Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INDAPAMIDE
SERVIER MALAYSIA SDN BHD
INDAPAMIDE
30Tablet Tablets
LES LABS SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 NATRILIX SR 1.5 MG _Indapamide 1.5mg _ WHAT IS IN THIS LEAFLET 1. What Natrilix SR 1.5 mg is used for 2. How Natrilix SR 1.5 mg works 3. Before you use Natrilix SR 1.5mg 4. How to use Natrilix SR 1.5 mg 5. While you are using it 6. Side effects 7. Storage and Disposal of Natrilix SR 1.5 mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NATRILIX SR 1.5MG IS USED FOR This medicine is intended to reduce high blood pressure (hypertension). It is a sustained-release film-coated tablet containing indapamide as active ingredient. HOW NATRILIX SR 1.5MG WORKS Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. In addition, indapamide widens blood vessels so that blood passes through more easily. This helps to lower blood pressure. BEFORE YOU USE NATRILIX SR 1.5MG - _When you must not use it _ _ _ DO NOT TAKE NATRILIX SR 1.5 MG - if you are allergic to indapamide or any other sulphonamide or to any of the other ingredients of this medicine (listed in section Product Description), - if you have severe kidney disease, - if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain), - if you have low potassium levels in your blood. 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. This medicine is not recommended during pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. Please tell your doctor if you are pregnant or wish to become pregnant. The active ingredient is excreted in milk. Breastfeeding is not recommended if you are taking this medicine. - _Before you start to use Прочитать полный документ
Final PI_Natrilix SR_17.05.2022 1/10 NATRILIX SR 1.5MG, SUSTAINED RELEASE FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT Natrilix SR 1.5 mg, sustained-release film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One sustained-release film-coated tablet contains 1.5 mg indapamide. Excipient with known effect: 124.5 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sustained-release tablet. White, round, film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Natrilix SR 1.5 mg is indicated in essential hypertension in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed. _ _ At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased. Special populations _ _ _Renal impairment (see sections 4.3 and 4.4): _ In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated. Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired. _ _ _Hepatic impairment (see sections 4.3 and 4.4): _ In severe hepatic impairment, treatment is contraindicated. _ _ _Elderly (see section 4.4): _ In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Natrilix SR 1.5 mg when renal function is normal or only minimally impaired. Paediatric population: The safety and efficacy of Natrilix SR 1.5 mg in children and adolescents have not been established. No data are available. Final PI_Natrilix SR_17.05.2022 2/10 Method of administration Oral use _ _ 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance, to other sulfonamides or to any of the excipients listed in section 6.1. - Severe renal failure. - Hepatic encephalopathy or _ _ severe impairment of liver function. - Hypokalaemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Special warnings Прочитать полный документ