Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
perindopril erbumine, Quantity: 4 mg
Servier Laboratories (Aust) Pty Ltd
Perindopril erbumine
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; hydrophobic colloidal silica anhydrous; magnesium stearate
Oral
30
(S4) Prescription Only Medicine
INDOSYL MONO is indicated for: The treatment of hypertension; INDOSYL MONO is indicated for: the treatment of heart failure. In such patients it is recommended that INDOSYL MONO be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of INDOSYL MONO has not been demonstrated for New York Heart Association Category IV patients) INDOSYL MONO is indicated for: 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: A white elongated rod shaped biconvex uncoated tablet with rounded ends, being 8mm long, 4mm in width and 2.75mm in depth with a breakline scored on both faces.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-02-04
INDOSYL MONO (PERINDOPRIL ERBUMINE) 1 INDOSYL MONO 2 INDOSYL MONO 4 INDOSYL MONO 8 _perindopril (pronounced per-in-do-pril) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about INDOSYL MONO. 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 INDOSYL MONO 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 INDOSYL MONO IS The name of your medicine is INDOSYL MONO. The medicine contains the active ingredient perindopril erbumine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. WHAT INDOSYL MONO IS USED FOR INDOSYL MONO is available only with a doctor's prescription. INDOSYL MONO 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. INDOSYL MONO helps lower your blood pressure. You may be prescribed INDOSYL MONO for heart failure. Heart failure means that the heart muscle cannot pump blood strongly Přečtěte si celý dokument
AUSTRALIAN PRODUCT INFORMATION - INDOSYL MONO (PERINDOPRIL ERBUMINE) Version: 11 1/24 AUSTRALIAN PRODUCT INFORMATION INDOSYL MONO (PERINDOPRIL ERBUMINE) UNCOATED TABLETS 1 NAME OF THE MEDICINE Perindopril erbumine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each INDOSYL MONO 2 tablet contains 2 mg of perindopril erbumine. Each INDOSYL MONO 4 tablet contains 4 mg of perindopril erbumine. Each INDOSYL MONO 8 tablet contains 8 mg of perindopril erbumine. Excipient with known effect: contains sugars as lactose. For the full list of excipients, _see section 6.1 - List of _ _excipients_. 3 PHARMACEUTICAL FORM INDOSYL MONO 2: Round biconvex white uncoated tablets. INDOSYL MONO 4: Rod-shaped biconvex scored white uncoated tablets. INDOSYL MONO 8: Round biconvex green uncoated tablets with a Servier logo on one face and a heart logo on the other face. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS INDOSYL MONO is indicated for: • the treatment of hypertension; • the treatment of heart failure. In such patients it is recommended that INDOSYL MONO be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of INDOSYL MONO 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 INDOSYL MONO 4 (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 INDOSYL MONO 8 (8 mg) tablet once daily. A starting dose of one INDOSYL MONO 2 (2 mg) tablet once daily is recommended in the following patients who may be at risk of ACE inhibitor-induced hypotension: • _Combination with a Diuretic _ The administration of INDOSYL MONO t Přečtěte si celý dokument