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, used to treat erectile dysfunction in adult men, a condition which means that the man cannot achieve or maintain an erection.

At least one in ten men has, at some time, problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel changes can lead to insufficient blood in the penis 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 that makes it difficult to maintain 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 (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 may seriously lower 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 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. 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 that they increase the effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Levitra.

Be cautious when taking Levitra

• If you have heart problems, as having sex can put extra strain on your heart.
• If you have irregular heartbeats (arrhythmias) or a family history of heart problems that affect your heartbeat.
• If you have a physical condition that affects the shape of your penis, such as 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 known as gastric or peptic ulcers).
• If you have bleeding disorders (such as hemophilia).

• If you are using any other treatments for erection problems, including Levitra orodispersible tablets (see section "Other medicines and Levitra").
• 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 using, have recently used, or might use 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 seriously lower your blood pressure.

• Medicines for treating irregular heartbeats, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, antifungal medicines.

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

Do not use Levitra film-coated tablets in combination with any other medicine for the treatment of 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 avoid taking it after a large or high-fat meal, as this may delay its effect.

• Do not drink grapefruit juice when taking Levitra, as it may interfere with the normal effect of the medicine.
• Drinking excessive amounts of alcohol can exacerbate erectile dysfunction.

Pregnancy and breastfeeding

Levitra should not be used in women.

Driving and using machines

In some people, Levitra may cause dizziness or affect 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

Follow the instructions for administration of this medicine exactly as prescribed by your doctor.

In case of doubt, consult your doctor or pharmacist again. 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 feel that the effect of Levitra is too strong or too weak, inform your doctor. He or she may suggest changing to another formulation of Levitra with a different dose, depending on your response to the medicine.

If you take more Levitra than you should

Taking too many Levitra tablets may cause more side effects and lead to a severe backache. If you have taken more Levitra than you should, consult 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 (including temporary reduction of blood flow to parts of the brain and bleeding in the brain), in men taking vardenafil. Most of these men 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 facial, lip, or throat swelling
• Sleep disturbances
• Numbness or altered sense of touch
• Drowsiness
• Effects on vision, eye redness, effects on color vision, eye pain, or discomfort, increased sensitivity to light

• Ringing in the ears, vertigo
• 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
• Skin rash, skin redness
• Back pain or muscle pain, increased muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness

• Prolonged erection
• General feeling of being unwell

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 reduction of 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 experience 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 the 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

Composition of Levitra

• 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 of the product and packaging

Levitra 10 mg film-coated tablets are orange, 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 authorization holder and manufacturer

Marketing authorization holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For further information, please contact your 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