vardenafil: package leaflet

Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.

Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.

Do not take Levitra
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Levitra.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
- If you have a severe heart or liver problem.
- If you are having kidney dialysis.
- If you have recently had a stroke or heart attack.
- If you have or have had low blood pressure.

• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
• 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 Levitra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levitra.

Take special care with Levitra
- If you have heart trouble. It may be risky for you to have sex.
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
- If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
- If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
- If you have stomach ulcers (also called gastric or peptic ulcers).
- If you have a bleeding disorder (such as haemophilia).
- If you are using any other treatments for erection difficulties, including Levitra orodispersible tablets (see section Other medicines and Levitra).
- Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop using Levitra and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
- If you experience sudden decrease or loss of vision or your vision is distorted or dimmed while you are taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use by children or adolescents under 18.

Other medicines and Levitra
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
- Ritonavir or indinavir, medicines for HIV.
- Ketoconazole or itraconazole, anti-fungal medicines.
- Erythromycin or clarithromycin, macrolide antibiotics.
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
- Riociguat.

Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drink and alcohol
- You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this may delay the effect.
- Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.

• Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding
Levitra is not for use by women.

Driving and using machines
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don’t drive or operate any tools or machines.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 10 mg.

Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
- Swallow one tablet with a glass of water.

Do not take Levitra film-coated tablets with any other forms of Levitra.

Do not take Levitra more than once a day.

Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.

If you take more Levitra than you should
Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra than you should, tell your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed, or blurred central vision in one or both eyes has been experienced by patients. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most 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 vardenafil.

The chance of having a side effect is described by the following categories:

Very common:
may affect more than 1 in 10 users
- Headache

Common:
may affect up to 1 in 10 users
- Dizziness
- Flushing
- Blocked or runny nose
- Indigestion

Uncommon:
may affect up to 1 in 100 users
- Swelling of skin and mucous tissue including swollen face, lips or throat
- Sleep disorder
- Numbness and impaired perception of touch
- Sleepiness
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
- Ringing in the ears, vertigo
- Fast heart beat or pounding heart
- Breathlessness
- Stuffy nose
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth
- Raised levels of liver enzymes in your blood
- Rash, reddened skin
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness
- Prolonged erections
- Malaise

Rare:
may affect up to 1 in 1,000 users
- Inflammation of the eyes (conjunctivitis)
- Allergic reaction
- Anxiety
- Fainting
- Amnesia
- Seizure
- Increased pressure in the eye (glaucoma), lacrimation increased
- Effects on the heart (such as heart attack, altered heart beat or angina)
- High or low blood pressure
- Nose bleed
- Effect on results of blood tests to check liver function
- Sensitivity of the skin to sun light
- Painful erections
- Chest pain
- Temporarily decreased blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data
- Blood in the urine (Haematuria)
- Penile bleeding (Penile Haemorrhage)
- Presence of blood in the semen (Haematospermia)
- Sudden death
- Bleeding in the brain
- Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Distorted, dimmed, or blurred central vision or sudden decrease of vision

Reporting of side effects
If you get any side effects, talk to your doctor. 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 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 Levitra contains
- The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
- The other ingredients of the tablets are:
Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).

What Levitra looks like and contents of the pack
Levitra 5 mg film-coated tablets are orange with the BAYER cross on one side and the strength (5) on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

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

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Lietuva
UAB Bayer
Tel: +370 523 36 868
България
Байер България ЕООД
Tел.: +359-(0)2-424 72 80
Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Česká republika
Bayer s.r.o.
Tel: +420 266 101 111
Magyarország
Bayer Hungária KFT
Tel.: +36 14 87-4100
Danmark
Bayer A/S
Tlf: +45 45 23 50 00
Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Deutschland
Jenapharm GmbH & Co. KG
Tel: +49 (0)3641-87 97 444
Nederland
Bayer B.V.
Tel: +31-(0)23 799 1000
Eesti
Bayer OÜ
Tel: +372 655 85 65
Norge
Bayer AS
Tlf: +47-23 13 05 00
Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500
Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0
España
Bayer Hispania S.L.
Tel: +34-93-495 65 00
Polska
Bayer Sp. z o.o.
Tel.: +48 22 572 35 00
France
Bayer HealthCare
Tél (N° vert) : +33-(0)800 87 54 54
Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00
Hrvatska
Bayer d.o.o.
Tel: + 385-(0)1-6599 900
România
SC Bayer SRL.
Tel: +40-21-529 59 00
Ireland
Bayer Limited
Tel: +353 1 216 3300
Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400
Ísland
Icepharma hf.
Sími: +354-540 8000
Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2-59 21 31 11
Italia
Bayer S.p.A.
Tel: +39 02 397 81
Suomi/Finland
Bayer Oy
Puh/Tel: +358-20 785 21
Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58
Sverige
Bayer AB
Tel: +46 (0)8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 845 563
United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000

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.

Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.

Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.

Do not take Levitra
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Levitra.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
- If you have a severe heart or liver problem.
- If you are having kidney dialysis.
- If you have recently had a stroke or heart attack.

• If you have or have had low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
• 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 Levitra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levitra.

Take special care with Levitra
- If you have heart trouble. It may be risky for you to have sex.
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
- If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
- If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
- If you have stomach ulcers (also called gastric or peptic ulcers).
- If you have a bleeding disorder (such as haemophilia).
- If you are using any other treatments for erection difficulties, including Levitra orodispersible tablets (see section Other medicines and Levitra).
- Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop using Levitra and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
- If you experience sudden decrease or loss of vision or your vision is distorted or dimmed while you are taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use by children or adolescents under 18.

Other medicines and Levitra
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
- Ritonavir or indinavir, medicines for HIV.
- Ketoconazole or itraconazole, anti-fungal medicines.
- Erythromycin or clarithromycin, macrolide antibiotics.
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
- Riociguat.

Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drink and alcohol
- You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this may delay the effect.
- Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.
- Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding
Levitra is not for use by women.

Driving and using machines
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don’t drive or operate any tools or machines.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 10 mg.

Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
- Swallow one tablet with a glass of water

Do not take Levitra film-coated tablets with any other forms of Levitra.

Do not take Levitra more than once a day.

Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.

If you take more Levitra than you should
Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra than you should, tell your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed, or blurred central vision in one or both eyes has been experienced by patients. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most 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 vardenafil.

The chance of having a side effect is described by the following categories:

Very common:
may affect more than 1 in 10 users
- Headache

Common:
may affect up to 1 in 10 users
- Dizziness
- Flushing
- Blocked or runny nose
- Indigestion

Uncommon:
may affect up to 1 in 100 users
- Swelling of skin and mucous tissue including swollen face, lips or throat
- Sleep disorder
- Numbness and impaired perception of touch
- Sleepiness
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
- Ringing in the ears, vertigo
- Fast heart beat or pounding heart
- Breathlessness
- Stuffy nose
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth
- Raised levels of liver enzymes in your blood
- Rash, reddened skin
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness
- Prolonged erections
- Malaise

Rare:
may affect up to 1 in 1,000 users
- Inflammation of the eyes (conjunctivitis)
- Allergic reaction
- Anxiety
- Fainting
- Amnesia
- Seizure
- Increased pressure in the eye (glaucoma), lacrimation increased
- Effects on the heart (such as heart attack, altered heart beat or angina)
- High or low blood pressure
- Nose bleed
- Effect on results of blood tests to check liver function
- Sensitivity of the skin to sun light
- Painful erections
- Chest pain
- Temporarily decreased blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data
- Blood in the urine (Haematuria)
- Penile bleeding (Penile Haemorrhage)
- Presence of blood in the semen (Haematospermia)
- Sudden death

• Bleeding in the brain
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Distorted, dimmed, or blurred central vision or sudden decrease of vision

Reporting of side effects
If you get any side effects, talk to your doctor. 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 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 Levitra contains
- The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
- The other ingredients of the tablets are:
Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).

What Levitra looks like and contents of the pack
Levitra 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

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

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Lietuva
UAB Bayer
Tel: +370 523 36 868
България
Байер България ЕООД
Tел.: +359-(0)2-424 72 80
Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Česká republika
Bayer s.r.o.
Tel: +420 266 101 111
Magyarország
Bayer Hungária KFT
Tel.: +36 14 87-4100
Danmark
Bayer A/S
Tlf: +45 45 23 50 00
Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Deutschland
Jenapharm GmbH & Co. KG
Tel: +49 (0)3641-87 97 444
Nederland
Bayer B.V.
Tel: +31-(0)23 799 1000
Eesti
Bayer OÜ
Tel: +372 655 85 65
Norge
Bayer AS
Tlf: +47-23 13 05 00
Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500
Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0
España
Bayer Hispania S.L.
Tel: +34-93-495 65 00
Polska
Bayer Sp. z o.o.
Tel.: +48 22 572 35 00
France
Bayer HealthCare
Tél (N° vert) : +33-(0)800 87 54 54
Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00
Hrvatska
Bayer d.o.o.
Tel: + 385-(0)1-6599 900
România
SC Bayer SRL.
Tel: +40-21-529 59 00
Ireland
Bayer Limited
Tel: +353 1 216 3300
Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400
Ísland
Icepharma hf.
Sími: +354-540 8000
Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2-59 21 31 11
Italia
Bayer S.p.A.
Tel: +39 02 397 81
Suomi/Finland
Bayer Oy
Puh/Tel: +358-20 785 21
Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58
Sverige
Bayer AB
Tel: +46 (0)8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 845 563
United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000

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.

Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.

Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.

Do not take Levitra
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Levitra.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
- If you are over 75 years of age and are taking ketaconazole or itraconazole, anti-fungal medicines.
- If you have a severe heart or liver problem.
- If you are having kidney dialysis.
- If you have recently had a stroke or heart attack.

• If you have or have had low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
• 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 Levitra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levitra.

Take special care with Levitra
- If you have heart trouble. It may be risky for you to have sex.
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
- If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
- If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
- If you have stomach ulcers (also called gastric or peptic ulcers).
- If you have a bleeding disorder (such as haemophilia).
- If you are using any other treatments for erection difficulties, including Levitra orodispersible tablets (see section Other medicines and Levitra).
- Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop using Levitra and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
- If you experience sudden decrease or loss of vision or your vision is distorted or dimmed while you are taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use by children or adolescents under 18.

Other medicines and Levitra
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
- Ritonavir or indinavir, medicines for HIV.
- Ketoconazole or itraconazole, anti-fungal medicines
- Erythromycin or clarithromycin, macrolide antibiotics
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
- Riociguat.

Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drink and alcohol
- You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this may delay the effect.

• Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.
• Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding
Levitra is not for use by women.

Driving and using machines
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don’t drive or operate any tools or machines.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 10 mg.

Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
- Swallow one tablet with a glass of water.

Do not take Levitra film-coated tablets with any other forms of Levitra.

Do not take Levitra more than once a day.

Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.

If you take more Levitra than you should
Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra than you should, tell your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed, or blurred central vision in one or both eyes has been experienced by patients. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most 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 vardenafil.

The chance of having a side effect is described by the following categories:

Very common:
may affect more than 1 in 10 users
- Headache

Common:
may affect up to 1 in 10 users
- Dizziness
- Flushing
- Blocked or runny nose
- Indigestion

Uncommon:
may affect up to 1 in 100 users
- Swelling of skin and mucous tissue including swollen face, lips or throat
- Sleep disorder
- Numbness and impaired perception of touch
- Sleepiness
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
- Ringing in the ears, vertigo
- Fast heart beat or pounding heart
- Breathlessness
- Stuffy nose
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth
- Raised levels of liver enzymes in your blood
- Rash, reddened skin
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness
- Prolonged erections
- Malaise

Rare:
may affect up to 1 in 1,000 users
- Inflammation of the eyes (conjunctivitis)
- Allergic reaction
- Anxiety
- Fainting
- Amnesia
- Seizure
- Increased pressure in the eye (glaucoma), lacrimation increased
- Effects on the heart (such as heart attack, altered heart beat or angina)
- High or low blood pressure
- Nose bleed
- Effect on results of blood tests to check liver function
- Sensitivity of the skin to sun light
- Painful erections
- Chest pain
- Temporarily decreased blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data
- Blood in the urine (Haematuria)
- Penile bleeding (Penile Haemorrhage)
- Presence of blood in the semen (Haematospermia)
- Sudden death
- Bleeding in the brain
- Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Distorted, dimmed, or blurred central vision or sudden decrease of vision

Reporting of side effects
If you get any side effects, talk to your doctor. 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 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 Levitra contains

- The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).
- The other ingredients of the tablets are:
Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).

What Levitra looks like and contents of the pack
Levitra 20 mg film-coated tablets are orange with the BAYER cross on one side and the strength (20) on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

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

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Lietuva
UAB Bayer
Tel: +370 523 36 868
България
Байер България ЕООД
Tел.: +359-(0)2-424 72 80
Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Česká republika
Bayer s.r.o.
Tel: +420 266 101 111
Magyarország
Bayer Hungária KFT
Tel.: +36 14 87-4100
Danmark
Bayer A/S
Tlf: +45 45 23 50 00
Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Deutschland
Jenapharm GmbH & Co. KG
Tel: +49 (0)3641-87 97 444
Nederland
Bayer B.V.
Tel: +31-(0)23 799 1000
Eesti
Bayer OÜ
Tel: +372 655 85 65
Norge
Bayer AS
Tlf: +47-23 13 05 00
Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500
Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0
España
Bayer Hispania S.L.
Tel: +34-93-495 65 00
Polska
Bayer Sp. z o.o.
Tel.: +48 22 572 35 00
France
Bayer HealthCare
Tél (N° vert) : +33-(0)800 87 54 54
Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00
Hrvatska
Bayer d.o.o.
Tel: + 385-(0)1-6599 900
România
SC Bayer SRL.
Tel: +40-21-529 59 00
Ireland
Bayer Limited
Tel: +353 1 216 3300
Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400
Ísland
Icepharma hf.
Sími: +354-540 8000
Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2-59 21 31 11
Italia
Bayer S.p.A.
Tel: +39 02 397 81
Suomi/Finland
Bayer Oy
Puh/Tel: +358-20 785 21
Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58
Sverige
Bayer AB
Tel: +46 (0)8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 845 563
United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000

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.

Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.

Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.

Do not take Levitra
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Levitra.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
- If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
- If you have a severe heart or liver problem.
- If you are having kidney dialysis.
- If you have recently had a stroke or heart attack.

• If you have or have had low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
• 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 Levitra have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levitra.

Take special care with Levitra
- If you have heart trouble. It may be risky for you to have sex.
- If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
- If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
- If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
- If you have stomach ulcers (also called gastric or peptic ulcers).
- If you have a bleeding disorder (such as haemophilia).
- If you are using any other treatments for erection difficulties, including Levitra film-coated tablets (see section Other medicines and Levitra).
- Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop using Levitra and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
- If you experience sudden decrease or loss of vision or your vision is distorted or dimmed while you are taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use by children or adolescents under 18.

Other medicines and Levitra
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
- Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
- Ritonavir or indinavir, medicines for HIV.
- Ketoconazole or itraconazole, anti-fungal medicines.
- Erythromycin or clarithromycin, macrolide antibiotics.
- Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
- Riociguat.

Do not use Levitra orodispersible tablets combined with any other treatment for erectile dysfunction, including Levitra film-coated tablets.

Levitra with food, drink and alcohol
- You can take Levitra orodispersible tablets with or without food but do not take this medicine with any liquid.

• Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.
• Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding
Levitra is not for use by women.

Driving and using machines
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don’t drive or operate any tools or machines.

Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol.
- Aspartame: This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

• Sorbitol: This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 10 mg.

Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.

• Do not remove the orodispersible tablet from the blister until you are going to take it. With dry hands press gently to release the tablet on your hand. Do not crush the tablet.
• Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take Levitra orodispersible tablets with any other forms of Levitra.

Do not take Levitra more than once a day.

Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.

If you take more Levitra than you should
Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra than you should, tell your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed, or blurred central vision in one or both eyes has been experienced by patients. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most 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 vardenafil.

The chance of having a side effect is described by the following categories:

Very common:
may affect more than 1 in 10 users
- Headache

Common:
may affect up to 1 in 10 users
- Dizziness
- Flushing
- Blocked or runny nose
- Indigestion

Uncommon:
may affect up to 1 in 100 users
- Swelling of skin and mucous tissue including swollen face, lips or throat
- Sleep disorder
- Numbness and impaired perception of touch
- Sleepiness
- Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
- Ringing in the ears, vertigo
- Fast heart beat or pounding heart
- Breathlessness
- Stuffy nose
- Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth
- Raised levels of liver enzymes in your blood
- Rash, reddened skin
- Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness
- Prolonged erections
- Malaise

Rare:
may affect up to 1 in 1,000 users
- Inflammation of the eyes (conjunctivitis)
- Allergic reaction
- Anxiety
- Fainting
- Amnesia
- Seizure

• Increased pressure in the eye (glaucoma), lacrimation increased
• Effects on the heart (such as heart attack, altered heart beat or angina)
• High or low blood pressure
• Nose bleed
• Effect on results of blood tests to check liver function
• Sensitivity of the skin to sun light
• Painful erections
• Chest pain
• Temporarily decreased blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data
- Blood in the urine (Haematuria)
- Penile bleeding (Penile Haemorrhage)
- Presence of blood in the semen (Haematospermia)
- Sudden death
- Bleeding in the brain
- Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Distorted, dimmed, or blurred central vision or sudden decrease of vision

Reporting of side effects
If you get any side effects, talk to your doctor. 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.

Store in the original package in order to protect from humidity and light.

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 Levitra contains
- The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
- The other ingredients of the tablets are:
Magnesium stearate, aspartame (E951), peppermint flavour, mannitol (E421), sorbitol (E420), crospovidone and silica colloidal hydrated. See section 2 “Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol”.

What Levitra looks like and contents of the pack
Levitra 10 mg orodispersible tablets are round and white. They are provided in packs of:
1 x 1 orodispersible tablet in alu/alu perforated unit dose blister,
2 x 1 orodispersible tablets in alu/alu perforated unit dose blisters,
4 x 1 orodispersible tablets in alu/alu perforated unit dose blisters,
8 x 1 orodispersible tablets in alu/alu perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

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

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Lietuva
UAB Bayer
Tel: +370 523 36 868
България
Байер България ЕООД
Tел.: +359-(0)2-424 72 80
Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Česká republika
Bayer s.r.o.
Tel: +420 266 101 111
Magyarország
Bayer Hungária KFT
Tel.: +36 14 87-4100
Danmark
Bayer A/S
Tlf: +45 45 23 50 00
Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Deutschland
Jenapharm GmbH & Co. KG
Tel: +49 (0)3641-87 97 444
Nederland
Bayer B.V.
Tel: +31-(0)23 799 1000
Eesti
Bayer OÜ
Tel: +372 655 85 65
Norge
Bayer AS
Tlf: +47-23 13 05 00
Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500
Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0
España
Bayer Hispania S.L.
Tel: +34-93-495 65 00
Polska
Bayer Sp. z o.o.
Tel.: +48 22 572 35 00
France
Bayer HealthCare
Tél (N° vert) : +33-(0)800 87 54 54
Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00
Hrvatska
Bayer d.o.o.
Tel: + 385-(0)1-6599 900
România
SC Bayer SRL.
Tel: +40-21-529 59 00
Ireland
Bayer Limited
Tel: +353 1 216 3300
Slovenija
Bayer d. o. o.
Tel: +386 (0)1 58 14 400
Ísland
Icepharma hf.
Sími: +354-540 8000
Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2-59 21 31 11
Italia
Bayer S.p.A.
Tel: +39 02 397 81
Suomi/Finland
Bayer Oy
Puh/Tel: +358-20 785 21
Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58
Sverige
Bayer AB
Tel: +46 (0)8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 845 563
United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000

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.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
OF THE MARKETING AUTHORISATION(S)

Scientific conclusions
Taking into account the PRAC Assessment Report on the PSUR(s) for vardenafil, the scientific conclusions of PRAC are as follows:
In view of available data on serous central chorioretinopathy and hypersensitivity regarding Stevens- Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) from the literature, spontaneous reports including in some cases a close temporal relationship, a positive de-challenge and in view of a plausible mechanism of action, the PRAC considers a causal relationship between vardenafil and serous central chorioretinopathy and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) is at least a reasonable possibility. In addition, visual defects, including central serous chorioretinopathy (CSCR), and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of vardenafil and other PDE5 inhibitors. The PRAC concluded that the product information of products containing vardenafil should be amended accordingly.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Grounds for the variation to the terms of the marketing authorisation(s)
On the basis of the scientific conclusions for vardenafil the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vardenafil is unchanged subject to the proposed changes to the product information.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.