LEVITRA 5 mg Film-Coated Tablets

Зміст інструкції

1. Levitra 5 mg film-coated tablets
   1. What is Levitra and what is it used for
   2. What you need to know before taking Levitra
   3. How to take Levitra
   4. Possible side effects
   5. How to store Levitra
   6. Contents of the pack and other information
2. Levitra 10 mg film-coated tablets
   1. What is Levitra and what is it used for
   2. What you need to know before taking Levitra
   3. How to take Levitra
   4. Possible side effects
   5. How to store Levitra
   6. Contents of the pack and other information
3. Levitra 20 mg film-coated tablets
   1. What is Levitra and what is it used for
   2. What you need to know before taking Levitra
   3. How to take Levitra
   4. Possible side effects
   5. How to store Levitra
   6. Contents of the pack and other information
4. Levitra 10 mg orodispersible tablets
   1. What is Levitra and what is it used for
   2. What you need to know before taking Levitra
   3. How to take Levitra
   4. Possible side effects
   5. HOW TO STORE LEVITRA
   6. Package contents and other information

Levitra 5 mg film-coated tablets

vardenafil

Read this leaflet carefully before you start taking this medicinebecause it contains
important information for you.
Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levitra is and what it is used for
• 2. What you need to know before you take Levitra
• 3. How to take Levitra
• 4. Possible side effects
• 5. How to store Levitra
• 6. Contents of the pack and other information

1. What is Levitra and what is it used for

Levitra contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition that involves difficulty achieving or maintaining an erection.
At least one in ten men occasionally have difficulty achieving or maintaining an erection. It may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Levitra only works in the presence of sexual stimulation. The medicine reduces the action of the chemical substance present in the body, which stops the erection. Levitra allows you to achieve and maintain an erection long enough to satisfactorily complete sexual intercourse.

2. What you need to know before taking Levitra

Do not take Levitra

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips and shortness of breath.
• If you have ever developed a severe skin rash or peeling, blisters and/or ulcers in the mouth after taking Levitra
• If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter 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 being treated with ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing kidney dialysis.
• If you have recently had a stroke or a 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 previously had a condition characterized by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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). It has been shown that PDE5 inhibitors, such as Levitra, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.

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

Pay particular attention with Levitra

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes changes in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism), such as sickle cell anemia, multiple myeloma or leukemia.
• If you have stomach ulcers (also called gastricor pepticulcers).
• If you have a bleeding disorder (such as hemophilia).
• If you are using other treatments for erectile difficulties, including Levitra orodispersible tablets (see Other medicines and Levitra).
• Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with vardenafil treatment. Stop taking Levitra and seek immediate medical attention if you notice any symptoms indicative of these severe skin reactions described in section 4.
• If you experience a sudden decrease or loss of vision, or if your vision is distorted or blurred while 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 years of age.

Other medicines and Levitra
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those available without a prescription.
Some medicines can cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone or sotalol
• Ritonavir or indinavir ,medicines for HIV.
• Ketoconazole or itraconazole ,antifungal medicines.
• Erythromycin or clarithromycin ,macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use Levitra film-coated tablets in association with other treatments for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drinks and alcohol

• You can take Levitra with or without food, but preferably not after a heavy or fatty meal as this may delay its effect.
• Do not drink grapefruit juice when taking Levitra. It may interfere with the effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
Levitra is not intended for use by women.

Driving and using machines
In some people Levitra may cause dizziness or alter vision. If you feel dizzy or notice
problems with your vision after taking Levitra, do not drive or operate tools or machinery.

3. How to take Levitra

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult
your doctor or pharmacist. The recommended dose is 10 mg.
Take one Levitra tablet approximately 25-60 minutes before sexual activity. If you are sexually
stimulated, you may achieve an erection within 25 minutes and up to four to five hours after taking
Levitra.

• Swallow a tablet with a glass of water

Do not take the film-coated tablets of Levitratogether with any other formulation of
Levitra.

Do not take Levitramore than once a day.
If you feel that the effect of Levitra is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of Levitra with a different dosage,
based on the effect the medicine has on you.

If you take more Levitra than you should
Patients who take an excessive amount of Levitra may experience more side effects or
severe back pain. If you take more Levitra than you should, consult your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss
of vision, or distorted, blurred or hazy vision in one or both eyes. Stop taking
Levitra and contact your doctor immediately.
A sudden decrease or loss of hearing has been reported.
Cases of sudden death, fast or altered heartbeat, heart attack, chest pain and
problems with the cerebral circulation (including a temporarily reduced blood flow in parts
of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Many
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 probability that a side effect occurs is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• Blocked or runny nose
• Indigestion

Uncommon:
may affect up to 1 in 100 people

• Swelling of the skin and mucous membranes including swelling of the face, lips or throat
• Sleep disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision, red eyes, effects on colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart with hammering sensation
• Shortness of breath
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell

Rare
may affect up to 1 in 1,000 people

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased eye pressure (glaucoma), increased tearing
• Effects on the heart (such as heart attack, altered heartbeat or angina)
• High or low blood pressure
• Nosebleed
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary decrease in blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 people or the frequency cannot be estimated on the basis of
the available data

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Presence of blood in the semen (haematospermia) Sudden death
• Cerebral haemorrhage
• Reddish, non-raised, target or circular spots on the trunk, often with central blisters, peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome,Toxic Epidermal Necrolysis)
• Distorted, blurred or hazy central vision or sudden loss of vision

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system
listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Levitra

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 pack after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levitra contains

• The active ingredient is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
• The other ingredients are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide. Film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Levitra and contents of the pack
Levitra 5 mg is presented as film-coated tablets, orange in colour, marked with the
BAYER cross on one side and the dosage (5) on the other. Packs of 2, 4, 8, 12 or 20
tablets in blisters are available. 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 further information on this medicine, 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

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu.

Levitra 10 mg film-coated tablets

vardenafil

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levitra is and what it is used for
• 2. What you need to know before you take Levitra
• 3. How to take Levitra
• 4. Possible side effects
• 5. How to store Levitra
• 6. Contents of the pack and other information

1. What is Levitra and what is it used for

Levitra contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition that involves difficulty achieving or maintaining an erection.
At least one man in ten occasionally has difficulty achieving or maintaining an erection. It may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Levitra only works in the presence of sexual stimulation. The medicine reduces the action of the chemical present in the body that stops the erection. Levitra allows you to achieve and maintain an erection long enough to satisfactorily complete sexual intercourse.

2. What you need to know before taking Levitra

Do not take Levitra

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips and shortness of breath.
• If you have ever developed a severe skin rash or peeling, blisters and/or ulcers in the mouth after taking Levitra.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter 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 being treated with ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing renal 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 previously had a condition characterised by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischaemic optic neuropathy (NAION).
• 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). It has been shown that PDE5 inhibitors, such as Levitra, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.

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

Pay particular attention with Levitra

• If you have heart problems. Sexual activity may be risky for you
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes changes in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism), such as sickle cell anaemia, multiple myeloma or leukaemia.
• If you have stomach ulcers (also called gastricor pepticulcers).
• If you have a bleeding disorder (such as haemophilia).
• If you are using other treatments for erectile difficulties, including Levitra orodispersible tablets (see section Other medicines and Levitra).
• Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with vardenafil treatment. Stop taking Levitra and seek immediate medical attention if you notice any symptoms indicative of these severe skin reactions described in section 4.
• If you experience a sudden decrease or loss of vision, or if your vision is distorted or blurred while taking Levitra, stop taking Levitra and contact your doctor immediately.

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

Other medicines and Levitra
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those available without a prescription.
Some medicines can cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone or sotalol
• Ritonavir or indinavir ,medicines for HIV.
• Ketoconazole or itraconazole ,antifungal medicines.
• Erythromycin or clarithromycin ,macrolide antibiotics.
• Alpha-blockers, a type of medicines used to treat high blood pressure and enlargement of the prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use Levitra film-coated tablets in combination with other treatments for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drinks and alcohol

• You can take Levitra with or without food - but preferably not after a heavy or fatty meal as this may delay its effect.
• Do not drink grapefruit juice when taking Levitra. It may interfere with the effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
Levitra is not intended for use by women.

Driving and using machines
In some people Levitra may cause dizziness or alter vision. If you feel dizzy or notice
problems with your vision after taking Levitra, do not drive or operate tools or machinery.

3. How to take Levitra

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist. The recommended dose is 10 mg.
Take one Levitra tablet approximately 25-60 minutes before sexual activity. If you are sexually
stimulated, you may achieve an erection within 25 minutes and up to four or five hours after taking
Levitra.

• Swallow one tablet with a glass of water

Do not take the film-coated tablets of Levitratogether with any other formulation of
Levitra.

Do not take Levitramore than once a day.
If you feel that the effect of Levitra is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of Levitra with a different dosage,
based on the effect the medicine has on you.

If you take more Levitra than you should
Patients who take an excessive amount of Levitra may experience more side effects or
severe back pain. If you take more Levitra than you should, consult your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The effects are usually mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss
of vision, or distorted, blurred or hazy vision in one or both eyes. Stop taking
Levitra and contact your doctor immediately.
A sudden decrease or loss of hearing has been reported.
Cases of sudden death, accelerated or altered heartbeat, heart attack, chest pain and
problems with cerebral circulation (including a temporarily reduced blood flow to parts
of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Many
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 probability that a side effect occurs is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• Blocked or runny nose
• Indigestion

Uncommon:
may affect up to 1 in 100 people

• Swelling of the skin and mucous membranes including swelling of the face, lips or throat
• Sleep disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision, red eyes, effects on colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart with pounding sensation
• Shortness of breath
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell

Rare:
may affect up to 1 in 1,000 people

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased eye pressure (glaucoma), increased tearing
• Effects on the heart (such as heart attack, altered heartbeat or angina)
• High or low blood pressure
• Nosebleed
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain Temporary decrease in blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 people or the frequency cannot be estimated on the basis of
the available data

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Presence of blood in the semen (haematospermia)
• Sudden death
• Cerebral haemorrhage Reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome,Toxic Epidermal Necrolysis)
• Distorted, blurred or hazy central vision or sudden loss of vision

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

5. How to store Levitra

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 pack after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levitra contains

• The active ingredient is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
• Other ingredients are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide. Film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of Levitra and contents of the pack
Levitra 10 mg is presented as orange film-coated tablets, marked with the
BAYER cross on one side and the dosage (10) on the other. Packs of 2, 4, 8, 12 or 20
tablets in blisters are available. 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 further information on this medicine, 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-

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

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Levitra 20 mg film-coated tablets

vardenafil

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levitra is and what it is used for
• 2. What you need to know before you take Levitra
• 3. How to take Levitra
• 4. Possible side effects
• 5. How to store Levitra
• 6. Contents of the pack and other information

1. What is Levitra and what is it used for

Levitra contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition that involves difficulty achieving or maintaining an erection.
At least one man in ten occasionally has difficulty achieving or maintaining an erection. It may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Levitra works only in the presence of sexual stimulation. The medicine reduces the action of the chemical present in the body that stops the erection. Levitra allows you to achieve and maintain an erection long enough to satisfactorily complete sexual intercourse.

2. What you need to know before taking Levitra

Do not take Levitra

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips and shortness of breath.
• If you have ever developed a severe skin rash or peeling, blisters and/or ulcers in the mouth after taking Levitra.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter 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 being treated with ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing renal 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 previously had a condition characterized by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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). It has been shown that PDE5 inhibitors, such as Levitra, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.

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

Pay particular attention with Levitra

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes changes in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism), such as sickle cell anemia, multiple myeloma or leukemia.
• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have a bleeding disorder (such as hemophilia).
• If you are using other treatments for erectile difficulties, including Levitra orodispersible tablets (see Other medicines and Levitra).
• Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with treatment with vardenafil. Stop taking Levitra and seek immediate medical attention if you notice any symptoms indicative of these severe skin reactions described in section 4.
• If you experience a sudden decrease or loss of vision or if your vision is distorted or blurred while 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 years of age.

Other medicines and Levitra
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those available without a prescription.
Some medicines can cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir ,medicines for HIV.
• Ketoconazole or itraconazole ,antifungal medicines.
• Erythromycin or clarithromycin ,macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use Levitra film-coated tablets in association with other treatments for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drinks and alcohol

• You can take Levitra with or without food - but preferably not after a heavy or fatty meal as this may delay its effect.
• Do not drink grapefruit juice when taking Levitra. It may interfere with the effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
Levitra is not intended for use by women.

Driving and using machines
In some people Levitra may cause dizziness or alter vision. If you feel dizzy or notice
problems with your vision after taking Levitra, do not drive or operate tools or machinery.

3. How to take Levitra

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. The recommended dose is 10 mg.
Take one Levitra tablet approximately 25-60 minutes before sexual activity. If you are sexually
stimulated, you may be able to achieve an erection within 25 minutes and up to four or five hours after taking
Levitra.

• Swallow one tablet with a glass of water

Do not take the film-coated tabletsof Levitra together with any other formulation of
Levitra.

Do not take Levitramore than once a day.
If you feel that the effect of Levitra is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of Levitra with a different dosage,
based on the effect the medicine has on you.

If you take more Levitra than you should
Patients who take an excessive amount of Levitra may experience more side effects or
severe back pain. If you take more Levitra than you should, consult your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss
of vision, or distorted, blurred or hazy vision in one or both eyes. Stop taking
Levitra and contact your doctor immediately.
A sudden decrease or loss of hearing has been reported.
Cases of sudden death, fast or altered heartbeat, heart attack, chest pain and
problems with cerebral circulation (including a temporarily reduced blood flow in parts
of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Many
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 probability that a side effect occurs is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• Blocked or runny nose
• Indigestion

Uncommon:
may affect up to 1 in 100 people

• Swelling of the skin and mucous membranes including swelling of the face, lips or throat
• Sleep disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision, red eyes, effects on colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart with pounding sensation
• Shortness of breath
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, malaise (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Malaise

Rare
may affect up to 1 in 1,000 people

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased eye pressure (glaucoma), increased tearing
• Effects on the heart (such as heart attack, altered heartbeat or angina)
• High or low blood pressure
• Nosebleed
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary decrease in blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 people or the frequency cannot be estimated on the basis of
the available data

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Presence of blood in the semen (haematospermia)
• Sudden death
• Cerebral haemorrhage
• Reddish, non-raised, target-like or circular spots on the trunk, often with central blisters, peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome,Toxic Epidermal Necrolysis)
• Distorted, blurred or hazy central vision or sudden loss of vision

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

5. How to store Levitra

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 pack after “Exp”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levitra contains

• The active ingredient is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).
• Other ingredients are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide. Film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of Levitra and contents of the pack
Levitra 20 mg presents as film-coated tablets, orange in colour, marked with the
BAYER cross on one side and the dosage (20) on the other. Packs of 2, 4, 8, 12 or 20
tablets in blisters are available. 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 further information on this medicine, 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-

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

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Levitra 10 mg orodispersible tablets

vardenafil

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Levitra is and what it is used for
• 2. What you need to know before you take Levitra
• 3. How to take Levitra
• 4. Possible side effects
• 5. How to store Levitra
• 6. Contents of the pack and other information

1. What is Levitra and what is it used for

Levitra contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition that involves difficulty achieving or maintaining an erection.
At least one in ten men occasionally have difficulty achieving or maintaining an erection. This may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Levitra only works in the presence of sexual stimulation. The medicine reduces the action of the chemical substance present in the body that stops the erection. Levitra allows you to achieve and maintain an erection long enough to satisfactorily complete sexual intercourse.

2. What you need to know before taking Levitra

Do not take Levitra

• If you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips and shortness of breath.
• If you have ever developed a severe skin rash or peeling, blisters and/or ulcers in your mouth after taking Levitra.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter 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 being treated with ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are on kidney dialysis.
• If you have recently had a stroke or a 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 previously had a condition characterised by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischaemic optic neuropathy (NAION).
• 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). It has been shown that PDE5 inhibitors, such as Levitra, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.

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

Take special care with Levitra

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes changes in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism), such as sickle cell anaemia, multiple myeloma or 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 other treatments for erectile difficulties, including Levitra film-coated tablets (see section Other medicines and Levitra).
• Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with treatment with vardenafil. Stop taking Levitra and seek immediate medical attention if you notice any symptoms indicative of these severe skin reactions described in section 4.
• If you experience a sudden decrease or loss of vision or if your vision is distorted or blurred while taking Levitra, stop taking Levitra and contact your doctor immediately.

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

Other medicines and Levitra
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines can cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Levitra could dangerously alter your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir ,medicines for HIV.
• Ketoconazole or itraconazole ,antifungal medicines.
• Erythromycin or clarithromycin ,macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate gland (such as benign prostatic hyperplasia).
• Riociguat.

Do not use Levitra orodispersible tablets in association with other treatments for erectile dysfunction, including Levitra film-coated tablets.

Levitra with food, drinks and alcohol

• You can take Levitra orodispersible tablets with or without food, but do not take this medicine with liquids.
• Do not drink grapefruit juice when taking Levitra. It may interfere with the effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
Levitra is not intended for use by women.

Driving and using machines
In some people Levitra may cause dizziness or alter vision. If you feel dizzy or notice
problems with your vision after taking Levitra, do not drive or operate tools or machinery.

Levitra 10 mg orodispersible tablets contains Aspartame and Sorbitol.

• Aspartame: This medicine contains 1.80 mg of aspartame per 10 mg orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes an accumulation of phenylalanine because the body cannot break it down properly.
• Sorbitol: This medicine contains 7.96 mg of sorbitol per 10 mg orodispersible tablet.

3. How to take Levitra

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. The recommended dose is 10 mg.
Take one Levitra tablet approximately 25 - 60 minutes before sexual activity. If you are sexually
stimulated, you may achieve an erection within 25 minutes and up to four or five hours after taking
Levitra.

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

Do not take Levitraorodispersible tabletstogether with any other formulation of Levitra.

Do not take Levitramore than once a day.
If you feel that the effect of Levitra is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of Levitra with a different dosage,
based on the effect the medicine has on you.

If you take more Levitra than you should
Patients who take an excessive amount of Levitra may experience more side effects or
severe back pain. If you take more Levitra than you should, consult your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The effects are usually mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss
of vision, or distorted, blurred or hazy vision in one or both eyes. Stop taking
Levitra and contact your doctor immediately.
A sudden decrease or loss of hearing has been reported.
Cases of sudden death, fast or altered heartbeat, heart attack, chest pain and
problems with brain circulation (including temporarily reduced blood flow to parts
of the brain and brain bleeding) have been reported in men taking vardenafil. Many
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 likelihood that a side effect will occur is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• Blocked or runny nose
• Indigestion

Uncommon:
may affect up to 1 in 100 people

• Swelling of the skin and mucous membranes including swelling of the face, lips or throat
• Sleep disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision, red eyes, effects on colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart with pounding sensation
• Shortness of breath
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell

Rare
may affect up to 1 in 1,000 people

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased pressure in the eye (glaucoma), increased tear production
• Effects on the heart (such as heart attack, altered heartbeat or angina)
• High or low blood pressure
• Nosebleed
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary decrease in blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 people or the frequency cannot be estimated based on
the available data

• Blood in the urine (hematuria)
• Bleeding from the penis (penile hemorrhage)
• Presence of blood in the semen (hematospermia)
• Sudden death
• Brain bleeding Reddish, target-like or circular spots on the trunk, often with central blisters, peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome,Toxic Epidermal Necrolysis)
• Distorted, blurred or hazy central vision or sudden loss of vision

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting system
listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE LEVITRA

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 pack after “Exp”. The expiry
date refers to the last day of that month.
Store in the original package to protect the medicine from moisture and light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levitra contains

• The active ingredient is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
• The other ingredients are:

Magnesium stearate, aspartame (E951), mint flavour, mannitol (E421), sorbitol (E420),
crospovidone, hydrated colloidal silica. See section 2 “Levitra 10 mg orodispersible tablets
contain Aspartame and Sorbitol”.

Description of the appearance of Levitra and contents of the pack
Levitra 10 mg orodispersible tablets are round and white. They are available in packs of:
1 x 1 orodispersible tablet in perforated alu/alu blister for single dose,
2 x 1 orodispersible tablets in perforated alu/alu blister for single dose,
4 x 1 orodispersible tablets in perforated alu/alu blister for single dose,
8 x 1 orodispersible tablets in perforated alu/alu blister for single dose.
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 further information on this medicinal product, 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-

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Scientific conclusions
In light of the assessment by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Reports (PSUR) for vardenafil, the scientific conclusions of the
PRAC are as follows:
In light of the available literature data on Central Serous Chorioretinopathy and hypersensitivity
concerning Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), spontaneous reports
which in some cases include a close temporal association, a positive de-challenge and in view of a plausible
mechanism of action, the PRAC considers that a causal relationship between vardenafil and Central Serous
Chorioretinopathy and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) is at least a
reasonable possibility. In addition, visual disturbances, including Central Serous Chorioretinopathy (CSCR),
and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in association with the
use of vardenafil and other PDE5 inhibitors.
Having examined the PRAC recommendation, the Committee for Medicinal Products for Human Use
(CHMP) agrees with the related overall conclusions and with the rationale for the recommendation.

Reasons for the variation of the terms of the marketing authorisations
Based on the scientific conclusions on vardenafil, the CHMP considers that the benefit-risk balance
of the medicinal product containing vardenafil remains unchanged, subject to the proposed changes to the
product information.