Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indapamide hemihydrate
Niche Generics Ltd
C03BA11
Indapamide hemihydrate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100; GTIN: 5060020121302 5060020121319
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 This medicine is intended to reduce high blood pressure (hypertension) in adults. The tablets contain 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. 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 2.5MG TABLETS: ■ if you are allergic to indapamide or any other sulfonamide drugs or 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 (liver problems which affect the brain and central nervous system), ■ if you have low potassium levels in your blood. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Indapamide Tablets: ■ if you have liver problems, ■ if you have any heart rhythm problems or problems with your kidneys, ■ if you suffer from gout (painful inflammation of the joints), ■ if you have diabetes, ■ if you need to have a test to check how well your parathyroid gland is working, ■ if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Indapamide tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicilli Lire le document complet
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. 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 section 4.4 Lire le document complet