Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide hemihydrate
DE Pharmaceuticals
C03BA11
Indapamide hemihydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100
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 The name of your medicine is Indapamide 2.5mg Tablets. They contain the active ingredient called Indapamide. Indapamide Tablets belong to a group of medicines called anti-hypertensives. This medicine is used to treat high blood pressure and works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. Indapamide is different from other medicines, as it only causes a slight increase in the amount of urine produced. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDAPAMIDE TABLETS DO NOT TAKE INDAPAMIDE TABLETS: • If you are allergic (hypersensitive) to Indapamide or any other sulfonamide or to any of the other ingredients of Indapamide Tablets. See section 6 • If you have or ever had severe kidney failure and/or liver problems • If you have severe liver disease or suffer from a condition called hepatic encephalopathy (liver problems which affect the brain and central nervous system) • If you have low potassium levels in the blood WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Indapamide tablets • If you have or ever had liver and/or kidney problems • If you have or ever had hea Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indapamide 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Indapamide as indapamide hemihydrate 2.5mg. Excipients with known effect 56.00mg Lactose monohydrate 25.18mg Sucrose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated Tablets White, biconvex, sugar coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indapamide is indicated in the treatment of essential hypertension. Indapamide may be used as sole therapy or combined with other antihypertensive agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS: The dosage of one tablet, containing 2.5mg indapamide, to be taken daily in the morning. The action of indapamide is progressive and the reduction of blood pressure may continue and not reach a maximum until several months after the start of therapy. A larger dose than 2.5mg 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 such as 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 _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 Indapamide SR whe Lees het volledige document