Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Frusemide; AMILORIDE HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
C03EB; C03EB01
Frusemide; AMILORIDE HYDROCHLORIDE
20 mg/2.5 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
1990-05-14
PACKAGE LEAFLET: INFORMATION FOR THE USER FRUMIL® 40MG/5MG TABLETS FRUMIL® LOW STRENGTH 20MG/2.5MG 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 or Frumil Low Strength 20mg/2.5 mg 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 o Lire le document complet
Health Products Regulatory Authority 29 September 2022 CRN00CTQV Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Frumil Low Strength 20mg/2.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of Furosemide and Amiloride Hydrochloride equivalent to 2.5 mg of Anhydrous Amiloride Hydrochloride. Excipients - contains Lactose Monohydrate 29.0mg and Sunset Yellow (E110) 0.15mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Flat, circular, bevelled edge, orange-coloured tablet, about 6 mm diameter, marked “LS” on one face. 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 for treatment should be used. Recommended Dosage: Adults: The usual adult dose is 1 tablet (20mg Furosemide and 2.5mg Amiloride Hydrochloride) to be taken 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. Frumil Low Strength may be used where a lower dosage is required e.g. in the elderly. 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 wome Lire le document complet