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1 Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT <[Invented name]> 25 µg tablets <[Invented name]> 50 µg tablets <[Invented name]> 63 µg tablets <[Invented name]> 75 µg tablets <[Invented name]> 88 µg tablets <[Invented name]> 100 µg tablets <[Invented name]> 112 µg tablets <[Invented name]> 125 µg tablets <[Invented name]> 137 µg tablets <[Invented name]> 150 µg tablets <[Invented name]> 175 µg tablets <[Invented name]> 200 µg tablets Active substance: levothyroxine sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet <[Invented name]> 25 µg contains 25 µg levothyroxine sodium. 1 tablet <[Invented name]> 50 µg contains 50 µg levothyroxine sodium. 1 tablet <[Invented name]> 63 µg contains 63 µg levothyroxine sodium. 1 tablet <[Invented name]> 75 µg contains 75 µg levothyroxine sodium. 1 tablet <[Invented name]> 88 µg contains 88 µg levothyroxine sodium. 1 tablet <[Invented name]> 100 µg contains 100 µg levothyroxine sodium. 1 tablet <[Invented name]> 112 µg contains 112 µg levothyroxine sodium. 1 tablet <[Invented name]> 125 µg contains 125 µg levothyroxine sodium. 1 tablet <[Invented name]> 137 µg contains 137 µg levothyroxine sodium. 1 tablet <[Invented name]> 150 µg contains 150 µg levothyroxine sodium. 1 tablet <[Invented name]> 175 µg contains 175 µg levothyroxine sodium. 1 tablet <[Invented name]> 200 µg contains 200 µg levothyroxine sodium. Excipients with known effect: Contains sodium: less than 1 mmol (23 mg) per tablet (in all presentations), see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White, round tablets with facet, a break mark on one side and the reference 1L, 2L, 2.5L, 3L, 3.5L, 4L, 4.5L, 5L, 5.5L, 6L, 7L or 8L engraved on both sides. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications The following indications are for all <[Invented name]> 25 / 50 / 63 / 75 / 88 / 100 / 112 / 125 / 137 / 150 / 175 / 200 µg strengths: − Replacement therapy in all forms of hypothyroidism, 2 − Prophylaxis against recurrence after surgery for euthyroid goitre, depending on the postoperative hormone status, − Therapy of benign euthyroid goitre, − Suppression and replacement therapy in patients with malignant thyroid tumours, particularly after thyroidectomy. In addition for <[Invented name]> 25 / 50 / 63 / 75 / 88 / 100 µg strengths: − As an adjunct to treatment of hyperthyroidism with antithyroid drugs after achievement of the euthyroid state. In addition for <[Invented name]> 100/150/200 µg strengths − Thyroid suppression test. 4.2 Posology and method of administration Dosage Information concerning dosages is given only for guidance. The individual daily dose should be determined by laboratory and clinical monitoring. A lower replacement dose may be sufficient if there is some residual thyroid function. 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 should be given which should then be increased slowly and at lengthy intervals with frequent monitoring of thyroid hormones. Experience has shown that a lower dose is sufficient in low- weight patients and in patients with a large goitre. As T4 or fT4 levels can be elevated in some patients, serum TSH concentrations are more suitable for monitoring the treatment regimen. Indication Dose (micrograms of levothyroxine sodium/day) Hypothyroidism: Adults (increase by 25- initially 25–50 50 micrograms in 2-to thereafter 100–200 4-week intervals) Prophylaxis against recurrence of goitre: 75–200 Benign euthyroid goitre: 75–200 Adjunct to treatment of hyperthyroidism with antithyroid 50–100 drugs: After thyreoidectomy for thyroid malignant tumour: 150–300 Thyroid suppression <[Invented name]> 100 µg 200 micrograms (equivalent to 2 tablets)/day (for test: 14 days before scintigraphy) <[Invented name]> 150 µg 150 micrograms (equivalent to 1 tablet)/day (for 14 days before scintigraphy) 3 <[Invented name]> 200 µg 200 micrograms (equivalent to 1 tablet)/day (for 14 days before scintigraphy) Paediatric population The maintenance dose is generally 100 to 150 micrograms per m² body surface area. For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15 micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values. For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50 micrograms per day. The dose should be increased gradually every 2 to 4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached. Method of administration The total daily dose should be taken in the morning, at least half an hour before breakfast, swallowed whole, preferably with liquid. Infants should be given the total daily dose at least half an hour before the first meal of the day. If necessary, tablets are to be disintegrated in some water (10 to 15 ml) and the resultant suspension, which must be prepared freshly as required, is to be administered with some more liquid (5 to 10 ml). Duration of administration Duration of treatment is usually for life in the case of substitution in hypothyroidism and after strumectomy or thyroidectomy and for relapse prophylaxis after euthyroid goiter removal. Concomitant therapy of hyperthyroidism is indicated for the period in which the antithyroid drug is given. For benign euthyroid goiter, a treatment duration of 6 months up to two years is necessary. If treatment with <[Invented name]> is not successful within this period, other treatment possibilities should be considered. Thyroid suppression test 150-200 micrograms of levothyroxine sodium daily for 14 days are taken for the thyroid suppression test. Dosage in the elderly In elderly patients, in some cases, e.g. those with cardiac problems, it is best to administer levothyroxine sodium in gradually increasing doses whilst monitoring TSH levels regularly. 4.3 Contraindications − Hypersensitivity to the active substance or to any of the in section 6.1 stated excipients, − untreated hyperthyroidism, − untreated adrenal insufficiency, − untreated pituitary insufficiency (when leading to adrenal insufficiency requiring treatment), − acute myocardial infarction, − acute myocarditis, − acute pancarditis. 4 Concomitant administration of levothyroxine and an antithyroid drug is not indicated during pregnancy. Use in pregnancy and lactation, see section 4.6. 4.4 Special warnings and precautions for use Before starting a thyroid hormone therapy, the following diseases or conditions should be excluded or treated: - Coronary heart disease, - angina pectoris, - hypertension, - pituitary and/or adrenal insufficiency, - thyroid autonomy. These diseases/conditions must also be excluded or treated before a thyroid suppression test is performed, except in the case of thyroid autonomy, which may be the reason for undertaking the suppression test. It is essential that even mild, drug-induced hyperthyroidism be avoided in patients with coronary heart disease, heart failure, tachyarrhythmias, myocarditis of non-acute course, chronic hypothyroidism or in patients who have already suffered a myocardial infarction. In these patients, more frequent monitoring of thyroid hormone parameters is essential during thyroid hormone therapy (see section 4.2). In cases of secondary hypothyroidism, simultaneous adrenal insufficiency must be ruled out. If found, hydrocortisone substitution must precede thyroid hormone replacement therapy. Thyroid replacement therapy might precipitate an acute adrenal crisis in patients with adrenal insufficiency or pituitary insufficiency without adequate corticosteroid coverage. In low birth weight premature neonates, extreme caution should be taken when initiating levothyroxine, due to the immature adrenal function, circulatory collapse may occur. (See section 4.8). Haemodynamic parameters should be monitored when levothyroxine therapy is initiated in very low birth weight preterm neonates as circulatory collapse may occur due to the immature adrenal function. If thyroid autonomy is suspected, a TRH test or suppression scintigram is recommended before treatment. During levothyroxine therapy of postmenopausal women with increased risk of osteoporosis, dosage of levothyroxine sodium should be titrated to the lowest possible effective level and thyroid function should be monitored more frequently to avoid levels of levothyroxine above the physiological range (see section 4.8). Thyroid hormones should not be administered for weight reduction. Normal doses do not result in any weight reduction in euthyroid patients. Higher doses may cause severe or even life-threatening adverse events, particularly in combination with certain substances, especially sympathomimetic amines, for weight reduction. Hypersensitivity reactions (including angioedema), sometimes serious, have been reported with <[Invented name]> use. If signs and symptoms of allergic reactions occur, treatment with <[Invented name]> must be discontinued and appropriate symptomatic treatment initiated (see Section 4.3 and 4.8). 5 Once a levothyroxine treatment has been established, a switch to another thyroid hormone containing medicinal product should only take place under close monitoring of laboratory
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