Vivanza
vardenafil
vardenafil
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.
What Vivanza is and what it is used for
What you need to know before you take Vivanza
How to take Vivanza
Possible side effects
How to store Vivanza
Contents of the pack and other information
Medicinal product no longer authorised
Vivanza contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.
At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.
Vivanza will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Vivanza allows an erection to last long enough for you to satisfactorily complete sexual activity.
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 Vivanza 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).
If you are taking riociguat. This drug 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 secondary to blood clots). PDE5 inhibitors, such as Vivanza have been
shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Talk to your doctor or pharmacist before taking Vivanza.
If you have heart trouble. It may be risky for you to have sex.
If you suffer from irregular heart beat (cardiac arrhythmia) 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 Vivanza orodispersible tablets (see section Other medicines and Vivanza).
If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor immediately.
Medicinal product no longer authorised
Vivanza is not intended for use by children or adolescents under 18.
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 Vivanza could seriously affect your blood pressure.
Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
Ritonavir or indinavir, medicines for HIV.
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).
Riociguat.
Do not use Vivanza film-coated tablets combined with any other treatment for erectile dysfunction, including Vivanza orodispersible tablets.
You can take Vivanza 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 Vivanza. It can interfere with the usual effect of the
medicine.
Alcoholic drink can make erection difficulties worse.
Vivanza is not for use by women.
Vivanza might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Vivanza don’t drive or operate any tools or machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 10 mg.
Take a Vivanza tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vivanza.
Swallow one tablet with a glass of water.
Tell your doctor if you think Vivanza is too strong or too weak. He or she may suggest a switch to an alternative vardenafil formulation with a different dose, depending on how well it works for you.
Men who take too much Vivanza may experience more side effects or may get severe back pain. If you take more Vivanza than you should, tell your doctor.
Medicinal product no longer authorised
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients. Stop taking Vivanza and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
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.
The chance of having a side effect is described by the following categories:
may affect more than 1 in 10 users
Headache
may affect up to 1 in 10 users
Dizziness
Flushing
Blocked or runny nose
Indigestion
may affect up to 1 in 100 users
Swelling of skin and mucous tissue including swollen face, lips or throat
Sleep disorder
Numbness and impaired perception of touch
Sleepiness
Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
Ringing in the ears, vertigo
Fast heart beat or pounding heart
Breathlessness
Stuffy nose
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (nausea), dry mouth
Raised levels of liver enzymes in your blood
Rash, reddened skin
Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness
Prolonged erections
Malaise
may affect up to 1 in 1,000 users
Inflammation of the eyes (conjunctivitis)
Allergic reaction
Anxiety
Fainting
Amnesia
Medicinal product no longer authorised
Seizure
Increased pressure in the eye (glaucoma), lacrimation increased
Effects on the heart (such as heart attack, altered heart beat or angina)
High or low blood pressure
Nose bleed
Effect on results of blood tests to check liver function
Sensitivity of the skin to sun light
Painful erections
Chest pain
Temporarily decreased blood flow to parts of the brain
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data
Blood in the urine (Haematuria)
Penile bleeding (Penile Haemorrhage)
Presence of blood in the semen (Haematospermia)
Sudden death
Bleeding in the brain
If you get any side effects, talk to your doctor. 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.
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 that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is vardenafil. Each tablet contains 5 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).
Vivanza 5 mg film-coated tablets are orange marked with a ‘v’ on one side and the strength (5) 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 Bayer AG
Medicinal product no longer authorised
51368 Leverkusen Germany
Manufacturer Bayer AG
Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Байер България ЕООД
Tел.: +359-(0)2-424 72 80
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Tel: +420 266 101 111
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Tel: +372 655 85 65
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Medicinal product no longer authorised
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Tél (N° vert) : +33-(0)800 87 54 54
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Tel: + 385-(0)1-6599 900
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Tel: +353 1 216 3300
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