Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
Amdipharm Limited
H03AA; H03AA01
Levothyroxine sodium
50 Micrograms/5ml
Oral solution
Thyroid hormones; levothyroxine sodium
Marketed
2012-07-06
PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOTHYROXINE 25 MICROGRAMS / 50 MICROGRAMS AND 100 MICROGRAMS PER 5ML ORAL SOLUTION 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levothyroxine Oral Solution is and what it is used for 2. What you need to know before you take Levothyroxine Oral Solution 3. How to take Levothyroxine Oral Solution 4. Possible side effects 5. How to store Levothyroxine Oral Solution 6. Contents of the pack and other information 1. WHAT LEVOTHYROXINE ORAL SOLUTION IS AND WHAT IT IS USED FOR Levothyroxine Oral Solution contains the active ingredient levothyroxine sodium. It is used to treat hypothyroidism, a condition in which the thyroid gland is underactive and so does not make enough thyroxine for the body's needs. Levothyroxine Oral Solution is also used to treat thyroid cancer and diffuse non-toxic goitre or Hashimoto's thyroiditis, conditions in which the thyroid gland becomes enlarged causing a swelling in the front of the neck. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOTHYROXINE ORAL SOLUTION DO NOT TAKE LEVOTHYROXINE ORAL SOLUTION: • if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6) • if you suffer from adrenal insufficiency and you do not have adequate corticosteroid cover • if you have a heart attack (acute myocardial infarction), inflammation of the heart muscle (acute myocarditis) or inflammation of the sac surrounding the heart (acute pancarditis) • if you Aqra d-dokument sħiħ
Health Products Regulatory Authority 31 July 2023 CRN00D7L5 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levothyroxine 50 micrograms per 5 ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of oral solution contains 50 micrograms Levothyroxine Sodium Excipients with known effect: Sodium methyl hydroxybenzoate (E219): 9mg per 5ml dose. Glycerol: 3,780mg per 5ml dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution. Clear colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levothyroxine Oral Solution is indicated for: i) hypothyroidism (congenital or acquired) ii) diffuse non toxic goitre iii) goitre associated with Hashimoto's thyroiditis iv) Suppression therapy in thyroid carcinoma 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS The treatment of any thyroid disorder should be determined on an individual basis, taking account of clinical response, biochemical tests and regular monitoring. 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 T4 and fT4, basal serum concentration of thyroid-stimulating hormone provides a more reliable basis for following treatment course. Patients switching from the oral solution to the tablet form or from the tablet form to the oral solution should be monitored closely. Levothyroxine is best taken as a single dose on an empty stomach, usually before breakfast. Hypothyroidism (congenital or acquired) Adults, children over 12 years Initial dose: 50 - 100 micrograms daily before breakfast. Usual maintenance 100 - 200 micrograms daily. Health Products Regulatory Authority 31 July 2023 CRN00D7L5 Page 2 of 9 dose: The initial dose is adjusted by 25 to 50 microgram increments at 3 – 4 week intervals until clinical response and measurements of plasma thyroxine and thyroid stimulating hormone indicate that the thyroid deficiency is corrected and a maintenance dose Aqra d-dokument sħiħ