Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Amlodipine besilate 13.87mg equivalent to 10.0 mg amlodipine base
REX Medical Ltd
Amlodipine besilate 13.87 mg (equivalent to 10.0 mg amlodipine base)
10 mg
Tablet
Active: Amlodipine besilate 13.87mg equivalent to 10.0 mg amlodipine base Excipient: Calcium hydrogen phosphate dihydrate Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Blister pack, Aluminium foil/PVC-VMCH coated, 30 tablets (10 per blister), 30 tablets
Prescription
Prescription
Cipla Ltd
Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.
Package - Contents - Shelf Life: Blister pack, Aluminium foil/PVC-VMCH coated, 30 tablets (10 per blister) - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, Aluminium foil/PVC-VMCH coated, 30 tablets (10 per blister) - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE with Tekni-Plex Foil Liner Bottle with CRC Cap and Induction Liner - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, HDPE with non-CRC cap and silica gel bag - 1000 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
2005-09-16
1 NEW ZEALAND CONSUMER MEDICINE INFORMATION VASOREX AMLODIPINE BESYLATE TABLETS 2.5 MG, 5 MG, AND 10 MG WHAT IS IN THIS LEAFLET The information enclosed answers several general questions about VASOREX. This leaflet does not include all the accessible information on VASOREX. All medication has benefits and risks. Your doctor will have considered the risks of you using VASOREX against the benefits expected. Discuss with your doctor any concerns you may have. This leaflet was last updated on the date at the end of this leaflet. KEEP THIS INFORMATION WITH YOUR MEDICINE AND REFER TO THIS LEAFLET IF YOU HAVE ANY QUERIES. WHAT VASOREX IS USED FOR VASOREX tablets are used for the treatment of: • Hypertension (high blood pressure) Blood pressure should be regularly checked as hypertension typically does not have any obvious symptoms. Hypertension can cause serious health issues if not managed effectively. • Chronic chest pain that occurs when the heart does not get enough oxygen-rich blood (angina), including a specific type of angina known as Prinzmental’s angina pectoris. VASOREX helps to prevent chest pain due to a shortage of oxygen-rich blood to the heart. It is not for the relief of a sudden angina attack. Your doctor will have prescribed you a “reliever” medication for sudden-onset chest pain. VASOREX tablets contain the active ingredient amlodipine, which belongs to the group of medicines known as calcium channel blockers or calcium channel antagonists. Calcium channel blockers block the entry of calcium into the heart muscle cells and blood vessel walls. This reduces electrical conduction in the heart and widens blood 2 vessels, making it easier for the heart to pump, increasing the supply of oxygen-rich blood to the heart and lowering blood pressure. You may also be prescribed other heart medications to be used with VASOREX to treat your heart condition. Your doctor may have prescribed VASOREX for a different reason. If you have any concerns about why VASOREX has been prescribed, please discuss this wi Læs hele dokumentet
1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Vasorex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amlodipine besilate 2.5 mg, 5 mg and 10 mg tablets 3 PHARMACEUTICAL FORM Vasorex 2.5 mg tablets are white to off white, round with “C” debossed on one side and “126” on the other side. Alternatively, they are debossed on one side with “3235” and “WPI” on the other side. Each tablet contains amlodipine besilate equivalent to 2.5 mg of amlodipine. Vasorex 5 mg tablets are white to off white, round with “C” debossed on one side and “127” on the other side. Alternatively, they are debossed on one side with “3236” and “WPI” on the other side. Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine. Vasorex 10 mg tablets are white to off white, round with “C” debossed on one side and “128” on the other side. Alternatively, they are debossed on one side with “3237” and “WPI” on the other side. Each tablet contains amlodipine besilate equivalent to 10 mg amlodipine. Do not halve the tablet as dose equivalence when the tablet is divided has not been established. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Vasorex is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor. Vasorex is indicated for the first line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Vasorex may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Vasorex may be used alone as monotherapy, or in combination with other anti Læs hele dokumentet