SILDENAFIL VIATRIS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Viatris 50 mg film-coated tablets EFG

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 experience 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 package leaflet

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

1. What is Sildenafilo Viatris and what is it used for

Sildenafilo Viatris belongs to a group of medicines called phosphodiesterase type 5 inhibitors. It works by relaxing the blood vessels in the penis, allowing blood to flow into the penis when you are sexually stimulated. Sildenafilo will only help you to get an erection if you are sexually stimulated.

Sildenafilo is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is when a man cannot get, or keep, a hard erection that is sufficient for satisfactory sexual activity.

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2. What you need to know before you take Sildenafilo Viatris

Do not takeSildenafilo Viatris

• If you are allergic to sildenafilo or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination may cause a potentially dangerous decrease in your blood pressure. Tell your doctor if you are taking any of these medicines, often used to relieve angina pectoris (or “chest pain”). If you are not sure, consult 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 cause a potentially dangerous decrease in 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). It has been shown that phosphodiesterase type 5 inhibitors, such as sildenafilo, increase the hypotensive effects of this medicine. If you are taking riociguat or are not sure, inform your doctor.
• If you have a severe heart or liver problem.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have certain rare inherited eye diseases, such as retinitis pigmentosa.
• If you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Sildenafilo Viatris:

• 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 penis deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can tolerate the extra strain of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking sildenafilo and contact your doctor immediately.

You should not use sildenafilo in combination with treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other phosphodiesterase type 5 inhibitor.

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

You should not take sildenafilo if you are a woman.

Children and adolescents

The use of sildenafilo is not indicated in persons under 18 years of age.

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.

Other medicines andSildenafilo Viatris

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

Sildenafilo Viatris tablets may interact with some medicines, especially those used to treat chest pain. In the event of a medical emergency, you should inform any healthcare professional treating your condition that you have taken Sildenafilo Viatris and when you took it. Do not take sildenafilo with other medicines unless your doctor tells you to.

You should not take sildenafilo if you are taking medicines called nitrates or nicorandil (a medicine similar to nitrates), as the combination of these products can cause a potentially dangerous decrease in blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pectoris (or “chest pain”).

You should not take sildenafilo if you are using any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products can also lead to a potentially dangerous decrease in blood pressure.

Tell your doctor or pharmacist if you are already 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 with the lowest dose (25 mg) of sildenafilo.

Some patients who are taking alpha-blockers, a medicine used to treat high blood pressure or prostate problems, 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 sildenafilo with alpha-blockers. This is more likely to happen within 4 hours of taking sildenafilo. To minimize the chance that these symptoms might happen, you should be taking your regular dose of alpha-blocker before starting sildenafilo. Your doctor may advise you to start with the lower dose (25 mg) of sildenafilo.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take medicines containing sacubitril/valsartan, used to treat heart failure.

TakingSildenafilo Viatriswith food and alcohol

Sildenafilo Viatris can be taken with or without food (see section 3 “How to take Sildenafilo Viatris”). However, you may notice that sildenafilo takes a little longer to start working if you take it with a large meal.

Drinking alcohol can temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking sildenafilo.

Pregnancy, breastfeeding, and fertility

The use of sildenafilo is not indicated in women.

Driving and using machines

Sildenafilo can cause dizziness and affect vision. Before driving or using machines, you should know how sildenafilo affects you.

Sildenafilo Viatriscontains sodium

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

3. How to take Sildenafilo Viatris

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. Ask your doctor or pharmacist if you are unsure.

The recommended initial dose is 50 mg.

You should not take Sildenafilo Viatris more than once a day.

You should take sildenafilo 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 sildenafilo is too strong or too weak, talk to your doctor or pharmacist. Sildenafilo will only work for you if you are sexually stimulated. The time sildenafilo takes to work varies from person to person, but it normally takes between 30 minutes and 1 hour. You may notice that sildenafilo takes longer to start working if you take it with a large meal.

If sildenafilo does not help you to get an erection, or if your erection does not last long enough for you to have sex, you should tell your doctor.

If you take more Sildenafilo Viatris than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

You should not take more tablets than your doctor tells you to.

Contact your doctor if you have taken more tablets than you should. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are normally mild to moderate in nature and are short-lived.

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

Uncommon(may affect up to 1 in 100 people)

• An allergic reaction.

Symptoms include sudden wheezing, coughing, chest pain, shortness of breath, or swelling of the eyelids, face, lips, or throat.

• Chest pain.

If this happens to you, sit up and try to relax. Do not use nitrates to treat chest pain.

Rare(may affect up to 1 in 1,000 people)

• Prolonged and sometimes painful erections.

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

• A sudden decrease or loss of vision.
• Severe skin reactions.

Symptoms can include severe skin rash, blistering, or peeling, mouth ulcers, fever.

• Seizures or fits.

Other side effects reported

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

• Headache.

Common(may affect up to 1 in 10 people)

• Nausea (feeling sick), redness of the face, hot flushes (symptoms include a sudden feeling of heat in the upper part of the body), indigestion, effects on vision (including abnormal color vision like blue color tinge, blurred vision, altered vision), nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people)

• Vomiting, skin rash, irritation of the eyes, eyes reddened and inflamed, eye pain, seeing flashes of light, increased sensitivity to light, watery eyes, strong 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 nose, inflammation of the lining of the nose (symptoms include runny nose, sneezing, and stuffy nose), pain in the upper abdomen, gastroesophageal reflux disease (symptoms include heartburn), pain in arms or legs, nosebleeds, blood in urine, feeling hot, and feeling tired.

Rare(may affect up to 1 in 1,000 people)

• Fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to parts of the brain, feeling of tightness in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in the eye, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, bleeding from the penis, blood in the semen, dryness in the nose, inflammation of the inside of the nose, feeling irritable, and sudden decrease or loss of hearing.

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

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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Viatris

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition ofSildenafilo Viatris

• The active substance is sildenafilo. Each tablet contains 50 mg of sildenafilo (as sildenafilo citrate).
• The other ingredients are:
• Core of the tablet: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), sodium croscarmellose (see section 2 “Sildenafilo Viatris contains sodium”), magnesium stearate.
• Coating: hypromellose (E-464), titanium dioxide (E-171), aluminum lake of indigo carmine (E-132), triacetin.

Appearance of the product and pack contents

Sildenafilo Viatris are blue, film-coated, round, biconvex tablets, engraved with “M” on one face and “SL 50” on the other.

The tablets are available in blister packs containing 1, 2, 4, 8, 12, 24, 36, or 48 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

H-2900 Komárom, Mylan utca 1

Hungary

or

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe,

Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352

Germany

You can ask for more information about this medicine from your local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: duraviril 50 mg Filmtabletten

Austria: Sildenafil Arcana 50 mg Filmtabletten

Belgium: Sildenafil Mylan 50 mg filmomhulde tabletten

Cyprus: Sildenafil Mylan 50 mg film-coated tablets

Denmark: Sildenafil Mylan

Slovakia: Sildenafil Mylan 50 mg Filmom obalené tablety

Slovenia: Sildenafil Mylan 50 mg filmsko obložene tablete

Spain: Sildenafilo Viatris 50 mg comprimidos recubiertos con película EFG

France: Sildenafil Viatris 50 mg comprimés pelliculés

Greece: Sildenafil Mylan 50 mg film-coated tablets

Ireland: Sildenafil Mylan 50 mg film-coated tablets

Iceland: Sildenafil Mylan 50 mg Filmuhúðaðar töflur

Italy: Sildenafil Mylan 50 mg compresse rivestite con film

Luxembourg: Sildenafil Mylan 50 mg comprimés pelliculés

Malta: Sildenafil Mylan 50 mg film-coated tablets

Norway: Sildenafil Mylan 50 mg tabletter, filmdrasjerte

Netherlands: Sildenafil Mylan 50 mg, filmomhulde tabletten

Portugal: Sildenafil Mylan 50 mg comprimido revestido por película

United Kingdom (Northern Ireland): Sildenafil Mylan 50 mg film-coated tablets

Czech Republic: Sildenafil Mylan

Sweden: Sildenafil Mylan 50 mg filmdragerade tabletter

Date of last revision of thisleaflet:July 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es /