Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOTHYROXINE SODIUM
Aspen Medical Products Malaysia Sdn Bhd
LEVOTHYROXINE SODIUM
100Tablet Tablets
Aspen Bad Oldesloe GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 OROXINE TABLET Levothyroxine Sodium (50mcg, 100mcg) WHAT IS IN THE LEAFLET 1. What Oroxine is used for 2. How Oroxine works 3. Before you use Oroxine 4. How to use Oroxine 5. While you are using it 6. Side effects 7. Storage and Disposal of Oroxine 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT OROXINE IS USED FOR Oroxine is used to treat thyroid hormone deficiency also known as hypothyroidism. HOW OROXINE WORKS Oroxine contains Levothyroxine Sodium. Levothyroxine Sodium is a thyroid hormone. It is used as replacement therapy in the treatment of thyroid hormone deficiency. Thyroxine (T 4 ) is a naturally occurring hormone produced by the thyroid gland and converted to the more active hormone tri- iodothyronine (T 3 ). The thyroid hormone are required for normal growth and development, particularly of the nervous system. Thyroid hormones enhance lipolysis and the utilization of carbohydrate. 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 USE OROXINE - _When you must not use it _ Do not take this medicine if you have an allergy to: • levothyroxine sodium • any other thyroid hormone • any of the other ingredients listed at the end of this leaflet Do not take this medicine if you have: • overactive thyroid gland, which is resulting in a rapid heartbeat and an increased rate of metabolism. • heart disease and inflammation of the cardiac muscle Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking this medicine, talk to your doctor. - _Before you start to use it _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any o Đọc toàn bộ tài liệu
OROXINE LEVOTHYROXINE SODIUM NAME OF THE MEDICINAL PRODUCT _OROXINE_ Tablets QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets containing anhydrous levothyroxine sodium, which is the monosodium salt of the levorotary isomer of thyroxine. 50 or 100 microgram non-scored tablets. PHARMACEUTICAL FORM _OROXINE_ Tablets 50mcg: White to off-white, round, bi-convex tablets imprinted GS 11E on one face and 50 on the other. _OROXINE_ Tablets 100mcg: White to off-white, round, bi-convex tablets imprinted GS 21C on one face and 100 on the other. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Hypothyroidism. POSOLOGY AND METHOD OF ADMINISTRATION Posology _General _ If the dose of levothyroxine is increased too rapidly, symptoms such as diarrhoea, nervousness, rapid pulse, insomnia, tremors and sometimes anginal pain where there is latent myocardial ischemia may occur, and the dosage must be reduced or withheld for a day or two, then restarted at a lower level. A pre-therapy ECG is valuable, as changes induced by hypothyroidism may be confused with ECG evidence of ischemia. Due to a lack of data it is not appropriate to crush levothyroxine tablets and levothyroxine tablets without a score-line must not be halved. Levothyroxine tablets should preferably be taken on an empty stomach. _Missed Dosage _ If a scheduled daily dose is missed, the dose should be taken as soon as the patient remembers, unless it is almost time for the patient’s next dose. Two doses should not be taken together. _Interactions _ In patients whose medications include levothyroxine and known interfering agents, administration should be separated by at least 4 hours. Populations _ _ _Adults _ Initially 50 to 100 micrograms daily, and adjusted at 4 to 6 week intervals by 50 micrograms until attainment of clinical and biochemical euthyroidism. This may require doses of 100 to 200 micrograms daily. With patients aged over 50 years, it is not advisable to exceed 50 micrograms a day initially. Where there is cardiac disease, 50 micrograms on alternate days is more Đọc toàn bộ tài liệu