LEV-ee-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

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, used to treat erectile dysfunction in adult men. This condition 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 causes, or a combination of both. Regardless of the cause, muscle and blood vessel changes, not enough blood in the penis, or a combination of these, can cause erectile dysfunction.

Levitra will only work when you are sexually stimulated. This medicine reduces the action of a natural chemical in your body, which is called phosphodiesterase type 5, that stops an 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. Taking these medicines with Levitra can cause a significant and potentially dangerous decrease in 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 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. Sex can be a strain on your heart, especially if you have heart problems.

• Had an irregular heartbeat (arrhythmia) or a condition called QT prolongation or you are taking medicines that prolong the QT interval.

• Ever had severe vision loss, or if you have an inherited eye condition called retinitis pigmentosa.

• Any physical condition that may cause problems with your penis or if you have had any operation to your penis.

• Any blood cell disorder such as sickle cell anaemia, multiple myeloma or leukaemia.

• Stomach ulcers (also called gastric or peptic ulcers).
• Bleeding disorders (such as haemophilia).

• If you experience sudden decrease or loss of vision or hearing, 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. Taking these medicines with Levitra can 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 enlarged prostate.

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 to work.

• Do not drink grapefruit juice when taking Levitra, as it may increase the levels of the active ingredient in your blood.

• Drinking alcohol may lower your blood pressure and this can increase the risk of dizziness when standing up.

Pregnancy and breast-feeding

Levitra is not for use in women.

Driving and using machines

Some people may feel dizzy or lightheaded after taking Levitra. If you feel dizzy or lightheaded, do not drive or operate machinery.

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 take more Levitra than you should, tell your doctor. Taking too much Levitra may cause more side effects and may increase the risk of getting a prolonged erection (more than 4 hours).

If you have any further questions on the use of this product, 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 decrease or loss of vision, stop taking Levitra and contact your doctor immediately.

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

Other reported side effects include:

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, eye redness, effects on colour vision, eye pain or discomfort, increased sensitivity to light

• Ringing in the ears, dizziness
• Fast or irregular heartbeat
• Difficulty breathing
• Blocked nose

• Acid reflux, gastritis, abdominal pain, diarrhoea, 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 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, altered heart rhythm 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 side effects (may affect less than 1 in 10,000 people):

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haematospermia)
• 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.

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 is in Levitra

• 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 contents of the pack

Levitra 20 mg film-coated tablets are orange, 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 the local representative of the marketing authorisation holder.

Date of last revision of this leaflet {month, year}

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