Author: Pfizer Limited


Long information

What is it and how is it used?

Revatio belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Revatio brings down pulmonary blood pressure by widening the blood vessels in the lungs. Revatio is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs).

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

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

You should not be given Revatio

  • If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Revatio.
  • If you are taking 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?). 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 have recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure (<90/50mmHg).</li>
  • If you are taking a medicine containing ketoconazole or itraconazole (to treat fungal infections) or 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).
Take special care with Revatio

Tell your doctor

  • If you have a severe heart problem.
  • If you have Retinitis pigmentosa (a rare inherited eye disease).
  • If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow), or any disease or deformity of the penis.
  • If you currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds.
  • If your disease is due to a blocked or narrow vein in the lungs rather than a blocked or narrow artery.
  • If you experience sudden decrease or loss of vision, stop takingRevatio and contact your doctor immediately.
Special considerations for children and adolescents

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

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking other therapies for pulmonary hypertension (e.g. bosentan, iloprost) ask your doctor or pharmacist for advice before taking Revatio.

If you are taking 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) please inform your doctor or pharmacist before taking Revatio

If you are taking medicines that inhibit blood clotting (for example warfarin) please inform your doctor or pharmacist before taking Revatio.

If you are taking medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), ask your doctor or pharmacist for advice before taking Revatio, as your dose may need to be adjusted.

If you are taking alpha-blocker therapy for the treatment of high blood pressure or prostate problems, ask your doctor or pharmacist for advice before taking Revatio.

Pregnancy and breast feeding

If you are pregnant, or think you might be pregnant, ask your doctor or pharmacist for advice before you are given Revatio. Revatio should not be used during pregnancy unless strictly necessary.Stop breast feeding when you start Revatio treatment. Revatio should not be given to women who are breast feeding since it is not known if the medicine passes into the breast milk.

Driving and using machines

Revatio can cause dizziness and can affect vision. You should be aware of how you react to the medicinal product before you drive or use machinery.

How is it used?

Revatio is given as an intravenous injection and will always be given to you by a doctor or a healthcare professional. 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 10mg (corresponding to 12.5ml) 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 anotherhealthcare professional immediately.

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 product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Revatio can cause side effects, although not everybody gets them.

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 (seen in less than 1 in 10 but more than 1 in 100 patients) were facial flushing, headache, low blood pressure and nausea. In clinical trials side effects reported commonly (seen in less than 1 in 10 but more than 1in100 patients) by patients with pulmonary arterial hypertension were facial flushing and nausea.

In clinical trials with Revatio tablets side effects reported very commonly (seen in more than 1 in 10 patients) were headache, facial flushing, indigestion, diarrhoea and limb pain.

Other side effects with Revatio tablets reported commonly (seen in less than 1 in 10 but more than 1 in 100 patients) included: infection under the skin, flu-like symptoms, sinusitis, anaemia, fluid retention, difficulty sleeping, anxiety, migraine, tremor, pins and needles, burning sensation, reduced skin sensation, 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.

Other side effects with Revatio tablets reported less commonly (seen in less than 1 in 100 but more than 1 in 1000 patients) included: reduced sharpness of vision, double vision, abnormal sensation in the eye and breast enlargement in men.
Skin rash has also been reported.
Sudden decrease or loss of hearing has been reported.
Decreased blood pressure has been reported.

Revatio contains the same active substance, sildenafil, that is used to treat men with male erectile dysfunction (MED). Sildenafil belongs to a class of medicine called phosphodiesterase type 5 (PDE5)

inhibitors. When used to treat MED, the following visual side effects have been reported with PDE5 inhibitors, including sildenafil: partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

Prolonged and sometimes painful erections have been reported after taking sildenafil. If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

How should it be stored?

Keep out of the reach and sight of children.

Do not use Revatio after the expiry date which is stated on the vial label and carton. The expiry date refers to the last day of that month.

Revatio does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Revatio contains

The active substance is sildenafil. Each ml of solution contains 0.8mg of sildenafil (as citrate).Each 20ml vial contains 10mg 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 20ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminium seal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Pfizer Limited , Sandwich, Kent , CT13 9NJ, United Kingdom.

Manufacturer:
Pfizer PGM , Zone Industrielle, 29 route des Industries , 37530 Poce-sur-Cisse, France.

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

België Belgique BelgienPfizer S.A.N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburgPfizer S.A.TélTel 32 02 554 62 1

, . 359 2 970 4333 MagyarországPfizer Kft.Tel. 36 1 488 37 0

eská republikaPfizer s.r.o.Tel 420-283-004-111 MaltaV.J. Salomone Pharma Ltd.Tel 356 21 22 01 7

Danmark NederlandPfizer ApSTlf 45 44 20 11 00 Pfizer bvTel 31 010 406 43 0

DeutschlandPfizer Pharma GmbHTel 49 030 550055 51000 NorgePfizer ASTlf 47 67 52 61 0

EestiPfizer Luxembourg SARL Eesti filiaalTel 372 6 405 328 ÖsterreichPfizer Corporation Austria Ges.m.b.H.Tel 43 01 521 15-

Pfizer Hellas A.E. 30 210 678 5800 PolskaPfizer Polska Sp. z o.o.,Tel. 48 22 335 61 0

EspañaPfizer S.A.Tel 34 91 490 99 00 PortugalLaboratórios Pfizer, Lda.Tel 351 21 423 550

FrancePfizer Tél 33 01 58 07 34 40 RomâniaPfizer România S.R.L.Tel 40 21 207 28 0

IrelandPfizer Healthcare IrelandSlovenijaPfizer Luxembourg SARLPfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, LjubljanaTel 386 0 1 52 11 400Tel 1800 633 363 toll free44 01304 61616

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ItaliaPfizer Italia S.r.l.Tel 39 06 33 18 21 SuomiFinlandPfizer OyPuhTel 358 09 43 00 4

GEO. PAVLIDES ARAOUZOS LTD, 35722818087 Sverige Pfizer ABTel 46 08 550 520 0

LatvijaPfizer Luxembourg SARL filile LatvijTel 371 670 35 775 United KingdomPfizer LimitedTel 44 01304 61616

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000

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