Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - revatio

Document Subject

Generated Narrative: MedicinalProductDefinition mp9aa25859b3b911a1afa24fe9c429ab94

identifier: http://ema.europa.eu/identifier/EU/1/05/318/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Revatio 20 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9aa25859b3b911a1afa24fe9c429ab94

identifier: http://ema.europa.eu/identifier/EU/1/05/318/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - revatio

Attesters

What is in this leaflet

1. What Revatio is and what it is used for
2. What you need to know before you take Revatio
3. How to take Revatio
4. Possible side effects
5. How to store Revatio
6. Contents of the pack and other information

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 and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

Do not take 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 containing nitrates, or nitric oxide donors such as amyl nitrate ( poppers ). These medicines are often given for relief of chest pain (or angina pectoris ). Revatio can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you are not certain, ask your doctor or pharmacist.

• if you are taking riociguat. This drug 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 secondary to blood clots). PDE5 inhibitors, such as Revatio have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell 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 containing ritonavir (for HIV).

• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions Talk to your doctor before taking Revatio if you:

have a disease due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.

• have a severe heart problem.
• have a problem with the pumping chambers of your heart
• have high blood pressure in the blood vessels in the lungs.
• have low blood pressure at rest.
• lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or diarrhoea.
• have a rare inherited eye disease (retinitis pigmentosa).
• have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells (leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of the penis.
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
• take medicines for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).

Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Children Revatio should not be given to children below 1 year of age.

Other medicines and Revatio Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Medicines containing nitrates, or nitric oxide donors such as amyl nitrate ( poppers ). These medicines are often given for relief of angina pectoris or chest pain (see section 2. Before you take Revatio) *
Tell your doctor or pharmacist if you are already taking riociguat. *
Therapies for pulmonary hypertension (e.g. bosentan, iloprost)
*
Medicines containing St. John s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
*
Blood thinning medicines (for example warfarin) although these did not result in any side effect. *
Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.

Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness). *
Medicines containing sacubitril/valsartan, used to treat heart failure.

Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio.

Pregnancy and breast-feeding If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Revatio should not be used during pregnancy unless strictly necessary. Revatio should not be given to women of child bearing potential unless using appropriate contraceptive methods. Revatio passes into your breast milk at very low levels and would not be expected to harm your baby.

Driving and using machines Revatio can cause dizziness and can affect vision. You should be aware of how you react to the medicine before you drive or use machines.

Revatio contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Revatio contains sodium Revatio 20 mg tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

Use in children and adolescents For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. Higher doses should not be used in children. This medicine should be used only in case of administration of 20 mg three times a day. Other pharmaceutical forms may be more appropriate for administration to patients 20 kg and other younger patients who are not able to swallow tablets.

If you take more Revatio than you should You should not take more medicine than your doctor tells you to.
If you take more medicine than you have been told to take contact your doctor immediately. Taking more Revatio than you should may increase the risk of known side effects.

If you forget to take Revatio If you forget to take Revatio, take a dose as soon as you remember, then continue to take your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Revatio Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Do not stop taking Revatio unless your doctor tells you to. Your doctor may tell you to 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.

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 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 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).

Children and adolescents The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.

The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.

Side effects reported very commonly (may affect more than 1 in 10 people) were headache, vomiting, infection of the throat, fever, diarrhoea, flu and nosebleed.

Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30OC. Store in the original package in order to protect from moisture.

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.

What Revatio contains

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as the citrate).
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium (see section 2 Revatio contains sodium ), magnesium stearate. Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2 Revatio contains lactose ), glycerol triacetate

What Revatio looks like and contents of the pack Revatio film-coated tablets are white and round in shape. The tablets are marked with PFIZER on one side and RVT 20 on the other. The tablets are provided in blister packs containing 90 tablets,
90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.

Manufacturer: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Poc -sur-Cisse, France.

or

Mylan Hungary Kft., Mylan utca 1, Kom rom 2900, Hungary.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Lietuva Viatris
Viatris UAB
T l/Tel: +32 (0)2 658 61 Tel: +370 52051
Luxembourg/Luxemburg

Viatris .: +359 2 44 55 T l/Tel: +32 (0)2 658 61 (Belgique/Belgien) esk republika Magyarorsz g Viatris CZ s.r.o. Viatris Healthcare Kft. Tel: +420 222 004 Tel.: + 36 1 465 2Danmark Malta V.J. Salomone Pharma Limited
Tel: (+356) 21 220 Viatris ApS Tlf: +45 28 11 69 Deutschland Nederland Viatris Healthcare GmbH Mylan Healthcare BV Tel: +49 (0)800 0700 Tel: +31 (0)20 426 3Eesti Norge Viatris O
Viatris AS Tel: +372 6363 Tlf: +47 66 75 33
sterreich Viatris Hellas Ltd Mylan sterreich GmbH : +30 2100 100 Tel: +43 1 86Espa a Polska Viatris Pharmaceuticals, S.L.U. Mylan Healthcare Sp. z o.o. Tel: +34 900 102 Tel.: +48 22 546 64 France Portugal Viatris Sant
Viatris Healthcare, Lda. T l: +33 (0)4 37 25 75 Tel: +351 21 412 72 Hrvatska Rom nia Viatris Hrvatska d.o.o. BGP Products SRL Tel: +385 1 23 50 Tel: +40 372 579 Ireland Slovenija Mylan Ireland Limited
Viatris d.o.o. Tel: +353 1 8711Tel: + 386 1 236 31 sland Slovensk republika Icepharma hf. Viatris Slovakia s.r.o.
S mi: + 354 540 8Tel: +421 2 32 199 Italia Suomi/Finland Viatris Pharma S.r.l. Viatris Oy Tel: +39 02 612 46Puh/Tel: +358 20 720 9
Sverige
GPA Pharmaceuticals Ltd Viatris AB : +357 22863Tel: + 46 (0)8 630 19 Latvija United Kingdom (Northern Ireland) Viatris SIA Mylan IRE Healthcare Limited Tel: +371 676 055 Tel: +353 18711This leaflet was last revised in

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 website about rare diseases and treatments.

Package leaflet: Information for the user

Revatio 0.8 mg/ml solution for injection sildenafil

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.