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 means that a man cannot achieve or maintain a penile erection sufficient for satisfactory sexual performance.

At least one in ten men has trouble getting or keeping an erection at some time. This can be due to physical or psychological causes, or a combination of both. Regardless of the cause, the muscular and vascular effects of the condition lead to insufficient blood flow to the penis, resulting in an inability to achieve or 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, which is involved in terminating the erection.

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.

• 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 having 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 diseases (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:

• Heart problems, as sexual activity may put a strain on your heart.

• Irregular heartbeats (arrhythmias) or a condition called QT prolongation, or if you are taking medicines that may affect your heart rhythm.

• A physical condition that may affect the shape of your penis, such as angulation, Peyronie's disease, or cavernosal fibrosis.

• A condition that may cause prolonged erections, such as sickle cell anemia, multiple myeloma, or leukemia.

• Stomach ulcers (also known as gastric or peptic ulcers).
• Bleeding disorders (such as hemophilia).
• If you are using any other treatments for erectile dysfunction.

• If you experience sudden 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 if taken with Levitra. These include:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite.

• Medicines for treating 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 group of medicines used to treat high blood pressure and enlarged prostate.

• 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 it is best to take it without a 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 excessive amounts of alcohol may exacerbate erectile dysfunction.

Pregnancy and breastfeeding

Levitra should not be used 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

Take Levitra exactly as your doctor has prescribed.

If you are unsure, consult your doctor or pharmacist. The recommended dose is 10 mg.

Take a Levitra tablet 25-60 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 think that the effect of Levitra is too strong or too weak, talk to your doctor. Your doctor may suggest changing to a different formulation of Levitra with a different dose.

If you take more Levitra than you should

Taking too many Levitra tablets may cause more side effects or make them worse. If you have taken more Levitra than you should, talk to 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 experienced a sudden loss of vision in one or both eyes. Stop taking Levitra and contact your doctor immediately.

There have also been reports of sudden loss of hearing.

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

The likelihood of experiencing side effects may be described using the following frequencies:

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
• Drowsiness
• 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 heartbeats
• Difficulty breathing
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling sick (nausea), dry mouth

• 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 erections
• General malaise

Rare side effects:

may affect up to 1 in 1,000 people

• Eye inflammation (conjunctivitis)
• Allergic reactions
• Anxiety
• Fainting
• Memory loss (amnesia)
• Seizures
• Increased pressure in the eye (glaucoma), increased tearing
• Heart problems (such as heart attack, irregular heartbeats, or angina)
• High or low blood pressure
• Nosebleeds
• Abnormal liver function tests
• Sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary disturbance in the circulation of blood 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
• 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.

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 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, colloidal anhydrous 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