País: Malta
Idioma: anglès
Font: Medicines Authority
INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C03BA11
INDAPAMIDE 1.5 mg
FILM-COATED TABLET PROLONGED-RELEASE TABLET
INDAPAMIDE 1.5 mg
POM
DIURETICS
Authorised
2005-09-01
1/7 PACKAGE LEAFLET: INFORMATION FOR THE USER NATRILIX SR 1.5 MG PROLONGED-RELEASE FILM-COATED TABLETS Indapamide READ ALL OF 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Natrilix SR 1.5 mg is and what it is used for 2. What you need to know before you take Natrilix SR 1.5 mg 3. How to take Natrilix SR 1.5 mg 4. Possible side effects 5. How to store Natrilix SR 1.5 mg 6. Contents of the pack and other information 1. WHAT NATRILIX SR 1.5 MG IS AND WHAT IT IS USED FOR Natrilix SR 1.5 mg is a prolonged-release film-coated tablet containing indapamide as active ingredient. This medicine is intended to reduce high blood pressure (hypertension) in adults. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRILIX SR 1.5 MG 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 6), - 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. WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacist before taking Natrilix Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Natrilix SR 1.5 mg, prolonged-release film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-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 Prolonged-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. 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 _ When liver function is impaired, thiazide-related diuretics may cause, particularly in case o Llegiu el document complet