LEV-ih-trah 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levitra 20 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

1. What you need to know before you take Levitra
2. 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 is also known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

At least one in ten men has trouble getting or keeping an erection at some time. This can be due to physical or psychological factors, or a combination of both. Whatever the cause, the result is that there is not enough blood flow to the penis to achieve and maintain an erection.

Levitra will only work when you are sexually stimulated. It works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. Levitra will not help you if you do not have erectile dysfunction. It is important to note that Levitra is not a hormone or an aphrodisiac.

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).

• 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. 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 shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

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 long QT syndrome.

• If you have a physical condition that affects the shape of your penis. This includes conditions called angulation, Peyronie's disease and cavernosal fibrosis.

• If you have an illness that can cause erections that will not go away (priapism), such as sickle cell disease, multiple myeloma or leukaemia.

• If you have a stomach ulcer or bleeding problems (such as haemophilia).
• If you are using any other treatments for erection problems.

• If you experience sudden decrease or loss of vision, 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 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, especially:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. The combination of these medicines and Levitra could cause a significant and potentially dangerous decrease in 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 enlargement of the 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, drink 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 work.

• Do not drink grapefruit juice when taking Levitra, as it may affect the efficacy of the medicine.
• Drinking alcohol may affect 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 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. Your doctor may suggest that you take a different dose of Levitra.

If you take more Levitra than you should

Taking too much Levitra may cause more side effects and may make them more severe. 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. This can be a sign of an underlying condition called NAION (non-arteritic anterior ischemic optic neuropathy). If you experience any decrease or loss of vision while taking Levitra, stop taking the medicine and seek medical help immediately.

Some patients have reported a sudden decrease or loss of hearing after taking Levitra. If you experience any decrease or loss of hearing while taking Levitra, stop taking the medicine and seek medical help immediately.

There have been reports of heart attack, stroke, irregular heartbeat, and death 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 the skin and mucous membranes, including swelling of the face, lips or throat
• Sleep disorders
• Numbness or altered sense of touch
• Somnolence
• Effects on vision, redness of the eyes, effects on colour vision, eye pain or discomfort, increased sensitivity to light

• Ringing in the ears, vertigo
• Fast or irregular heartbeat
• Difficulty breathing
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling sick (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 erection
• 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, irregular heartbeat or angina)
• High or low blood pressure
• Nosebleeds
• Abnormal liver function tests
• Sensitivity to sunlight
• Painful erection
• 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 the frequency cannot be estimated from the available data

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

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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 20 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 packaging

Levitra 20 mg film-coated tablets are orange, round, and marked with the Bayer cross on one side and the strength (20) 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 on this medicine, 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