REVATIO 20 mg FILM-COATED TABLETS

2. What you need to know before you take Revatio

Do not take Revatio

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

• if you are taking medicines that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often used to relieve chest pain (or angina). Revatio can increase the effects of these medicines. You should tell your doctor if you are taking any of these medicines. If you are not sure, consult your doctor or pharmacist.

• 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 Revatio, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.

• if you have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50 mmHg).

• if you are taking a medicine for fungal infections such as ketoconazole or itraconazole or medicines that contain ritonavir (for HIV).

• if you have previously experienced a loss of vision due to a problem with blood flow to the nerve of the eye called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Revatio if

• you have a disease due to a blockage or narrowing of a vein in the lungs rather than a blockage or narrowing of an artery.
• you have a serious heart problem.
• you have a problem with the pumping chambers of the heart.
• you have high blood pressure in the blood vessels of the lungs.
• you have low resting blood pressure.
• you lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough fluids. This can happen if you are ill with fever, vomiting or diarrhea.
• you suffer from a rare inherited eye disease (retinitis pigmentosa).

• you suffer from an abnormality of the red blood cells (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma) or any disease or deformity of the penis.
• you suffer from a stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.
• you use medicines for erectile dysfunction.

When PDE5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with an unknown frequency: decreased or loss of vision, temporary or permanent, of one or both eyes. If you experience a reduction or loss of vision, stop taking Revatio and inform your doctor immediately(see also section 4).

Prolonged and sometimes painful erections have been reported in men taking sildenafil. If you have an erection that lasts for more than 4 hours, stop taking Revatio and consult your doctor immediately(see also section 4).

Special precautions in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children

Revatio should not be given to children under 1 year of age.

Taking Revatio with other medicines

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

• Medicines that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve chest pain or angina (see section 2. What you need to know before you take Revatio).
• Tell your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g. bosentan, iloprost).
• Medicines that contain St. John's Wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy).
• Medicines that inhibit blood clotting (e.g. warfarin), although they have not caused any adverse effects.
• Medicines that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for depression), as a dose adjustment may be necessary.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of hypertension or prostate problems, as the combination of the two medicines can cause symptoms of reduced blood pressure (e.g. dizziness, fainting).
• Medicines that contain sacubitril/valsartan, used to treat heart failure.

Taking Revatio with food and drinks

Do not take grapefruit juice when being treated with Revatio.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Revatio should not be used during pregnancy unless absolutely necessary.

Revatio should not be given to women of childbearing potential unless adequate contraceptive methods are used.

Revatio passes into breast milk at very low levels and is not expected to harm your baby.

Driving and using machines

Revatio may cause dizziness and affect vision. You should know how you react to this medicine before driving or using machines.

Revatio contains lactose

Before taking this medicine, consult your doctor if you have been told that you have an intolerance to some sugars.

Revatio contains sodium

Revatio 20 mg film-coated tablets contain less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, “sodium-free”.

3. How to take Revatio

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For adults, the recommended dose is 20 mg three times a day (taken at intervals of 6 to 8 hours) taken with or without food.

Use in children and adolescents

For children and adolescents from 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day in children and adolescents > 20 kg, administered with or without food. In children, doses higher than those recommended should not be used. This medicine should only be used for cases where 20 mg three times a day is to be administered. For administration in patients ≤ 20 kg and in other younger patients who cannot swallow tablets, other pharmaceutical forms more suitable for their age and weight can be used.

If you take more Revatio than you should

Do not take more medicine than your doctor has told you.

If you have taken more medicine than you should, talk to your doctor immediately.

Taking more Revatio than you should can increase the risk of known side effects.

If you forget to take Revatio

If you have forgotten to take Revatio, take the dose as soon as you remember and then continue to take your medicine at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Revatio

Sudden interruption of treatment with Revatio may lead to worsening of your symptoms. Do not stop taking Revatio unless your doctor tells you to. Your doctor will tell you how to reduce the dose over a few days before stopping completely.

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.

If you experience any of the following side effects, stop taking Revatio and inform your doctor immediately (see also section 2):

• if you experience a reduction or loss of vision (frequency not known).
• if you have an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported in men taking sildenafil (frequency not known).

Adults

The following side effects have been reported very frequently (may affect more than 1 in 10 people): headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The following side effects have been reported frequently (may affect up to 1 in 10 people): infection under the skin, flu-like symptoms, inflammation of the nasal passages, reduction in the number of red blood cells (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, changes in vision, blurred vision, and sensitivity to light, effects on color perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, hemorrhoids, abdominal distension, dry mouth, hair loss, skin flushing, night sweats, muscle pain, back pain, and increased body temperature.

The following side effects have been reported infrequently (may affect up to 1 in 100 people): reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in the semen and/or urine, and gynecomastia.

The following have also been reported with an unknown frequency (frequency cannot be estimated from the available data): skin rash, sudden decrease or loss of hearing, and decreased blood pressure.

Children and adolescents

The following serious side effects have been reported frequently (may affect up to 1 in 10 patients): pneumonia, right heart failure, cardiogenic shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral gastroenteritis, urinary tract infections, and tooth abscesses.

The following serious side effects have been reported infrequently (may affect up to 1 in 100 patients): allergic reaction (such as skin rash, facial swelling, lip and tongue swelling, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disorders, shortness of breath, gastrointestinal inflammation, and sneezing due to airway disorders.

The following side effects have been reported very frequently (may affect more than 1 in 10 people): headache, vomiting, sore throat, fever, diarrhea, flu, and nosebleeds.

The following side effects have been reported frequently (may affect up to 1 in 10 patients): nausea, increased erections, pneumonia, and runny nose.

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 Vigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Revatio

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 the month shown.

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. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Revatio

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).

• The other ingredients are:

Core of the tablet: microcrystalline cellulose, calcium phosphate dibasic (anhydrous), sodium croscarmellose (see section 2 “Revatio contains sodium”), magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “Revatio contains lactose”), glycerol triacetate.

Appearance of Revatio and contents of the pack

Revatio film-coated tablets are white and round. The tablets are marked with “VLE” on one side and “RVT 20” on the other. The tablets are available in blisters containing 90 tablets, single-dose blisters containing 90 x 1 tablets, and blisters containing 300 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den Ijssel, Netherlands

Manufacturer:

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary.

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

Spain

Viatris Pharmaceuticals, S.L.U.

Tel: +34 900 102 712

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.