Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
perindopril arginine, Quantity: 2.5 mg
Servier Laboratories (Aust) Pty Ltd
perindopril arginine
Tablet, film coated
Excipient Ingredients: lactose monohydrate; sodium starch glycollate; magnesium stearate; maltodextrin; hydrophobic colloidal silica anhydrous; macrogol 6000; Colour
Oral
30
(S4) Prescription Only Medicine
COVERSYL is indicated for: the treatment of hypertension; and the treatment of heart failure. In such patients it is recommended that COVERSYL be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of COVERSYL has not been demonstrated for New York Heart Association Category IV patients); and patients with established coronary artery disease (See Clinical Trials) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.
Visual Identification: White, round, convex, film-coated tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2005-06-08
COVERSYL ® 2.5 COVERSYL ® 5 COVERSYL ® 10 _perindopril (pronounced per-in-do-pril)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COVERSYL. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. All medicines have risks and benefits. Your doctor has weighed the risks of taking COVERSYL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST OR NURSE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT COVERSYL IS The name of your medicine is COVERSYL. The medicine contains the active ingredient perindopril arginine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. WHAT COVERSYL IS USED FOR COVERSYL is available only with a doctor's prescription. COVERSYL lowers high blood pressure, a condition which doctors call hypertension. Everyone has blood pressure. This pressure helps get your blood all around the body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have high blood pressure when your blood pressure stays higher than is needed, even when you are calm or relaxed. There are usually no symptoms of high blood pressure. The only way of knowing that you have it is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually it can cause stroke, heart disease and kidney failure. COVERSYL helps lower your blood pressure. You may be prescribed COVERSYL for heart failure. Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is Đọc toàn bộ tài liệu
AUSTRALIAN PRODUCT INFORMATION – COVERSYL® (PERINDOPRIL ARGININE) Version: 25 1/26 AUSTRALIAN PRODUCT INFORMATION COVERSYL ® (PERINDOPRIL ARGININE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Perindopril arginine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each COVERSYL 2.5 tablet contains 2.5 mg of perindopril arginine. Each COVERSYL 5 tablet contains 5 mg of perindopril arginine. Each COVERSYL 10 tablet contains 10 mg of perindopril arginine. Excipient with known effect: contains sugars as lactose For the full list of excipients, _see section 6.1 - List of excipients_. 3 PHARMACEUTICAL FORM COVERSYL 2.5 is a white, round, convex, film-coated tablet. COVERSYL 5 is a light-green, rod-shaped, film-coated tablet engraved with a logo on one face and scored on both edges. COVERSYL 10 is a green, round, biconvex film-coated tablet with a logo on one face and a logo on the other face. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS COVERSYL is indicated for: • the treatment of hypertension; • the treatment of heart failure. In such patients it is recommended that COVERSYL be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of COVERSYL has not been demonstrated for New York Heart Association Category IV patients); and • patients with established coronary artery disease (_see section 5.1 - Pharmacodynamic _ _properties_) who are stable on concomitant therapy and have no heart failure to reduce the risk of non-fatal myocardial infarction or cardiac arrest. 4.2 D OSE AND METHOD OF ADMINISTRATION HYPERTENSION The usual starting dose is one COVERSYL 5 tablet once daily, taken in the morning. Optimum control of blood pressure is achieved by increasing the dose, titrating it against the blood pressure to a maximum of one COVERSYL 10 tablet once daily. A starting dose of one COVERSYL 2.5 tablet once daily is recommended in the following patients who may be at risk of ACE inhibitor-induced hypotension: AUSTRALIAN PRODUCT INFORMATION – COVERSYL® (PERINDOPRIL ARGININE) V Đọc toàn bộ tài liệu