Brand name Levitra

Form tablets, film-coated

Active substance / Dosage

VARDENAFIL HYDROCHLORIDE

Prescription type Prescription only

ATC code

G04BE09

Registration number 035734

Manufacturer BAYER AG

Table of Contents

Patient Information Leaflet: Information for the User
Levitra 5 mg film-coated tablets
1. What Levitra is and what it is used for
2. What you should know before taking Levitra
3. How to take Levitra
4. Possible side effects
5. How to store Levitra
6. Package contents and other information
Package leaflet: information for the user
Levitra 10 mg film-coated tablets
1. What Levitra is and what it is used for
2. What you should know before taking Levitra
3. How to take Levitra
4. Possible side effects
5. How to store Levitra
6. Package contents and other information
Package leaflet: Information for the user
Levitra 20 mg film-coated tablets
1. What Levitra is and what it is 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
Package leaflet: information for the user
Levitra 10 mg orodispersible tablets
1. What Levitra is and what it is 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

Patient Information Leaflet: Information for the User

Levitra 5 mg film-coated tablets

vardenafil
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levitra is and what it is used for
What you need to know before taking Levitra
How to take Levitra
Possible side effects
How to store Levitra
Contents of the pack and other information

1. What Levitra is and what it is 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 characterized by difficulty in achieving or maintaining an erection. At least one man in ten occasionally experiences difficulty in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, an insufficient amount of 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 a chemical substance in the body that causes the erection to subside. Levitra enables men to achieve and maintain an erection long enough to complete sexual intercourse satisfactorily.

2. What you should 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). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath.
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers 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 lower 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 old 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 there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
If you have previously experienced a condition characterized by sudden loss of vision due to damage of the optic nerve from 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 due to blood clots). PDE5 inhibitors such as Levitra have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform 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 inherited heart diseases that affect the electrocardiogram.
If you have a physical condition causing deformities of the penis. These include conditions known as penile curvature, Peyronie’s disease, and cavernosal fibrosis.
If you have a disease that may cause prolonged 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 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 indicating these serious skin reactions described in section 4.
If you experience a sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use in 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, including those without a prescription.
Some medicines may cause problems, particularly:

Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Levitra could dangerously lower your blood pressure.
Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
Ritonavir or indinavir, medicines for HIV.
Ketoconazole or itraconazolo, 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 combination with other treatments for erectile dysfunction, including Levitra orodispersible tablets.
Levitra with food, drinks and alcohol

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

Pregnancy and breastfeeding
Levitra is not intended for use in women.
Driving and using machines
In some people, Levitra may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Levitra, do not drive or operate tools or machinery.

3. How to take Levitra

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take one Levitra tablet approximately 25 to 60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking Levitra and up to four to five hours afterwards.

Swallow the tablet with a glass of water.

Do not take Levitra film-coated tablets together with any other Levitra formulation.
Do not take Levitra more than once a day.
If you think that the effect of Levitra is too strong or too weak, talk to your doctor.
Your doctor may advise you to take an alternative Levitra formulation with a different dose, depending on how the medicine affects 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 how to use this medicine, talk to 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 reduction or loss of vision, or distorted, blurred or fuzzy vision in one or both eyes. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain and problems with cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Many of these men had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing a side effect is described using the following categories:

Very common:
may affect more than 1 in 10 people

Headache

Common:
may affect up to 1 in 10 people

Dizziness
Flushing
Stuffy 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 disorders
Numbness and reduced tactile perception
Drowsiness
Visual disturbances, red eyes, disturbances in colour perception, eye pain and discomfort, sensitivity to light
Ringing in the ears, dizziness
Rapid heartbeat or pounding heart
Shortness of breath
Nasal congestion
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, malaise (nausea), dry mouth
Increased levels of liver enzymes in the blood
Rash, red skin
Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) 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
Seizure
Increased eye pressure (glaucoma), increased tear production
Effects on the heart (such as heart attack, irregular heartbeat or angina)
High or low blood pressure
Nosebleeds
Effects on liver function test results
Skin sensitivity to sunlight
Painful erections
Chest pain
Temporary reduction in blood flow to parts of the brain

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

Blood in the urine (haematuria)
Bleeding from the penis (penile haemorrhage)
Blood in the semen (haemospermia)
Sudden death
Cerebral haemorrhage
Flat, non-elevated, target-like or circular red spots on the trunk, often with central blisters, peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
Distorted, blurred or fuzzy central vision or sudden decrease in vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via 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 stated on the pack after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater 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 substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
The other components are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica. Coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Levitra and package contents
Levitra 5 mg are orange, film-coated tablets, marked with the BAYER cross on one side and the dosage (5) on the other. Available in packs of 2, 4, 8, 12 or 20 tablets in blisters. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer AG
51368 Leverkusen
Germany

Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien

Package leaflet: information for the user

Levitra 10 mg film-coated tablets

vardenafil
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levitra is and what it is used for
What you need to know before taking Levitra
How to take Levitra
Possible side effects
How to store Levitra
Contents of the pack and other information

1. What Levitra is and what it is used for

Levitra contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition that causes difficulty in achieving or maintaining an erection. At least one man in ten occasionally experiences difficulty in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, insufficient 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 a chemical substance in the body that causes the erection to subside. Levitra enables you to achieve and maintain an erection long enough to complete sexual intercourse satisfactorily.

2. What you should 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). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath.
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers 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 lower 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 old 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 heart attack.
If you have, or have had, low blood pressure.
If there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
If you have ever had a condition characterized by sudden vision loss due to damage to the optic nerve from insufficient blood flow, 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 due to blood clots). PDE5 inhibitors such as Levitra have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform 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 inherited heart diseases that affect the electrocardiogram.
If you have a physical condition that causes changes in the shape of the penis. These include conditions known as curvature, Peyronie’s disease, and cavernosal fibrosis.
If you have a disease that may cause prolonged 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 erection difficulties, including Levitra orodispersible tablets (see section Other medicines and Levitra).
Serious 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 indicating these serious skin reactions described in section 4.
If you experience a sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use in 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, including those obtained without a prescription.
Some medicines may cause problems, particularly the following:

Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Levitra could dangerously lower 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 combination with other treatments for erectile dysfunction, including Levitra orodispersible tablets.
Levitra with food, drinks and alcohol

You may take Levitra with or without food – but preferably not after a heavy or high-fat meal, as this may delay its effect.
Do not drink grapefruit juice when taking Levitra. It may interfere with the medicine’s effect.
Alcoholic beverages may worsen erection difficulties.

Pregnancy and breastfeeding
Levitra is not intended for use in women.
Driving and using machines
In some people, Levitra may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Levitra, do not drive or operate tools or machinery.

3. How to take Levitra

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take one tablet of Levitra approximately 25 to 60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking Levitra and up to four to five hours afterwards.

Swallow the tablet with a glass of water.

Do not take Levitra film-coated tablets together with any other formulation of Levitra.
Do not take Levitra more than once a day.
If you feel that the effect of Levitra is too strong or too weak, talk to your doctor.
Your doctor may advise you to take an alternative formulation of Levitra with a different dosage, depending on how the medicine affects 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 how to use this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent reduction or loss of vision, or distorted, blurred or fuzzy vision in one or both eyes. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain and problems with cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral bleeding) have been reported in men taking vardenafil. Many of the men who experienced these side effects already had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing a side effect is described using 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
Stuffy or runny nose
Indigestion

Uncommon:
may affect up to 1 in 100 users

Swelling of the skin and mucous membranes, including swelling of the face, lips or throat
Sleep disturbance
Numbness and reduced tactile sensation
Drowsiness
Visual disturbances, red eyes, disturbances in colour perception, eye pain and discomfort, sensitivity to light
Ringing in the ears, dizziness
Rapid heartbeat or pounding heart
Shortness of breath
Nasal congestion
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, malaise (nausea), dry mouth
Increased levels of liver enzymes in the blood
Rash, red skin
Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness
Prolonged erections
Malaise

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

Inflammation of the eyes (conjunctivitis)
Allergic reaction
Anxiety
Fainting
Memory loss (amnesia)
Seizure
Increased eye pressure (glaucoma), increased tear production
Effects on the heart (such as heart attack, irregular heartbeat or angina)
High or low blood pressure
Nosebleeds
Effects on liver function test results
Skin sensitivity to sunlight
Painful erections
Chest pain
Temporary reduction in blood flow to parts of the brain

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

Blood in the urine (haematuria)
Bleeding from the penis (penile haemorrhage)
Blood in the semen (haemospermia)
Sudden death
Cerebral haemorrhage
Flat, non-elevated red target-like or circular skin rashes on the trunk, often with central blisters, peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
Distorted, blurred or fuzzy central vision or sudden vision loss

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via 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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater 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 substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
The other components are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica. 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 10 mg is an orange, film-coated tablet marked with the BAYER cross on one side and the dosage (10) on the other. Packs containing 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel: +370 523 36 868

България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359-(0)2- Tél/Tel: +32-(0)2-535 63 11

Česká republika Magyarország
Bayer s.r.o. Bayer Hungária KFT
Tel: +420 266 101 111 Tel.: +36 14 87-4100

Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf: +45 45 23 50 00 Tel: +35 621 44 62 05

Deutschland Nederland
Jenapharm GmbH & Co. KG Bayer B.V.
Tel: +49 (0)3641- 87 97 444 Tel: +31-(0)23 799 1000

Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 85 65 Tlf: +47-23 13 05 00

Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges. m. b. H.
Τηλ: +30 210 61 87 500 Tel: +43-(0)1-711 46-0

España Polska
Bayer Hispania S.L. Bayer Sp. z o.o.
Tel: +34-93-495 65 00 Tel.: +48 22 572 35 00

France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert) : +33-(0)800 87 54 54 Tel: +351 21 416 42 00

Hrvatska România
Bayer d.o.o. SC Bayer SRL.
Tel: + 385-(0)1-6599 900 Tel: +40-21-529 59 00

Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 (0)1 58 14 400

Ísland Slovenská republika
Icepharma hf. Bayer, spol. s r.o.
Sími: +354-540 8000 Tel: +421 2-59 21 31 11

Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 81 Puh/Tel: +358-20 785 21

Κύπρος Sverige
NOVAGEM Limited Bayer AB
Τηλ: +357 22 48 38 58 Tel: +46 (0)8 580 223 00

Latvija United Kingdom (Northern Ireland)
SIA Bayer Bayer AG
Tel: +371 67 845 563 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.

Package leaflet: Information for the user

Levitra 20 mg film-coated tablets

vardenafil
Please read this entire leaflet carefully before taking this medicine, as 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levitra is and what it is used for
What you need to know before taking Levitra
How to take Levitra
Possible side effects
How to store Levitra
Contents of the pack and other information

1. What Levitra is and what it is used for

Levitra contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition characterized by difficulty in achieving or maintaining an erection. At least one in ten men occasionally experiences difficulty in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, an insufficient amount of blood is retained in the penis to allow and sustain 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 a chemical substance naturally present in the body that causes the end of an erection. Levitra enables men to achieve and maintain an erection long enough to complete sexual intercourse satisfactorily.

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). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath.
If you have ever developed a severe skin rash, peeling, blisters, and/or mouth ulcers 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 lower 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 old 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 heart attack.
If you have, or have had, low blood pressure.
If there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
If you have ever had a condition characterized by sudden vision loss due to damage of the optic nerve from 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 due to blood clots). PDE5 inhibitors such as Levitra have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform 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 inherited heart diseases that affect the electrocardiogram.
If you have a physical condition that causes changes in the shape of the penis. These include conditions known as curvature, Peyronie's disease, and cavernosal fibrosis.
If you have a disease that may cause prolonged erections ( priapism ), such as sickle cell anemia, multiple myeloma, or leukemia.
If you have stomach ulcers (also known as gastric or peptic ulcers).
If you have a bleeding disorder (such as haemophilia).
If you are using other treatments for erection 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 help if you notice any symptoms indicating these severe skin reactions described in section 4.
If you experience a sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Levitra, stop taking Levitra and contact your doctor immediately.

Children and adolescents
Levitra is not intended for use in 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, including those without a prescription.

Some medicines can cause problems, especially:

Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these together with Levitra could dangerously lower 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 combination with other treatments for erectile dysfunction, including Levitra orodispersible tablets.
Levitra with food, drinks and alcohol

You may take Levitra with or without food – but preferably not after a heavy or high-fat meal, as this may delay its effect.
Do not drink grapefruit juice when taking Levitra. It may interfere with the medicine's effect.
Alcoholic beverages may worsen erection difficulties.

Pregnancy and breastfeeding
Levitra is not intended for use in women.
Driving and using machines
In some people, Levitra may cause dizziness or affect vision. If you feel dizzy or notice vision problems after taking Levitra, do not drive or operate tools or machinery.

3. How to take Levitra

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

Swallow the tablet with a glass of water.

Do not take the film-coated tablets of Levitra together with any other formulation of Levitra.
Do not take Levitra more than once a day.
If you feel that the effect of Levitra is too strong or too weak, consult your doctor.
Your doctor may advise you to take an alternative formulation of Levitra with a different dosage, depending on how the medicine affects 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 questions 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 everyone will experience them.
The side effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent reduction or loss of vision, or distorted, blurred or fuzzy vision in one or both eyes. Stop taking Levitra and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and problems with cerebral circulation (including 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 pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing a side effect is described using the following categories:

Very common:
may affect more than 1 in 10 people

Headache

Common:
may affect up to 1 in 10 people

Dizziness
Flushing
Nasal congestion 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 disorders
Numbness and reduced tactile sensation
Drowsiness
Visual disturbances, red eyes, disturbances in colour perception, eye pain and discomfort, light sensitivity
Ringing in the ears, vertigo
Rapid heartbeat or pounding heart sensation
Shortness of breath
Nasal congestion
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, malaise (nausea), dry mouth
Increased levels of liver enzymes in the blood
Skin rash, flushed skin
Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) 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
Seizure
Increased eye pressure (glaucoma), increased tear production
Effects on the heart (such as heart attack, irregular heartbeat or angina)
High or low blood pressure
Nosebleeds
Effects on liver function test results
Skin sensitivity to sunlight
Painful erections
Chest pain
Temporary reduction 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 from the available data

Blood in the urine (haematuria)
Bleeding from the penis (penile haemorrhage)
Blood in the semen (haemospermia)
Sudden death
Cerebral haemorrhage
Flat, non-elevated red spots, target-like or circular rashes on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
Distorted, blurred or fuzzy central vision or sudden decrease in vision

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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 packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater 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 substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).
The other components are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica. Film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Levitra and pack contents
Levitra 20 mg are orange, film-coated tablets marked with the BAYER cross on one side and the dosage (20) on the other. Available 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel: +370 523 36 868

България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359-(0) 2- Tél/Tel: +32-(0)2-535 63 11

Česká republika Magyarország
Bayer s.r.o. Bayer Hungária KFT
Tel: +420 266 101 111 Tel.: +36 14 87-4100

Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf: +45 45 23 50 00 Tel: +35 621 44 62 05

Deutschland Nederland
Jenapharm GmbH & Co. KG Bayer B.V.
Tel: +49 (0)3641-87 97 444 Tel: +31-(0)23 799 1000