Buy Revatio Malaysia

Package insert: Information for the patient

Revatio 20 mg film-coated tablets

Sildenafil

Read 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. Do not pass it on to others, even if the symptoms of the disease are the same as yours, as this can be dangerous.
• If you experience side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See paragraph 4.

  What is in this brochure

  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 save 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 inhibitors (PDE5). Revatio lowers blood pressure in the blood vessels of the lungs by expanding the blood vessels in the lungs.

     Revatio is used to treat adults, children and adolescents aged 1 to 17 years with increased pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

  2. What you need to know before taking Revatio Do not take Revatio

     • if you are allergic to sildenafil or any of the other ingredients in this medicine (see section 6).
     • if you are taking medicines containing nitrates or if you are taking substances that release nitrogen oxides, such as amyl nitrate ("poppers"). These drugs are often used to treat bouts of chest pain (or "angina pectoris"). Revatio can significantly increase the effectiveness of these medicines. Tell your doctor if you are taking any of them. If you have any doubts, ask your doctor or pharmacist.
     • if you are taking riociguat This medicine is used to treat pulmonary arterial hypertension (i.e. increased blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. increased blood pressure in the lungs due to blood clots). PDE5 inhibitors like Revatio have been shown to increase the blood pressure lowering effect of this medicine. If you take riociguat or if you have any doubts, tell your doctor.
     • if you have had a recent stroke, heart attack, or had severe liver disease or very low blood pressure (Moins 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 had vision loss in the past caused by a problem with blood flow to the ocular 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 constipation or narrowing of a pulmonary vein rather than an artery.
     • have a serious heart problem.
     • Have cardiac ventricular problems.
     • have high blood pressure in the blood vessels of your lungs.
     • have low blood pressure at rest.
     • lose large amounts of body fluids (dehydration), which can occur if you sweat a lot or if you do not drink enough fluids. This can happen if he has fever, vomiting or diarrhea.
     • have a rare hereditary eye disease (retinitis pigmentosa).
     • have an abnormality of red blood cells (sickle cell anemia), a blood cell tumor (leukemia), a bone marrow tumor (multiple myeloma) or a disease or deformity of the penis.
     • Currently has a stomach ulcer, coagulation disorder (such as hemophilia) or nasal bleeding problems.
     • takes medication for erectile dysfunction.

       The following visual side effects with unknown frequency have been reported with partial PDE5 inhibitors, including sildenafil, in the treatment of erectile dysfunction (ED): partial, sudden, temporary, or permanent reduction or vision loss in one or both eyes.

       If you notice a 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 after taking Sildenfil in men. If you have an erection that lasts longer 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 you should tell your doctor as a dose adjustment may be required.

       children

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

       Other drugs and revatio

       Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines.

     • Medicines that contain nitrates or substances that release nitrogen oxides, such as amyl nitrate ("poppers"). These medicines are often used to treat seizures or "chest pain" (see section 2. What you need to know before taking Revatio).
     • Tell your doctor or pharmacist if you are already taking riociguat.
     • Pulmonary arterial hypertension therapies (e.g. bosentan, iloprost) ask your doctor or pharmacist for advice before taking Revatio.
     • Medicines containing St. John's wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used to treat epilepsy).
     • Medicines that inhibit blood clotting (e.g. warfarin) although no side effects have been shown.
     • Medicines containing erythromycin, clarithromycin, telithromycin (they are antibiotics used to treat some bacterial infections), saquinavir (for HIV) or nefazodone (for depression), as a dose adjustment may be required.
     • Alpha blocker therapy (e.g. doxazosin) to treat high blood pressure or prostate problems, as the combination of the two medicines can cause symptoms that lead to a drop in blood pressure (e.g. dizziness, emptiness).

       Revatio with food and drink

       You must not drink grapefruit juice while you are being treated with Revatio.

       pregnancy and breast feeding period

       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 absolutely necessary.

       Revatio should not be used in women of childbearing potential unless they use appropriate contraceptive methods.

       Revatio is excreted in breast milk in small amounts and is not considered harmful to the baby.

       Drive and use machines

       Revatio can cause dizziness and impair vision. Before you drive and operate machinery, you should know how you react to this medicine.

       Revatio contains lactose

       If your doctor has diagnosed that you have an intolerance to some sugars, contact your doctor before taking this medicine.

  3. How to take Revatio

     Always take this medicine exactly as your doctor has told you. If you are not sure, contact your doctor or pharmacist.

     For adults, the recommended dose is 20 mg three times a day (6 to 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 plus 20 kg. take with or without food. Higher doses should not be used in children. This medicine should only be used when 20 mg is given three times a day.

     Other pharmaceutical forms may be more suitable for administration to weight patients

     ≤ 20 kg and to other younger patients who cannot swallow the tablets.

     If you take more Revatio than you should

     You must not take more than what your doctor has told you to do.

     If you take more than the prescribed amount of medication, contact your doctor immediately. Taking more Revatio than necessary can increase the risk of known side effects.

     If you forget to take Revatio

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

     If you stop taking Revatio

     Stopping Revatio suddenly can make the symptoms worse. Do not stop taking Revatio unless your doctor decides. Your doctor may tell you to reduce the dose over a few days before stopping treatment completely.

     If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  4. possible side effects

     Like all medications, Revatio can have side effects, although not everyone gets them.

     If you experience any of the following side effects, stop taking Revatio and contact your doctor immediately (see also section 2):

• if there is a sudden decrease or loss of vision (frequency not known)
• if you have an erection that lasts over 4 hours. Prolonged and sometimes painful erections with unknown frequency have been reported after taking Sildenafil.

Adults

The most common side effects reported (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhea and pain in the arms or legs.

The commonly reported side effects (which may affect up to 1 in 10 people) include: subcutaneous infections, flu symptoms, sinusitis, reduced red blood cells (anemia), fluid retention, sleep disorders, anxiety, headache, tremors, pinprick sensation, burning sensation, decreased sensation of touch, Bleeding in the back of the eye, effects on vision, blurred vision and sensitivity to light, effects on color perception, eye irritation, inflammation / reddening of the eyes, dizziness, bronchitis, nosebleeds, increased nasal secretion, cough, nasal congestion, stomach inflammation,

Gastroenteritis, heartburn, hemorrhoids, flatulence, dry mouth, hair loss, reddening of the skin, night sweats, muscle pain, back pain and increased body temperature.

Uncommon side effects reported (may affect up to 1 in 100 people) are: decreased visual acuity, double vision, abnormal eye sensation, bleeding from the penis, blood in semen and / or urine and excessive development of the male breast.

Rash, sudden decrease or loss of hearing, and decrease in blood pressure have also been reported with an unknown frequency (the frequency cannot be determined from the available data).

Children and adolescents

The following serious adverse events have been reported frequently (may affect up to 1 in 10 people): pneumonia, heart failure, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infection and dental caries.

The following serious adverse events have been considered treatment-related and have been reported occasionally (may affect up to 1 in 100 people): allergic reactions (such as rash, swelling of the face, lips and tongue, wheezing, difficulty breathing) or swallowing, convulsions, irregular heartbeat , Hearing loss, shortness of breath, inflammation of the digestive system, wheezing due to breathing problems.

The most common side effects reported (may affect more than 1 in 10 people) were: headache, vomiting, sore throat, fever, diarrhea, flu 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 get any side effects, 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 Appendix V. By reporting side effects, you can provide more information on the safety of this medicine.

1. How to save Revatio

   Keep this medicine out of the sight and reach of children.

   Do not use this medicine after the expiry date on the pack after EXP. The expiry date refers to the last day of the month.

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

   Do not throw medication into wastewater or household waste. Ask your pharmacist how you can get rid of medicines you no longer use. This helps protect the environment.

2. Package contents and other information What Revatio contains

The active substance is sildenafil. Each tablet contains 20 mg sildenafil (as citrate).

The other ingredients are:

Internal part: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), lactose monohydrate, glycerol triacetate.

Description of the appearance of Revatio and the contents of the pack

Revatio tablets are white, film-coated and have a round shape. The tablets have "PFIZER" on one side and "RVT 20" on the other. The tablets are available in blisters in packs of 90 tablets, 90 x 1 tablets in blisters that are divisible by the unit dose, and in blisters in packs of 300 tablets.

It is possible that not all pack sizes will be marketed.