Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bendroflumethiazide
Genesis Pharmaceuticals Ltd
C03AA01
Bendroflumethiazide
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020100; GTIN: 5060014443298 5060014443298
PACKAGE LEAFLET: INFORMATION FOR THE USER BENDROFLUMETHIAZIDE 2.5 MG TABLETS BP BENDROFLUMETHIAZIDE 5 MG TABLETS BP bendroflumethiazide 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 any of the 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 Bendroflumethiazide Tablets contain bendroflumethiazide as the active ingredient. They belong to a group of medicines called thiazide diuretics (water tablets). They may be used to: • reduce fluid retention (oedema) particularly in the heart, kidneys, liver or that caused by medication, by increasing the flow of urine • reduce high blood pressure alone or with other medication. • stop the production of breast milk. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENDROFLUMETHIAZIDE TABLETS DO NOT TAKE BENDROFLUMETHIAZIDE TABLETS IF YOU: • are allergic to bendroflumethiazide, thiazides or any of the other ingredients of this medicine (listed in section 6) • have severely impaired kidney or liver function • have high level of calcium in your blood (hypercalcaemia) • have low levels of sodium in your blood (hyponatraemia) • have low levels of potassium in your blood which has not responded to treatment (refractory hypokalaemia) • have had Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendroflumethiazide 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bendroflumethiazide 2.5mg For the full list of excipients, see section 6.1 Each tablet contains 49.85mg of lactose. 3 PHARMACEUTICAL FORM White, circular flat tablets with bevelled edges, having a CP logo on one side and B 2.5 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 CONTRAI Прочитайте повний документ