Vizarsin 50 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Vizarsin 50 mg film-coated tablets

sildenafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Vizarsin is and what it is used for
2. What you need to know before taking Vizarsin
3. How to take Vizarsin
4. Possible side effects
5. How to store Vizarsin
6. Contents of the pack and other information

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 dilating the blood vessels in the penis, allowing blood flow into it when you are sexually stimulated. Vizarsin will only help you achieve an erection if you are sexually stimulated.

Vizarsin is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Vizarsin

Do not take Vizarsin

• If you are allergic to sildenafil or to 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 drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often prescribed to relieve angina pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are using any nitric oxide donors such as amyl nitrate ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.

• If you are taking riociguat. This medicine 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 caused by blood clots). PDE5 inhibitors such as Vizarsin have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

• If you have a serious heart or liver condition.

• If you have recently had a stroke or heart attack, or if you have low blood pressure.

• If you have a rare inherited eye disease (such as retinitis pigmentosa).

• If you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Vizarsin:

• If you have sickle cell anemia (a red blood cell disorder), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer).

• If you have a penile deformity or Peyronie's disease.

• If you have heart problems. Your doctor should carefully assess whether your heart can tolerate the additional physical stress of sexual activity.

• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).

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

It is not recommended to use Vizarsin together with any other oral or local treatments for erectile dysfunction.

You must not take Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.

You must not take Vizarsin if you do not have erectile dysfunction. The use of Vizarsin is not indicated in women.

Special considerations in patients with kidney or liver problems

Inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Vizarsin is not indicated in individuals under 18 years of age.

Taking Vizarsin with other medicines

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

Vizarsin tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking Vizarsin and when you took it. Do not take Vizarsin with other medicines unless advised by your doctor.

Do not take Vizarsin if you are taking medicines called nitrates, as combining these medicines may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina (or "chest pain").

Do not take Vizarsin if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as combining these medicines may also cause a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Vizarsin.

Some patients taking an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking Vizarsin with alpha-blockers. This is more likely to occur within 4 hours after taking Vizarsin. To reduce the likelihood of these symptoms, you should already be on a stable daily dose of the alpha-blocker before starting Vizarsin. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Vizarsin.

Taking Vizarsin with food, drinks, and alcohol

Vizarsin can be taken with or without food. However, you may notice that Vizarsin takes longer to work if taken with a heavy meal.

Drinking alcohol may temporarily impair your ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking Vizarsin.

Pregnancy, breastfeeding, and fertility

The use of Vizarsin is not indicated in women.

Driving and using machines

Vizarsin may cause dizziness and affect vision. You should know how you react to Vizarsin before driving or operating machinery.

Vizarsin contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Vizarsin

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Vizarsin must not be taken more than once a day.

You should take Vizarsin approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you notice that the effect of Vizarsin is too strong or too weak, inform your doctor or pharmacist.

Vizarsin will only help you achieve an erection if you are sexually stimulated. The time Vizarsin takes to work varies from person to person, but generally ranges between half an hour and one hour. The effect of Vizarsin may be delayed if taken with a heavy meal.

If Vizarsin does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Vizarsin than you should

You may experience an increase in the frequency and severity of adverse effects. Doses higher than 100 mg do not increase efficacy.

You must not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. The adverse effects reported with Vizarsin are generally mild to moderate in intensity and short-lived.

If you experience any of the following serious adverse effects, stop taking Vizarsin and seek immediate medical attention:

• Allergic reaction – this occurs infrequently (may affect up to 1 in 100 people).

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

• Chest pain – this occurs infrequently.

If chest pain occurs during or after sexual activity:

• Sit in a semi-upright position and try to relax.

• Do not use nitrates to treat chest pain.

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

If you have an erection lasting more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision – this occurs rarely.

• Severe skin reactions – this occurs rarely.

Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – this occurs rarely.

Other adverse 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 (including sudden feeling of warmth in the upper body), indigestion, abnormal colour vision, blurred vision, visual disturbance, nasal congestion and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flickering lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensation to touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (including runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and feeling of fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of throat tightness, numbness of the mouth, bleeding at the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, dilatation of the pupil, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to Vizarsin.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Vizarsin Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vizarsin

• The active substance is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.

• The other components are:

See section 2 "Vizarsin contains lactose and sodium":

Appearance of the medicinal product and contents of the container

Vizarsin 50 mg film-coated tablets are white, oblong tablets, with "50" engraved on one side.

Vizarsin 50 mg film-coated tablets are available in packs containing 1 film-coated tablet in a blister, and also in packs of 4 x 1, 8 x 1 or 12 x 1 film-coated tablets in single-dose perforated blisters.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.