Prospecto: information for the patient

Revatio 20mg film-coated tablets

sildenafil

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospectus. See section 4.

Content of theprospectus

1. What Revatio is and for what it is used
2. What you need to know before starting to take Revatio
3. How to take Revatio
4. Possible adverse effects
5. Storage of Revatio

6.Content of the package and additional information

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) in adults and children and adolescents between 1 and 17 years.

Do not take Revatio

• if you are allergic to sildenafil or any of the other ingredients of this medication (see 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 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 clots). Phosphodiesterase type 5 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 mmHg).

• 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 non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 disorder (retinitis pigmentosa).

• you have a blood disorder (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.

The following visual adverse effects have been reported with an unknown frequency when phosphodiesterase type 5 inhibitors, including sildenafil, are used to treat erectile dysfunction:partial or complete, sudden, temporary, or permanent loss of vision in one or both eyes.Stop taking Revatio and inform your doctor immediately if you experience a reduction or loss of vision.(see also section 4).

Prolonged and sometimes painful erections 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

Revatio should not be administered to children under 1 year.

Taking Revatio with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 taking Revatio).
• 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 reduced blood pressure (e.g., dizziness, fainting).
• Medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Revatio with food and drinks

Do not take grapefruit juice while being treated with Revatio.

Pregnancy and breastfeeding

If you are pregnant orbreastfeeding,or think you may be pregnantor plan to become pregnant,consult your doctor or pharmacist before using this medication. 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 your vision. You should know how you react to this medication before driving vehicles or operating machinery.

Revatio contains lactose

Before taking this medication, consult your doctor if they have told you that you have an intolerance to some sugars.

Revatio contains sodium

Revatio 20 mg tablets contain less than1mmolof sodium (23mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

For adults, the recommended dose is 20 mg three times a day (taken at intervals of 6 to 8 hours) taken with or without food.

Use in children and adolescents

For children and adolescents from 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day in children and adolescents > 20 kg, administered with or without food. In children, do not use higher doses than recommended.This medication should only be used in cases where 20 mg three times a day is to be administered.Patients weighing ≤ 20 kg and other younger patients who cannot swallow the tablets may use other pharmaceutical forms that are more suitable.

If you take more Revatio than you should

You should not take more medication than your doctor indicates.

If you have taken more medication than advised, consult your doctor immediately.

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

If you forgot to take Revatio

If you have forgotten to take Revatio, take the dose as soon as you remember and continue taking your medication at the usual hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Revatio

Stopping treatment with Revatio abruptly may lead to worsening of your symptoms. Do not stop taking Revatio unless your doctor tells you to. Your doctor will instruct you on how to reduce the dose over 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, this medicine 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 reported very frequently (may affect more than 1 in 10 patients) were, headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The side effects reported frequently (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, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision, and light sensitivity, color perception effects, eye irritation, red or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, burning, 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, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

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

Children and adolescents

Frequent side effects (may affect up to 1 in 10 patients) reported in children and adolescents included: pneumonia, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral infections in the stomach and intestines, urinary tract infections, and tooth perforations.

Severe side effects considered related to treatment and reported infrequently (may affect up to 1 in 100 patients) included: allergic reaction (such as skin rash, facial swelling, lips and tongue inflammation, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, digestive tract inflammation, and sneezing due to airway obstruction.

The side effects reported very frequently (may affect more than 1 in 10 patients) were headache, vomiting, throat infection, fever, diarrhea, flu, and nasal bleeding.

The side effects reported frequently (may affect up to 1 in 10 patients) were nausea, increased erections, pneumonia, and runny nose.

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 Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

Do not store above30°C. Store in the original packaging to protect it from moisture.

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

Composition of Revatio

• The active ingredient is sildenafil. Each tablet contains 20mg of sildenafil (as citrate).

• The other components are:

Tablet core: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium croscarmellose (see section 2 “Revatio contains sodium”), magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 “Revatio contains lactose”), triacetin.

Appearance of Revatio and contents of the packaging

Revatio film-coated tablets are white, round, and marked with “VLE” on one face and “RVT 20” on the other. The tablets are presented in blisters containing 90 tablets, single-dose blisters containing 90 x 1 tablets, and blisters containing 300 tablets.The packaging sizes may vary.

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.

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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Spain

Viatris Pharmaceuticals, S.L.U.

Phone: +34 900 102 712

Last revision date of thisleaflet:

Other sources of information

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