Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bendroflumethiazide
A A H Pharmaceuticals Ltd
C03AA01
Bendroflumethiazide
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100; GTIN: 5025903001904
PACKAGE LEAFLET: INFORMATION FOR THE USER BENDROFLUMETHIAZIDE 2.5MG TABLETS BENDROFLUMETHIAZIDE 5MG TABLETS Bendroflumethiazide (Referred to as Bendroflumethiazide Tablets in the remainder of the 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, please 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 Bendroflumethiazide Tablets are and what they are used for 2. What you need to know before you take Bendroflumethiazide Tablets 3. How to take Bendroflumethiazide Tablets 4. Possible side effects 5. How to store Bendroflumethiazide Tablets 6. Contents of the pack and other information 1. WHAT BENDROFLUMETHIAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Bendroflumethiazide Tablets. The active ingredient in your medicine is bendroflumethiazide. Bendroflumethiazide Tablets belong to a group of medicines called diuretics (water tablets) which increase the amount of urine you produce. Bendroflumethiazide Tablets are used to treat high blood pressure (hypertension) and fluid retention (oedema) associated with kidney, liver or heart problems, and pre-menstrual syndrome. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENDROFLUMETHIAZIDE TABLETS DO NOT TAKE BENDROFLUMETHIAZIDE TABLETS IF YOU: • are allergic to bendroflumethiazide, or other sulphonamide-derived medicine or any of the other ingredients of this medicine (listed in section 6). • have high levels of calcium in your blood (hypercalcaemia) • have severe liver or kidney problems, or you are unable to pass water (urine) • have underactive adrenal glands (Addison Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendroflumethiazide 5mg_ _Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bendroflumethiazide 5mg For the full list of excipients, see section 6.1 Each tablet contains 49.92mg of lactose. 3 PHARMACEUTICAL FORM White, circular flat faced tablets with bevelled edges having a CP logo on one face and B 5 separated by a breakline on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bendroflumethiazide is indicated for: Cases where the reduction of fluid retention by diuresis is required; oedema of cardiac, renal or hepatic origin and iatrogenic oedema. Bendroflumethiazide produces a moderate but usefully prolonged fall of blood pressure in hypertensive patients. It may be used as the sole antihypertensive agent or as an adjunct to other drugs whose action it potentiates. In non-oedematous patients, there may be little noticeable diuretic effect. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology It is recommended that the tablets should be taken in the morning to avoid nocturia. _Adults and children aged 12 years and over: _ _ _ Oedema: 5-10mg daily in the morning initially. Maintenance: usually 2.5mg-5mg on only two or three days in the week. A single dose may be sufficient. Essential Hypertension: 2.5mg in the morning. Doses above 2.5mg are rarely necessary. Bendroflumethiazide is used concurrently with other specific hypotensive agents, the dosage of such agents should be reduced and then adjusted as necessary. Pre-menstrual syndrome: 2.5mg each morning for seven days before the period is due. _Elderly_ _ _ Particular caution is needed in the elderly because of their susceptibility to electrolyte imbalance. Lower initial doses should be used and electrolyte balance and renal function should be carefully monitored. _Children under 12 years:_ Oedema: Up to 400µg per kg body weight daily initially, reducing to 50-100µg per kg for maintenance. A more appropriate dosage form may be required. METHOD OF ADMINISTRATION: Oral. 4.3 CONTRAIN Прочитать полный документ