Revatio

Helstu upplýsingar

  • Heiti vöru:
  • Revatio
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Revatio
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • UROLOGICALS
  • Lækningarsvæði:
  • Hypertension, Pulmonary
  • Ábendingar:
  • Treatment of adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable. Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III,
  • Vörulýsing:
  • Revision: 36

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000638
  • Leyfisdagur:
  • 27-10-2005
  • EMEA númer:
  • EMEA/H/C/000638
  • Síðasta uppfærsla:
  • 28-03-2019

Opinber matsskýrsla

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London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/667007/2016

EMEA/H/C/000638

EPAR summary for the public

Revatio

sildenafil

This is a summary of the European public assessment report (EPAR) for Revatio. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Revatio.

For practical information about using Revatio, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Revatio and what is it used for?

Revatio is a medicine used to treat adults and children from 1 year of age with pulmonary arterial

hypertension (PAH, abnormally high blood pressure in the arteries of the lungs). In adults, Revatio is

used in patients with class II (slight limitation of physical activity) or class III (marked limitation of

physical activity) PAH.

Revatio contains the active substance sildenafil.

How is Revatio used?

Revatio can only be obtained with a prescription and treatment should only be started and monitored

by a doctor who has experience in the treatment of PAH.

Revatio is available as tablets (20 mg), a solution for injection (0.8 mg/ml) and a powder to be made

up into an oral suspension (10 mg/ml). The solution for injection is for adults who cannot take Revatio

tablets or oral suspension for a short period, but whose condition is stable.

In adults, Revatio is taken at a dose of 20 mg three times a day. Lower doses of Revatio may be

needed in patients taking some medicines that affect the way Revatio is broken down in the body. In

adults who cannot take the tablets or oral suspension, the solution for injection is injected into a vein

by a doctor or nurse at a dose of 10 mg (12.5 ml) three times a day.

Revatio

EMA/667007/2016

Page 2/3

In children aged 1 to 17 years, the recommended dose is 10 mg three times a day in children weighing

less than 20 kg and 20 mg three times a day in those over 20 kg. Higher doses should not be used.

How does Revatio work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the

lungs. This leads to high blood pressure in the vessels taking blood from the heart to the lungs and

reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more

difficult.

The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘phosphodiesterase

type 5 (PDE5) inhibitors’, which means that it blocks the PDE5 enzyme. This enzyme is found in the

blood vessels of the lungs. When it is blocked, a substance called ‘cyclic guanine monophosphate’

(cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and

widening of the blood vessels. In patients with PAH, sildenafil widens the blood vessels of the lungs,

which lowers the blood pressure and improves symptoms.

What benefits of Revatio have been shown in studies?

Revatio was more effective than placebo (a dummy treatment) at improving exercise capacity in one

main study in adults and another main study in children.

The main study in adults involved 277 patients with PAH, most of whom had class II or class III

disease. Change in exercise capacity was measured as the improvement in the distance patients could

walk in 6 minutes after 12 weeks of treatment. Before treatment, adults with class II disease could

walk an average of 378m in 6 minutes. After 12 weeks, this distance had increased by 49 m more in

the patients taking 20 mg Revatio than in the patients taking placebo. Adults with class III disease

could walk an average of 326 m at the start of the study. This distance had increased by 45 m more in

the patients taking 20 mg Revatio than in those taking placebo after 12 weeks.

The main study in children involved 235 children aged 1 to 17 years with PAH. Change in exercise

capacity in this study was measured as the improvement in the maximum volume of oxygen used

during exercise after 16 weeks of treatment, in children able to perform the exercise tests. After 16

weeks, the maximum volume of oxygen the children used during exercise increased on average by

10.2% with Revatio compared with 0.5% with placebo.

The company also presented the results of studies showing that the tablets were equivalent to the oral

suspension (produced similar levels of sildenafil in the blood), and that a 10 mg injection was

equivalent to a 20 mg tablet.

What are the risks associated with Revatio?

The most common side effects with Revatio in adults (which may affect more than 1 patient in 10) are

headache, flushing (reddening of the skin), dyspepsia (heartburn), diarrhoea and pain in arm or leg.

Side effects are similar with the solution for injection. In children, the most common side effects

(which may affect up to 1 patient in 10) are throat and nose infections, headache, vomiting, fever,

diarrhoea, flu and nosebleeds. For the full list of all side effects reported with Revatio, see the package

leaflet.

Revatio must not be taken by patients who have ever had a problem with blood flow in the eye called

non-arteritic anterior ischaemic optic neuropathy (NAION). Revatio must not be taken with nitrates

(medicines used to treat angina), or with medicines that could affect the way that Revatio is broken

Revatio

EMA/667007/2016

Page 3/3

down in the body, such as ketoconazole or itraconazole (antifungal medicines) and ritonavir (used to

treat HIV infection). It must not be started in patients with severe liver disease or severe hypotension

(very low blood pressure), or who have recently had a stroke or heart attack, because Revatio has not

been studied in these groups of patients. For the full list of restrictions, see the package leaflet.

Why is Revatio approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Revatio’s benefits

are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded

that Revatio provides an alternative treatment option for PAH.

What measures are being taken to ensure the safe use of Revatio?

The company that markets Revatio will agree with each European Union Member State on how the

solution for injection will be distributed. It will also ensure that doctors and pharmacists who will

prescribe or dispense the solution for injection in each Member State receive information about how it

should be used and how to report side effects such as low blood pressure.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Revatio have also been included in the summary of product characteristics and the

package leaflet.

Other information about Revatio

The European Commission granted a marketing authorisation valid throughout the European Union for

Revatio on 28 October 2005.

The full EPAR for Revatio can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Revatio,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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

What Revatio is and what it is used for

What you need to know before you take Revatio

How to take Revatio

Possible side effects

How to store Revatio

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

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.

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.

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 30

C. 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 Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

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

Tel: +43 (0)1 521 15-0

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

svetovanje

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

What Revatio is and what it is used for

What you need to know before you are given Revatio

How Revatio is given

Possible side effects

How to store Revatio

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

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.

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.

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 Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

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

Tel: +43 (0)1 521 15-0

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

svetovanje

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

What Revatio is and what it is used for

What you need to know before you take Revatio

How to take Revatio

Possible side effects

How to store Revatio

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.

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 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.

Tap the bottle to release the powder.

Remove the cap.

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

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

figure 2

Remove the cap.

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

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

figure 4

Remove the cap.

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

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.

Shake the closed bottle of constituted oral suspension vigorously for a minimum of 10 seconds

before use. Remove the cap (figure 6).

figure 6

While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the

adaptor (figure 7).

figure 7

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

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.

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

syringe from the bottle.

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

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 Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

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

Tel: +43 (0)1 521 15-0

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

svetovanje

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.