LEVİTRA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levitra 10 mg Film-Coated Tablets

vardenafil

Read all of 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Levitra and what is it used for
2. What you need to know before you take Levitra
3. How to take Levitra

1. Possible side effects
2. Storage of Levitra
3. Contents of the pack and further information

1. What is Levitra and what is it used for

Levitra contains vardenafil, which belongs to a group of medicines called phosphodiesterase 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition which means that a man cannot achieve or maintain a penile erection sufficient for satisfactory sexual performance.

At least one in ten men has occasional problems with their penis getting hard, either all or most of the time. This can be caused by psychological, physical or emotional issues, or a combination of these. Regardless of the cause, phosphodiesterase type 5 inhibitors like Levitra work by increasing blood flow to the penis to help a man get and keep an erection when he is sexually stimulated.

Levitra will only work when you are sexually stimulated. It reduces the action of a natural chemical in your body called phosphodiesterase type 5, which is involved in terminating erections. This allows an erection to last long enough for satisfactory sexual intercourse.

2. What you need to know before you take 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 rash, itching, swollen face or lips and shortness of breath.

• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.

• If you are taking ritonavir or indinavir, medicines for HIV.
• If you are over 75 years old and are taking ketoconazol or itraconazol, antifungal medicines.
• If you have a severe heart or liver problem.
• If you are on kidney dialysis.

• If you have recently had a stroke or heart attack.
• If you have low blood pressure.

• If you have a family history of degenerative eye disorders (such as retinitis pigmentosa).
• If you have ever had a loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).

• If you are taking riociguat, a medicine for high blood pressure in the lungs.

Warnings and precautions

Before taking Levitra, tell your doctor if you have:

Be cautious with Levitra

• If you have heart problems. Sex can be a strain on your heart, especially if you have heart problems.
• If you have an irregular heartbeat (arrhythmia) or a condition called QT prolongation, affecting your heart rhythm.
• If you have a physical condition that affects the shape of your penis. This includes conditions called angulation, Peyronie's disease or cavernosal fibrosis.
• If you have a condition that may lead to prolonged erections, such as sickle cell anemia, multiple myeloma or leukemia.
• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have bleeding disorders (such as hemophilia).

• If you are using any other treatments for erection problems.
• If you experience sudden loss of vision in one or both eyes, stop taking Levitra and contact your doctor immediately.

Children and adolescents

Levitra should not be used in children and adolescents under 18 years of age.

Other medicines and Levitra

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially:

• Nitrates, medicines for angina pectoris or nitric oxide donors, such as amyl nitrite. The combination of these medicines and Levitra could cause a significant drop in your blood pressure.

• Medicines for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazol or itraconazol, antifungal medicines.

• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlarged prostate (as in benign prostatic hyperplasia).
• Riociguat.

Do not take Levitra film-coated tablets in combination with another medicine for erectile dysfunction, including Levitra orodispersible tablets.

Taking Levitra with food, drinks and alcohol

You can take Levitra with or without food, but if you have a meal with a high fat content, it may take longer for Levitra to start working.

• Do not drink grapefruit juice when taking Levitra, as it may affect the efficacy of the medicine.
• Drinking alcohol may impair your ability to get an erection.

Pregnancy and breast-feeding

Levitra is not for use by women.

Driving and using machines

Levitra may cause dizziness or affect your vision. Do not drive or operate machinery if you feel dizzy or have any problems with your vision after taking Levitra.

3. How to take Levitra

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

The recommended dose is 10 mg.

Take a Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation, you may achieve an erection from 25 minutes up to 4-5 hours after taking Levitra.

• Swallow the tablet with water

Do not take Levitra film-coated tabletswith any other formulation of Levitra.

Do not take Levitramore than once a day.

If you think that the effect of Levitra is too strong or too weak, talk to your doctor.

If you take more Levitra than you should

Taking too many Levitra tablets may cause more side effects. If you take more Levitra than you should, tell your doctor.

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

4. Possible side effects

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

Some patients have reported a sudden decrease or loss of vision in one or both eyes after taking Levitra. If you experience a sudden loss of vision, stop taking Levitra and contact your doctor immediately.

There have also been reports of a sudden decrease or loss of hearing in one or both ears after taking Levitra.

There have been reports of sudden death, fast or irregular heartbeats, heart attack, chest pain and temporary decreases or losses of blood flow to parts of the brain (including stroke and "mini-stroke" or transient ischemic attack) in men taking vardenafil. Most of the men who experienced these side effects had pre-existing heart problems. It is not possible to determine whether these events were directly related to vardenafil.

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

Very common side effects:

may affect more than 1 in 10 people

• Headache

Common side effects:

may affect up to 1 in 10 people

• Dizziness
• Flushing

• Nasal congestion
• Indigestion

Uncommon side effects:

may affect up to 1 in 100 people

• Swelling of skin and mucous tissue, including swelling of face, lips or throat
• Sleep disorders
• Numbness or altered sense of touch
• Somnolence
• Effects on vision, redness of the eyes, effects on color vision, eye pain or discomfort, increased sensitivity to light

• Ringing in the ears, dizziness
• Fast or irregular heartbeat
• Difficulty breathing
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth

• Increased liver enzymes in the blood
• Rash, redness of the skin
• Back pain or muscle pain, increased muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness

• Prolonged erections
• General malaise

Rare side effects:

may affect up to 1 in 1,000 people

• Eye inflammation (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Memory loss (amnesia)
• Seizures
• Increased pressure in the eye (glaucoma), increased tearing
• Heart problems (such as heart attack, abnormal heart rhythm or angina)
• High or low blood pressure
• Nosebleeds
• Abnormal liver function tests
• Sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary decrease in blood flow to parts of the brain

Very rare or not known side effects:

may affect less than 1 in 10,000 people or frequency cannot be estimated from the available data

• Blood in urine (hematuria)
• Bleeding from the penis (penile hemorrhage)
• Blood in the semen (hematospermia)
• Sudden death
• Stroke

Reporting of side effects

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

5. Storage of 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 carton after "EXP". The expiry date refers to the last day of that month.

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

6. Contents of the pack and further information

What Levitra contains

• The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).

• The other ingredients are:

In the tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.

In the film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance and contents of the pack

Levitra 10 mg film-coated tablets are orange, round, biconvex and marked with the Bayer cross on one side and the strength (10) on the other. Each pack contains 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, please contact your local representative:

Date of last revision of this leaflet {month, year} Other sources of information

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