Sildenafil ViatriS 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sildenafil Viatris 100 mg film-coated tablets EFG

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 must not be given to other people, 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 such effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Sildenafil Viatris belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing the blood vessels in the penis, allowing blood to flow into the penis when sexually stimulated. Sildenafil will only help you achieve an erection if you are sexually stimulated.

Sildenafil is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This occurs when a man cannot achieve or maintain an erect penis suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Viatris

Do not take Sildenafil Viatris

• 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 cause a dangerous drop in your blood pressure. Inform 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 nitrite (“poppers”), as the combination may cause a dangerous drop 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). PDE5 inhibitors such as sildenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, inform 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 certain rare inherited eye diseases (such as retinitis pigmentosa).
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sildenafil Viatris:

• If you have sickle cell anemia (a red blood cell disorder), leukemia (cancer of 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 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 sildenafil and contact your doctor immediately.

You should not use sildenafil concurrently with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

Do not take sildenafil if you do not have erectile dysfunction.

Do not take sildenafil if you are a woman.

Children and adolescents

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

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.

Other medicines and Sildenafil Viatris

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

Sildenafil Viatris tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional treating you that you have taken Sildenafil Viatris and when you took it. Do not take sildenafil with other medicines unless your doctor tells you it is safe.

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

Do not take sildenafil if you are using any medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination may also cause a dangerous drop in blood pressure.

Inform your doctor or pharmacist if you are already 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 sildenafil.

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

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

Taking Sildenafil Viatris with food and alcohol

Sildenafil Viatris can be taken with or without food (see section 3 “How to take Sildenafil Viatris”). However, you may notice that sildenafil takes slightly longer to work if taken with a heavy meal.

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

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and using machines

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

Sildenafil Viatris contains sodium

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

3. How to take Sildenafil Viatris

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended starting dose is 50 mg.

Do not take Sildenafil Viatris more than once a day.

You should take sildenafil approximately one hour before sexual intercourse. Swallow the tablet whole with a glass of water.

If you feel that the effect of sildenafil is too strong or too weak, inform your doctor or pharmacist. Sildenafil will only help you achieve an erection if you are sexually stimulated. The time needed for sildenafil to take effect varies from person to person, but usually ranges between half an hour and one hour. You may notice that sildenafil takes slightly longer to work if taken with a heavy meal.

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

If you take more Sildenafil Viatris 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.

Do not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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. These adverse effects are usually mild to moderate in intensity and short-lived.

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

Uncommon (may affect up to 1 in 100 people)

• An allergic reaction.

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

• Chest pain.

If this occurs before or after sexual activity, assume a semi-upright position 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 lasting more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision.
• Severe skin reactions.

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

• Seizures or fits.

Other reported adverse effects

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

• Headache.

Common (may affect up to 1 in 10 people)

• Nausea (feeling unwell), facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, visual disturbances (including abnormal colour perception such as blue-tinged vision, blurred vision, changes in vision), nasal congestion, and dizziness.

Uncommon (may affect up to 1 in 100 people)

• Vomiting, skin rash, eye irritation, bloodshot or red eyes, eye pain, seeing flashes of light, increased visual clarity, light sensitivity, watery eyes, strong heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), pain in arms or legs, nosebleeds, blood in urine, feeling of warmth, and fatigue.

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

• Fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to parts of the brain, throat tightness, numbness of the mouth, 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 of the inner nose, 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 sildenafil.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Pack contents and other information

Composition of Sildenafil Viatris

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
• The other components are:
• Tablet core: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), sodium croscarmellose (see section 2 “Sildenafil Viatris contains sodium”), magnesium stearate.
• Coating: hypromellose (E-464), titanium dioxide (E-171), indigo carmine aluminium lake (E-132), triacetin.

Appearance of the product and pack contents

Sildenafil Viatris are film-coated, blue, round, biconvex tablets, engraved with “M” on one side and “SL 100” on the other.

The tablets are supplied in blisters containing 1, 2, 4, 8, 12, 24, 36 or 48 tablets.

Only some 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

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

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Germany: duraviril 100 mg Filmtabletten
Austria: Sildenafil Arcana 100 mg Filmtabletten
Belgium: Sildenafil Mylan 100 mg filmomhulde tabletten
Cyprus: Sildenafil Mylan 100 mg film-coated tablets
Denmark: Sildenafil Mylan
Slovakia: Sildenafil Mylan 100 mg Filmom obalené tablety
Slovenia: Sildenafil Mylan 100 mg filmsko obložene tablete
Spain: Sildenafil Viatris 100 mg film-coated tablets EFG
France: Sildenafil Viatris 100 mg comprimés pelliculés
Greece: Sildenafil Mylan 100 mg film-coated tablets
Hungary: Sildenafil Viatris 100 mg filmtabletta
Ireland: Sildenafil Mylan 100 mg film-coated tablets
Iceland: Sildenafil Mylan 100 mg Filmuhúðaðar töflur
Italy: Sildenafil Mylan 100 mg compresse rivestite con film
Luxembourg: Sildenafil Mylan 100 mg comprimés pelliculés
Malta: Sildenafil Mylan 100 mg film-coated tablets
Norway: Sildenafil Mylan 100 mg tabletter, filmdrasjerte
Netherlands: Sildenafil Mylan 100 mg, filmomhulde tabletten
Portugal: Sildenafil Mylan 100 mg comprimido revestido por película
United Kingdom (Northern Ireland): Sildenafil Mylan 100 mg film-coated tablets
Czech Republic: Sildenafil Mylan
Sweden: Sildenafil Mylan 100 mg filmdragerade tabletter

Date of the most recent review of this package leaflet: July 2020

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/