VIZARSIN 100 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Vizarsin 100 mg Orodispersible Tablets

sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 symptoms 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.

Contents of the pack and other information

1. What is Vizarsin and what is it used for
2. What you need to know before you take Vizarsin

1. How to take Vizarsin

1. Possible side effects
2. Storage of Vizarsin

1. Contents of the pack and other information

1. What is Vizarsin and what is it 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 of the penis, allowing blood flow when you are sexually stimulated. Vizarsin will only help you to get an erection if you are sexually stimulated.

Vizarsin is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory 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 can cause a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are using any of the medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination can cause a dangerous decrease 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 shown that they 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 a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vizarsin:

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

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

• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra strain of having sex.

• If you currently have stomach ulcers or bleeding problems (such as hemophilia).

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

It is not recommended to use Vizarsin at the same time as any other oral or local treatment for erectile dysfunction.

Do not take Vizarsin with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

Do 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

You should 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 persons under 18 years of age.

Using Vizarsin with other medicines

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

Vizarsin may interfere with some medicines, especially those used to treat chest pain. In case of 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 your doctor advises you to.

Do not take Vizarsin if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous decrease 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 pectoris (or "chest pain").

Do not take Vizarsin if you are taking medicines called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination of these medicines can also cause a dangerous decrease in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Vizarsin.

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which can be caused by a decrease 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 happen within 4 hours of taking Vizarsin. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Vizarsin. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Vizarsin.

Using Vizarsin with food, drinks, and alcohol

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

Consuming large amounts of alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended 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 can cause dizziness and affect vision. You should know how you react to Vizarsin before driving vehicles or using machines.

Vizarsin contains aspartame (E951) and sucrose

This medicine contains 1.5 mg of aspartame in each 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 is unable to eliminate it properly.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Vizarsin

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Do not take Vizarsin more than once a day.

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

You should take Vizarsin about an hour before you plan to have sex.

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

For blisters of 1 tablet:

For blisters of 4 tablets:

1. Hold the blister pack by the edges and separate one of the units by carefully tearing along the perforations.

1. Completely peel off the backing by pulling upwards from the edge.

1. Turn the blister pack over to place the tablet in your hand.
2. Once the tablet is out, place it on your tongue.

It will start to dissolve in seconds, so you can take it with or without water.

You should have an empty mouth before placing the tablet on your tongue.

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

Vizarsin will only help you to get an erection if you are sexually stimulated. The time it takes for Vizarsin to work varies from person to person, usually between half an hour and one hour. The effect of Vizarsin can be delayed if you take it with a large meal.

In the event that Vizarsin does not help you to get an erection or if the erection is not maintained for long enough to complete sexual intercourse, consult 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 efficacy.

Do not take more tablets than your doctor recommends.

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

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 short duration.

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

• Allergic reaction - this occurs with rare frequency(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 with rare frequency.

If they occur during or after sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.

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

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden decrease or loss of vision - this occurs very rarely.

• Severe skin reactions - this occurs very rarely.

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

• Seizures or fits - this occurs very 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 (including symptoms such as a sudden feeling of heat in the upper body), indigestion, abnormal color perception, 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, flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of tiredness, reduced touch sensation, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose (including symptoms such as runny nose, sneezing, and nasal congestion), abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood present 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, temporary decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decrease in visual acuity, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling of irritability, and sudden decrease or loss of hearing.

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

Reporting of side effects

If you experience 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 through 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. 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 is the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from moisture.

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

6. Package Contents and Additional Information

Vizarsin Composition

• The active ingredient is sildenafil. Each buccal dispersible tablet contains 100 mg of sildenafil.

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

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

Product Appearance and Package Contents

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

Vizarsin buccal dispersible tablets are available in boxes of 1 buccal dispersible tablet in a blister pack and also in boxes of 2 x 1, 4 x 1, 8 x 1, 12 x 1, or 24 x 1 buccal dispersible tablets in perforated unit-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization 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 more information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/BelgienLietuva

KRKA Belgium, SA. UAB KRKA Lietuva

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

БългарияLuxembourg/Luxemburg

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

Тел: + 359 (02) 962 34 50 Tel: +32 (0) 487 50 73 62 (BE)

Česká republikaMagyarország

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

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

DanmarkMalta

KRKA Sverige AB E. J. Busuttil Ltd.

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

DeutschlandNederland

TAD Pharma GmbH KRKA Belgium, SA.

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

EestiNorge

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

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

ΕλλάδαÖsterreich

KRKA ΕΛΛΑΣ ΕΠΕ KRKA Pharma GmbH, Wien

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

EspañaPolska

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

HrvatskaRomânia

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

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

IrelandSlovenija

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

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

ÍslandSlovenská republika

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

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

ItaliaSuomi/Finland

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

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

ΚύπροςSverige

KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB

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

LatvijaUnited Kingdom

KRKA Latvija SIA Consilient Health (UK) Ltd.

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

Date of Last Revision of this Leaflet:

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