País: Israel
Idioma: inglés
Fuente: Ministry of Health
CAPTOPRIL
DEXCEL LTD, ISRAEL
C09AA01
TABLETS
CAPTOPRIL 50 MG
PER OS
Required
DEXCEL LTD, ISRAEL
CAPTOPRIL
CAPTOPRIL
-HypertensionCongestive Heart Failure-insulin dependent diabetic nephropathy in hypertensive and non hypertensive patients in cases where the serum creatinine level < 2.5 mg/dl.-improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less or equals to 40% and to reduce the incidence of overt heart failure and subsequent hospitalization for congestive heart failure in these patients.
2022-07-31
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS ) – 1986 This medicine can be sold with a physician’s prescription only ACERIL ® 12.5, 25, 50 MG, TABLETS Each tablet contains Captopril 12.5, 25 or 50 mg respectively. Inactive ingredients and allergens in the medicine – see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of the medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think that their medical condition is the same as yours. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the treatment of high blood pressure, congestive heart failure, diabetic nephropathy (kidney damage caused by diabetes), for treatment after a heart attack. THERAPEUTIC GROUP: Angiotensin Converting Enzyme (ACE) inhibitors. Angiotensin converting enzyme inhibitors work by dilating your blood vessels, so that it will be easier for your heart to pump blood through them. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: You are hypersensitive (allergic) to the active ingredient (captopril), to any of the other ingredients this medicine contains (see section 6) or to other medicines of the ACE inhibitors group. You have ever had a reaction which included swelling of the hands, lips, face or tongue where the cause was unknown. You have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. You are more than three months pregnant (it is also better to avoid taking ACERIL in early pregnancy – see section "Pregnancy and breastfeeding"). If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angi Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aceril 12.5, 25, 50 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aceril 12.5 Each tablet contains 12.5 mg of Captopril. Excipient with known effect: Each tablet contains approximately 17 mg of lactose. Aceril 25 Each tablet contains 25 mg of Captopril. Excipient with known effect: Each tablet contains approximately 33 mg of lactose. Aceril 50 Each tablet of contains 50 mg of Captopril. Excipient with known effect: Each tablet contains approximately 67 mg of lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. White, round, biconvex, scored tablet. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Congestive heart failure Insulin depended diabetic nephropathy in hypertensive and non-hypertensive patients in cases where the serum creatinine level < 2.5 mg/dl. Improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction less or equals to 40% and to reduce the incidence of overt heart failure and subsequent hospitalization for congestive heart failure in these patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Dose should be individualised according to patient's profile (see section 4.4) and blood pressure response. The recommended maximum daily dose is 150 mg. Aceril may be taken before, during and after meals. ADULTS _Hypertension: _Treatment with captopril should be at the lowest effective dose which should be titrated according to the needs of the patient. The recommended starting dose is 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure. Captopril can be used alone or with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). A once-daily dosing regimen may be Leer el documento completo