国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiloride hydrochloride; Furosemide
Sanofi
C03EB01
Amiloride hydrochloride; Furosemide
2.5mg ; 20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020400; GTIN: 5000283652243 5000283652250
89032265 4/4 89032265 1/4 _PACK. ITEM:_ ARKHÉ S.N.C. Tel. 0862.404140 fax 0862.090006 1 - Prima realizzazione REFLEX BLUE SANOFI S.P.A. Verificare la corrispondenza dell’artwork approvato - la nostra responsabilità è limitata al rifacimento dei file forniti. 14-09-2017 IST FRUMIL LS 20/2,5MG GB I02 ISTRUZIONI GB: GREAT BRITAIN 89032265 89030906 62C0007 V.1.0 00101100000 167 X 315MM DP 1 - - 11 PT SU 12 PT 4, 1 / 4 • If you have diabetes you may be less able to control the levels of glucose in your blood • Passing more water (urine) than you usually do. This normally happens 1 or 2 hours after taking this medicine. • Symptoms vary considerably between patients but the most common are: joint aches and pains, swollen joints, headaches, increased sensitivity to sunlight, skin rashes, kidney problems, fatigue and weakness, mouth ulcers, hair loss, anxiety and depression, fevers and night sweats, abdominal pain, chest pain, shortness of breath, anaemia (Systemic lupus erythematosus) • Lichenoid reactions, characterized as small, itchy reddish-purple, polygon-shaped lesions on the skin, genitals or in the mouth. BLOOD TESTS Frumil LS can change the levels of liver enzymes or body fats such as cholesterol and triglycerides shown up on blood tests. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE FRUMIL LS TABLETS • Keep this medicine out of the sight and reach of children. • Do not take Frumil LS Tablets after the expiry date which is stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month • Store below 25°C. Keep the blister strip in the outer carton in order to protect from light and moisture. Medicines should not be disposed of 阅读完整的文件
OBJECT 1 FRUMIL LS Summary of Product Characteristics Updated 18-May-2018 | SANOFI 1. Name of the medicinal product Frumil LS 20 mg/2.5 mg Tablets 2. Qualitative and quantitative composition The active ingredient is Furosemide 20.0mg and amiloride hydrochloride equivalent to 2.5mg anhydrous amiloride hydrochloride. For excipients, see section 6.1 3. Pharmaceutical form Tablets for oral administration. 4. Clinical particulars 4.1 Therapeutic indications Frumil LS 20 mg/2.5 mg Tablets 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 Adults: One or two tablets to be taken in the morning. Children: Not recommended for children under 18 years of age as safety and efficacy have not been established. Elderly: The dosage should be adjusted according to the 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 2 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, severe hyponatraemia, concomitant potassium supplements or potassium sparing diuretics, precomatose states associated with cirrhosis, Addison's disease, and breast feeding women. Frumil LS 20 mg/2.5 mg Tablets 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 any of the excipients of the product. 4.4 Special 阅读完整的文件