Prospecto: information for the user

Vizarsin 100 mg buccal dispersible tablets

sildenafil

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you must 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 not listed in this prospect. See section 4.

Vizarsin contains the active ingredient sildenafilo, 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 when 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 obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not take Vizarsin

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).

• If you are taking certain medications 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 medications, which are often used to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

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

• If you are taking riociguat. This medication 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 clots). PDE5 inhibitors, such as Vizarsin, have shown to increase the hypotensive effect of this medication. 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 disorder (such as retinitis pigmentosa).

• If you have experienced previous vision loss 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 blood disorder), 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 must carefully check if your heart can handle the additional strain of sexual activity.

• If you have a current stomach ulcer 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 simultaneously with 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 renal or hepatic problems

You must inform your doctor if you have renal or hepatic problems. Your doctor may decide to reduce your dose.

Children and adolescents

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

Use of Vizarsin with other medications

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

Vizarsin may interact with some medications, 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 medications unless your doctor advises you to.

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

Do not take Vizarsin if you are taking medications called 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 medications 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 taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, 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 receiving 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.

Use of 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 take effect if taken with a large meal. You should have an empty mouth before taking the tablet.

Consuming alcohol may temporarily impair your ability to achieve an erection. Therefore, to get the maximum benefit from the medication, 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 operating machinery

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

Vizarsin contains aspartame (E951) and sucrose

This medication contains 1.5 mg of aspartame in each buccal dispersible tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, 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 buccal tablets at the same time as other presentations of Vizarsin.

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

Vizarsin tablets are fragile. Do not push them through the blister packaging because

they may break. Do not handle the tablets with wet hands, as they may break. To remove a tablet, follow these steps:

For blisters of 1 tablet:

For blisters of 4 tablets:

1. Hold the blister by the edges and separate one of the units by carefully tearing along the embossed marks.

1. Completely remove the sheet by pulling upwards on the edge.

1. Turn the blister over to place the tablet in your hand.
2. As soon as the tablet has come out, place it on the tongue.

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

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

If you notice that the action 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 it takes for Vizarsin to take effect varies from person to person, usually ranging from half an hour to one hour. The effect of Vizarsin may be delayed if taken with a large 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 above 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported associated with the use of Vizarsin are generally of mild to moderate intensity and short duration.

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

• Allergic reaction - this occurs withlow frequency(may affect up to 1 in 100 people).

The symptoms include sudden hissing when breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs withlow frequency.

If they occur during or after sexual intercourse:

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

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

• Sudden loss or decrease in vision - this occursinfrequently.

• Severe skin reactions - this occursinfrequently.

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures - this occursinfrequently.

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,heat sensation (including sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, 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, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, arm or leg pain, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke,heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding from the penis, blood in semen, dry nose, nasal swelling, 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 is worth noting that most men who experienced these side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to Vizarsin.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthe national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after EXP. The expiration date is the last day of the month indicated.

Do not store above 30?°C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medication that you no longer need. This will help protect the environment.

Composition of Vizarsin

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

• The rest of the ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951), neohesperidin-dihydrochalcone (E959), spearmint flavor, peppermint flavor (sucrose), crospovidone, calcium silicate and magnesium stearate (E470b).

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

Appearance of the product and contents of the pack

White or off-white, round, biconvex tablets, which may have darker spots.

Vizarsin buccal tablets are available in packs of 1 buccal tablet in a blister pack and also in packs of 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 buccal 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:

Belgium/Belgique/BelgienLietuva

KRKA Belgium, SA.UAB KRKA Lietuva

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

????????Luxembourg/Luxemburg

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

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

Czech RepublicMagyarország

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

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

DenmarkMalta

KRKA Sverige ABE. J. Busuttil Ltd.

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

GermanyNetherlands

TAD Pharma GmbHKRKA Belgium, SA.

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

EstoniaNorway

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

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

GreeceAustria

KRKA ΕΛΛΑΣ ΕΠΕKRKA Pharma GmbH, Wien

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

SpainPoland

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

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

FrancePortugal

KRKA France EurlKRKA Farmacêutica, Sociedade Unipessoal Lda.

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

CroatiaRomania

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

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

IrelandSlovenia

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

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

IcelandSlovakia

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

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

ItalyFinland

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

Phone: + 39 02 3300 8841Phone: +358 20 754 5330

CyprusSweden

KI.PA. (PHARMACAL) LIMITEDKRKA Sverige AB

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

LithuaniaUnited Kingdom

KRKA Latvija SIAConsilient Health (UK) Ltd.

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

Last date of revision of the summary of product characteristics:

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