LEVİTRA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levitra 5 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

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 other 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 condition occurs when a man cannot achieve or maintain an erection.

At least one in ten men has, at some point, experienced problems with achieving or maintaining an erection. This can be due to either physical or psychological factors, or a combination of both. Regardless of the cause, muscle and blood vessel changes in the penis lead to insufficient blood flow to achieve and maintain an erection.

Levitra will only work when you are sexually stimulated. This medicine reduces the action of a natural chemical in your body called phosphodiesterase type 5 (PDE5), which relaxes the muscle in the blood vessels of the penis and increases blood flow.

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.

• 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 severe heart or liver problems.
• 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 especially cautious when taking 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 an illness that can cause erections that will not go away (priapism), such as sickle cell anemia, multiple myeloma, or leukemia.

• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have bleeding problems (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 if taken with Levitra. These include:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect 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 enlargement of the prostate (as in benign prostatic hyperplasia).

• Riociguat.

Do not take Levitra film-coated tablets with another medicine called Levitra orodispersible tablets.

Taking Levitra with food, drinks, and alcohol

You can take Levitra with or without food, but it is best to take it without a large or high-fat meal, as this may delay the effect.

• 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 breastfeeding

Levitra is not for use in 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 vision problems 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 a glass of water.

Do not take Levitra film-coated tabletswith 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, talk to your doctor.

If you take more Levitra than you should

Taking too much Levitra may cause more side effects or make them worse. If you have taken 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. Stop taking Levitra and contact your doctor immediately.

There have also been reports of a sudden decrease or loss of hearing.

There have been reports of sudden death, fast or irregular heartbeat, heart attack, chest pain, and stroke in men taking vardenafil. Most of these men had pre-existing heart problems.

The likelihood of experiencing side effects varies from person to person. The following side effects have been reported:

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, eye redness, effects on color vision, eye pain, or discomfort

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

• Increased liver enzymes in the blood
• Skin 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 tear production
• Heart problems (such as heart attack, irregular heartbeat, or angina)
• High or low blood pressure
• Nosebleeds
• Changes in liver function tests
• Sensitivity to sunlight
• Painful erection
• Chest pain
• Temporary decrease in blood flow to parts of the brain

Very rare or unknown 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.

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 other information

What Levitra contains

• The active substance is vardenafil. Each tablet contains 5 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 5 mg film-coated tablets are orange, with the Bayer cross on one side and the strength (5) on the other. Each pack contains 2, 4, 8, 12, or 20 tablets. 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 on this medicine, contact the local representative of the marketing authorization holder.

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