Revatio
(Sildenafil Citrate)

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 brings down blood pressure in the lungs by widening the blood vessels in the lungs. Revatio is used to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension). Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.

How to take Revatio

Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse. Your doctor will determine the duration of your treatment and how much Revatio intravenous injection you will receive each day and will monitor your response and condition. The usual dose is 10 mg (corresponding to 12.5 ml) three times a day. A Revatio intravenous injection will be given to you instead of your Revatio tablets. If you receive more Revatio than you should If you are concerned that you may have been given too much Revatio, tell your doctor or nurse immediately. Taking more Revatio than you should may increase the risk of known side effects. If you miss a dose of Revatio As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten. A double dose should not be given to make up for a forgotten dose. If you stop use of Revatio Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Your doctor may 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.

Possible side effects

Like all medicines, Revatio can cause side effects, although not everybody gets them. If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2):
•if you experience sudden decrease or loss of vision (frequency not known)
•if you have an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known). Adults Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets. In clinical trials the side effects reported commonly (may affect up to 1 in 10 people) were facial flushing, headache, low blood pressure and nausea. In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea. In clinical trials with Revatio tablets side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs. Side effects reported commonly (may affect up to 1 in 10 people) included: infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature. Side effects reported uncommonly (may affect up to 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men. Skin rash and sudden decrease or loss of hearing and decreased blood pressure have also been reported at an unknown frequency (frequency cannot be estimated from the available data).

Reporting of side effects If you get 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store 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 vial label and carton after EXP. The expiry date refers to the last day of that month. Revatio does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment