Vizarsin 100 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vizarsin 100 mg orodispersible 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 others, even if they have the same symptoms, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 to flow in 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 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 used to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.

• If you are using any medicines known as 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 problem.

• 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult 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 must carefully assess whether your heart can tolerate the additional strain 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.

The use of Vizarsin is not recommended 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 renal or hepatic impairment

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

Consult your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Vizarsin 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.

You must not take Vizarsin if you are taking medicines called nitrates, as the combination of these medicines may lead to 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 pain (or “chest pain”).

You must not take Vizarsin if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination may also lead to 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 alpha-blockers, medicines 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 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. The tablet should be taken on an empty mouth.

Alcohol intake may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is recommended not to consume 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 aspartame (E951) and sucrose

This medicine contains 1.5 mg of aspartame per orodispersible tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

3. How to take Vizarsin

Follow exactly the instructions for use of this medicine 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.

Do not take Vizarsin orodispersible tablets at the same time as other presentations of Vizarsin.

You should take Vizarsin approximately one hour before you plan to have sexual intercourse.

Vizarsin tablets are fragile. Do not push them through the blister pack foil, as this may break the tablets. Do not handle the tablets with wet hands, as they may break. To remove a tablet, follow these steps:

For single-dose blisters:

For 4-tablet blisters:

1. Hold the blister pack by the edges and carefully tear off one unit along the perforated marks.

2. Completely peel off the foil by pulling upwards from the edge.

3. Turn the blister pack over to place the tablet on your tongue.

4. As soon as the tablet comes out, place it on your tongue.

Within seconds it will begin to disintegrate in the mouth, so it can be taken with or without water.

Your mouth must be empty before placing the tablet on your tongue.

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 from half an hour to one hour. The effect of Vizarsin may be delayed if taken after 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 adverse effects and their severity. Doses higher than 100 mg do not increase efficacy.

Do 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 can cause adverse effects, although not everyone experiences them. The adverse effects reported with the use of Vizarsin are generally mild to moderate in intensity and short in duration.

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

• Allergic reaction – this occurs uncommonly (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 uncommonly.

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, you must 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 sensation of heat 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 flashing lights, clear vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensation to touch, vertigo, tinnitus (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, throat tightness, mouth numbness, bleeding behind 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, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritability, and 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 listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vizarsin

• The active substance is sildenafil. Each orodispersible tablet contains 100 mg of sildenafil.

• The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951), neohesperidin dihydrochalcone (E959), peppermint flavour, mint flavour (sucrose), crospovidone, calcium silicate and magnesium stearate (E470b).

See section 2 “Vizarsin contains aspartame (E951) and sucrose”.

Nature of the product and contents of the pack

White or almost white, round, biconvex tablets, possibly with darker spots.

Vizarsin orodispersible tablets are available in packs of 1 orodispersible tablet in a blister, and also in packs of 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible tablets in single-dose perforated blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturers

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

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

Belgium/Belgium/BelgienLithuania

KRKA Belgium, SA. UAB KRKA Lietuva

Tél/Tel: +32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

BulgariaLuxembourg/Luxemburg

???? ???????? ???? KRKA Belgium, SA.

Te?.: + 359 (02) 962 34 50 Tél/Tel: +32 (0) 487 50 73 62 (BE)

Czech RepublicHungary

KRKA CR, s.r.o. KRKA Magyarország Kereskedelmi Kft.

Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

DenmarkMalta

KRKA Sverige AB E. J. Busuttil Ltd.

Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

GermanyNetherlands

TAD Pharma GmbH KRKA Belgium, SA.

Tel: + 49 (0) 4721 606-0 Tel: +32 (0) 487 50 73 62 (BE)

EstoniaNorway

KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB

Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

GreeceAustria

KRKA ΕΛΛΑΣ ΕΠΕ KRKA Pharma GmbH, Wien

Τηλ: + 30 2100101613 Tel: + 43 (0)1 66 24 300

SpainPoland

KERN PHARMA, S.L. KRKA-POLSKA Sp. z o.o.

Tel: + 34 93 700 25 25 Tel.: + 48 (0)22 573 7500

FrancePortugal

KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

CroatiaRomania

KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest

Tel: + 385 1 6312 100 Tel: + 4 021 310 66 05

IrelandSlovenia

KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto

Tel: + 353 1 293 91 80 Tel: + 386 (0) 1 47 51 100

IcelandSlovakia

LYFIS ehf. KRKA Slovensko, s.r.o.

Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

ItalyFinland

KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy

Tel: + 39 02 3300 8841 Puh/Tel: +358 20 754 5330

CyprusSweden

KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB

Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

LatviaUnited Kingdom

KRKA Latvija SIA Consilient Health (UK) Ltd.

Tel: + 371 6 733 86 10 Tel: + 44(0)203 751 1888

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.