Revatio 0.8 mg/ml solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Revatio 0.8 mg/ml solution for injection
sildenafil
Read the entire leaflet carefully before you are administered 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, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, 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 such effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Revatio is and what it is used for
- What you need to know before you are administered Revatio
- How Revatio is administered
- Possible adverse effects
- How to store Revatio
- 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 lowers blood pressure in the lungs by dilating the pulmonary blood vessels. Revatio is used to treat high blood pressure in the blood vessels of the lung (pulmonary arterial hypertension).
Revatio injectable solution is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
2. What you need to know before Revatio is administered to you
Do not take Revatio
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if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
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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.
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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.
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if you have recently had a stroke, a myocardial infarction, or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
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if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole, or medicines containing ritonavir (for AIDS).
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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 before starting to use Revatio if:
- you have a disease 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 are losing 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 are using 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: decrease or partial, sudden, temporary or permanent loss of vision 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 more than 4 hours, stop taking Revatio and contact 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 and adolescents
Revatio must not be administered to children and adolescents under 18 years of age.
Use of Revatio with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
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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 Revatio is administered to you).
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Inform your doctor or pharmacist if you are taking riociguat.
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Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
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Medicines containing St. John's wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
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Medicines that inhibit blood coagulation (e.g., warfarin), although no adverse effects have been reported.
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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.
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Alpha-blocker therapy (e.g., doxazosin) for the treatment of hypertension or prostate problems, as the combination of both medicines may cause symptoms of low blood pressure (e.g., dizziness, fainting).
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Medicines containing sacubitril/valsartan, used to treat heart failure.
Use of Revatio with food and drinks
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 this medicine is administered to you. Revatio should not be used during pregnancy unless absolutely necessary.
Revatio must not be administered 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 use of machines
Revatio may cause dizziness and affect vision. You should know how you react to this medicine before driving or operating machinery.
3. How Revatio is administered
Revatio is given as an intravenous injection and will always be administered by a doctor or nurse. Your doctor will decide the duration of treatment and the amount of injectable Revatio solution you should receive daily, and will monitor your response and your condition. The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day.
An intravenous injection of Revatio should be administered instead of Revatio tablets.
If you receive more Revatio than you should
If you are concerned that you have received too much Revatio, inform your doctor or nurse immediately.
Receiving more Revatio than prescribed may increase the risk of known adverse effects.
If you miss a dose of Revatio
Since you will be receiving this medicine under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor or pharmacist if you think a dose has been omitted. Do not administer a double dose to make up for a missed dose.
If treatment with Revatio is stopped
Suddenly stopping treatment with Revatio may lead to worsening of your symptoms.
Your doctor may gradually reduce the dose over a few days before completely stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Revatio can cause adverse effects, although not everyone experiences 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
The adverse effects observed in an intravenous Revatio clinical trial were similar to those observed in clinical trials with Revatio tablets. In clinical trials, the commonly reported adverse effects (may affect up to 1 in 10 patients) were facial flushing, headache, low blood pressure, and nausea.
In clinical trials, the commonly reported adverse effects (may affect up to 1 in 10 patients) in patients with pulmonary arterial hypertension were facial flushing and nausea.
In clinical trials with Revatio tablets, the very commonly reported adverse effects (may affect more than 1 in 10 patients) were headache or facial redness, indigestion, diarrhea, and pain in arms and legs.
The 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 (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, decreased sense of touch, bleeding from the back of the eye, visual disturbances, blurred vision and light sensitivity, effects on color perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, nasal congestion, stomach inflammation, gastroenteritis, burning sensation, hemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.
The 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).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and outer packaging, after EXP. The expiry date refers to the last day of the month indicated.
Revatio does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Revatio
The active substance is sildenafil. Each ml of solution contains 0.8 mg of sildenafil (as citrate).
Each 20 ml vial contains 10 mg of sildenafil (as citrate).
The other components are: glucose and water for injections.
Appearance of Revatio and contents of the pack
Each pack of Revatio for injectable solution contains one 20 ml clear glass vial, closed with a chlorobutyl rubber stopper and sealed with an aluminium cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands.
Manufacturer:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
For further information about this medicinal product, please contact 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 leaflet:
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 provided.