Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Enalapril maleate 2.5mg;
Viatris Limited
Enalapril maleate 2.5 mg
2.5 mg
Tablet
Active: Enalapril maleate 2.5mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Sodium bicarbonate Starch
Blister pack, Cold form laminate/Al/PVC, 30 tablets
Prescription
Prescription
Neuland Laboratories Limited
· All grades of essential hypertension. · Renovascular hypertension.
Package - Contents - Shelf Life: Blister pack, Cold form laminate/Al/PVC - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
1998-10-13
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION ACETEC _ENALAPRIL MALEATE TABLETS 5 MG, 10 MG & 20 MG _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Acetec. 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 Acetec 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 ACETEC IS USED FOR Acetec contains the active ingredient enalapril maleate. It belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. Acetec lowers high blood pressure, which doctors call hypertension. It is also used to treat heart failure. HYPERTENSION Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension 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 hypertension can cause stroke, heart disease and kidney failure. Acetec helps to lower your blood pressure. 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 not the same as heart attack and does not mean that the heart stops working. Heart failure may start off with no symptoms, but as the condition progresses, patients may feel short of breath or may get tired easily after light physical activity such as walkin Lugege kogu dokumenti
Page 1 of 15 NEW ZEALAND DATA SHEET ACETEC 1. PRODUCT NAME Acetec, 5, 10 & 20 mg, tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg, 10 mg, or 20 mg of enalapril maleate. Excipients with known effect: Maize starch and lactose. Allergen declaration: sulfites and sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Acetec 5 mg tablets are white arc triangle shaped biconvex tablets, debossed with “5” over “G” on one side and scoreline on the other side. Each tablet contains 5 mg of the active ingredient, enalapril maleate. Acetec 10 mg tablets are rusty red, arc triangle shaped biconvex tablets, debossed with “10” over “G” on one side and scoreline on the other side. Each tablet contains 10 mg of the active ingredient, enalapril maleate. Acetec 20 mg tablets are peach, arc triangle shaped biconvex tablets, debossed with “20” over “G” on one side and scoreline on the other side. Each tablet contains 20 mg of the active ingredient, enalapril maleate. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Treatment of: • All grades of essential hypertension • Renovascular hypertension • All degrees of heart failure In patients with symptomatic heart failure, enalapril maleate is also indicated to: • Improve survival • Retard the progression of heart failure • Reduce hospitalisation for heart failure • Prevention of symptomatic heart failure Page 2 of 15 In asymptomatic patients with left ventricular dysfunction, enalapril maleate is indicated to: • Retard the development of symptomatic heart failure • Reduce hospitalisation for heart failure • Prevention of coronary ischaemic events in patients with left ventricular dysfunction Enalapril maleate is indicated to: • Reduce the incidence of myocardial infarction • Reduce hospitalisation for unstable angina pectoris. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE _ESSENTIAL HYPERTENSION_ The initial dose is 5 mg an Lugege kogu dokumenti