Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Furosemide ; AMILORIDE HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
C03EB; C03EB01
Furosemide ; AMILORIDE HYDROCHLORIDE
40mg /5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
High-ceiling diuretics and potassium-sparing agents; furosemide and potassium-sparing agents
Marketed
1991-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER FRUMIL® 40MG/5MG TABLETS_Furosemide _ _Amiloride Hydrochloride _ Is this leaflet hard to see or read? Phone 01 403 5600 for help. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Frumil Tablets are and what they are used for 2. What you need to know before you take Frumil Tablets 3. How to take Frumil Tablets 4. Possible side effects 5. How to store Frumil Tablets 6. Contents of the pack and other information 1. WHAT FRUMIL TABLETS ARE AND WHAT THEY ARE USED FOR WHAT FRUMIL TABLETS ARE The name of your medicine is Frumil 40mg/5mg Tablets (called Frumil Tablets throughout this leaflet). Frumil Tablets contain two different medicines called: furosemide and amiloride hydrochloride. Both belong to a group of medicines called diuretics (water tablets). WHAT FRUMIL TABLETS ARE USED FOR Frumil 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 FRUMIL TABLETS WORK Frumil Tablets works 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 vessel, lungs, kidneys or liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FRUMIL TABLETS DO NOT TAKE FRUMIL TABLETS: • You are allergic (hypersensitive) to furosemide, amiloride hydrochloride or any of the other ingredients of Frumil Tablets (listed in Section 6 below). Signs of an allergic reaction include: Прочитайте повний документ
Health Products Regulatory Authority 06 March 2024 CRN00F528 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Frumil 40mg/5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg of furosemide and amiloride hydrochloride equivalent to 5 mg of anhydrous amiloride hydrochloride. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Orange, circular, uncoated tablets, 8 mm in diameter, with a breakline on one face and ‘FRUMIL’ 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 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. Recommended Dosage: Adults: The usual adult dose is 1 tablet (40mg 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. Elderly patients: The dosage should be adjusted according to diuretic response. Extreme care should be taken with dosage in the elderly as this patient group are more susceptible to serious side effects associated with electrolyte disturbances. 4.3 CONTRAINDICATIONS 1. Use in patients with Addison’s disease. 2. Use in patients hypersensitive to the active ingredients, furosemide, amiloride, sulfonamides or sulfonamide derivatives, or any of the excipients of Frumil. Patients allergic to sulfonamides may show cross-sensitivity to furosemide. 3. During pregnancy 4. In breast-feeding women. 5. Use in children. 6. Use in patients with impaired renal function and a creatine clearance below 30 ml/min per 1.73 m 2 body surface area, acute renal failure or anuria. 7. Use in patients with hyperkalemia 8. Use in Прочитайте повний документ