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Revatio (sildenafil) – Package leaflet - G04BE03

Updated on site: 09-Oct-2017

Medication nameRevatio
ATC CodeG04BE03
Substancesildenafil
ManufacturerPfizer Limited

Package leaflet: Information for the patient

Revatio 20 mg film-coated tablets

Sildenafil

Read all of this leaflet carefully before you start taking 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 or pharmacist.

-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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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 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).

2. What you need to know before you take Revatio

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).

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.

Stop breast-feeding when you start Revatio treatment. Revatio should not be given to women who are breast-feeding since it is not known if the medicine passes into the breast milk.

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.

3.How to take Revatio

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.

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 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.

5.How to store 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 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.

6. Contents of the pack and other information

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, magnesium stearate.

Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate, 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:

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer:

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

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

België /Belgique / Belgien

Lietuva

Pfizer S.A./N.V.

Pfizer Luxembourg SARL filialas Lietuvoje

Tél/Tel: +32 (0)2 554 62 11

Tel. +3705 2514000

България

Luxembourg/Luxemburg

Пфайзер Люксембург САРЛ, Клон България

Pfizer S.A.

Тел.: +359 2 970 4333

Tél/Tel: +32 (0)2 554 62 11

Česká republika

Magyarország

Pfizer s.r.o.

Pfizer Kft.

Tel: +420-283-004-111

Tel.: + 36 1 488 37 00

Danmark

Malta

Pfizer ApS

V.J. Salomone Pharma Ltd.

Tlf: +45 44 20 11 00

Tel : + 356 21 22 01 74

Deutschland

Nederland

Pfizer Pharma PFE GmbH

Pfizer bv

Tel: +49 (0)800 8535555

Tel: +31 (0)10 406 43 01

Eesti

Norge

Pfizer Luxembourg SARL Eesti filiaal

Pfizer AS

Tel: +372 666 7500

Tlf: +47 67 52 61 00

Ελλάδα

Österreich

Pfizer Ελλάς A.E.

Pfizer Corporation Austria Ges.m.b.H.

Τηλ: +30 210 678 5800

España

Polska

Pfizer GEP, S.L.

Pfizer Polska Sp. z o.o.,

Tel: +34 91 490 99 00

Tel.: +48 22 335 61 00

France

Portugal

Pfizer PFE France

Laboratórios Pfizer, Lda.

Tél: +33 (0)1 58 07 34 40

Tel: +351 21 423 5500

Hrvatska

România

Pfizer Croatia d.o.o.

Pfizer România S.R.L.

Tel: +385 1 3908 777

Tel: +40 21 207 28 00

Ireland

Slovenija

Pfizer Healthcare Ireland

Pfizer Luxembourg SARL

 

Pfizer, podružnica za svetovanje s področja

 

farmacevtske dejavnosti, Ljubljana

Tel: 1800 633 363 (toll free)

Tel: + 386 (0) 1 52 11 400

+44 (0)1304 616161

 

Ísland

Slovenská republika

Icepharma hf.

Pfizer Luxembourg SARL, organizačná zložka

Sími: + 354 540 8000

Tel: +421-2-3355 5500

Italia

Suomi/Finland

Pfizer Italia S.r.l.

Pfizer Oy

Tel: +39 06 33 18 21

Puh/Tel: +358 (0)9 43 00 40

Κύπρος

Sverige

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)

Pfizer AB

Τηλ: +357 22 817690

Tel: + 46 (0)8 550 520 00

Latvija

United Kingdom

Pfizer Luxembourg SARL filiāle Latvijā

Pfizer Limited

Tel: +371 670 35 775

Tel: +44 (0)1304 616161

This 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.

What is in this leaflet

1.What Revatio is and what it is used for

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

3.How Revatio is given

4.Possible side effects

5 How to store Revatio

6.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 brings down blood pressure in the lungs by widening the blood vessels in the lungs. Revatio is used to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

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

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 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 using 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 and adolescents

Revatio should not be given to children and adolescents under the age of 18.

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 effects.

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 of low blood pressure (e.g. dizziness, lightheadedness).

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.

Stop breast-feeding when you start Revatio treatment. Revatio should not be given to women who are breast-feeding since it is not known if the medicine passes into the breast milk.

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.

3.How Revatio is given

Revatio is given as an intravenous injection and will always be given to you by a doctor or a nurse. Your doctor will determine the duration of your treatment and how much Revatio intravenous injection you will receive each day and will monitor your response and condition. The usual dose is 10 mg (corresponding to 12.5 ml) three times a day.

A Revatio intravenous injection will be given to you instead of your Revatio tablets.

If you receive more Revatio than you should

If you are concerned that you may have been given too much Revatio, tell 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

As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten.

A double dose should not be given to make up for a forgotten dose.

If you stop use of Revatio

Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Your doctor may 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.

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

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

In clinical trials with Revatio tablets 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, inflammationof 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 upto 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).

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.

5. How to store 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 vial label and carton after EXP. The expiry date refers to the last day of that month.

Revatio does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how tothrow away medicines you no longer use. These measures will help to 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 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 one 20 ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminium seal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer:

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

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

België /Belgique / Belgien

Pfizer S.A./N.V.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333

Česká republika

Pfizer s.r.o.

Tel: +420-283-004-111

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Deutschland

Pfizer Pharma PFE GmbH

Tel: +49 (0)800 8535555

Eesti

Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500

Ελλάδα

Pfizer Ελλάς A.E. Τηλ: +30 210 678 5800

España

Pfizer GEP, S.L.

Tel: +34 91 490 99 00

France

Pfizer PFE France

Tél: +33 (0)1 58 07 34 40

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Malta

V.J. Salomone Pharma Ltd.

Tel : + 356 21 22 01 74

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Österreich

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

Hrvatska

România

Pfizer Croatia d.o.o.

Pfizer România S.R.L.

Tel: +385 1 3908 777

Tel: +40 21 207 28 00

Ireland

Slovenija

Pfizer Healthcare Ireland

Pfizer Luxembourg SARL

 

Pfizer, podružnica za svetovanje s področja

 

farmacevtske dejavnosti, Ljubljana

Tel: 1800 633 363 (toll free)

Tel: + 386 (0) 1 52 11 400

+44 (0)1304 616161

 

Ísland

Slovenská republika

Icepharma hf.

Pfizer Luxembourg SARL, organizačná zložka

Sími: + 354 540 8000

Tel: +421-2-3355 5500

Italia

Suomi/Finland

Pfizer Italia S.r.l.

Pfizer Oy

Tel: +39 06 33 18 21

Puh/Tel: +358 (0)9 43 00 40

Κύπρος

Sverige

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)

Pfizer AB

Τηλ: +357 22 817690

Tel: + 46 (0)8 550 520 00

Latvija

United Kingdom

Pfizer Luxembourg SARL filiāle Latvijā

Pfizer Limited

Tel: +371 670 35 775

Tel: +44 (0)1304 616161

This 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 patient

Revatio 10 mg/ml powder for oral suspension

Sildenafil

Read all of this leaflet carefully before you start taking 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 or pharmacist.

-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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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 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).

2. What you need to know before you take Revatio

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 of low blood pressure (e.g. dizziness, light headedness).

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.

Stop breast-feeding when you start Revatio treatment. Revatio should not be given to women who are breast-feeding since it is not known if the medicine passes into the breast milk.

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 sorbitol

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

3. How to take Revatio

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 (1 ml of oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food. Higher doses should not be used in children.

The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.

Instructions to reconstitute the oral suspension

It is recommended that your pharmacist reconstitutes (makes up) the oral suspension before giving it to you.

If reconstituted, the oral suspension is in a liquid form. If the powder is not reconstituted, you should reconstitute the oral suspension by following the instructions below.

Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking should be used to reconstitute the contents of the bottle.

1.Tap the bottle to release the powder.

2.Remove the cap.

3.Measure 30 ml of water by filling the measuring cup (included in the carton) to the marked line then pour the water into the bottle. Using the cup measure another 30 ml of water and add this to the bottle (figure 1).

figure 1

4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 2).

figure 2

5.Remove the cap.

6.Using the cup measure another 30 ml of water and add this to the bottle. You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3).

figure 3

7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 4).

figure 4

8.Remove the cap.

9.Press the bottle adaptor into the neck of the bottle (as shown on figure 5 below). The adaptor is provided so that you can fill the oral dosing syringe with medicine from the bottle. Replace the cap on the bottle.

figure 5

10.Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 30 days from the date of constitution). Any unused oral suspension should be discarded or returned to your pharmacist after this date.

Instructions for use

Your pharmacist should advise you how to measure the medicine using the oral dosing syringe provided in the pack. Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack. Please see instructions below before using the oral suspension.

1.Shake the closed bottle of constituted oral suspension vigorously for a minimum of 10 seconds before use. Remove the cap (figure 6).

figure 6

2.While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the adaptor (figure 7).

figure 7

3.Turn the bottle upside down while holding the oral dosing syringe in place. Slowly pull back the plunger of the oral dosing syringe to the graduation mark that marks the dose for you (withdrawing 1 ml provides a 10 mg dose, withdrawing 2 ml provides a 20 mg dose). To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).

figure 8

4.If large bubbles can be seen, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat step 3 again.

5.Turn the bottle back upright with the oral dosing syringe still in place. Remove the oral dosing syringe from the bottle.

6.Put the tip of the oral dosing syringe into the mouth. Point the tip of the oral dosing syringe towards the inside of the cheek. SLOWLY push down the plunger of the oral dosing syringe. Do not squirt the medicine out quickly. If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine (figure 9).

figure 9

7.Replace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral dosing syringe as instructed below.

Cleaning and storing the syringe:

1.The syringe should be washed after each dose. Pull the plunger out of the syringe and wash both parts in water.

2.Dry the two parts. Push the plunger back in to the syringe. Keep it in a clean safe place with the medicine.

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.

4. Possible side effects

Like all medicines, this medicine 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 up to 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.

5. How to store 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 bottle after ‘EXP’. The expiry date refers to the last day of that month.

Powder

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Reconstituted oral suspension

Store below 30°C or in refrigerator at 2ºC to 8°C. Do not freeze. Any remaining oral suspension should be discarded 30 days after constitution.

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 protect the environment.

6. Contents of the pack and other information

What Revatio contains

-The active substance is sildenafil (as sildenafil citrate).

After reconstitution, each ml of the oral suspension contains 10 mg of sildenafil (as citrate) One bottle of reconstituted oral suspension (112 ml) contains 1.12 g of sildenafil (as citrate)

-The other ingredients are: Powder for oral suspension: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, titanium dioxide (E171), sodium benzoate (E211), silica, colloidal anhydrous; Grape flavour: maltodextrin, grape juice concentrate, gum acacia, pineapple juice concentrate, citric acid anhydrous, natural flavouring

What Revatio looks like and contents of the pack

Revatio is supplied as a white to off-white powder for oral suspension providing a white, grape flavoured oral suspension when constituted with water.

One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.

Once reconstituted the bottle contains 112 ml of oral suspension, of which 90 ml is intended for dosing and administration.

Pack size: 1 bottle

Each pack also contains a polypropylene measuring cup (graduated to indicate 30 ml), polypropylene oral dosing syringe (3 ml) with HDPE plunger and a LDPE press-in bottle adaptor.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer

Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.

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

België /Belgique / Belgien

Pfizer S.A./N.V.

Tél/Tel: +32 (0)2 554 62 11

България

Пфайзер Люксембург САРЛ, Клон България Тел.: +359 2 970 4333

Česká republika

Pfizer s.r.o.

Tel: +420-283-004-111

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Deutschland

Pfizer Pharma PFE GmbH

Tel: +49 (0)800 8535555

Eesti

Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500

Ελλάδα

Pfizer Ελλάς A.E. Τηλ: +30 210 678 5800

España

Pfizer GEP, S.L.

Tel: +34 91 490 99 00

France

Pfizer PFE France

Tél: +33 (0)1 58 07 34 40

Hrvatska

Pfizer Croatia d.o.o.

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

Magyarország

Pfizer Kft.

Tel.: + 36 1 488 37 00

Malta

V.J. Salomone Pharma Ltd.

Tel : + 356 21 22 01 74

Nederland

Pfizer bv

Tel: +31 (0)10 406 43 01

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Österreich

Polska

Pfizer Polska Sp. z o.o.,

Tel.: +48 22 335 61 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

România

Pfizer România S.R.L.

Tel: +385 1 3908 777

Tel: +40 21 207 28 00

Ireland

Slovenija

Pfizer Healthcare Ireland

Pfizer Luxembourg SARL

 

Pfizer, podružnica za svetovanje s področja

 

farmacevtske dejavnosti, Ljubljana

Tel: 1800 633 363 (toll free)

Tel: + 386 (0) 1 52 11 400

+44 (0)1304 616161

 

Ísland

Slovenská republika

Icepharma hf.

Pfizer Luxembourg SARL, organizačná zložka

Sími: + 354 540 8000

Tel: +421-2-3355 5500

Italia

Suomi/Finland

Pfizer Italia S.r.l.

Pfizer Oy

Tel: +39 06 33 18 21

Puh/Tel: +358 (0)9 43 00 40

Κύπρος

Sverige

PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)

Pfizer AB

Τηλ: +357 22 817690

Tel: + 46 (0)8 550 520 00

Latvija

United Kingdom

Pfizer Luxembourg SARL filiāle Latvijā

Pfizer Limited

Tel: +371 670 35 775

Tel: +44 (0)1304 616161

This 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.

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