Vizarsin - patient leaflet, side effects, dosage

1. What Vizarsin is and what it is used for

Vizarsin contains the active substance sildenafil which 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.

Vizarsin is a treatment for adult 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.

2. What you need to know before you take Vizarsin

Do not take Vizarsin

• – If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section

• 6).

• – If you are taking medicines called nitrates, as the combination may lead to a dangerous fall 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 medicines known as nitric oxide donors such as amyl nitrite

(“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.

• – 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 Vizarsin have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• – 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking Vizarsin:

• – 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 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.

You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.

You should not take Vizarsin if you do not have erectile dysfunction.

You should not take Vizarsin if you are a woman.

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.

Children and adolescents

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

Other medicines and Vizarsin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Vizarsin tablets may interfere with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should tell your doctor, pharmacist or nurse 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 medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor, pharmacist or nurse 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 medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.

Tell your doctor or pharmacist if you are already taking riociguat.

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 happen within 4 hours after taking Vizarsin. To reduce the chance that these symptoms might happen, 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.

Vizarsin with food, drink and alcohol

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.

Vizarsin contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Vizarsin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended 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 feel 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of Vizarsin are usually mild to moderate and of a short duration.

If you experience any of the following serious side effects stop taking Vizarsin and seek medical help immediately:

• – An allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people)

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

• – Chest pains – this occurs uncommonly

If this occurs during or after intercourse:

• – Get in a semi-sitting position and try to relax.

• - Do not use nitrates to treat your chest pain.

• – Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000

people)

If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

• – A sudden decrease or loss of vision - this occurs rarely

• – Serious skin reactions - this occurs rarely

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.

• – Seizures or fits – this occurs rarely

Other side effects:

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

Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.

Rare (may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.

From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely. Of note, most but not all, 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 Vizarsin.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5. How to store Vizarsin

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 box and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Vizarsin contains

• – The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent

to 25 mg sildenafil.

• – The other ingredients are:

What Vizarsin looks like and contents of the pack

Vizarsin 25 mg film-coated tablets are white, oblong and marked “25” on one side.

Vizarsin 25 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 × 1, 8 × 1 or 12 × 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, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

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

Lietuva

UAB KRKA Lietuva

Tél/Tel: + 32 (0) 487 50 73 62

Luxembourg/Lu­xemburg

KRKA Belgium, SA.

Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Magyarország

KRKA Magyarország Kereskedelmi Kft.

Tel.: + 36 (1) 355 8490

Malta

E. J. Busuttil Ltd.

Tel: + 356 21 445 885

Nederland

KRKA Belgium, SA.

Tel: + 32 (0) 487 50 73 62 (BE)

Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Österreich

KRKA Pharma GmbH, Wien

Tel: + 43 (0)1 66 24 300

Polska

KRKA-POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500

Portugal

KRKA Farmacéutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

Romania

KRKA Romania S.R.L., Bucharest

Tel: + 4 021 310 66 05

Slovenija

KRKA, d.d., Novo mesto

Tel: + 386 (0) 1 47 51 100

Slovenská republika

KRKA Slovensko, s.r.o.

Tel: + 421 (0) 2 571 04 501

Suomi/Finland

KRKA Finland Oy

Puh/Tel: + 358 20 754 5330

Sverige

KRKA Sverige AB

Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom (Northern Ireland)

Consilient Health Limited

Tel: + 353 (0)1 2057760

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: