Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
FUROSEMIDE, AMILORIDE HYDROCHLORIDE
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
C03EB01
FUROSEMIDE, AMILORIDE HYDROCHLORIDE
40/5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
High-ceiling diuretics and potassium-sparing agents
Authorised
1992-04-22
PACKAGE LEAFLET: INFORMATION FOR THE USER FRUCO 40 MG/5 MG TABLETS Furosemide / Amiloride Hydrochloride 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. IN THIS LEAFLET 1. WHAT FRUCO TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FRUCO TABLETS 3. HOW TO TAKE FRUCO TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FRUCO TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FRUCO TABLETS ARE AND WHAT THEY ARE USED FOR Fruco 40 mg/5 mg Tablets contain furosemide and amiloride hydrochloride. Furosemide and amiloride hydrochloride belong to a group of medicines known as diuretics. Diuretics increase the amount of urine you produce by making your kidneys allow more water and salts to be removed from your body. Fruco Tablets are used to stop the build-up of extra water in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FRUCO TABLETS Do NOT take Fruco Tablets if you: • are allergic to furosemide or amiloride hydrochloride or any of the other ingredients of this medicine (listed in section 6) • have suffered from an allergic reaction to sulfonamides (medicines used to treat infections e.g. trimethoprim, sulfasalazine or sulfamethoxazole) • suffer from Addison’s disease (adrenal gland does not make enough corticosteroid) • Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fruco 40 mg/5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains furosemide 40mg and amiloride hydrochloride equivalent to 5mg of anhydrous amiloride hydrochloride. Each tablet also contains lactose monohydrate 60 mg and sunset yellow (E110) 0.4 mg. For a full list of excipents, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Round orange flat, bevelled tablet, coded ‘Fruco’ and a breakline on one face, plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Uses: In the management of fluid retention where potassium conservation is desirable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_: The usual adult dose is 1 tablet (40 mg furosemide and 5 mg amiloride) in the morning. This may be increased to 2 tablets if the initial response is unsatisfactory. In this case it is best to divide the dosage into two daily doses, one to be taken in the morning and the other at noon. _Geriatric population_: The dosage should be adjusted according to diuretic response: serum electrolytes and urea should be carefully monitored. Extreme care should be taken with dosage in the elderly as this group are more susceptible to serious side effects associated with electrolyte disturbances. _Paediatric population_: There is no relevant use of Fruco in the paediatric population. Method of administration The route of administration is oral. The tablets are to be swallowed whole with sufficient amounts of liquid (approx. half a glass). They are best taken on an empty stomach. The lowest possible dose should be used for treatment. 4.3 CONTRAINDICATIONS Use in patients with Addison’s disease. HEALTH PRODUCTS REGULATORY AUTHORITY _____________________________________________________________ Lue koko asiakirja