国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
perindopril arginine, Quantity: 5 mg
Arrotex Pharmaceuticals Pty Ltd
perindopril arginine
Tablet, film coated
Excipient Ingredients: iron oxide yellow; isomalt; magnesium stearate; hypromellose; brilliant blue FCF aluminium lake; titanium dioxide; hyprolose; colloidal anhydrous silica; macrogol 8000
Oral
30, 100
(S4) Prescription Only Medicine
Treatment of hypertension and the treatment of heart failure. In such patients it is recommended that perindopril arginine be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril arginine 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: Light green coloured, capsule-shaped, biconvex, film coated tablets, with notch and engraved APO on one side and P 5 on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-04-26
APO-PERINDOPRIL ARGININE 1 APO-PERINDOPRIL ARGININE _Perindopril Arginine _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Perindopril Arginine tablets. It contains the active ingredient perindopril arginine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. It is used to treat high blood pressure, heart failure or coronary artery disease. 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 available only with a doctor's prescription. _HIGH BLOOD PRESSURE _ 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. Perindopril arginine helps lower your blood pressure. _HEART FAILURE _ Heart failure means that the heart muscle cannot pump blood strongly enough to 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION – APO-PERINDOPRIL ARGININE (PERINDOPRIL ARGININE) TABLETS 1 NAME OF THE MEDICINE Perindopril Arginine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg, 5 mg or 10 mg perindopril arginine, as the active ingredient. 3 PHARMACEUTICAL FORM 2.5 MG TABLETS: White coloured, round shaped, biconvex, film coated tablets, with engraved “APO” on one side and “2.5” on the other side. 5 MG TABLETS: Light green coloured, capsule-shaped, biconvex, film coated tablets, with notch and engraved “APO” on one side and “P 5” on the other side. 10 MG TABLETS: Green coloured, round shaped, biconvex, film coated tablets, with engraved “APO” on one side and “P 10” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • The treatment of hypertension. • The treatment of heart failure. In such patients it is recommended that perindopril arginine be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril arginine 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, 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. 4.2 DOSE AND METHOD OF ADMINISTRATION Perindopril Arginine tablets are intended for oral administration. HYPERTENSION The usual starting dose is one perindopril arginine 5 mg 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 perindopril arginine 10 mg tablet once daily. A starting dose of one perindopril arginine 2.5 mg tablet per day is recommended in the following patients who may be at risk of ACE inhibitor-induced hypotension: 2 Combination with a Diuretic The administration of perindopril arginine to patients currently treate 阅读完整的文件