Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Furosemide
Brillpharma (Ireland) Limited
C03CA; C03CA01
Furosemide
20 milligram(s)
Tablet
Sulfonamides, plain; furosemide
Marketed
2006-05-26
PACKAGE LEAFLET: INFORMATION FOR THE USER FUROSEMIDE 20MG TABLETS FUROSEMIDE 40MG TABLETS 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 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 WHAT IS IN THIS LEAFLET: 1. What Furosemide Tablets are and what they are 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 THEY ARE USED FOR Furosemide belongs to a group of medicines called diuretics, which increase the amount of urine passed by the kidneys, helping to remove excess fluids from the body. Diuretics are also known as ‘water tablets’. Furosemide tablets are used in the treatment of oedema (fluid retention) caused by disorders of the heart, kidneys or liver alone or in combination with other anti-hypertensive agents. The tablets may also be used to treat pulmonary oedema (build up of fluid in the lungs) and mild to moderate hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE TABLETS DO NOT TAKE FUROSEMIDE TABLETS IF: • you are allergic(hypersensitive) to Furosemide or any of the other ingredients in the tablets (these are listed in section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • you are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or co-trimoxazole. • you have been told that you have a low blood volume of fluid in yo Read the complete document
Health Products Regulatory Authority 21 October 2019 CRN008YDQ Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furosemide Bristol 20 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of Furosemide. Excipient(s): Each tablet contains 52.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white to off-white tablet embossed ‘F 20’ on one side and ‘BL’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Furosemide is a potent diuretic with rapid action. Furosemide tablets are indicated for: 1) The treatment of fluid retention associated with heart failure, including left ventricular failure, cirrhosis of the liver and renal disease, including nephrotic syndrome. 2) The treatment of mild to moderate hypertension (alone, or in combination with other antihypertensive agents in the treatment of more severe cases). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is recommended that Furosemide tablets are taken on an empty stomach, and with plenty of liquid. 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. Children: Contra-indicated (see section 4.3) Elderly: Caution is advised as furosemide is eliminated more slowly in elderly patients.Treatment should be started with 20mg and titrated upwards as required (see section 4.4). Method of Administration: For oral administration 4.3 CONTRAINDICATIONS • Hypersensitivity to furosemide or any of the excipients of this product. • Hypersensitivity to amiloride, sulphonamides or sulphonamide derivatives (because of cross-sensitivity between sulphonamides and furosemide). • Hypovolaemia or dehydration (with or without accompanying hypotension) (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 Read the complete document