Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
TABLET
EACH TABLET CONTAINS LEVOTHYROXINE SODIUM 125,0 ug
Registered
2018-06-09
_ZA_ELTRNFTAB_1609_02 _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 12 _ 1.3.2 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S3 PROPRIETARY NAME AND DOSAGE FORM ELTROXIN NEW FORMULATION 25 ΜG ELTROXIN NEW FORMULATION 50 ΜG ELTROXIN NEW FORMULATION 75 ΜG ELTROXIN NEW FORMULATION 88 ΜG ELTROXIN NEW FORMULATION 100 ΜG ELTROXIN NEW FORMULATION 112 ΜG ELTROXIN NEW FORMULATION 125 ΜG ELTROXIN NEW FORMULATION 137 ΜG ELTROXIN NEW FORMULATION 150 ΜG ELTROXIN NEW FORMULATION 175 ΜG ELTROXIN NEW FORMULATION 200 ΜG Tablet _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ELTROXIN NEW FORMULATION Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. ELTROXIN NEW FORMULATION has been prescribed for you personally and you should not share ELTROXIN NEW FORMULATION with other people. It may harm them, even if their symptoms are the same as yours. _ZA_ELTRNFTAB_1609_02 _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 12 _ WHAT ELTROXIN NEW FORMULATION CONTAINS The active substance is levothyroxine sodium. Each tablet of ELTROXIN NEW FORMULATION contains 25 µg, 50 µg, 75 µg, 88 µg, 100 µg, 112 µg, 125 µg, 137 µg, 150 µg, 175 µg, or 200 µg of levothyroxine sodium. The inactive ingredients include: Colloidal silica dioxide, magnesium stearate, microcrystalline cellulose, pregelatinised maize starch, talc. Sugar free. WHAT ELTROXIN NEW FORMULATION IS USED FOR ELTROXIN NEW FORMULATION is used to treat hypothyroidism, a disease in which the thyroid gland is underactive and does not produce enough thyroxine, a hormone, which is important for controlling your metabolism. BEFORE YOU TAKE ELTROXIN NEW FORMULATION DO NOT TAKE ELTROXIN NEW FORMULATION IF: You have had an allergic reaction before, to the active ingredient or any of the other ingredients in ELTROXIN NEW FORMULATION listed above. You have untreated hyperthyroidism, a disease in which the thyroid gland is overactive and produces too much thyroxine (this can lead to a life- th Les hele dokumentet
_ZA_ELTRNFTAB_1609_02 _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 18 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS S3 PROPRIETARY NAME AND DOSAGE FORM ELTROXIN NEW FORMULATION 25 ΜG (tablet) ELTROXIN NEW FORMULATION 50 ΜG (tablet) ELTROXIN NEW FORMULATION 75 ΜG (tablet) ELTROXIN NEW FORMULATION 88 ΜG (tablet) ELTROXIN NEW FORMULATION 100 ΜG (tablet) ELTROXIN NEW FORMULATION 112 ΜG (tablet) ELTROXIN NEW FORMULATION 125 ΜG (tablet) ELTROXIN NEW FORMULATION 137 ΜG (tablet) ELTROXIN NEW FORMULATION 150 ΜG (tablet) ELTROXIN NEW FORMULATION 175 ΜG (tablet) ELTROXIN NEW FORMULATION 200 ΜG (tablet) COMPOSITION Each tablet of ELTROXIN NEW FORMULATION contains 25 µg, 50 µg, 75 µg, 88 µg, 100 µg, 112 µg, 125 µg, 137 µg, 150 µg, 175 µg, or 200 µg of levothyroxine sodium. _Excipients: _ Colloidal silica dioxide, magnesium stearate, microcrystalline cellulose, pregelatinised maize starch, talc. Sugar free. _ZA_ELTRNFTAB_1609_02 _ _ _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 18 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ CATEGORY AND CLASS A 21.3 Thyroid preparations PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Thyroxine (T 4 ) is a naturally occurring hormone produced by the thyroid gland and converted to the more active hormone tri-iodothyronine (T 3 ) in peripheral tissues. The precise signals controlling the conversion of T 4 to T 3 within the cell are not known. The thyroid hormones are required for normal growth and development, particularly of the nervous system. They increase the resting or basal metabolic rate of the whole organism and have stimulatory effects on the heart, skeletal muscle, liver and kidney. Thyroid hormones enhance lipolysis and the utilisation of carbohydrate. 100 µg thyroxine is equivalent in activity to 20 µg to 30 µg liothyronine/tri-iodothyronine or 60 mg thyroid BP. PHARMACOKINETIC PROPERTIES ABSORPTION Following oral administration the absorption of thyroxine is incomplete and variable especially when taken Les hele dokumentet