Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide
Waymade Healthcare Plc
C03BA11
Indapamide
1.5mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100
NATRILIX ® SR 1.5 MG TABLETS (indapamide) PATIENT INFORMATION LEAFLET 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. This medication is available using the above name but will be referred to as Natrilix SR throughout the following. WHAT IS IN THIS LEAFLET: 1. What Natrilix SR is and what it is used for 2. What you need to know before you take Natrilix SR 3. How to take Natrilix SR 4. Possible side effects 5. How to store Natrilix SR 6. Contents of the pack and other information 1. WHAT NATRILIX SR IS AND WHAT IT IS USED FOR Natrilix SR is a prolonged-release film-coated tablet containing indapamide as the active ingredient. 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. This medicine is intended to reduce high blood pressure (hypertension) in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRILIX SR DO NOT TAKE NATRILIX SR: - if you are allergic to indapamide or any other sulfonamide 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 SR: - if you have liver problems, - if you have diabetes, - if you suffer from gout, - if you have any h Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Natrilix SR 1.5 mg 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 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 when renal function is normal or only minimally impaired. _Paediatric population: _ The safety and efficacy of Natrilix SR 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 hepatic encephalopathy, particularly in case of electrolyte imbalance. Administration Read the complete document