Patient Information Leaflet: Package Leaflet

Revatio 0.8 mg/ml Injectable Solution

sildenafil

Read this leaflet carefully before you receive 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Revatio contains the active ingredient 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).

Revatio injectable solution is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.

Do not administer Revatio

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

• if you are taking medications that contain nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medications are often used to relieve chest pain (or angina). Revatio may increase the effects of these medications. Inform your doctor if you are taking any of these medications. If you are unsure, consult your doctor or pharmacist.

• if you are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Revatio, have shown to increase the hypotensive effect of this medication. 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).

• if you are taking a medication to treat fungal infections such as ketoconazole or itraconazole or medications that contain ritonavir (for HIV/AIDS).

• if you have previously experienced vision loss due to a problem with blood flow to an eye nerve called nonarteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor before starting to use Revatio if:

• you have a disease caused by a blockage or narrowing of a vein in the lungs instead of 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 blood pressure at rest.
• you lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with fever, vomiting, or diarrhea.
• you have a rare inherited eye disease (retinitis pigmentosa).
• you have an abnormality of red blood cells (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• you have an active stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.
• you are taking medications 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: sudden, temporary, or permanent partial or complete loss of vision in one or both eyes. If you experience a sudden loss or reduction of vision, stop taking Revatio and inform your doctor immediately (see also section 4).

Prolonged erections, and sometimes painful, have been observed in men taking sildenafil. If you have an erection that lasts 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

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

Children and adolescents

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

Use of Revatio with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Medications that contain nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medications are often used to relieve chest pain or angina (see section 2. What you need to know before Revatio is administered to you).
• Inform your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).

• Medications that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).

• Medications that inhibit blood coagulation (e.g., warfarin) although no adverse effects have been reported.
• Medications that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV/AIDS), 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 medications may cause symptoms of low blood pressure (e.g., dizziness, fainting).
• Medications that contain sacubitril/valsartan, used to treat heart failure.

Use of Revatio with food and drinks

Do not take grapefruit juice while being treated with Revatio.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before this medication is administered to you. Revatio should not be used during pregnancy unless absolutely necessary.

Revatio should not be administered 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 operating machinery

Revatio may cause dizziness and affect vision. You should know how you react to this medication before driving vehicles or operating machinery.

Revatio is administered 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 Revatio injectable 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.

They should administer an intravenous injection of Revatio 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.

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

If you miss a dose of Revatio

Since you will receive this medication under close medical supervision, it is unlikely that you will miss a dose. However, inform your doctor or pharmacist if you think they have forgotten a dose. Do not administer a double dose to make up for missed doses.

If treatment with Revatio is interrupted

Stopping Revatio treatment abruptly may lead to worsening of your symptoms.

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

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

Like all medicines, Revatio can cause side effects, although not everyone will experience 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 sudden reduction or loss of vision (unknown frequency).
• if you have an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported after taking sildenafil in men (unknown frequency).

Adults

The side effects observed in a clinical trial with Revatio intravenous were similar to those observed in clinical trials with Revatio tablets. In clinical trials, the side effects frequently reported (may affect up to 1 in 10 patients) were facial flushing, headache, low blood pressure, and nausea.

In clinical trials, the side effects frequently reported (may affect up to 1 in 10 patients) by patients with pulmonary arterial hypertension were facial flushing and nausea.

In clinical trials with Revatio tablets, the side effects very frequently reported (may affect more than 1 in 10 patients) were headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The side effects frequently reported (may affect up to 1 in 10 patients) are: skin infection, flu-like symptoms, nasal congestion, reduction in red blood cell count (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 or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, 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 side effects reported infrequently (may affect up to 1 in 100 patients) included: reduced visual acuity, double vision, abnormal sensation in the eye, bleeding from the penis, presence of blood in semen and/or urine, and breast enlargement in men.

Also, skin eruptions, decreased or sudden loss of hearing, and reduced blood pressure have been reported with an unknown frequency (the frequency cannot be estimated with the available data).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Revatio does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Revatio

The active ingredient is sildenafil. Each milliliter of solution contains 0.8 mg of sildenafil (as citrate).

Each vial of 20 ml contains 10 mg of sildenafil (as citrate).

The other components are: glucose and water for injectable preparations.

Appearance of Revatio and contents of the packaging

Each Revatio injectable solution packaging 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 request more information about this medication by contacting the local representative of the marketing authorization holder:

Spain

Viatris Pharmaceuticals, S.L.U.

Phone: +34 900 102 712

Last review date of this leaflet:

Other sources of information

The detailed information about this medication 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 drugs.