Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
Aristo Pharma GmbH
H03AA; H03AA01
Levothyroxine sodium
50 microgram(s)
Tablet
Thyroid hormones; levothyroxine sodium
Marketed
2020-01-10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVOTHYROXINE SODIUM ARISTO 25 MICROGRAM TABLETS LEVOTHYROXINE SODIUM ARISTO 50 MICROGRAM TABLETS LEVOTHYROXINE SODIUM ARISTO 75 MICROGRAM TABLETS LEVOTHYROXINE SODIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levothyroxine sodium Aristo is and what it is used for 2. What you need to know before you take Levothyroxine sodium Aristo 3. How to take Levothyroxine sodium Aristo 4. Possible side effects 5. How to store Levothyroxine sodium Aristo 6. Contents of the pack and other information 1. WHAT LEVOTHYROXINE SODIUM ARISTO IS AND WHAT IT IS USED FOR Thyroxine is a hormone which is produced naturally in the body by the thyroid gland. Levothyroxine sodium is a synthetic version of this hormone. Levothyroxine sodium Aristo is used to replace the missing thyroid hormone and/or to relieve stress on the thyroid gland. Levothyroxine sodium Aristo is used • to replace the missing thyroid hormone in all forms of underactive thyroid function _(hypothyroidism)_ or after the removal of the thyroid gland, • to prevent the return of new goitres after goitre surgery in patients with normal thyroid function, • to treat non-malignant goitre _(benign struma)_ in patients with normal thyroid function, • as add on therapy in the antithyroid treatment of an overactive thyroid, after normal metabolic status has been reached, • for malignant thyroid tumours, particularly after surgery to suppress new tumour growth and as a supplement for missing thyro Perskaitykite visą dokumentą
Health Products Regulatory Authority 11 July 2023 CRN00D9L5 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levothyroxine sodium Aristo 50 micrograms tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 microgram anhydrous levothyroxine sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Levothyroxine sodium Aristo tablets are white, round uncoated vaulted tablets (snap tab) with a break mark on one side and the numeric strength (50) embossed on the other. The tablets have an approximate diameter of 7 mm and approximate height of 3 mm. The tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypothyroidism Prophylaxis against goitre recurrence following resection of euthyroid goitre Benign, euthyroid goitre Suppression and replacement therapy in thyroid malignancy, especially post thyroidectomy Co-therapy in the antithyroid treatment of hyperthyroidism, once euthyroid status has been achieved 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Thyroid hormone therapy/replacement _Posology_ The dosing information serves as a guideline. The individual daily dose should be determined by laboratory diagnostic tests and clinical examinations. If any residual thyroid function remains, a lower replacement dose may be sufficient. In elderly patients, in patients with coronary heart disease, and in patients with severe or long-existing hypothyroidism, special caution is required when initiating therapy with thyroid hormones, that is, a low initial dose (for example 12.5 microgram/day) should be given which should then be increased slowly and at lengthy intervals (e.g. a gradual increment of 12.5 microgram/day fortnightly) with frequent monitoring of thyroid hormones. Experience has shown that a lower dose is also sufficient in patients with a low body weight and in patients with a large goitre. As T 4 or fT 4 levels may be increased in some patients, determination of the serum TSH conce Perskaitykite visą dokumentą