Land: Malta
Språk: engelsk
Kilde: Medicines Authority
AMILORIDE HYDROCHLORIDE, FUROSEMIDE
Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland
C03EB01
AMILORIDE HYDROCHLORIDE 5.68 mg FUROSEMIDE 40 mg
TABLET
AMILORIDE HYDROCHLORIDE 5.68 mg FUROSEMIDE 40 mg
POM
DIURETICS
Withdrawn
2006-08-18
PACKAGE LEAFLET: INFORMATION FOR THE USER CO-AMILOFRUSE 2.5MG/20MG TABLETS CO-AMILOFRUSE 5MG/40MG TABLETS CO-AMILOFRUSE 10MG/80MG TABLETS Amiloride Hydrochloride and Furosemide 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, please 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. WHAT IS IN THIS LEAFLET: 1. What Co-Amilofruse Tablets are and what they are used for 2. What you need to know before you take Co-Amilofruse Tablets 3. How to take Co-Amilofruse Tablets 4. Possible side effects 5. How to store Co-Amilofruse Tablets 6. Contents of the pack and other information 1. WHAT CO-AMILOFRUSE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Co-Amilofruse Tablets. Co-Amilofruse Tablets contain two different medicines called: furosemide and amiloride hydrochloride. Both belong to a group of medicines called diuretics (water tablets). WHAT CO-AMILOFRUSE TABLETS ARE USED FOR Co-Amilofruse Tablets can be used to stop the build up of extra water in your body. This extra water can cause swollen ankles, shortness of breath and feeling more tired than usual. HOW CO-AMILOFRUSE TABLETS WORK Co-Amilofruse Tablets work by helping you to pass more water (urine) than you usually do. If the extra water in your body is not removed, it can put extra strain on the heart, blood vessels, lungs, kidneys or liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOFRUSE TABLETS DO NOT TAKE CO-AMILOFRUSE TABLETS IF: You are allergic to furosemide, amiloride hydrochloride, sulphonamides (such as sulfadiazine or co-trimoxazole) or to any of the other ingredients of this medi Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Co-Amilofruse 5mg/40mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Furosemide 40mg Amiloride Hydrochloride (dihydrate) 5.68mg Excipient with known effect: Lactose: 84.6mg per tablet Sunset Yellow FCF: 0.2mg per tablet Sodium: 0.2mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet for oral use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Co-Amilofruse is a potassium sparing diuretic which is indicated where a prompt diuresis is required. It is of particular value in conditions where potassium conservation is important: congestive cardiac failure, nephrosis, corticosteroid therapy, oestrogen therapy and for ascites associated with cirrhosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The starting dose is usually 40/5mg, subsequent dosage being adjusted to suit the needs of the patient. _Adults: _ One to two tablets to be taken in the morning. _Children: _ Not indicated for children under 18 years of age. _ Elderly: _ The dosage should be adjusted according to diuretic response. Serum electrolytes and urea should be carefully monitored. 4.3 CONTRAINDICATIONS Patients with hypovolaemia or dehydration (with or without accompanying hypotension). Patients with an impaired renal function and a creatinine clearance below 30ml/min per 1.73 m body surface area, 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, hyperkalaemia, severe hypokalaemia (see section 4.8), severe hyponatraemia, concomitant potassium supplements or potassium sparing diuretics, precomatose states associated with cirrhosis, Addison's disease, and breast feeding women. Co-amilofruse is contraindicated in children and adolescents under 18 years of age as safety in this age group has not yet been established. Hypersensitivity to furosemide, amiloride, sulphonamides or sulphonamide derivatives, or Les hele dokumentet