国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
nifedipine, Quantity: 30 mg
Bayer Australia Ltd
Tablet, modified release
Excipient Ingredients: magnesium stearate; cellulose acetate; polyethylene oxide; macrogol 3350; hypromellose; iron oxide red; sodium chloride; titanium dioxide; propylene glycol; hyprolose; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
30 Tablets, 10 tablets
(S4) Prescription Only Medicine
INDICATIONS: Nifedipine is indicated for: 1. The treatment of mild to moderate hypertension. 2. The prophylaxis of chronic stable angina pectoris.
Visual Identification: Round, biconvex, rose-pink, film-coated tablet. with "30" printed on one side and blank on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2000-12-22
Adalat Oros® CMI vX 1.0 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. 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. Your doctor, however, may prescribe Adalat Oros for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ADALAT OROS HAS BEEN PRESCRIBED FOR YOU. • rash, itching or hives on the skin. DO NOT TAKE ADALAT OROS IF YOU ARE IN CARDIOGENIC SHOCK (VERY LOW BLOOD PRESSURE DUE TO A FAILING HEART). TELL YOUR DOCTOR IF YOU HAVE HAD A HEART ATTACK IN THE LAST WEEK OR SO. DO NOT TAKE ADALAT OROS IF YOU HAVE A KOCK POUCH OR ILEOSTOMY (A SURGICALLY CREATED RESERVOIR IN THE SMALL INTESTINE). DO NOT TAKE ADALAT OROS IF YOU ARE TAKING ANOTHER MEDICINE CONTAINING THE ACTIVE SUBSTANCE RIFAMPICIN, AN ANTIBIOTIC USED TO TREAT TUBERCULOSIS AND OTHER SERIOUS INFECTIONS. DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT. KEEP THIS LEAFLET WITH THE It may affect your developing baby MEDICINE. You may need to read it again. BEFORE YOU TAKE ADALAT OROS if you take it during pregnancy. DO NOT BREAST-FEED IF YOU ARE _ _ _ _ _WHEN YOU MUST NOT TAKE IT _ T 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION ADALAT® OROS (NIFEDIPINE) CONTROLLED RELEASE TABLETS Adalat Oros® PI vX1.0 CCDS17 Page 1 of 19 1 NAME OF THE MEDICINE nifedipine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Adalat OROS tablets are a controlled release formulation (GITS, GastroIntestinal Therapeutic System) containing nifedipine 20 mg, 30 mg or 60 mg. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Adalat OROS tablets are similar in appearance to conventional tablets. Each tablet consists of a semipermeable membrane surrounding an osmotically active core. The core itself is divided into two layers: an "active" layer containing nifedipine, and a "push" layer containing pharmacologically inert but osmotically active components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and "pushes" against the nifedipine layer, releasing nifedipine through a precision laser-drilled tablet orifice in the "active" layer. The coating of Adalat OROS remains intact during the gastrointestinal passage and is eliminated in the faeces. All strengths of Adalat OROS are round, biconvex shaped, rose-pink, film-coated tablets. Tablet diameters are 8.4 mm (20 mg), 9 mm (30 mg) and 11 mm (60 mg). Adalat OROS 20 mg tablets are marked in black with the product name on one side (“Adalat 20”) and the Adalat OROS 30 mg and 60 mg tablets are marked with the dose strength on one side (“30” or “60”). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adalat OROS is indicated for: 1. the treatment of mild to moderate hypertension 2. the prophylaxis of chronic stable angina pectoris 4.2 DOSE AND METHOD OF ADMINISTRATION As far as possible the treatment must be tailored to the needs of the individual and depending on the clinical picture in each case, the basic dose must be introduced gradually. In patients with impaired liver function, careful monitoring is advised and, in severe cases, a dose reduction may be necessary. The tablets are swallowed 完全なドキュメントを読む