国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)
Alphapharm Pty Ltd
amlodipine besilate
Tablet, uncoated
Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; microcrystalline cellulose; pregelatinised maize starch
Oral
28, 30, 14
(S4) Prescription Only Medicine
Hypertension - NORDIP 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 NORDIP, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. Angina - NORDIP is indicated for the first line treatment of chronic stable angina. NORDIP may be used alone, as monotherapy or in combination with other antianginal drugs.
Visual Identification: White to off-white, round tablet with "AB" over scoreline over "5"on one side and "G" on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2007-11-30
NORDIP ® _contains the active ingredient amlodipine besilate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nordip. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Nordip against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NORDIP IS USED FOR _WHAT IT DOES_ Nordip is used to: • lower high blood pressure (hypertension). 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. • treat angina pectoris. Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or neck, and sometimes to the shoulders and back. The pain of angina is due to a shortage of oxygen to the heart. Nordip is not for the relief of a sudden attack of angina. Your doctor will give you other medication to treat this. _HOW IT WORKS_ Nordip belongs to a group of medicines called calcium channel blockers or calcium ion antagonists. They work by widening your blood vessels, making it easier for your heart to pump blood around the body and help increase the supply of blood and oxygen to your heart. Calcium channel blockers do not change the amount of calcium in your blood or bones. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NORDIP HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine in children. BEFORE YOU TAKE NORDIP _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE NORDIP IF YOU HAVE AN ALLERGY TO: 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION NORDIP _Amlodipine besilate _ 1 NAME OF THE MEDICINE Amlodipine besilate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Nordip tablet contains 5 mg or 10 mg of amlodipine (as besilate) as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Nordip 5 mg : White to off-white, round tablet with “AB” over scoreline over “5” on one side and “G” on the other. Nordip 10 mg : White to off-white, round tablet with “AB” over scoreline over “10” on one side and “G” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1) HYPERTENSION Nordip 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 Nordip, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. 2) ANGINA Nordip is indicated for the first line treatment of chronic stable angina. Nordip may be used alone, as monotherapy or in combination with other antianginal drugs. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE For hypertension or angina the usual initial dose is 2.5 to 5 mg once daily which may be increased to a maximum dose of 10 mg depending on the individual patient's response. METHOD OF ADMINISTRATION Nordip is for oral administration. DOSAGE ADJUSTMENT Small, fragile or elderly individuals, or patients with hepatic insufficiency should be started on 2.5 mg once daily and this dose may be used when adding Nordip to other antihypertensive therapy. Dosage should be adjusted according to each patient's need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently. See 完全なドキュメントを読む