Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Cilazapril monohydrate 2.606mg equivalent to 2.5 mg cilazapril
Apotex NZ Ltd
Cilazapril monohydrate 2.606 mg (equivalent to 2.5 mg cilazapril)
2.5 mg
Film coated tablet
Active: Cilazapril monohydrate 2.606mg equivalent to 2.5 mg cilazapril Excipient: Hyprolose Hypromellose Iron oxide red Macrogol 8000 Maize starch Microcrystalline cellulose Purified water Sodium stearyl fumarate Titanium dioxide
Bottle, plastic, 75 mL HDPE, 200 tablets
Prescription
Prescription
Hetero Labs Limited
APO-CILAZAPRIL is indicated in the treatment of all grades of essential hypertension and renovascular hypertension.
Package - Contents - Shelf Life: Bottle, plastic, 75 mL HDPE - 200 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
2007-10-24
New Zealand Consumer Medicine Information APO-CILAZAPRIL _CILAZAPRIL _ 2.5mg & 5mg tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Apo-Cilazapril. This leaflet answers some common questions about Apo-Cilazapril. 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 using Apo-Cilazapril against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT APO-CILAZAPRIL IS USED FOR Apo-Cilazapril contains the active ingredient cilazapril. It belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Apo-Cilazapril is used to treat • high blood pressure (hypertension) • heart failure HIGH BLOOD PRESSURE (HYPERTENSION) Apo-Cilazapril is used to lower high blood pressure (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, including stroke, heart disease and kidney failure. HEART FAILURE Heart failure means that the heart muscle is weak and 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. Heart failure may start off with no symptoms, but as the condition progresses, patients may feel short of breath or may get tired easily af Les hele dokumentet
NEW ZEALAND DATA SHEET APO-CILAZAPRIL 1. APO-CILAZAPRIL (1MG, 2.5MG & 5MG FILM COATED TABLETS) APO-CILAZAPRIL 1mg film coated tablets APO-CILAZAPRIL 2.5mg film coated tablets APO-CILAZAPRIL 5mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cilazapril monohydrate 1.0425mg (equivalent to Cilazapril 1mg) Cilazapril monohydrate 2.606mg (equivalent to Cilazapril 2.5mg) Cilazapril monohydrate 5.213mg (equivalent to Cilazapril 5mg) Chemical Structure: Molecular Formula: C 22 H 31 N 3 O 5 .H 2 O Molecular Mass: 435.50 Excipient(s) with known effect APO-CILAZAPRIL contains corn starch. APO-CILAZAPRIL is gluten free and lactose free For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM 1mg APO-CILAZAPRIL Yellow, oval, biconvex, film coated tablet. Engraved “CZ” over European bisect “1” on one side, “APO” on the other side. Each tablet typically weighs 82mg 2.5mg APO-CILAZAPRIL Dusty rose, oval, biconvex, film coated tablet. Engraved “CZ” over European bisect “2.5” on one side, ’APO” on the other side. Each tablet typically weighs 82mg. Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 of 14 APO-CILAZAPRIL 5mg APO-CILAZAPRIL Reddish-brown, oval, biconvex, film coated tablet. Engraved “CZ” over European bisect “5” on one side, “APO” on the other side. Each tablet typically weighs 82mg. The tablet can be divided into equal doses 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • APO-CILAZAPRIL is indicated in the treatment of all grades of essential hypertension and renovascular hypertension. • APO-CILAZAPRIL is also indicated in the treatment of congestive heart failure as an adjunctive therapy with digitalis and/or diuretics. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE STANDARD DOSAGE APO-CILAZAPRIL should be administered once daily. As food intake has no clinically significant influence on absorption, APO-CILAZAPRIL can be administered before or after a meal. The dose should always be taken at about the sa Les hele dokumentet