Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOTHYROXINE SODIUM
MERCK SDN. BHD.
LEVOTHYROXINE SODIUM
100 Tablet Tablets; 100Tablet Tablets; 100 Tablet Tablets
Merck Healthcare KGaA
1 EUTHYROX ® TABLET Levothyroxine Sodium (25mcg, 50mcg, 100mcg) Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What Euthyrox is used for 2. How Euthyrox works 3. Before you use Euthyrox 4. How to take Euthyrox 5. While you are using Euthyrox 6. Side Effects 7. Storage and Disposal of Euthyrox 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number What Euthyrox is used for Euthyrox 25 - 100 microgram is used for: - Treatment of benign euthyroid goiter (condition present which is causing the thyroid to grow abnormally when there is correct amount of hormone produced), mainly in adults when iodine is not indicated. - Prophylaxis of relapse after surgery for euthyroid goitre, depending on the post-operative hormone status - Substitution therapy in underactive thyroid gland - Suppression therapy in thyroid cancer - Concomitant supplementation during anti-thyroid medicine treatment of overactive thyroid gland Euthyrox 100 microgram: - Diagnostic use for thyroid suppression tes t ing How Euthyrox works Euthyrox contains levothyroxine sodium, which is a synthetic thyroid hormone. The levothyroxine sodium in Euthyrox is intended to replace a hormone that is normally produced by your thyroid gland. Euthyrox, when taken correctly, reverses the symptoms of underactive thyroid gland. Before you use Euthyrox - When you must not take it Do not use this medication if: you have had an allergic reaction before to any of the ingredients in Euthyrox you have had uncorrected adrenal insufficiency (lack of hormone) you have had uncorrected pituitary insufficiency you have untreated thyrotoxicosis, a disease in which the thyroid gland is overactive and produces too much thyroxine you have had an acute myocardial infarction (heart attack) - Before you start to take it Tell your doctor before or while you are using Euthyrox if you are allergic to any foods, medicines or are lactose intolerant. Inform your doctor if you have, Baca dokumen lengkapnya
PAGE 1 fold fold 7894570047 EUTHYROX ® 25 MICROGRAM TABLETS EUTHYROX ® 50 MICROGRAM TABLETS EUTHYROX ® 100 MICROGRAM TABLETS NAME OF THE MEDICINAL PRODUCT Euthyrox 25 microgram tablets Euthyrox 50 microgram tablets Euthyrox 100 microgram tablets QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet Euthyrox 25 microgram contains 25 microgram levothyroxine sodium. 1 tablet Euthyrox 50 microgram contains 50 microgram levothyroxine sodium. 1 tablet Euthyrox 100 microgram contains 100 microgram levothyroxine sodium. For a full list of excipients, see List of excipients. PHARMACEUTICAL FORM Tablet. Off white, round, flat on both sides, with a bevelled edge, a dividing score and an inscription on top: Euthyrox 25 microgram EM 25 Euthyrox 50 microgram EM 50 Euthyrox 100 microgram EM 100 The tablet can be divided into equal doses. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Euthyrox 25 - 100 microgram: − Treatment of benign euthyroid goitre, mainly in adults when iodine is not indicated. − Prophylaxis of relapse after surgery for euthyroid goitre, depending on the post-operative hormone status − Substitution therapy in hypothyroidism − Suppression therapy in thyroid cancer − Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism Euthyrox 100 microgram: − Diagnostic use for thyroid suppression tesTing POSOLOGY AND METHOD OF ADMINISTRATION In order to treat each patient according to his/her individual needs, tablets are available with a levothyroxine sodium content ranging from 25 to 200 microgram. Patients therefore usually need to take only one tablet per day. The dosage recommendations given are only for guidance. The individual daily dose should be determined on the basis of laboratory tests and clinical examinations. As a number of patients show elevated concentrations of T 4 and fT 4 , basal serum concentration of thyroid-stimulating hormone provides a more reliable basis for following treatment course. Thyroid hormone therapy should be started at low dose and increased graduall Baca dokumen lengkapnya