REVATIO 0.8 mg/mL INJECTABLE SOLUTION

2. What you need to know before you are given Revatio

You should not be given 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 given 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 to treat 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 optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor before starting to use 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 heart's pumping chambers.
• 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) which 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 have a rare inherited eye disease (retinitis pigmentosa).
• you have 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 have 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 sudden, temporary, or permanent loss of vision in one or both eyes. If you experience a reduction or sudden 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 tell your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children and adolescents

Revatio should not be given to children and adolescents under 18 years.

Using 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 are given 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 (a 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 low blood pressure (e.g., dizziness, fainting).
• Medicines that contain sacubitril/valsartan, used to treat heart failure.

Using Revatio with food and drink

You should not drink 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 being given this medicine. Revatio should not be used during pregnancy unless absolutely necessary.

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

3. How Revatio is given

Revatio is given as an intravenous injection and will always be given by a doctor or nurse. Your doctor will decide the duration of treatment and the amount of Revatio solution for injection you should receive daily and will monitor your response and disease. The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day.

You should be given an intravenous injection of Revatio instead of Revatio tablets.

If you are given too much Revatio

If you are concerned that you have been given too much Revatio, tell your doctor or nurse immediately.

Taking more Revatio than you should can 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 you will miss a dose. However, tell your doctor or pharmacist if you think a dose has been missed. You should not be given a double dose to make up for missed doses.

If treatment with Revatio is stopped

Sudden stopping of treatment with Revatio can lead to worsening of your symptoms.

Your doctor may reduce the dose over a few days before stopping it completely.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. 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, stop taking Revatio and tell your doctor immediately (see also section 2):

• if you experience a sudden 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 side effects seen with Revatio intravenous were similar to those seen with Revatio tablets. In clinical trials, the most common side effects (may affect up to 1 in 10 patients) were facial flushing, headache, low blood pressure, and nausea.

In clinical trials, the most common side 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 most common side effects (may affect more than 1 in 10 patients) were headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

Common side effects (may affect up to 1 in 10 patients) include: 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, decreased 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.

Uncommon side effects (may affect up to 1 in 100 patients) include: decreased visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in the semen and/or urine, and breast enlargement in men.

Rashes, decreased hearing, and low blood pressure have also been reported with an unknown frequency (frequency cannot be estimated from the available data).

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 Monitoring System: 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 label of the vial and on the carton after EXP. The expiry date is the last day of the month shown.

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 medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Revatio contains

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 ingredients are: glucose and water for injections.

What Revatio looks like and contents of the pack

Each pack of Revatio solution for injection contains a 20 ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminum seal.

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.

You can obtain further information on 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 about rare diseases and orphan medicines.