Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Furosemide
A A H Pharmaceuticals Ltd
C03CA01
Furosemide
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020200; GTIN: 5025903001645
Top of page cut-off to middle of registration mark: 44 mm. PAGE 1: FRONT FACE (INSIDE OF REEL) 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 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. 1. What Furosemide is and what it is used for 2. What you need to know before you take Furosemide 3. How to take Furosemide 4. Possible side effects 5. How to store Furosemide 6. Contents of the pack and other information. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR Furosemide belongs to a group of medicines known as diuretics (water tablets). You should only use this high-dose formulation if you have severely reduced kidney function (glomerular filtration rate (GFR) < 20 ml/min). Furosemide is used to treat reduced urine production (oliguria) in chronic kidney failure. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE DO NOT TAKE FUROSEMIDE • If you are allergic to furosemide, sulphonamides or any of the other ingredients of this medicine (listed in section 6), • If you have normal or mildly to moderately reduced kidney function with a GFR greater than 20 ml/min, because of the risk of severe fluid and salt (electrolyte) loss, • If you have kidney failure and your kidneys do not produce urine at all (anuria), • If you have liver failure with alterations of consciousness (hepatic coma and pre-coma), • If you have potassium deficiency, • If you have sodium deficiency, • If you have too little blood (hypovolaemia) or body water (dehydration), • If you are breast-feeding (see Pregnancy and breast-feeding below), • If you have cardiac glycoside poisoning. Cardiac glyc Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furosemide 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Furosemide BP 500 mg. Excipient(s) with known effect: Lactose, Ultralake tartrazine E102 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow coloured round, flat uncoated tablets embossed with FW & 151 on one side of the tablets and a crossline on the other side of the tablets. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS The management of oliguria due to acute or chronic renal failure. _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Posology: In patients with chronic renal insufficiency an initial daily dose of 250mg is employed. If a satisfactory diuresis is not produced then the dose may be increased in steps of 250mg at 4 - 6 hourly intervals up to a maximum daily dose of 1,500mg in 24 hours. In exceptional cases up to 2,000mg in 24 hours may be given. Method of administration: For oral administration. _ _ 4.3 CONTRAINDICATIONS - Hypersensitivity to furosemide or to any of the excipients listed in section 6.1 -Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives. - Hypovolaemia and dehydration (with or without accompanying hypotension) (see section 4.4) - Severe hypokalaemia: severe hyponatraemia (see section 4.4). - Comatose or pre-comatose states associated with hepatic cirrhosis (see section 4.4). - Anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents or renal failure associated with hepatic coma - Impaired renal function with a creatinine clearance below 30ml/min per 1.73 m 2 body surface area (see section 4.4). - Addison's disease (see section 4.4). - Children and adolescents under 18 years of age (safety in this age group has not yet been established). - Digitalis intoxication (see section 4.5). - Concomitant potassium Read the complete document