Country: Malta
Language: English
Source: Medicines Authority
BENDROFLUMETHIAZIDE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
C03AA01
BENDROFLUMETHIAZIDE 2.5 mg
TABLET
BENDROFLUMETHIAZIDE 2.5 mg
POM
DIURETICS
Withdrawn
2012-07-16
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends • Pharmacode placed on 8mm from the cutting edge _1st fold_ _(26.25mm)_ _2nd fold_ _(26.25mm)_ _3r_ _d fold_ _(26.25mm)_ _4th fold_ _(26.25mm)_ _5th fold_ _(26.25mm)_ _6th fold_ _(26.25mm)_ _7th fold_ _(26.25mm)_ _8th fold_ _(26.25mm)_ _9th fold_ _(26.25mm)_ _10th fold_ _(26.25mm)_ _11th fold_ _(26.25mm)_ _12th fold_ _(26.25mm)_ _13th fold_ _(26.25mm)_ _14th fold_ _(26.25mm)_ _15th fold_ _(26.25mm)_ _16th fold_ _(26.25mm)_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Bendroflumethiazide Tablets are and what they are used for 2. Before you take Bendroflumethiazide Tablets 3. How to take Bendroflumethiazide Tablets 4. Possible side effects 5. How to store Bendroflumethiazide Tablets 6. Further 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. BEFORE YOU T Read the complete document
_ _ Page 1 of 9 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendroflumethiazide 2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bendroflumethiazide 2.5mg For excipients, see 6.1 3 PHARMACEUTICAL FORM White, circular flat faced tablets with bevelled edges, having a CP logo on one face and B 2.5 separated by a breakline on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bendroflumethiazide is a diuretic. The tablets are indicated in the treatment of essential hypertension and oedema associated with such conditions as nephrotic syndrome, cirrhosis of the liver, congestive heart failure and pre-menstrual syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _ _ _Adults_ 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. 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. _ _ Page 2 of 9 _ _ _ _ _Children _ _ _ _ _ Oedema: Up to 400µg per kg body weight daily initially, reducing to 50-100µg per kg for maintenance. 4.3 CONTRAINDICATIONS Sensitivity to bendroflumethiazide or other sulphonamide-derived drugs. Hypercalcaemia. Severe renal insufficiency or anuria, severe hepatic impairment (risk of precipitation of encephalopathy), Addison’s disease. Bendroflumethiazide tablets should not be administered with lithium carbonate. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Continued or intensive use of bendroflumethiazide may produce potassium depletion. A potassium chloride supplement is recommended in these circumstances. Potassium replacement or conservation is also likely to be necessary in patients at risk from the cardiac effects Read the complete document