Levitra 10mg film-coated tablets

Read all of this leaflet carefully before you start using 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.

What is in this leaflet

1. What Levitra is and what it is used for
2. What you need to know before you take Levitra
3. How to take Levitra
4. Possible side effects
5. How to store Levitra
6. Contents of the pack and other information

Do not take Levitra

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
• If you are taking medicines containing nitrates, such as glycerol 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 used to treat human immunodeficiency virus (HIV) infections.
• If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal 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 or have had low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Levitra.

Take special care with Levitra

• If you have heart trouble. It may be risky for you to have sex.
• If you suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases affecting your electrocardiogram.
• If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
• If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have a bleeding disorder (such as haemophilia).
• If you are using any other treatments for erection difficulties, including Levitra orodispersible tablets. (see section: Other medicines and Levitra).
• If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor immediately.

Children and adolescents

Levitra is not intended for use by children or adolescents under 18.

Other medicines and Levitra

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Some medicines may cause problems, especially these:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure. Talk to a doctor without taking Levitra.
• Medicine for the treatment of arrythmias, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV. Talk to a doctor without taking Levitra.
• Ketoconazole or itraconazole, anti-fungal medicines
• Erythromycin or clarithromycin, macrolide antibiotics
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).

Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, including Levitra orodispersible tablets.

Taking Levitra with food and drink

• You can take Levitra with or without food – but preferably not after a heavy or high-fat meal as this may delay the effect.
• Don’t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.
• Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Levitra is not for use by women.

Driving and using machines

Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don’t drive or operate any tools or machines.

If you take more Levitra than you should

Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra than you should, tell your doctor.

What Levitra contains

• The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride ).
• The other ingredients of the tablets are:
  Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
  Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).

What Levitra looks like and contents of the pack

Levitra 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.