Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
perindopril erbumine, Quantity: 2 mg
Lupin Australia Pty Limited
Perindopril erbumine
Tablet, uncoated
Excipient Ingredients: silica dimethyl silylate; magnesium stearate; microcrystalline cellulose; lactose monohydrate
Oral
30 tablets
(S4) Prescription Only Medicine
PERINDOPRIL GENERICHEALTH TABLETS are indicated for: The treatment of hypertension.The treatment of heart failure. In such patients it is recommended that PERINDOPRIL GENERICHEALTH TABLETS be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril tablets have 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 to off-white, round, biconvex tablets, plain on one side and debossed with '2' on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2007-10-03
CONSUMER MEDICINE INFORMATION PERINDOPRIL GENERICHEALTH (PERINDOPRIL ERBUMINE) UNCOATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Perindopril generichealth. 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 Perindopril generichealth 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 PERINDOPRIL GENERICHEALTH IS USED FOR The name of your medicine is Perindopril generichealth. This medicine contains the active ingredient perindopril erbumine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Perindopril generichealth is available only with a doctor's prescription. Perindopril generichealth 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. Perindopril generichealth helps lower your blood pressure. You may be prescribed Perindopril generichealth for heart failure. Heart failure means that the heart muscle cannot pump Prečítajte si celý dokument
AUSTRALIAN PRODUCT INFORMATION – PERINDOPRIL GENERICHEALTH (PERINDOPRIL ERBUMINE) UNCOATED TABLET 1 NAME OF THE MEDICINE Perindopril erbumine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Perindopril generichealth tablet contains 2 mg, 4 mg or 8 mg of perindopril erbumine. List of excipients with known effect: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Perindopril generichealth 2 mg tablets: White to off-white, round, biconvex tablets, plain on one side and debossed with ‘2’ on the other side. Perindopril generichealth 4 mg tablets: White to off-white, capsule-shaped tablets, with a break line on both sides and debossed with ‘4’ on either side of the break line on one side of the tablet. Perindopril generichealth 8 mg tablets: White to off-white, round, biconvex tablets, plain on one side and debossed with ‘8’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perindopril generichealth tablets are indicated for: • the treatment of hypertension; • the treatment of heart failure. In such patients it is recommended that Perindopril generichealth tablets be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of Perindopril tablets have 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 HYPERTENSION The usual starting dose is one 4 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 8 mg tablet once daily. Perindopril generichealth v11.0 Page 2 of 24 (perindopril erbumine) uncoated tablet A starting dose of one 2 mg tablet per day Prečítajte si celý dokument