Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Nifedipine 20mg;
Douglas Pharmaceuticals Limited
Nifedipine 20 mg
20 mg
Modified release tablet
Active: Nifedipine 20mg Excipient: Iron oxide black Iron oxide red Lactose monohydrate Macrogol 4000 Magnesium stearate Methylcellulose Microcrystalline cellulose Polysorbate 80 Pregelatinised maize starch Purified water Titanium dioxide
Blister pack, 30 tablets
Prescription
Prescription
Siegfried Ltd
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture
1986-02-20
CONSUMER MEDICINE INFORMATION 1 NYEFAX RETARD™ _nifedipine _ 20 mg tablets WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING NYEFAX RETARD This leaflet answers some common questions about NYEFAX RETARD. 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 taking NYEFAX RETARD 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 NYEFEX RETARD™ IS USED FOR NYEFAX RETARD is used for the treatment of coronary heart disease, angina pectoris - exercise induced chest pain, hypertension - high blood pressure. NYEFAX RETARD contains nifedipine, which belongs to a group of medicines called calcium antagonist. For angina, NYEFAX RETARD works by relaxing and expanding the arteries supplying the heart which allows more blood and oxygen to reach the heart and this decreasing the strain on it. For high blood pressure, NYEFAX RETARD works by relaxing and expanding the blood vessels which makes the blood flow more easily and lowers blood pressure. NYEFAX RETARD does not change the amount of calcium in your blood or bones. Your doctor may have prescribed NYEFAX RETARD for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NYEFAX RETARD HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE NYEFAX RETARD™ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE NYEFAX RETARD IF YOU HAVE AN ALLERGY TO: • nifedipine • other calcium channel blockers • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • difficulty in breathing or wheezing • shortness of breath • swelling of the face, tongue, lips, or other parts of the body • hives on the skin, rash, or itching DO NOT Perskaitykite visą dokumentą
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME Nyefax® Retard modified-release tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains 20 mg nifedipine. EXCIPIENT(S) WITH KNOWN EFFECT Contains lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablets. Pale pink, biconvex, film-coated tablet of 7 mm diameter. 4. CLINICAL PARTICULARS 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 DOSE RECOMMENDED USUAL DOSE As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient’s response. Depending on the clinical picture in each case, the basic dose must be introduced gradually. In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary. _ADULTS _ Unless otherwise prescribed, the following dosage guidelines apply for adults: 2 | P a g e IN CORONARY HEART DISEASE Chronic stable angina pectoris (angina of effort) 1 Nyefax Retard tablet twice daily (2 x 20 mg/day) If higher dosages are necessary, the dose can be increased in stages up to a maximum of 60 mg daily. IN HYPERTENSION 1 Nyefax Retard tablet twice daily (2 x 20 mg/day) If higher dosages are necessary, the dose can be increased in stages up to a maximum of 60 mg daily. Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (refer to section 4.5). DURATION OF TREATMENT The attending doctor will determine the duration of use. Because Nyefax Retard has a pronounced anti-ischaemic and anti-hypertensive action, it should be discontinued gradually, particularly when high doses are used. _SPECIAL POPULATION _ Use in elderly The pharmacokinetics of nifedipine are altered in the elderly so that lower main Perskaitykite visą dokumentą