions
Talk to your doctor before using Revatio if you:
- have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
- have a severe heart problem.
- have a problem with the pumping chambers of your heart
- have high blood pressure in the blood vessels in the lungs.
- have low blood pressure at rest.
- lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea.
- have a rare inherited eye disease (retinitis pigmentosa).
- have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
- currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
- take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.
If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Children and adolescents
Revatio should not be given to children and adolescents under the age of 18.

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

Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Before you take Revatio).

Tell your doctor or pharmacist if you are already taking riociguat.

Therapies for pulmonary hypertension (e.g. bosentan, iloprost).

Medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).

Blood thinning medicines (for example warfarin) although these did not result in any side effects.

Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.

Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms of low blood pressure (e.g. dizziness, lightheadedness).

Medicines containing sacubitril/valsartan, used to treat heart failure.

Revatio with food and drink
You should not drink grapefruit juice while you are being treated with Revatio.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Revatio should not be used during pregnancy unless strictly necessary.
Revatio should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.

Driving and using machines
Revatio can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines.

Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse.
Your doctor will determine the duration of your treatment and how much Revatio intravenous injection you will receive each day and will monitor your response and condition. The usual dose is 10 mg (corresponding to 12.5 ml) three times a day.

A Revatio intravenous injection will be given to you instead of your Revatio tablets.

If you receive more Revatio than you should
If you are concerned that you may have been given too much Revatio, tell your doctor or nurse immediately. Taking more Revatio than you should may increase the risk of known side effects.

If you miss a dose of Revatio
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.
A double dose should not be given to make up for a forgotten dose.

If you stop use of Revatio
Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Your doctor may reduce the dose over a few days before stopping completely.

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

Like all medicines, Revatio can cause side effects, although not everybody gets them.

If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2):
- if you experience sudden decrease or loss of vision (frequency not known)
- if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults
Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets. In clinical trials the side effects reported commonly (may affect up to 1 in 10 people) were facial flushing, headache, low blood pressure and nausea.

In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea.

In clinical trials with Revatio tablets side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.

Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammationof the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.

Side effects reported uncommonly (may affect upto 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).

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 vial label and carton after EXP.
The expiry date refers to the last day of that month.

Revatio does not require any special storage conditions.

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

What Revatio contains
- The active substance is sildenafil. Each ml of solution contains 0.8 mg of sildenafil (as citrate).
Each 20 ml vial contains 10 mg sildenafil (as citrate).
- The other ingredients are glucose and water for injections.

What Revatio looks like and contents of the pack
Each pack of Revatio solution for injection contains one 20 ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminium seal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Lietuva
Viatris
Viatris UAB
Tél/Tel: +32 (0)2 658 61 00
Tel: +370 52051288
България
Luxembourg/Luxemburg
Виатрис ЕООД
Viatris
Тел.: +359 2 44 55 400
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika
Magyarország
Viatris CZ s.r.o.
Viatris Healthcare Kft.
Tel: +420 222 004 400
Tel.: + 36 1 465 2100

Danmark
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Viatris ApS
Tlf: +45 28 11 69 32

Deutschland
Nederland
Viatris Healthcare GmbH
Viatris Healthcare BV
Tel: +49 (0)800 0700 800
Tel: +31 (0)20 426 3300

Eesti
Norge
Viatris OÜ
Viatris AS
Tel: +372 6363 052
Tlf: +47 66 75 33 00
Ελλάδα
Österreich
Viatris Hellas Ltd
Viatris Austria GmbH
Τηλ: +30 2100 100 002
Tel: +43 1 86390
España
Polska
Viatris Pharmaceuticals, S.L.
Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712
Tel.: +48 22 546 64 00

France
Portugal
Viatris Santé
Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00
Tel: +351 21 412 72 00

Hrvatska
România
Viatris Hrvatska d.o.o.
BGP Products SRL
Tel: +385 1 23 50 599
Tel: +40 372 579 000

Ireland
Slovenija
Viatris Limited
Viatris d.o.o.
Tel: +353 1 8711600
Tel: + 386 1 236 31 80
Ísland
Slovenská republika
Icepharma hf.
Viatris Slovakia s.r.o.
Sími: +354 540 8000
Tel: +421 2 32 199 100

Italia
Suomi/Finland
Viatris Pharma S.r.l.
Viatris Oy
Tel: +39 02 612 46921
Puh/Tel: +358 20 720 9555
Κύπρος
Sverige
CPO Pharmaceuticals Limited
Viatris AB
Τηλ: +357 22863100
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA

Tel: +371 676 055 80

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu. There are also links to other website about rare diseases and treatments.

10 seconds before use. Remove the cap (figure 6).
figure 6

adaptor (figure 7).
figure 7

the plunger of the oral dosing syringe to the graduation mark that marks the dose for you (withdrawing 1 ml provides a 10 mg dose, withdrawing 2 ml provides a 20 mg dose). To

measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).

figure 8

medicine back into the bottle. Repeat step 3 again.

syringe from the bottle.

towards the inside of the cheek. SLOWLY push down the plunger of the oral dosing syringe.
Do not squirt the medicine out quickly. If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine (figure 9).

figure 9

7. Replace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral dosing syringe as instructed below.

Cleaning and storing the syringe:
1. The syringe should be washed after each dose. Pull the plunger out of the syringe and wash both parts in water.
2. Dry the two parts. Push the plunger back in to the syringe. Keep it in a clean safe place with the medicine.

If you take more Revatio than you should
You should not take more medicine than your doctor tells you to.
If you take more medicine than you have been told to take contact your doctor immediately. Taking more Revatio than you should may increase the risk of known side effects.

If you forget to take Revatio
If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Revatio
Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Do not stop taking Revatio unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

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

4.
Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2):
- if you experience sudden decrease or loss of vision (frequency not known)
- if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults
Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.

Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.

Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in 10 people);
pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.

The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed.

Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.

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.

5.
How to store Revatio

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 bottle after ‘EXP’. The expiry date refers to the last day of that month.

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

Reconstituted oral suspension
Store below 30°C or in refrigerator at 2ºC to 8°C. Do not freeze. Any remaining oral suspension should be discarded 30 days after reconstitution.

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.

6.
Contents of the pack and other information

What Revatio contains
- The active substance is sildenafil (as sildenafil citrate).
After reconstitution, each ml of the oral suspension contains 10 mg of sildenafil (as citrate) One bottle of reconstituted oral suspension (112 ml) contains 1.12 g of sildenafil (as citrate)

- The other ingredients are: Powder for oral suspension: sorbitol (E420) (see section 2 “Revatio contains sorbitol”), citric acid anhydrous, sucralose, sodium citrate (E331) (see section 2 “Revatio contains sodium”), xanthan gum, titanium dioxide (E171), sodium benzoate (E211) (see section 2 “Revatio contains sodium benzoate” and “Revatio contains sodium”), silica, colloidal anhydrous;
Grape flavour: maltodextrin, grape juice concentrate, gum acacia, pineapple juice concentrate, citric acid anhydrous, natural flavouring

What Revatio looks like and contents of the pack
Revatio is supplied as a white to off-white powder for oral suspension providing a white, grape flavoured oral suspension when reconstituted with water.
One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.

Once reconstituted the bottle contains 112 ml of oral suspension, of which 90 ml is intended for dosing and administration.

Pack size: 1 bottle

Each pack also contains a polypropylene measuring cup (graduated to indicate 30 ml), polypropylene oral dosing syringe (3 ml) with HDPE plunger and a LDPE press-in bottle adaptor.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

or

Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00
Lietuva
Viatris UAB
Tel: +370 52051288
България
Luxembourg/Luxemburg
Виатрис ЕООД
Viatris
Тел.: +359 2 44 55 400
Tél/Tel: +32 (0)2 658 61 00

(Belgique/Belgien)
Česká republika
Magyarország
Viatris CZ s.r.o.
Viatris Healthcare Kft.
Tel: +420 222 004 400
Tel.: + 36 1 465 2100

Danmark
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Viatris ApS
Tlf: +45 28 11 69 32

Deutschland
Nederland
Viatris Healthcare GmbH
Viatris Healthcare BV
Tel: +49 (0)800 0700 800
Tel: +31 (0)20 426 3300

Eesti
Norge
Viatris OÜ
Viatris AS
Tel: +372 6363 052
Tlf: +47 66 75 33 00
Ελλάδα
Österreich
Viatris Hellas Ltd
Viatris Austria GmbH
Τηλ: +30 2100 100 002
Tel: +43 1 86390
España
Polska
Viatris Pharmaceuticals, S.L.
Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712
Tel.: +48 22 546 64 00

France
Portugal
Viatris Santé
Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00
Tel: +351 21 412 72 00

Hrvatska
România
Viatris Hrvatska d.o.o.
BGP Products SRL
Tel: +385 1 23 50 599
Tel: +40 372 579 000

Ireland
Slovenija
Viatris Limited
Viatris d.o.o.
Tel: +353 1 8711600
Tel: + 386 1 236 31 80
Ísland
Slovenská republika
Icepharma hf.
Viatris Slovakia s.r.o.
Sími: +354 540 8000
Tel: +421 2 32 199 100

Italia
Suomi/Finland
Viatris Pharma S.r.l.
Viatris Oy
Tel: +39 02 612 46921
Puh/Tel: +358 20 720 9555
Κύπρος
Sverige
CPO Pharmaceuticals Limited
Viatris AB
Τηλ: +357 22863100
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA

Tel: +371 676 055 80

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu. There are also links to other website about rare diseases and treatments.

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Do not take VIAGRA
−
If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

−
If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

−
If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

−
If you 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 Viagra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

−
If you have a severe heart or liver problem.

−
If you have recently had a stroke or a heart attack, or if you have low blood pressure.

−
If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

−
If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
−
If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

−
If you have a deformity of your penis or Peyronie’s Disease.

−
If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

−
If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

−
If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents
VIAGRA should not be given to individuals under the age of 18.

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

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose (25 mg) of VIAGRA.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with food and drink and alcohol
VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use by women.

Driving and using machines
VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to VIAGRA before you drive or use machinery.

VIAGRA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with other sildenafil containing products including VIAGRA orodispersible tablets or VIAGRA orodispersible films.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

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

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of VIAGRA are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek medical help immediately:

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• Chest pains - this occurs uncommonly

If this occurs during or after intercourse

• Get in a semi-sitting position and try to relax.

• Do not use nitrates to treat your chest pain.

• Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1 000 people) If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

• A sudden decrease or loss of vision - this occurs rarely

• Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• Seizures or fits - this occurs rarely

Other side effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1 000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to VIAGRA.

Reporting of side effects
If you get any side effects, talk to you doctor or pharmacist or nurse. 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 store above 30 oC.

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 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 VIAGRA contains
−
The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as the citrate salt).
−
The other ingredients are:
−
Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium (see section 2 “VIAGRA contains sodium”),

magnesium stearate
−
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2

“VIAGRA contains lactose”), triacetin, indigo carmine aluminium

lake (E132)

What VIAGRA looks like and contents of the pack
VIAGRA film-coated tablets (tablets) are blue, with a rounded-diamond shape. They are marked “VIAGRA” on one side and “VGR 25” on the other side. The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

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

België /Belgique / Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

България
Виатрис ЕООД
Тел.: +359 2 44 55 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100
Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Nederland
Viatris Healthcare BV
Tel: +31 (0) 20 426 3300
Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800
Norge
Viatris AS
Tlf: +47 66 75 33 00
Eesti
Viatris OÜ
Tel: +372 6363 052

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

Ελλάδα
Viatris Hellas Ltd
Τηλ.: +30 2100 100 002

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712
Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

România
BGP Products SRL
Tel: +40 372 579 000

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ireland
Viatris Limited
Tel: + 353 1 8711600
Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921
Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

Latvija
Viatris SIA
Tel: +371 676 055 80

Lietuva
Viatris UAB
Tel. +370 52051288

This leaflet was last revised in.

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

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help you to get an erection if you are sexually stimulated.
VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Do not take VIAGRA
− If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

−
If you 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 Viagra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

− If you have a severe heart or liver problem.

− If you have recently had a stroke or a heart attack, or if you have low blood pressure.

− If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

− If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
− If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

− If you have a deformity of your penis or Peyronie’s Disease.

−
If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents
VIAGRA should not be given to individuals under the age of 18.

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

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking VIAGRA. In order to reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose (25 mg) of VIAGRA.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with food and drink and alcohol
VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use by women.

Driving and using machines
VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to VIAGRA before you drive or use machinery.

VIAGRA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with other sildenafil containing products including VIAGRA orodispersible tablets or VIAGRA orodispersible films.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

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

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of VIAGRA are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek medical help immediately:

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

- Chest pains - this occurs uncommonly
If this occurs during or after intercourse

• Get in a semi-sitting position and try to relax.

• Do not use nitrates to treat your chest pain.

• Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1 000 people) If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

• A sudden decrease or loss of vision - this occurs rarely

• Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• Seizures or fits - this occurs rarely

Other side effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation

of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1 000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen,dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to VIAGRA.

Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. 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 store above 30 oC.

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 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 VIAGRA contains
−
The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as the citrate salt).
−
The other ingredients are:
−
Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium (see section 2 “VIAGRA contains sodium”),

magnesium stearate
−
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2

“VIAGRA contains lactose”), triacetin, indigo carmine aluminium

lake (E132)

What VIAGRA looks like and contents of the pack
VIAGRA film-coated tablets (tablets) are blue, with a rounded-diamond shape. They are marked “VIAGRA” on one side and “VGR 50” on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 24 tablets in a carton or card packaging. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

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

België /Belgique / Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

България
Виатрис ЕООД
Тел.: +359 2 44 55 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100
Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Nederland
Viatris Healthcare BV
Tel: +31 (0) 20 426 3300
Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800
Norge
Viatris AS
Tlf: +47 66 75 33 00
Eesti
Viatris OÜ
Tel: +372 6363 052

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

Ελλάδα
Viatris Hellas Ltd
Τηλ.: +30 2100 100 002

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712
Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

România
BGP Products SRL
Tel: +40 372 579 000

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ireland
Viatris Limited
Tel: + 353 1 8711600
Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921
Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

Latvija
Viatris SIA
Tel: +371 676 055 80

Lietuva
Viatris UAB
Tel. +370 52051288

This leaflet was last revised in.

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

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Do not take VIAGRA
− If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

− If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

− If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

−
If you 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 Viagra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

− If you have a severe heart or liver problem.

− If you have recently had a stroke or a heart attack, or if you have low blood pressure.

− If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

− If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
− If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

− If you have a deformity of your penis or Peyronie’s Disease.

− If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

− If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

− If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents
VIAGRA should not be given to individuals under the age of 18.

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

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose (25 mg) of VIAGRA.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with food and drink and alcohol
VIAGRA can be taken with or without food. However, you may find that VIAGRA takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use by women.

Driving and using machines
VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to VIAGRA before you drive or use machinery.

VIAGRA contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking VIAGRA.

VIAGRA 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA film-coated tablets in combination with other sildenafil containing products including VIAGRA orodispersible tablets or VIAGRA orodispersible films.

You should take VIAGRA about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that VIAGRA takes longer to work if you take it with a heavy meal.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

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

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of VIAGRA are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek medical help immediately:

• An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

- Chest pains - this occurs uncommonly
If this occurs during or after intercourse

• Get in a semi-sitting position and try to relax.

• Do not use nitrates to treat your chest pain.

• Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1 000 people)

If you have an erection which lasts for more than 4 hours, you should contact a doctor

immediately.

• A sudden decrease or loss of vision - this occurs rarely

• Serious skin reactions - this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth,

genitals and around the eyes, fever.

• Seizures or fits - this occurs rarely

Other side effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation

of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1 000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to VIAGRA.

Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. 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 store above 30 oC.

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 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 VIAGRA contains
−
The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as the citrate salt).
−
The other ingredients are:
−
Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous),

croscarmellose sodium (see section 2 “VIAGRA contains sodium”),

magnesium stearate
−
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2

“VIAGRA contains lactose”), triacetin, indigo carmine aluminium

lake (E132)

What VIAGRA looks like and contents of the pack
VIAGRA film-coated tablets (tablets) are blue, with a rounded-diamond shape. They are marked “VIAGRA” on one side and “VGR 100” on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 24 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

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

België /Belgique / Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

България
Виатрис ЕООД
Тел.: +359 2 44 55 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100
Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Nederland
Viatris Healthcare BV
Tel: +31 (0) 20 426 3300
Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800
Norge
Viatris AS
Tlf: +47 66 75 33 00
Eesti
Viatris OÜ
Tel: +372 6363 052

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

Ελλάδα
Viatris Hellas Ltd
Τηλ.: +30 2100 100 002

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712
Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

România
BGP Products SRL
Tel: +40 372 579 000

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ireland
Viatris Limited
Tel: + 353 1 8711600
Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921
Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

Latvija
Viatris SIA
Tel: +371 676 055 80

Lietuva
Viatris UAB
Tel. +370 52051288

This leaflet was last revised in.

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

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help you to get an erection if you are sexually stimulated.
VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Do not take VIAGRA
−
If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

−
If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

−
If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

−
If you 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 Viagra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

−
If you have a severe heart or liver problem.

−
If you have recently had a stroke or a heart attack, or if you have low blood pressure.

−
If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

−
If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
−
If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

−
If you have a deformity of your penis or Peyronie’s Disease.

−
If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

−
If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

−
If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents
VIAGRA should not be given to individuals under the age of 18.

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

VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg film-coated tablets) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose (25 mg film-coated tablets) of VIAGRA.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with alcohol
Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use by women.

Driving and using machines
VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to VIAGRA before you drive or use machinery.

VIAGRA 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA orodispersible tablets in combination with other sildenafil containing products including VIAGRA film-coated tablets or VIAGRA orodispersible films.

You should take VIAGRA about one hour before you plan to have sex. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour.

Place the orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva or water.

The orodispersible tablets should be taken on an empty stomach as you may find that it takes longer to start working if you take it with a heavy meal.

If you require a second 50 mg orodispersible tablet to make a 100 mg dose, you should wait until the first one has completely disintegrated and you have swallowed it before taking the second orodispersible tablet.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should:
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

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

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of VIAGRA are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek medical help immediately:

• An allergic reaction – (this occurs uncommonly may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

- Chest pains - this occurs uncommonly
If this occurs during or after intercourse:

• Get in a semi-sitting position and try to relax.

• Do not use nitrates to treat your chest pain.

• Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1 000 people) If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

• A sudden decrease or loss of vision - this occurs rarely

• Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• Seizures or fits - this occurs rarely

Other side effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1 000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to VIAGRA.

Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. 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.
This medicine does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.

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 VIAGRA contains
−
The active substance is sildenafil. Each orodispersible tablet contains 50 mg of sildenafil (as the citrate salt).
−
The other ingredients are:
− microcrystalline cellulose, silica hydrophobic colloidal, croscarmellose sodium (see section 2 “VIAGRA contains sodium”), magnesium stearate, indigo carmine aluminium lake (E132), sucralose, mannitol, crospovidone, polyvinyl acetate, povidone, − flavouring containing: maltodextrin and dextrin, − natural flavouring containing: maltodextrin, glycerol (E422) and propylene glycol (E1520), − lemon flavouring containing: maltodextrin and alpha-tocopherol (E307)).

What VIAGRA looks like and contents of the pack
VIAGRA orodispersible tablets are blue, diamond shape, marked “V50” on one side. The orodispersible tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

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

België /Belgique / Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

България
Виатрис ЕООД
Тел.: +359 2 44 55 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100
Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400
Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Nederland
Viatris Healthcare BV
Tel: +31 (0) 20 426 3300
Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800
Norge
Viatris AS
Tlf: +47 66 75 33 00
Eesti
Viatris OÜ
Tel: +372 6363 052

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

Ελλάδα
Viatris Hellas Ltd
Τηλ.: +30 2100 100 002

Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712
Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

România
BGP Products SRL
Tel: +40 372 579 000

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ireland
Viatris Limited
Tel: + 353 1 8711600
Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921
Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

Latvija
Viatris SIA
Tel: +371 676 055 80

Lietuva
Viatris UAB
Tel. +370 52051288

This leaflet was last revised in.

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

VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. VIAGRA will only help you to get an erection if you are sexually stimulated.

VIAGRA is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Do not take VIAGRA
−
If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

−
If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

−
If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your 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 VIAGRA have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

−
If you have a severe heart or liver problem.

−
If you have recently had a stroke or a heart attack, or if you have low blood pressure.

−
If you have certain rare inherited eye diseases (such as retinitis pigmentosa).

−
If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking VIAGRA
−
If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).

−
If you have a deformity of your penis or Peyronie’s disease.

−
If you have problems with your heart. Your doctor should carefully check whether your heart can take the additional strain of having sex.

−
If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

−
If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.

You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
You should not use VIAGRA with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take VIAGRA if you do not have erectile dysfunction.

You should not take VIAGRA if you are a woman.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Children and adolescents
VIAGRA should not be given to individuals under the age of 18.

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

VIAGRA may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse that you have taken VIAGRA and when you did. Do not take VIAGRA with other medicines unless your doctor tells you that you can.

You should not take VIAGRA if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).

You should not take VIAGRA if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg film-coated tablets) of VIAGRA.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers. This is most likely to happen within 4 hours after taking VIAGRA. To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start VIAGRA. Your doctor may start you on a lower dose (25 mg film-coated tablets) of VIAGRA.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

VIAGRA with alcohol
Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.

Pregnancy, breast-feeding and fertility
VIAGRA is not indicated for use by women.

Driving and using machines
VIAGRA can cause dizziness and can affect vision. You should be aware of how you react to VIAGRA before you drive or use machinery.

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

The recommended starting dose is 50 mg.

You should not take VIAGRA more than once a day.

Do not take VIAGRA orodispersible films in combination with other sildenafil containing products including VIAGRA film-coated tablets or VIAGRA orodispersible tablets.

You should take VIAGRA about one hour before you plan to have sex. The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour.

Carefully peel open the aluminium pouch with dry hands. Do not cut it open. Take out the orodispersible film with a dry finger and immediately place the orodispersible film on the tongue, where it will disintegrate in seconds with or without water. During disintegration saliva may be swallowed, but without swallowing the film.

The orodispersible film should be taken on an empty stomach as you may find that it takes longer to start working if you take it with a heavy meal.

If you require a second 50 mg orodispersible film to make a 100 mg dose, you should wait until the first one has completely disintegrated and you have swallowed it before taking the second orodispersible film.

If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.

VIAGRA will only help you to get an erection if you are sexually stimulated.

If VIAGRA does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more VIAGRA than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.

You should not take more films than your doctor tells you to.

Contact your doctor if you take more films than you should.

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

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects reported in association with the use of VIAGRA are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking VIAGRA and seek medical help immediately:

• An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

- Chest pains - this occurs uncommonly
If this occurs during or after intercourse:

• Get in a semi-sitting position and try to relax.

• Do not use nitrates to treat your chest pain.

• Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1 000 people) If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

• A sudden decrease or loss of vision - this occurs rarely

• Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• Seizures or fits - this occurs rarely

Other side effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding

heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1 000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to VIAGRA.

Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. 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 pouch after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

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 VIAGRA contains
−
The active substance is sildenafil. Each orodispersible film contains 50 mg of sildenafil (as the citrate salt).
−
The other ingredients are hydroxypropylcellulose (E463), macrogol, crospovidone (E1202), povidone (E1201), sucralose (E955), macrogol poly(vinyl alcohol) grafted copolymer, levomenthol, hypromellose (E464), titanium dioxide (E171), ferric oxide red (E172).

What VIAGRA looks like and contents of the pack
Each orodispersible film is packed in an individual foil pouch.
They are supplied in cartons containing 2, 4, 8 or 12 pouches.

Some pack sizes may not be marketed in your country.

Marketing Authorisation Holder
Viatris EESV, Krijgsman 20, 1186 DM, Amstelveen, Netherlands.

Manufacturer
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, Andernach, Rhineland-Palatinate, 56626, Germany.

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

België /Belgique / Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel. +370 52051288
България
Виатрис ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400
Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 4 65 2100
Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 220 174
Deutschland
Viatris Healthcare GmbH
Tel: +49 (0) 800 0700 800
Nederland
Viatris Healthcare BV
Tel: +31 (0) 20 426 3300
Eesti
Viatris OÜ
Tel: +372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ.: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712
Polska
Viatris Healthcare Sp. z o.o.,
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600
Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921
Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

This leaflet was last revised in.

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