Revatio

Package leaflet: Information for the patient

Revatio 20 mg film-coated tablets

sildenafil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Revatio is and what it is used for
2. What you need to know before taking 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 class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. Revatio reduces blood pressure in the lung blood vessels by dilating the pulmonary blood vessels.
Revatio is used to treat adults, and children and adolescents aged 1 to 17 years, who have high blood pressure in the lung blood vessels (pulmonary arterial hypertension).

2. What you need to know before taking Revatio

Do not take Revatio
if you are allergic to sildenafil or to any of the other ingredients of this medicine
(listed in section 6).
if you are taking medicines containing nitrates or if you are taking substances that release
nitric oxide, such as amyl nitrate ("poppers"). These medicines are often
used to relieve episodes of chest pain (or "angina pectoris"). Revatio may cause
a significant increase in the effects of these medicines. Inform your doctor if you are
taking any of these medicines. If you are unsure, consult your doctor or
pharmacist.
if you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors, such as Revatio, have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform 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 previously experienced vision loss caused by a problem with blood flow to the optic nerve known as non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Revatio if:
your condition is due to obstruction or narrowing of a pulmonary vein rather than an artery.
you have a serious heart condition.
you have problems with your heart ventricles.
you have high blood pressure in the blood vessels of the lungs.
you have low blood pressure while at rest.
you are losing large amounts of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.
you have a rare inherited eye disease (retinitis pigmentosa).
you have an abnormality of red blood cells (sickle cell anemia), a blood cell tumor (leukemia), a bone marrow tumor (multiple myeloma), or any disease or deformity of the penis.
you currently have a stomach ulcer, a bleeding disorder (such as hemophilia), or nosebleeds.
you are taking medicines for erectile dysfunction.

When used to treat erectile dysfunction (ED), PDE5 inhibitors, including sildenafil, have been associated with the following visual side effects, with unknown frequency: partial, sudden, temporary or permanent reduction 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).

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

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor, as a dose adjustment may be necessary.

Children
Revatio must not be given to children under 1 year of age.

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

Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrate ("poppers"). These medicines are often used to relieve angina pectoris attacks or "chest pain" (see section 2. What you need to know before taking Revatio).

• Inform your doctor or pharmacist if you are already taking riociguat.

Therapies for pulmonary arterial hypertension (e.g. bosentan, iloprost): consult your doctor or pharmacist before taking Revatio.

Medicines containing St. John’s wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used for epilepsy).

Medicines that inhibit blood coagulation (e.g. warfarin), although no adverse effect has been observed.

Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as dose adjustment may be necessary.

Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as concomitant use of these medicines may cause symptoms leading to low blood pressure (e.g. dizziness, feeling of emptiness in the head).

Medicines containing sacubitril/valsartan, used for the treatment of heart failure.

Revatio with food and drink
You must not drink grapefruit juice while being treated with Revatio.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Revatio must not be taken during pregnancy unless absolutely necessary.
Revatio must not be administered to women of childbearing potential unless they are using adequate contraceptive methods.
Revatio passes into breast milk in small amounts and is not considered harmful to the infant.

Driving and using machines
Revatio may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to this medicine.

Revatio contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Revatio contains sodium
Revatio 20 mg tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Revatio

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults, the recommended dose is 20 mg three times a day (taken 6–8 hours apart), with or without food.

Use in children and adolescents
For children and adolescents aged 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg, or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. Higher doses must not be used in children. This medicine should only be used when administered at a dose of 20 mg three times a day. Other pharmaceutical forms may be more suitable for administration to patients weighing ≤ 20 kg and to younger patients who are unable to swallow tablets.

If you take more Revatio than you should
Do not take more medicine than prescribed by your doctor.
If you take more medicine than prescribed, contact your doctor immediately. Taking more Revatio than recommended may increase the risk of known side effects.

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

If you stop taking Revatio
Stopping treatment with Revatio suddenly may cause worsening of symptoms. Do not stop treatment with Revatio unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any questions about 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 must stop taking Revatio and contact your doctor immediately (see also section 2):

• sudden decrease or loss of vision (frequency not known)
• an erection that persists continuously for more than 4 hours. After taking sildenafil, prolonged erections, sometimes painful, have been reported, with frequency not known.

Adults
The side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea, and pain in arms or legs.
The side effects reported commonly (may affect up to 1 in 10 people) include:
subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, sleep disorders, anxiety, headache, tremor, prickling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision and light sensitivity, effects on colour perception, eye irritation, eye inflammation/redness, dizziness, bronchitis, nosebleeds, increased nasal secretions, cough, nasal congestion, stomach inflammation, gastroenteritis, heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.
The side effects reported uncommonly (may affect up to 1 in 100 people) include: reduced visual acuity, double vision, abnormal sensation in the eye, bleeding from the penis, blood in semen and/or urine, and excessive breast development in males.
Skin rash, sudden decrease or loss of hearing, and low blood pressure have also been reported, with frequency not known (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-sided heart failure, cardiogenic shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral gastroenteritis, urinary tract infection, and dental caries.
The following serious adverse events considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people): allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to breathing problems.
The side effects reported very commonly (may affect more than 1 in 10 people) were: headache, vomiting, throat infection, fever, diarrhoea, influenza, and nosebleeds.
The 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the pack, following "Exp." The expiry date refers to the last day of the month.
Do not store above 30°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Revatio contains
The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
The excipients are:
Inner core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium croscarmellose
(see section 2 “Revatio contains sodium”), magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), lactose monohydrate (see section 2
“Revatio contains lactose”), glycerol triacetate.

Description of the appearance of Revatio and pack contents
Revatio tablets are white, film-coated, round tablets. The tablets are marked with “VLE” on one side and “RVT 20” on the other. The tablets are available in blisters in packs of 90 tablets, 90 x 1 tablet in divisible blisters for single doses, and in blisters in packs of 300 tablets.
Not all pack sizes may be marketed.

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

Manufacturers:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France
or Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 Hungary.

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

België /Belgique / Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: + 370 52051288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0)800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 236 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. Additionally, links to other websites on rare diseases and their therapeutic treatments are provided.

Package leaflet: Information for the user

Revatio 0.8 mg/ml solution for injection

sildenafil
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Revatio is and what it is used for
2. What you need to know before using Revatio
3. How to use 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 class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. Revatio reduces blood pressure in the lungs
by dilating the blood vessels in the lungs.
Revatio is used to treat adults with high blood pressure in the blood vessels of the lungs
(pulmonary arterial hypertension).
Revatio injectable solution is an alternative formulation of Revatio for patients who
are temporarily unable to take Revatio tablets.

2. What you need to know before taking Revatio

Do not take Revatio
if you are allergic to sildenafil or to any of the other ingredients of this medicine
(listed in section 6).
if you are taking medicines containing nitrates or if you are taking substances that release
nitric oxide, such as amyl nitrate ("poppers"). These medicines are often
used to relieve chest pain attacks (or "angina pectoris"). Revatio may cause
a significant increase in the effects of these medicines. Inform your doctor if you are
taking any of these medicines. If you have any doubts, consult your doctor or
pharmacist.
if you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors, such as Revatio, have been shown to enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform 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 for fungal infections, such as ketoconazole or itraconazole, or medicines containing ritonavir (for HIV).
if you have previously experienced vision loss caused by a problem with blood flow to the optic nerve known as non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Revatio if:
your condition is due to obstruction or narrowing of a vein rather than an artery.
you have a serious heart condition.
you have problems with your heart ventricles.
you have high blood pressure in the blood vessels of the lungs.
you have low blood pressure while at rest.
you are losing large amounts of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.
you have a rare inherited eye disease (retinitis pigmentosa).
you have an abnormality of red blood cells (sickle cell anemia), a blood cell tumor (leukemia), a bone marrow tumor (multiple myeloma), or any disease or deformity of the penis.
you currently have a stomach ulcer, a bleeding disorder (such as hemophilia), or nosebleeds.
you are taking medicines for erectile dysfunction.

When used to treat erectile dysfunction (ED), PDE5 inhibitors, including sildenafil, have been associated with rare cases of the following vision-related adverse effects, with unknown frequency: partial, sudden, temporary or permanent reduction 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 that lasts continuously for more than 4 hours, stop taking Revatio
and contact your doctor immediately (see also section 4).

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor, as a dose adjustment may be necessary.

Children and adolescents
Revatio must not be given to children and adolescents under 18 years 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 substances that release nitric oxide, such as amyl nitrate ("poppers"). These medicines are often used to relieve angina pectoris or "chest pain" (see section 2. What you need to know before taking Revatio).

Inform your doctor or pharmacist if you are already taking riociguat.

Therapies for pulmonary arterial hypertension (e.g. bosentan, iloprost).

Medicines containing St. John’s wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used for epilepsy).

Medicines that thin the blood (e.g. warfarin), although no adverse effect has been observed.

Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as a dose adjustment may be necessary.

Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as combining these medicines may cause symptoms of low blood pressure (e.g. dizziness, lightheadedness).

Medicines containing sacubitril/valsartan, used to treat heart failure.

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Revatio should not be taken during pregnancy unless absolutely necessary.
Revatio must not be administered to women of childbearing potential unless they are using adequate contraceptive methods.
Revatio passes into breast milk in small amounts and is not considered harmful to the infant.

Driving and using machines
Revatio may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to this medicine.

3. How to use Revatio

Revatio is administered intravenously and will always be given to you by a doctor or a nurse. The doctor will determine the duration of treatment and the dose of Revatio to be administered each day, and will monitor your response to treatment and your clinical condition. The usual dose is 10 mg (corresponding to 12.5 ml) three times daily.
An intravenous injection of Revatio will be used instead of Revatio tablets.

If you use more Revatio than you should
If you are concerned that you may have been given too high a dose of Revatio, inform your doctor or nurse immediately. Taking more Revatio than recommended may increase the risk of known side effects.

If you forget to use Revatio
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor or pharmacist if you think a dose has been missed. Do not administer a double dose to make up for a missed dose.

If you stop using Revatio
Stopping treatment with Revatio abruptly may cause a worsening of symptoms. Your doctor may gradually reduce the dose over several days before completely stopping treatment.

If you have any doubts about how to use this medicine, consult 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 must stop taking Revatio and contact your doctor immediately (see also section 2):

• sudden decrease or loss of vision (frequency not known)
• an erection that persists continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported with sildenafil, with frequency not known.

Adults
The side effects reported in a clinical study with injectable Revatio are similar to those reported in clinical studies with Revatio tablets. In clinical studies, the commonly reported side effects (may affect up to 1 in 10 people) were facial flushing, headache, low blood pressure, and nausea.
In clinical studies, the commonly reported side effects in patients with pulmonary arterial hypertension (may affect up to 1 in 10 people) were facial flushing and nausea.
In controlled studies with Revatio tablets, the very commonly reported side effects (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea, and pain in the arms or legs.
The commonly reported side effects (may affect up to 1 in 10 people) include:
subcutaneous infections, influenza-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, sleep disorders, anxiety, headache, tremor, prickling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, eye-related effects, blurred vision and light sensitivity, effects on colour perception, eye irritation, eye inflammation/redness, dizziness, bronchitis, nosebleeds, increased nasal secretions, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.
The non-commonly reported side effects (may affect up to 1 in 100 people) include:
reduced visual acuity, double vision, abnormal sensation in the eye, bleeding from the penis, blood in the semen and/or urine, and excessive breast development in males.
Skin rash, sudden decrease or loss of hearing, and low blood pressure have also been reported, with frequency not known (frequency cannot be estimated from the available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the vial label and on the
packaging, after Exp. The expiry date refers to the last day of the month.
Revatio does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 of sildenafil (as citrate).
The excipients are glucose and water for injections.

Description of the appearance of Revatio and contents of the pack
Each pack of Revatio injectable solution contains one 20 ml clear glass vial,
closed with a chlorobutyl rubber stopper and an aluminium seal.

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

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

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174

Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0)800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

Patient Information Leaflet

Revatio 10 mg/ml oral suspension powder

sildenafil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Revatio is and what it is used for
2. What you need to know before taking 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 class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Revatio reduces pulmonary blood pressure by dilating the blood vessels in the lungs.
Revatio is used to treat adults, children, and adolescents aged 1 to 17 years with pulmonary arterial
hypertension (high blood pressure in the blood vessels of the lungs).

2. What you need to know before taking Revatio

Do not take Revatio
if you are allergic to sildenafil or to any of the other ingredients of Revatio listed in
section 6.
if you are taking medicines containing nitrates or if you are taking substances that release
nitric oxide, such as amyl nitrate (“poppers”). These medicines are often
used to relieve angina attacks (or “chest pain”). Revatio may significantly increase the effects of these medicines. Inform your doctor if you are
taking any of these medicines. If you are unsure, consult your
doctor or pharmacist.
if you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors, such as Revatio, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform 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 containing ketoconazole or itraconazole (for fungal infections) or ritonavir (for HIV).
if you have previously experienced vision loss caused by a problem with blood flow to the optic nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Revatio if:
the disease is due to obstruction or narrowing of a pulmonary vein rather than a pulmonary artery.
you have severe heart disease.
you have problems with the heart ventricles.
you have high blood pressure in the blood vessels of the lungs.
you have low blood pressure at rest.
you are losing large amounts of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhoea.
you have a rare inherited eye disease ( retinitis pigmentosa ).
you have a red blood cell disorder (sickle cell anemia), a blood cell tumour (leukemia), a bone marrow tumour (multiple myeloma), or any disease or deformity of the penis.
you currently have a stomach ulcer, a bleeding disorder (such as haemophilia), or nosebleeds.
you are taking medicines for erectile dysfunction.

When used to treat erectile dysfunction (ED), PDE5 inhibitors, including sildenafil, have been associated with the following visual adverse effects, with unknown frequency: partial, sudden, temporary or permanent reduction 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).

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

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor, as a dose adjustment may be necessary.

Children
Revatio must not be given to children under 1 year of age.

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

Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrate (“poppers”). These medicines are often used to relieve angina attacks or “chest pain” (see section 2. What you need to know before taking Revatio).
Inform your doctor or pharmacist if you are already taking riociguat.
Therapies for pulmonary arterial hypertension (e.g. bosentan, iloprost).
Medicines containing St. John’s wort (a herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used for epilepsy).
Medicines that inhibit blood clotting (e.g. warfarin), although no adverse effects have been reported.
Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), as dose adjustment may be necessary.
Alpha-blocker therapy (e.g. doxazosin) for treating high blood pressure or prostate problems, as combining these medicines may cause symptoms leading to low blood pressure (e.g. dizziness, lightheadedness).
Medicines containing sacubitril/valsartan, used for the treatment of heart failure.

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Revatio must not be taken during pregnancy unless absolutely necessary.
Revatio must not be given to women of childbearing age unless they are using adequate contraceptive methods.
Revatio passes into breast milk in small amounts and is not considered harmful to the infant.

Driving and using machines
Revatio may cause dizziness and may affect vision. Before driving and using machinery, you should be aware of how you react to this medicine.

Revatio contains sorbitol
Revatio 10 mg/ml oral suspension powder contains 250 mg of sorbitol per ml of reconstituted oral suspension.
Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot metabolize fructose, discuss this with your doctor before you (or your child) take or receive this medicine.

Revatio contains sodium benzoate
Revatio 10 mg/ml oral suspension powder contains 1 mg of sodium benzoate per ml of reconstituted oral suspension. Sodium benzoate may increase levels of a substance called bilirubin. High bilirubin levels may cause jaundice (yellowing of the skin and eyes) and may also lead to brain damage (encephalopathy) in newborns (up to 4 weeks of age).

Revatio contains sodium
Revatio 10 mg/ml oral suspension powder contains less than 1 mmol (23 mg) of sodium per ml of reconstituted oral suspension, i.e. essentially ‘sodium-free’.

3. How to take Revatio

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
For adults, the recommended dose is 20 mg three times daily (taken 6–8 hours apart), with or without food.

Use in children and adolescents
For children and adolescents aged 1 to 17 years, the recommended dose is 10 mg (1 ml of oral suspension) three times daily for children and adolescents ≤ 20 kg, or 20 mg (2 ml of oral suspension or 1 tablet) three times daily for children and adolescents > 20 kg, taken with or without food. Higher doses must not be used in children.
The oral suspension must be shaken well for at least 10 seconds before use.

Instructions for reconstituting the oral suspension
It is recommended that the pharmacist reconstitute the oral suspension before handing it to you.
After reconstitution, the oral suspension is in liquid form. If the powder has not been reconstituted, follow the instructions below to reconstitute the oral suspension.

Important: To reconstitute the contents of the bottle, a total volume of 90 ml of water (3 x 30 ml) must be used, regardless of the dose to be taken.

1. Tap the bottle gently to loosen the powder.
2. Remove the cap.
3. Measure 30 ml of water by filling the dosing cup (included in the package) up to the mark, then pour the water into the bottle. Measure another 30 ml of water using the dosing cup and add it to the bottle. (Figure 1)

Figure 1

4. Close the bottle with the cap and shake vigorously for at least 30 seconds. (Figure 2)

Figure 2

5. Remove the cap.
6. Measure another 30 ml of water with the dosing cup and add it to the bottle. A total of 90 ml of water (3 x 30 ml) must always be added, regardless of the dose to be taken. (Figure 3)

Figure 3

7. Close the bottle with the cap and shake vigorously for at least 30 seconds. (Figure 4)

Figure 4

8. Remove the cap.
9. Push the bottle adapter firmly into the neck of the bottle (as shown in Figure 5 below). The adapter is used to fill the oral dosing syringe directly from the bottle. Close the bottle with the cap.

Figure 5

10. Write the expiry date of the reconstituted oral suspension on the bottle label (the expiry date of the reconstituted oral suspension is 30 days from the date of reconstitution). After this date, any unused oral suspension must be discarded or returned to the pharmacist.

Instructions for use
Your pharmacist can provide instructions on how to measure the medicine using the oral dosing syringe supplied in the package. After reconstitution, the oral suspension must only be administered using the oral dosing syringe provided in each package. Before using the oral suspension, read the following instructions.

1. Before use, shake the closed bottle containing the reconstituted oral suspension vigorously for at least 10 seconds. Remove the cap. (Figure 6)

Figure 6

2. Place the bottle upright on a flat surface and insert the tip of the oral dosing syringe into the adapter. (Figure 7)

Figure 7

3. Invert the bottle while keeping the oral dosing syringe inserted. Slowly pull back the plunger of the oral dosing syringe to the graduation mark indicating the correct dose (1 ml drawn equals a 10 mg dose; 2 ml drawn equals a 20 mg dose). To measure the dose accurately, align the top edge of the plunger with the appropriate graduation mark on the oral dosing syringe. (Figure 8)

Figure 8

4. If large air bubbles are visible, slowly push the plunger back into the syringe. This will return the medicine to the bottle. Repeat step 3.
5. Turn the bottle upright again with the oral dosing syringe still inserted. Remove the oral dosing syringe from the bottle.
6. Place the tip of the oral dosing syringe into the mouth. Direct the tip of the oral dosing syringe towards the inside of the cheek. Push the plunger of the oral dosing syringe SLOWLY. Do not expel the medicine too quickly. If the medicine is to be administered to a child, ensure the child is sitting upright or otherwise kept in an upright position before administering the medicine. (Figure 9)

Figure 9

7. Close the bottle with the cap, leaving the adapter in place. Wash the oral dosing syringe according to the instructions below.

How to wash and store the syringe:

1. The syringe must be washed after each dose. Remove the plunger from the syringe and wash both components with water.
2. Dry the two components. Reinsert the plunger into the syringe. Store it in a clean and safe place together with the medicine.

If you take more Revatio than you should
Do not take more medicine than prescribed by your doctor.
If you take more medicine than prescribed, contact your doctor immediately. Taking more Revatio than recommended may increase the risk of known side effects.

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

If you stop taking Revatio
Stopping treatment with Revatio suddenly may cause your symptoms to worsen. Do not stop treatment with Revatio unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Revatio can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, you must stop taking
Revatio and contact your doctor immediately (see also section 2):

• sudden decrease or loss of vision (frequency not known)
• an erection that persists continuously for more than 4 hours. After taking sildenafil, prolonged and sometimes painful erections have been reported, with frequency not known.

Adults
The very common side effects (may affect more than 1 in 10 people) reported were
headache, facial flushing, indigestion, diarrhoea, and pain in the arms or legs.
Commonly reported side effects (may affect up to 1 in 10 people) include:
subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia),
fluid retention, sleep disorders, anxiety, headache, tremor, prickling sensation,
burning sensation, reduced sense of touch, bleeding at the back of the eye, visual disturbances,
blurred vision and light sensitivity, effects on colour perception, eye irritation, eye inflammation/redness,
dizziness, bronchitis, nosebleeds, increased nasal secretions, cough, nasal congestion, stomach inflammation,
gastroenteritis, heartburn, haemorrhoids, abdominal bloating, dry mouth, hair loss,
skin redness, night sweats, muscle pain, back pain, and increased body temperature.
Uncommonly reported side effects (may affect up to 1 in 100 people)
include: reduced visual acuity, double vision, abnormal sensation in the eye,
penile bleeding, blood in semen and/or urine, and excessive development of male breast tissue.
Rash, sudden decrease or loss of hearing, and low blood pressure
have also been reported, with frequency not known (frequency cannot be estimated from the available data).

Children and adolescents
The following serious adverse events have been commonly reported (may affect up to 1 in 10 people):
pneumonia, heart failure, right-sided heart failure, cardiac shock, high blood pressure in the lungs,
chest pain, fainting, respiratory infection, bronchitis, viral infection of the stomach and intestine,
urinary tract infection, and dental caries.
The following serious adverse events considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people):
allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing),
seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract,
and wheezing due to breathing problems.
Very commonly reported side effects (may affect more than 1 in 10 people) were:
headache, vomiting, sore throat, fever, diarrhoea, influenza, and nosebleeds.
Commonly reported side effects (may affect up to 1 in 10 people) were:
nausea, increased erections, pneumonia, and runny nose.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system listed in Annex 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 stated on the container, after Exp. The expiry date refers to the last day of the month.

Powder
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.

Reconstituted oral suspension
Store below 30°C or in the refrigerator at 2°C to 8°C. Do not freeze. Any reconstituted oral suspension remaining after 30 days must be discarded.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Revatio contains

• The active substance is sildenafil (as citrate). After reconstitution, each ml of oral suspension contains 10 mg of sildenafil (as citrate). A bottle of reconstituted oral suspension (112 ml) contains 1.12 g of sildenafil (as citrate).
• The other components are:
  Oral suspension powder: sorbitol (E420) (see section 2 “Revatio contains sorbitol”), anhydrous citric acid, sucralose, sodium citrate (E331) (see section 2 “Revatio contains sodium” and “Revatio contains sodium benzoate”), xanthan gum, titanium dioxide (E171), sodium benzoate (E211) (see section 2 “Revatio contains sodium benzoate” and “Revatio contains sodium”), anhydrous colloidal silica;
  Grape flavour: maltodextrin, concentrated grape juice, acacia gum, concentrated pineapple juice, anhydrous citric acid, natural flavour.

Description of Revatio and contents of the pack
Revatio is a white or almost white powder for oral suspension which, when reconstituted with water, forms a white grape-flavoured oral suspension.
A 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.
After reconstitution, the bottle contains 112 ml of oral suspension, of which 90 ml will be used for dosing and administration.
Pack contents: 1 bottle.
Each pack also contains a polypropylene dosing cup (with a 30 ml graduated mark), a polypropylene dosing syringe (3 ml) with a piston made of HDPE, and an LDPE press-in bottle adapter.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands
Manufacturer:
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France or Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 Hungary

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 52051288
България Luxembourg/Luxemburg
Mylan EOOD Viatris
Tel.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 220 174
Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0)800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00
France Portugal
Viatris Santé Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00
Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. Additionally, links to other websites on rare diseases and their therapeutic treatments are provided.