País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
etacrynic acid
A Menarini Australia Pty Ltd
Registered
EDECRIN _etacrynic acid_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EDECRIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking EDECRIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EDECRIN IS USED FOR EDECRIN helps to reduce the amount of fluid in the body for people who have: • swelling of the ankles, feet and legs, which is called oedema • fluid accumulation in the lungs, which is called pulmonary oedema • fluid accumulation around the eyes due to kidney disease • fluid accumulation in the stomach area, which is also called ascites, due to liver disease • a heart condition called congestive heart failure. EDECRIN is also used in children over 2 years old to remove fluid that occurs in some heart and kidney conditions. EDECRIN belongs to a group of medicines called diuretics or fluid tablets. It works by making your kidneys pass more water and salt from the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. BEFORE YOU TAKE EDECRIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE EDECRIN IF YOU HAVE AN ALLERGY TO: • EDECRIN • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. Like most medicines, EDECRIN is not recommended for use during pregnancy. DO NOT TAKE THIS MEDICINE IF YOU ARE NOT PA Leer el documento completo
AUSTRALIAN PRODUCT INFORMATION – EDECRIN (ETACRYNIC ACID) TABLETS EDECRIN PI vA04-0 Page 1 of 7 1 NAME OF THE MEDICINE Etacrynic acid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EDECRIN tablet contains 25 mg etacrynic acid. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM EDECRIN 25 mg tablets are white capsule-shaped tablets, scored and engraved “VRX 205” on one side and the other side engraved “EDECRIN”. The splitting of EDECRIN 25 mg tablets is not advised. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EDECRIN is indicated for the treatment of oedema when urgent diuresis by a potent saluretic-diuretic agent with rapid onset of action is essential. • Congestive heart failure • Pulmonary oedema • Renal oedema • Hepatic cirrhosis with ascites • Oedema due to other causes Paediatric Indications EDECRIN tablets have been found useful in patients of the paediatric age group with the nephrotic syndrome. This experience has generally been limited to short term therapy in hospitalised patients resistant to other therapy. Paediatric patients with congenital heart disease also have responded to EDECRIN. EDECRIN should not be given to infants under two years of age. (see also section 4.3 CONTRAINDICATIONS) 4.2 DOSE AND METHOD OF ADMINISTRATION The dosage must be carefully regulated so as to adjust the diuretic response to the rate and extent most desirable for the individual patient. Daily weighings and, when possible, serum electrolyte determinations will contribute greatly to the success of treatment. Oral Use The splitting of EDECRIN 25 mg tablets is not advised. Initial Dosage The smallest dose required to produce a gradual weight loss (about 1/2 to 1 kg per day) is recommended. EDECRIN PI vA04-0 Page 2 of 7 ADULTS The recommended dose is 50 mg (2 tablets) daily immediately after breakfast. If necessary, increase the total daily dosage by amounts of 25 to 50 mg (1 to 2 tablets). The usual effective daily Leer el documento completo