Levitra

• Treats symptoms of erectile dysfunction
• Tablet for oral use
• Effective within about 30 minutes
• Can cause dizziness/blurred vision

Levitra is a treatment for erectile dysfunction (ED). This medicine reduces the action of the natural chemical in your body which makes erections go away. This allows an erection to last long enough for you to satisfactorily complete sexual activity. Levitra contains the active substance vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. These medicines will only work when you are sexually stimulated.

You should take the tablet about one hour before you plan to have sex. With sexual stimulation, you may achieve an erection after about 30 minutes of taking the tablet. It may take longer for Levitra to take effect if it is taken with food. Do not drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.

Levitra allows you to achieve an erection up to four to five hours.

Dosage

The general dosage guidelines are as follows:

• Adult men: maximum of one tablet a day.

This ED medicine is not intended for use by children or adolescents under 18 years of age.

Alcohol/driving

Limit or stop drinking alcohol while using Levitra. Alcoholic drink can make erection difficulties worse.

This medicine may cause dizziness and blurred vision. Do not drive or use machinery if you experience these symptoms.

If you use more Levitra than you should

If you take more Levitra than you were told to, contact your doctor or pharmacist. Men who take too much Levitra may experience more side effects or may get severe back pain.

Do not take Levitra if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Levitra contains'). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
• You are taking any form of nitrate medication such as glyceryl trinitrate, commonly used for angina pectoris or products that release nitrogen monoxide, such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure.
• You are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infection.
• You are over 75 years of age and are taking ketoconazole or itraconazole, antifungal medicines.
• You have a severe heart or kidney problem.
• You are having kidney dialysis.
• You have recently had a stroke or heart attack.
• You have, or have had, low blood pressure.
• Your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• You have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as nonarteritic ischemic optic neuropathy (NAION).
• You are taking riociguat, a medicine used to treat pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Levitra, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

When should this medicine be used with caution?

Levitra should be used with caution if:

• You have heart problems. It may be risky for you to have sex.
• You suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
• You have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
• You have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
• You have stomach ulcers (also called gastric or peptic ulcers).
• You have a bleeding disorder (such as haemophilia).
• You are using any other treatments for erection difficulties. This includes 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.

Pregnancy and breastfeeding

This medicine is not for women.

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, herbal medicines or other natural products.

Some medicines may cause problems, especially these:

• Nitrates, medicines for angina or nitric oxide donors, such as amyl nitrite ('poppers)'. Taking these medicines with Levitra could seriously affect your blood pressure.
• Medicines for an irregular heartbeat (arrhythmia), such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alphablockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
• Riociguat.

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

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Serious side effects:

Patients who have taken Levitra have experienced partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. If this happens, stop using this medicine and contact your doctor immediately.

Sudden decrease or loss of hearing has been experienced by users.

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

Other side effects:

Very common (may affect more than 1 in 10 people):

• Headache.

Common (may affect up to 1 in 10 people):

• Dizziness.
• Facial flushing.
• Blocked nose or runny nose.
• Indigestion.

Uncommon (may affect up to 1 in 100 people):

• Swelling of the face, mouth, lips, throat or neck.
• Sleep problems.
• Numbness, reductions of sensation to pain or touch.
• Sleepiness.
• Problems with your sight, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity.
• Ringing in the ears (tinnitus), a spinning sensation when standing or sitting (vertigo).
• Fast heartbeat or pounding heart.
• Breathlessness.
• Nasal congestion.
• Acid reflux, inflamed stomach (gastritis), stomach pain, diarrhoea, vomiting, nausea, dry mouth.
• Elevated liver enzymes in the blood.
• Rash, reddened skin.
• Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness.
• Prolonged erections.
• Malaise (feeling unwell).

More side effects have been reported. For a complete list of side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance is vardenafil. Each 5-mg tablet contains 5 mg of vardenafil (as hydrochloride trihydrate).

Read the package leaflet before use. The official package leaflet of Levitra is available for download here.