Vardenafil

• Used to treat erectile dysfunction
• Effective within about 30 minutes
• Only works with sexual stimulation
• Caution with alcohol and grapefruit juice

Vardenafil is an erection pill. This medicine is used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection. Vardenafil does not cure erectile dysfunction but can improve your ability to get an erection. The active ingredient reduces the action of the natural chemical in your body which makes erections go away. Vardenafil allows an erection to last long enough for you to satisfactorily complete sexual activity.

Vardenafil will only work when you are sexually stimulated. Vardenafil will not help you if you do not have erectile dysfunction and is not intended for use by children or adolescents under 18 years.

Vardenafil tablets should be taken 25 to 60 minutes before sexual activity. The tablet should be swallowed with a drink of water. It may take longer for the tablet to take effect if it is taken with food. Do not have grapefruits or grapefruit juice while taking Vardenafil. Grapefruit is known to intensify the side effects of this medicine.

With sexual stimulation, you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vardenafil.

Dosage

The recommended dose is 10 mg. Do not use Vardenafil more than once a day.

Alcohol/driving

Limit or stop drinking alcohol while taking this medicine. Alcohol can intensify the side effects of this medicine. Drinking alcohol may also decrease your ability to get an erection.

Vardenafil might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Vardenafil, do not drive or operate any tools or machines.

If you use more Vardenafil than you should

If you take more Vardenafil tablets than you were told to, consult your doctor or pharmacist.

Vardenafil tablets are not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Vardenafil contains').
• 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.
• You are taking ritonavir or indinavir, medicines used to treat 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 non-arteritic 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).

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking Vardenafil 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 a stomach ulcer.
• You have a bleeding disorder (such as haemophilia).
• You are using any other treatments for erection difficulties, including Vardenafil orodispersible tablets (see section ‘Other medicines and Vardenafil’).
• If you experience sudden decrease or loss of vision, stop taking Vardenafil and contact your doctor immediately.

Pregnancy and breastfeeding

Vardenafil is not for women.

Other medicines and Vardenafil

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Vardenafil is known to interact with other medicines, including:

• nitrates, medicines for angina such as nicorandil or nitroglycerin, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil could seriously affect your blood pressure. Talk to your doctor or pharmacist before taking Vardenafil.
• Medicines for an irregular heartbeat (arrhythmia), such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take Vardenafil without consulting a doctor first.
• Ketoconazole or itraconazole (antifungal medicines).
• Erythromycin or clarithromycin (macrolide antibiotics used to treat bacterial infections).
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
• Riociguat.

Do not use Vardenafil tablets combined with any other treatment for erectile dysfunction. This includes Vardenafil orodispersible tablets. For more information, see the package leaflet.

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

Serious side effects:

• 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.

Other, less serious, side effects that are known to be associated with Vardenafil include:

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, sleepiness.
• Numbness, reductions of sensation to pain or touch.
• 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.
• 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), which can be seen in a blood test.
• Muscle stiffness.
• Prolonged erections.
• Feeling unwell.

Rare (may affect up to 1 in 1,000 people):

• Inflammation of the eyes (conjunctivitis).
• Allergic reactions.
• Anxiety.
• Fainting.
• Amnesia.
• Loss of consciousness accompanied by involuntary movements (convulsions).
• Raised the pressure in the eye (glaucoma), watery eyes.
• Heart problems (e.g., heart attack, changes in heart rhythm, angina).
• High or low blood pressure.
• Nose bleed.
• Abnormalities seen on liver function tests.
• Increased sensitivity of the skin to sunlight.
• Painful erections.
• Chest pain.

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

The active substance is vardenafil.

• Each Vardenafil 5-mg tablet contains 5 mg of vardenafil (as hydrochloride).
• Each Vardenafil 10-mg tablet contains 10 mg of vardenafil (as hydrochloride).
• Each Vardenafil 20-mg tablet contains 20 mg of vardenafil (as hydrochloride).

The other ingredients are:

• Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica (anhydrous).
• Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol//PEG 3350 (E1521), methacrylic acid-ethyl acrylate copolymer (1:1) Type A, iron oxide yellow (E172), sodium bicarbonate (E500 (ii)), iron oxide red (E172).

The manufacturer of Vardenafil is:

Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
ZTN 3000, Zejtun
Malta

Read the package leaflet before use.