Leaflet: information for the user

Sildenafilo Viatris100 mg film-coated tablets EFG

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1. What isSildenafilo Viatrisand what is it used for

2.What you need to know before you start takingSildenafilo Viatris

3. How to takeSildenafilo Viatris

4. Possible side effects

5. Storage ofSildenafilo Viatris

6.Contents of the pack and additional information

Sildenafilo Viatrisbelongs 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. Sildenafilo will only help you get an erection if you are sexually stimulated.

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

.

Do not takeSildenafilo 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. Tell your doctor if you are taking any of these medicines, which are often used to relieve chest pain (or "angina"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called 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). It has been shown that PDE5 inhibitors, such as sildenafil, increase the hypertensive effects of this medicine. If you are taking riociguat or are unsure, tell 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 disorders (such asretinitis 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 starting to takeSildenafilo Viatris:

• If you have sickle cell anaemia (a blood disorder), leukaemia (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 must carefully check if your heart can cope with the extra effort of having sex.
• If you have a stomach ulcer or bleeding problems (such as haemophilia).
• If you experience a sudden reduction or loss of vision, stop taking sildenafil and contact your doctor immediately.

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

You must not take sildenafil if you do not have erectile dysfunction.

You must not take sildenafil if you are a woman.

Children and adolescents

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

Special considerations in patients with kidney or liver problems

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

Other medicines andSildenafilo Viatris

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

TheSildenafilo Viatristablets may interact with some medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional treating your condition that you have takenSildenafilo Viatrisand when you took it. Do not take sildenafil with other medicines unless your doctor tells you that you can.

You must 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. Inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve chest pain (or "angina").

You must not take sildenafil if you are using any of the medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a dangerous drop in blood pressure.

Inform 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 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 happen in the 4 hours following sildenafil intake. To reduce the possibility of these symptoms, you should be receiving your regular daily dose of alpha-blocker before starting sildenafil. Your doctor may recommend that you start treatment with the lower dose (25 mg) of sildenafil.

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

TakingSildenafilo Viatriswith food and alcohol

Sildenafilo Viatriscan be taken with or without food (see section 3 "How to takeSildenafilo Viatris”). However, you may notice that sildenafil takes a little longer to work if you take it with a large meal.

Consuming alcohol may temporarily impair your ability to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to consume large amounts of alcohol before taking sildenafil.

Pregnancy, breastfeeding and fertility

The use of sildenafil is not indicated in women.

Driving and operating machinery

Sildenafil may cause dizziness and affect your vision. Before driving vehicles or operating machinery, you must know how you react to sildenafil.

Sildenafilo Viatriscontains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended initial dose is 50 mg.

Do not take Sildenafilo Viatris more than once a day.

Take sildenafilo approximately one hour before sexual activity. Swallow the tablet whole with a glass of water.

If you estimate that the action of sildenafilo is too strong or too weak, inform your doctor or pharmacist. Sildenafilo will only help you achieve an erection if you are sexually stimulated. The time it takes for sildenafilo to take effect varies from person to person, but generally ranges from 30 minutes to one hour. You may notice that sildenafilo takes a bit longer to take effect if you take it with a large meal.

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

If you take more Sildenafilo Viatris 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.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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. These side effects are usually mild to moderate in intensity and of short duration.

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

Rare(may affect up to 1 in 100 people)

• Allergic reaction.

Symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of eyelids, face, lips, or throat.

• Chest pain.

If this occurs before or after sexual activity, sit in a semi-recumbent position and try to relax.

Do not use nitratesto treat chest pain.

Uncommon(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 must contact your doctor immediately.

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

Symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, fever.

• Seizures or convulsions.

Other reported side effects

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

• Headache.

Frequent(may affect up to 1 in 10 people)

• Nausea(dyspepsia), flushing of the face, hot flushes (symptoms include a sudden feeling of heat in the upper body), indigestion, effects on vision (including abnormal color perception such as blue vision, blurred vision, altered vision), nasal congestion, and dizziness.

Rare(may affect up to 1 in 100 people)

• Vomiting, skin rash, eye irritation, bloodshot or injected eyes, eye pain, seeing flashes of light, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling drowsy, reduced tactile sensation, vertigo, tinnitus in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (symptoms include nasal discharge, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), pain in the arms or legs, nasal bleeding, blood in the urine, feeling hot, and feeling tired.

Very rare(may affect up to 1 in 1,000 people)

• Loss of consciousness,stroke, heart attack, irregular heartbeat,temporary decrease in blood flow to parts of the brain, feeling of throat constriction, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, halos around lights, pupil dilation, change in the color of the white part of the eye,penile bleeding, blood in the semen, nasal dryness, nasal mucosa inflammation, feeling irritable, 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 pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of 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 through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 packaging after the CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSildenafilo Viatris

- The active ingredient is sildenafilo. Each tablet contains 100 mg of sildenafilo (as citrato de sildenafilo).

- The other components are:

- Tablet core: microcrystalline cellulose, dibasic calcium phosphate anhydrous (fosfato cálcico dibásico (anhidro)), croscarmellose sodium (croscarmelosa sódica) (see section 2 “Sildenafilo Viatris contains sodium”), magnesium stearate (estearato de magnesio).

- Coating: hypromellose (E-464), titanium dioxide (E-171), lacquer of carmine of indigo (laca de aluminio carmín de índigo (E-132)), triacetin, triacetina.

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area 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:Sildenafi l Mylan 100 mg Filmom obalené tablety

Slovenia:Sildenafil Mylan 100 mg filmsko obložene tablete

Spain:Sildenafilo Viatris 100 mg comprimidos recubiertos con película EFG

France:Sildenafil Viatris 100 mg comprimés pelliculés

Greece:Sildenafi l 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

Last revision date of thisleaflet:July 2020

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/