Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SILDENAFIL CITRATE
PFIZER (MALAYSIA) SDN. BHD.
SILDENAFIL CITRATE
90Tablet Tablets
Fareva Amboise
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_ _)_ REVATIO FILM-COATED TABLET Sildenafil citrate (20 mg) 1 PLD TITLE : Revatio PLD DATE : 27 June 2019 COUNTRY : Malaysia REFERENCE DOCUMENTS : Revatio 20 mg, Film-coated Tablet, Malaysia LPD, Dated 29 January 2018 REASON FOR CHANGE : Resubmission of document to incorporate changes requested by officer. Update as per current approved Malaysia LPD, Dated 19 April 2016. Update PIL as per BoH remarks. Update to Section (Fertility, Pregnancy and Lactation) concerning the detection of sildenafil and its active metabolite in human breast milk and the potential for impact on the breastfed infant To update PIL as per request by local BoH To update PRH address Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_ _)_ REVATIO FILM-COATED TABLET Sildenafil citrate (20 mg) 2 WHAT IS IN THIS LEAFLET 1. What REVATIO is used for 2. How REVATIO works 3. Before you use REVATIO 4. How to use REVATIO 5. While you are using it 6. Side Effects 7. Storage and Disposal of REVATIO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT REVATIO IS USED FOR REVATIO is indicated to treat adults with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension), to improve exercise capacity. HOW REVATIO WORKS REVATIO 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. BEFORE YOU USE REVATIO _- When you must not use it_ - if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of this medicine (listed in section “_Ingredients”_). - if you are taking medicines containing nitrates or nitric oxide donors. REVATIO can cause a serious increase in the low blood pressure 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 pulmonary hypertension d সম্পূর্ণ নথি পড়ুন
Pfizer Confidential 1 LPD Title : Sildenafil citrate LPD Date : 29 January 2018 Country : Malaysia Reference : EU SmPC (Dated 04 December 201 7), CDS version 1 1 (Dated 23 May 2017), USPI (Dated July 2017) (Section 4.4- Paediatric warning) Reasons of Change: The Revatio (sildenafil citrate) CDS is being updated to include a revised statement in Section 4.6 (Fertility, Pregnancy and Lactation) concerning the detection of sildenafil and its active metabolite in human breast milk and t he potential for impact on the breastfed infant. PFIZER REVATIO* Sildenafil Citrate 1. NAME OF THE MEDICINAL PRODUCT Revatio 20 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film -coated tablet contains 20 mg of sildenafil (as citrate). Revatio tablets also contain lactose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film -coated tablet: White, round, biconvex film -coated tablets marked “PFIZER” on one side and “RVT 20”on the other. 4. CLINICAL PART ICULARS 4.1 Therapeutic indications Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hype rtension associated with connective tissue disease. 4.2 Posology and method of administration Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration i n spite of Revatio treatment, alternative therapies should be considered. Adults ( ≥18 years): The recommended dose is 20 mg three times a day (TID). Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose. সম্পূর্ণ নথি পড়ুন