Vizarsin 50 mg film-coated tablets

Vizarsin belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Vizarsin will only help you to get an erection if you are sexually stimulated. You should not take Vizarsin if you do not have erectile dysfunction. You should not take Vizarsin if you are a woman.

Vizarsin is a treatment for men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.

Do not take Vizarsin

• If you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or ?chest pain?). If you are not certain, ask your doctor or pharmacist.
• If you are using any of the drugs known as nitric oxide donors such as amyl nitrite (?poppers?), as the combination may also lead to a potentially dangerous decrease in your blood pressure.
• If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Vizarsin.
• If you have a severe heart or liver problem.
• If you have recently had a stroke or a heart attack, or if you have low blood pressure.
• If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
• If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Take special care with Vizarsin

Tell your doctor

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
• If you have a deformity of your penis or Peyronie?s Disease.
• If you have problems with your heart. Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
• If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
• If you experience sudden decrease or loss of vision, stop taking Vizarsin and contact your doctor immediately.

You should not use Vizarsin with any other oral or local treatments for erectile dysfunction.

Special considerations for children and adolescents

Vizarsin should not be given to individuals under the age of 18.

Special considerations for patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose for you.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without prescription.

Vizarsin tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell any health care professional treating your condition that you have taken Vizarsin and when you did. Do not take Vizarsin with other medicines unless your doctor tells you that you can.

You should not take Vizarsin if you are taking medicines called nitrates, as the combination of these products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist if you are taking any of these medicines that are often used for the relief of angina pectoris (or ?chest pain?).

You should not take Vizarsin if you are using any of the drugs known as nitric oxide donors such as amyl nitrite (?poppers?) as the combination may also lead to a potentially dangerous decrease in your blood pressure.

If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Vizarsin.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking Vizarsin with alpha-blockers. This is most likely to occur within 4 hours after taking Vizarsin. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start Vizarsin. Your doctor may start you on a lower dose (25 mg) of Vizarsin.

Taking Vizarsin with food and drink
Vizarsin can be taken with or without food. However, you may find that Vizarsin takes longer to start working if you take it with a heavy meal.

Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Vizarsin.

Pregnancy and Breast feeding

Vizarsin is not indicated for use by women.

Driving and using machines
Vizarsin can cause dizziness and can affect vision. You should be aware of how you react to Vizarsin before you drive or use machinery.

Important information about some of the ingredients of Vizarsin

Vizarsin contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Vizarsin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual starting dose is 50 mg.

You should not take Vizarsin more than once a day.

You should take Vizarsin about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

If you have the impression that the effect of Vizarsin is too strong or too weak, talk to your doctor or pharmacist.

Vizarsin will only help you to get an erection if you are sexually stimulated. The amount of time Vizarsin takes to work varies from person to person, but it normally takes between half an hour and one hour. You may find that Vizarsin takes longer to work if you take it with a heavy meal.

If Vizarsin does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.

If you take more Vizarsin than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase the efficacy.
You should not take more tablets than your doctor tells you to.

Contact your doctor if you take more tablets than you should.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Vizarsin can cause side effects although not everybody gets them. These effects are usually mild to moderate and of a short duration.

If you have chest pains during or after intercourse:

• Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.
• Contact your doctor immediately.

All medicines including Vizarsin can cause allergic reactions. You should contact your doctor immediately if you experience any of the following symptoms after taking Vizarsin: sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

Prolonged and sometimes painful erections have been reported after taking Vizarsin. If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking Vizarsin and contact your doctor immediately.

A very common side effect (likely to occur in more than 1 in 10 patients) is headache.

Common side effects (likely to occur in 1 to 10 patients in 100) include: facial flushing, indigestion, effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and dizziness.

Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include: vomiting, skin rash, bleeding at the back of the eye, eye irritation, bloodshot eyes /red eyes, eye pain, double vision, abnormal sensation in the eye, irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, nausea, dry mouth, chest pain and feeling tired.

Rare side effects (likely to occur in 1 to 10 patients in 10000) include: high blood pressure, low blood pressure, fainting, stroke, nosebleed and sudden decrease or loss of hearing.

Additional side effects reported from post-marketing experience include: pounding heartbeat, chest pain, sudden death, heart attack or temporary decreased blood flow to parts of the brain. Most, but not all, of these men had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to sildenafil. Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin and pain which require immediate medical attention have also been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor.

Keep out of the reach and sight of children.

Do not use Vizarsin after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage precautions.

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

What Vizarsin contains

• The active substance is sidenafil. Each film-coated tablet contains 50 mg sildenafil (as citrate).
• The other ingredients are:
• Tablet core:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (E464), magnesium stearate
• Film coat:lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin

What Vizarsin looks like and contents of the pack

Vizarsin 50 mg film-coated tablets are white, oblong and marked ?50? on one side.

Vizarsin 50 mg film-coated tablets is available in a box of 1 film-coated tablet in blister and also in boxes of 4 x 1, 8 x 1 and 12 x 1 film-coated tablet in a perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

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

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52

KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490

eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Danmark KRKA Sverige AB Tlf 46 08 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE

Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 08 643 67 66 SE

Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 597 365 Österreich KRKA Pharma GmbH, Wien Tel 43 01 66 24 300

QUALIA PHARMA S.A. 30 0210 2832941 Polska KRKA-POLSKA Sp. z o.o. Tel. 48 022 573 7500

España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650

France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE România KRKA Romania S.R.L., Bucharest Tel 402 01 310 66 05

Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100

Ísland KRKA Sverige AB Sími 46 08 643 67 66 SE Slovenská republika KRKA Slovensko, s.r.o., Tel 421 0 2 571 04 501

Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 08 643 67 66 SE

Kipa Pharmacal Ltd. 357 24 651 882 Sverige KRKA Sverige AB Tel 46 08 643 67 66 SE

Latvija KRKA, d.d., Novo mesto Tel 371 6 733 86 10 United Kingdom Consilient Health UK Ltd. Tel 44 02089562310

Lietuva

UAB KRKA Lietuva
Tel: + 370 5 236 27 40

This leaflet was last approved in