LEVITRA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Levitra 10 mg Orodispersible Tablets

vardenafil

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Levitra and what is it used for
2. What you need to know before you take Levitra

1. How to take Levitra
2. Possible side effects
3. Storage of Levitra

1. 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. This is a condition where a man cannot achieve or maintain a penile erection sufficient for satisfactory sexual performance.

At least one in ten men has, at some point, problems achieving or maintaining an erection. This can be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel disorders lead to insufficient blood flow to 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 substance in your body that prevents erection. Levitra allows you to achieve an erection sufficient for satisfactory sexual activity.

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, swelling of the face or lips and difficulty breathing.

• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or medicines that release nitric oxide, such as amyl nitrite. Taking these medicines with Levitra may seriously affect your blood pressure.

• If you are taking ritonavir or indinavir, medicines for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.

• If you are having kidney dialysis.
• If you have had a stroke or heart attack recently.

• 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 loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).

• If you are taking riociguat, 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 caused by 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

Consult your doctor or pharmacist before taking Levitra.

Be cautious when taking Levitra

• If you have heart problems, as having sex can be a strain on your heart.
• If you have irregular heartbeats (cardiac arrhythmia) or a hereditary heart condition that affects your electrocardiogram.
• If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, and cavernosal fibrosis.
• If you have a condition that may cause 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 treatment for erection problems, including Levitra film-coated 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 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 medicines that release nitric oxide, such as amyl nitrite. Taking these medicines with Levitra can seriously affect 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 (such as benign prostatic hyperplasia).
• Riociguat.

Do not use Levitra orodispersible tablets in combination with any other form of Levitra.

Taking Levitra with food, drinks, and alcohol

• You can take Levitra orodispersible tablets with or without food, but do not take this medicine with liquid. Do not drink grapefruit juice when taking Levitra, as it may interfere with the normal effect of the medicine.
• Drinking alcohol can make erection problems worse.

Pregnancy and breastfeeding

Levitra should not be used in women.

Driving and using machines

In some people, Levitra can cause dizziness or affect vision. Do not drive or use tools or machines if you feel dizzy or have problems with your vision after taking Levitra.

Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol

• Aspartame: This medicine contains 1.80 mg of aspartame in each 10 mg orodispersible tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• Sorbitol: This medicine contains 7.96 mg of sorbitol in each 10 mg orodispersible tablet.

3. How to take Levitra

Take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist. 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.

• Do not remove the orodispersible tablet from the blister pack until you are ready to take it. With dry hands, gently press the blister to release the tablet into your hand. Do not break the tablet.

• Place the orodispersible tablet in your mouth, on your tongue, where it will dissolve in seconds, and then swallow with your saliva. The orodispersible tablet should be taken without any liquid.

Do not take Levitra orodispersible tabletswith any other form of Levitra.

Do not take Levitramore than once a day.

If you feel that the effect of Levitra is too strong or too weak, tell your doctor. He or she may suggest 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 may cause intense back pain. 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 or partial loss of vision, temporary or permanent, 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, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary disruption of blood flow to parts of the brain and cerebral hemorrhage) in men taking vardenafil. Most of these men had pre-existing heart problems before taking this medicine. 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 disorders

• Numbness and altered sense of touch
• Somnolence
• Effects on vision, eye redness, effects on color vision, eye pain and discomfort, photosensitivity
• Ringing in the ears, vertigo

• Increased heart rate or palpitations
• 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 malaise

Rare side effects:

may affect up to 1 in 1,000 people

• Eye inflammation (conjunctivitis)

• Allergic reaction

• Anxiety

• Fainting

• Amnesia (memory loss)

• Seizures

• Increased intraocular pressure (glaucoma), increased tearing

• Effects on the heart (such as heart attack, irregular heartbeat, or angina)

• High or low blood pressure

• Nosebleeds

• Abnormal liver function test results
• Skin sensitivity to sunlight

• Painful erection

• Chest pain

• Temporary disruption of blood flow to parts of the brain

Very rare or unknown frequency side effects:

may affect less than 1 in 10,000 people or the frequency cannot be estimated from the available data

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this package 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 packaging after "EXP". The expiry date refers to the last day of the month stated.

Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levitra

• The active ingredient is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
• The other components are:

Magnesium stearate, aspartame (E951), peppermint flavor, mannitol (E421), sorbitol (E420), crospovidone, and hydrated silica. See section 2 "Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol".

Appearance of the Product and Package Contents

Levitra 10 mg orodispersible tablets are white, round. They are available in packs of:

1 x 1 orodispersible tablet in a perforated unit dose alu/alu blister,

2 x 1 orodispersible tablets in perforated unit dose alu/alu blisters,

4 x 1 orodispersible tablets in perforated unit dose alu/alu blisters,

8 x 1 orodispersible tablets in perforated unit dose alu/alu blisters.

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 medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of Last Revision of this Leaflet {Month YYYY} Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu