Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide hemihydrate
Kent Pharma (UK) Ltd
C03BA11
Indapamide hemihydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100
PACKAGE LEAFLET: INFORMATION FOR THE USER INDAPAMIDE 2.5MG TABLETS INDAPAMIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMAION 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. 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 is and what it is 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 IS AND WHAT IT IS USED FOR Indapamide Tablets are a sugar coated tablets containing indapamide as the active ingredient. Indapamide is a diuretic (water tablet) which belongs to a group of medicines called sulphonamides. Diuretics increase the amount of water and salts (mostly sodium and chlorides) you pass in your urine. This essentially reduces blood pressure. Indapamide tablets are used to: − treat high blood pressure (essential hypertension) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDAPAMIDE TABLETS DO NOT TAKE INDAPAMIDE TABLETS: − if you are allergic to indapamide, sulphonamides, or any of the other ingredients of this medicine (listed in section 6) − if you suffer from - severe kidney failure - severe impairment of the liver function - hepatic encephalopathy − This is a liver disease causing symptoms that affect your central nervous system such as changes in mood, confusion or drowsiness - hypokalaemia (low potassium levels in your blood) − if you recently suffered a stroke WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Indapamide Tablets: − if your liver is not workin Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indapamide 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 2.5mg of the active substance Indapamide Ph. Eur. Excipients with known effect: Each tablet contains 82.75mg Lactose Monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat bevelled edge tablet; debossed with I and 2.5 on one side, plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indapamide is indicated in adults for 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 is one tablet, containing 2.5mg indapamide, daily, to be taken 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 Indapamide daily is not recommended as there is no appreciable additional antihypertensive 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 antihypertensive 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 2.5mg Tablets. _ _ _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 sec Lees het volledige document