Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Furosemide
Phoenix Healthcare Distribution Ltd
C03CA01
Furosemide
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020200
PACKAGE LEAFLET: INFORMATION FOR THE USER FUROSEMIDE 20MG TABLETS FUROSEMIDE 40MG TABLETS (furosemide) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Furosemide Tablets are and what are they used for 2. What you need to know before you take Furosemide Tablets 3. How to take Furosemide Tablets 4. Possible side effects 5. How to store Furosemide Tablets 6. Contents of the pack and other information 1. WHAT FUROSEMIDE TABLETS ARE AND WHAT ARE THEY USED FOR Furosemide Tablets contain furosemide as the active ingredient. This belongs to a group of medicines called diuretics (also called water tablets). Furosemide Tablets are used to treat oedema (fluid retention) caused by heart failure, mild to moderate hypertension (high blood pressure) and certain liver and kidney disorders. They are also used to manage a condition called oliguria where the body produces an abnormally small amount of urine, due to kidney disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE TABLETS DO NOT TAKE FUROSEMIDE TABLETS IF YOU: • are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue. • are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or cotrimoxazole • have a low blood volume or are dehydrated (with or without accompanying low blood pressure) • have too little potassium or sodium in your blood (shown in blood test) • have already Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furosemide 40mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Furosemide 40mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White-to off white, flat, uncoated tablets with beveled edges, debossed on one side and breakline on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Furosemide is a potent diuretic with rapid action. Furosemide tablets are indicated for: • The treatment of fluid retention associated with heart failure, including left ventricular failure, cirrhosis of the liver and renal disease, including nephrotic syndrome. • The treatment of mild to moderate hypertension when brisk diuretic response is required. Alone or in combination with other anti- hypertensive agents in the treatment of more severe cases. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults: The initial adult dose is 40mg daily, reduced to 20mg daily or 40mg on alternative days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. Elderly: Caution is advised as furosemide is excreted more slowly in the elderly. Treatment should be started with 20mg and titrated upwards as required (see section 4.4). Children: Contra-indicated (see section 4.3) 4.3. CONTRAINDICATIONS - Hypersensitivity to furosemide, amiloride, sulphonamides or sulphonamide derivatives, and/or any of the excipients of the product. - 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. Read the complete document