Revatio 20 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Revatio 20 mg Film-coated Tablets

sildenafil

Read the entire leaflet carefully before you start taking this medicine, as 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. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Revatio is and what it is used for

2. What you need to know before taking Revatio

3. How to take Revatio

4. Possible side effects

5. How to store Revatio

6. Contents of the pack and other information

1. What Revatio is and what it is used for

Revatio contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Revatio reduces blood pressure in the lungs by dilating the blood vessels in the lungs.

Revatio is used to treat high blood pressure in the blood vessels of the lung (pulmonary arterial hypertension) in adults and children and adolescents aged 1 to 17 years.

2. What you need to know before taking 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 containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often used to relieve chest pain (or angina). Revatio may significantly increase the effects of these medicines. You must inform your doctor if you are taking any of these medicines. If you are unsure, 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, 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 to treat fungal infections such as ketoconazole or itraconazole, or medicines containing ritonavir (for AIDS).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Revatio if

• you have a condition caused by blockage or narrowing of a vein in the lungs rather than blockage or narrowing of an artery.

• you have a serious heart condition.

• 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 blood pressure at rest.

• you lose a large amount of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.

• you suffer from a rare inherited eye disease (retinitis pigmentosa).

• you have an abnormality of red blood cells (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.

• you currently have a stomach ulcer, 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 unknown frequency: decreased or sudden partial, temporary, or permanent vision loss in one or both eyes. If you experience sudden decrease or loss of vision, stop taking Revatio and inform your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection lasting longer 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 dose adjustment may be necessary.

Children

Revatio must 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 need to use any other medicines.

• Medicines containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often used to relieve chest pain or angina (see section 2. What you need to know before taking Revatio).
• Inform your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
• Medicines containing 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 no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for AIDS), or nefazodone (for depression), as dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of these two medicines may cause symptoms of low blood pressure (e.g., dizziness, fainting).
• Medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Revatio with food and drink

You should not drink grapefruit juice while being treated with Revatio.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Revatio must not be used during pregnancy unless absolutely necessary.

Revatio must not be given to women of childbearing age 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 operating machinery.

Revatio contains lactose

Before taking this medicine, consult your doctor if you have been diagnosed with an intolerance to certain sugars.

Revatio contains sodium

Revatio 20 mg tablets contain less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Revatio

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

For adults, the recommended dose is 20 mg three times daily (taken at 6 to 8-hour intervals), taken with or without food.

Use in children and adolescents

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

If you take more Revatio than you should

Do not take more medicine than your doctor has prescribed.

If you have taken more medicine than recommended, consult your doctor immediately.

Taking more Revatio than you should may increase the risk of known adverse effects.

If you forget to take Revatio

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

If you stop taking Revatio

Stopping treatment with Revatio suddenly may lead to worsening of your symptoms. Do not stop taking Revatio unless your doctor tells you to. Your doctor will advise you on how to gradually reduce the dose over several days before stopping completely.

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 can cause adverse effects, although not everyone will experience them.

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

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

Adults

Very commonly reported adverse effects (may affect more than 1 in 10 patients) were: headache or facial flushing, indigestion, diarrhoea, and pain in arms and legs.

Commonly reported adverse effects (may affect up to 1 in 10 patients) are: skin infection, flu-like symptoms, sinus inflammation, reduction in the number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, vision disturbances, blurred vision and light sensitivity, effects on colour perception, eye irritation, red eyes, dizziness, bronchitis, nosebleed, rhinorrhoea, cough, nasal congestion, stomach inflammation, gastroenteritis, heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

Uncommonly reported adverse effects (may affect up to 1 in 100 patients) included: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Skin rashes, sudden decrease or loss of hearing, and reduction in blood pressure have also been reported with unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents

The following serious adverse effects have been frequently reported (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 infection of the stomach and intestine, urinary tract infections, and dental perforations.

The following serious adverse effects considered related to treatment have been reported uncommonly (may affect up to 1 in 100 patients): allergic reaction (such as skin rash, swelling of face, lips and tongue, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, gastrointestinal inflammation, and sneezing due to airflow disturbances.

Very commonly reported adverse effects (may affect more than 1 in 10 people) were: headache, vomiting, throat infection, fever, diarrhoea, flu, and nosebleed.

Commonly reported adverse effects (may affect up to 1 in 10 patients) were: nausea, increased erections, pneumonia, and runny nose.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C. Keep in the original container to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:

Tablet core: 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”), glyceryl triacetate.

Appearance of Revatio and contents of the pack

Revatio film-coated tablets are white, round tablets. The tablets are marked with “VLE” on one side and “RVT 20” on the other. The tablets are supplied in blisters containing 90 tablets, unit dose blisters containing 90 x 1 tablets, and blisters containing 300 tablets. Only certain 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

Manufacturers:

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

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Spain

Viatris Pharmaceuticals, S.L.U.

Tel: +34 900 102 712

Date of the most recent revision of this product information:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also available.