Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
LEVOTHYROXINE SODIUM
Mercury Pharmaceuticals Limited
H03AA01
LEVOTHYROXINE SODIUM
TABLET
LEVOTHYROXINE SODIUM 25 µg
POM
THYROID THERAPY
Authorised
2015-03-04
Please read this leaflet carefully before you start to take your medicine. This leaflet does not contain all the information about your medicine. If you have any questions or you are not sure about anything ask your doctor or pharmacist. THE NAME OF YOUR MEDICINE IS: Eltroxin Tablets. Either 25, 50 or 100 micrograms. THE ACTIVE INGREDIENT IS: Each white tablet contains respectively Anhydrous Levothyroxine Sodium 25 micrograms, 50 micrograms and 100 micrograms. Each tablet is scored on one side and is engraved on the other side with either 25mcg - FW41 50mcg - Eltroxin 50 100mcg - Eltroxin 100. Eltroxin 25, 50 and 100 microgram tablets are available in blister packs of 28, 56 or 112 tablets and polypropylene containers of 100 or 1000 tablets. Eltroxin 25 microgram tablets are also available in polypropylene containers of 28, 56 and 112 tablets. Not all pack sizes may be marketed. The active medicine is Levothyroxine Sodium. This is the new name for Thyroxine Sodium. The ingredient itself has not changed. WHAT ELSE IS IN YOUR MEDICINE: As well as Levothyroxine Sodium, the tablets also contain Sodium Citrate, Lactose monohydrate, Maize Starch, Acacia Powder and Magnesium Stearate. The active ingredient, Levothyroxine Sodium, although synthetic, is similar to the natural thyroid hormone (chemical messenger) in your body. Thyroid hormone is produced by the thyroid gland in your neck and regulates metabolism. Eltroxin Tablets are made for the below PA holder, Eltroxin 25mcg PA 899/20/1 Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK Eltroxin 50mcg PA 701/1/1 Eltroxin 100mcg PA 701/1/2 Mercury Pharma Group Limited, Capital House, 85 King William Street, London EC4N 7BL, UK Manufacturer: Custom Pharmaceuticals Ltd, Tecore House, Conway Street, Hove, East Sussex, BN3 3LW, UK. WHAT IS YOUR MEDICINE USED FOR? Eltroxin Tablets are given to you by your doctor because you have low levels of thyroid hormone (hypothyroidism) and your metabolism is lower than normal. Thyroid hormone is vit Prečítajte si celý dokument
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eltroxin 25 microgram Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 micrograms levothyroxine sodium anhydrous. Excipients: contains Lactose 30.49mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White uncoated biconvex tablets engraved on one face “FW41” and a score line on the other. The scoreline is to allow breaking for ease of swallowing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism and juvenile myxoedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Initially 50 to 100 micrograms daily (2 to 4 tablets daily), preferably taken before breakfast. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained: this may require doses of 100 to 200 micrograms daily. For patients over 50 years, it is not advisable to exceed 50 micrograms daily initially and where there is cardiac disease, 25 micrograms daily or 50 micrograms on alternate days is more suitable initially. In this condition the daily dose may be increased by 25 micrograms at intervals of perhaps 4 weeks. For patients younger than 50 years, and in the absence of heart disease, a serum thyroxine (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less than 5 milliunits per litre should be targeted. For patients aged over 50 years, with or without cardiac disease, clinical response is probably a more acceptable criterion of dosage, rather that serum levels. A pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of cardiac ischaemia. If too rapid an increase in metabolism is produced (causing diarrhoea, nervousness, rapid pulse, insomnia, tremors, and sometimes anginal pain where there is latent cardiac ischaemia,) dosage must be reduced, or withheld, for a day or two, and then re-started at a lower dose Prečítajte si celý dokument