Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Nifedipine 90mg
Bayer New Zealand Limited
Nifedipine 90 mg
90 mg
Modified release tablet
Active: Nifedipine 90mg Excipient: Cellulose acetate Hyprolose Hypromellose Iron oxide red Macrogol 3350 Magnesium stearate Polyethylene oxide Propylene glycol Sodium chloride Titanium dioxide
Blister pack, 30 tablets
Prescription
Prescription
Bayer AG
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 30 tablets - 24 months from date of manufacture stored at or below 30°C
1970-01-01
New Zealand Consumer Medicine Information 131112AdalatOrosNZCMI 1 ADALAT ® OROS (ADD·A·LAT OR·US) _nifedipine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Adalat Oros. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet is for Adalat Oros. It is different from the leaflet for other forms of Adalat products. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Adalat Oros 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 ADALAT OROS IS USED FOR Adalat Oros is used either to treat high blood pressure or to prevent a type of angina (chest pain), known as chronic stable angina. ADALAT OROS IS NOT USED FOR THE RELIEF OF A SUDDEN ATTACK OF ANGINA OR TO MANAGE UNSTABLE ANGINA . Adalat Oros contains the active substance nifedipine which belongs to a group of medicines called calcium channel blockers. They work by opening up blood vessels in the body to lower blood pressure and improve the supply of blood and oxygen to the heart. Adalat Oros is specially designed to allow the slow release of the active substance from the tablet after it is taken. It is composed of a strong outer shell which does not dissolve in the body and is excreted in the faeces. It is normal to find these “ghost-tablets” in the faeces. The active substance contained in them has been absorbed by the body before excretion. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE ADALAT OROS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ADALAT OROS IF YOU HAVE AN ALLERGY TO: • nifedipine, the active ingredient in Adalat Oros • any of the ingredients listed at the end of this leaflet Some of the symptoms of an a Baca dokumen lengkap
170626 Adalat OROS DS Page 1 of 19 DATA SHEET 1. ADALAT OROS ® (30 MG, 60 MG MODIFIED RELEASE TABLET) Adalat OROS nifedipine 30 mg modified release tablets Adalat OROS nifedipine 60 mg modified release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Adalat OROS 30 modified release tablet contains 30 mg nifedipine Each Adalat OROS 60 modified release tablet contains 60 mg nifedipine EXCIPIENTS WITH KNOWN EFFECT Each Adalat OROS 30 modified release tablet contains 23.9 mg sodium chloride, see Section 4.4. Each Adalat OROS 60 modified release tablet contains 47.8 mg sodium chloride, see Section 4.4. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Round, convex extended release tablet, with pink coat, laser hole on one side. 4. CLINICAL PARICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of coronary heart disease Chronic stable angina pectoris (angina of effort) Treatment of hypertension 4.2 DOSE AND METHOD OF ADMINISTRATION. 4.2.1 DOSE As far as possible the treatment must be tailored to the needs of the individual. Depending on the clinical picture in each case, the basic dose must be introduced gradually. Unless otherwise prescribed, the following dosage guidelines are recommended for adults: For coronary heart disease: Chronic stable angina pectoris (angina of effort) 170626 Adalat OROS DS Page 2 of 19 One Adalat OROS 30 tablet once daily (1 x 30 mg/day) One Adalat OROS 60 tablet once daily (1 x 60 mg/day) For hypertension: One Adalat OROS 30 tablet once daily (1 x 30 mg/day) One Adalat OROS 60 tablet once daily (1 x 60 mg/day) In general, therapy should be initiated with 30 mg once daily. Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the Adalat OROS dose or not to use Adalat OROS at all (see Section 4.5). The attending doctor will determine the duration of use. 4.2.1.1 SPECIAL POPULATIONS 4.2.1.1.1 ELDERLY Based on the pharmacokinetic data for Adalat OROS, no dose adaptation in elderly people above 65 years Baca dokumen lengkap