Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide hemihydrate
Strides Pharma UK Ltd
C03BA11
Indapamide hemihydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100; GTIN: 5031676003205
Strides Pharma UK Ltd. Front & Back Printing. To be supplied in the unfolded size. PC-TSG/2021/451 - Record Number: 323561 60 GSM Paper. Pack Insert 150 X 310 MM 1046119 1046552 -- 1 11.0 INDAPAMIDE TABLETS 2.5 MG BLACK Printing clarity to be clear & sharp. PACKAGE LEAFLET: INFORMATION FOR THE USER INDAPAMIDE TABLETS 2.5 MG [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 Indapamide Tablets are and what they are used for 2. What you need to know before you take Indapamide Tablets 3. How to take Indapamide Tablets 4. Possible side effects 5. How to store Indapamide Tablets 6. Contents of the pack and other information 1. WHAT INDAPAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR Indapamide Tablets contain the active substance indapamide. Indapamide is a diuretic and is intended to reduce high blood pressure (hypertension) in adults. 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 INDAPAMIDE TABLETS DO NOT TAKE INDAPAMIDE TABLETS: • 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 hepati Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indapamide 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Indapamide 2.5mg Excipient(s) with known effect Lactose Sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Co ate d tab let White, biconvex, sugar coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of essential hypertension 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _ The dosage is one tablet, containing 2.5mg indapamide, to be taken daily in the morning. The action of indapamide is progressive and the reduction in blood pressure may continue and not reach a maximum until several months after the start of therapy. A larger dose than 2.5mg of indapamide daily is not recommended as there is no appreciable additional anti-hypertensive effect but a diuretic effect may become apparent. If a single daily tablet of indapamide does not achieve a sufficient reduction in blood pressure, another anti- hypertensive agent may be added; those which have been used in combination with indapamide include beta- blockers, ACE inhibitors, methyldopa, clonidine and other adrenergic blocking agents. The co-administration of indapamide with diuretics which may cause hypokalaemia is not recommended. There is no evidence of rebound hypertension on withdrawal of indapamide. Special populations _ _ _Renal failure (see sections 4.3 and 4.4):_ In severe renal failure (creatinine clearance below 30ml/min), treatment is contraindicated. Thiazides 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 indapamide when renal function is normal or only minimally impaired. _Paediatric population:_ Indapamide is not recommende Aqra d-dokument sħiħ