País: Malta
Idioma: inglés
Fuente: Medicines Authority
IODINE
Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
H03CA
IODINE 200 µg
TABLET
IODINE 200 µg
POM
THYROID THERAPY
Authorised
2013-01-16
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER YODAFAR 200 MICROGRAMS TABLETS Iodine 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. WHAT IS IN THIS LEAFLET 1. What Yodafar 200 is and what it is used for 2. What you need to know before you take Yodafar 200 3. How to take Yodafar 200 4. Possible side effects 5. How to store Yodafar 200 6. Contents of the pack and other information 1. WHAT YODAFAR 200 IS AND WHAT IT IS USED FOR Yodafar is a supplement of potassium iodide indicated in: _Adults:_ Correction of nutritional deficiencies. _Pregnancy and lactation:_ Correction of nutritional deficiencies and the prevention of neural tube defects as well as fetal neurological disorders. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YODAFAR 200 DO NOT TAKE YODAFAR 200 - if you are allergic to iodine or any of the other ingredients of this medicine (listed in section 6): - if you have acute bronchitis - if you have overt hyperthyroidism - if you have latent hyperthyroidism and the recommended dose exceeds 150 micrograms daily - if you have a thyroid adenoma - if you have a renal failure WARNINGS AND PRECAUTIONS Talk to your doctor before starting the treatment with Yodafar 200 in any of the situations listed below: - Hypocomplementemic vasculitis (vessel inflammation) - Goitre (enlarged thyroid gland) - Autoimmune thyroid (inflammation of the thyroid gland) - Renal disease (kidney disease) - Hyperkalemia (high blood potassium levels) 2 - Active tuberculosis - Concomitant use of some diuretic drugs (potassium-sparing diuretics) Urinary iodine should b Leer el documento completo
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT YODAFAR 200 micrograms tablets YODAFAR 300 micrograms tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION YODAFAR 200 micrograms tablets: each tablet contains 262 micrograms of potassium iodide, equivalent to 200 micrograms of iodine. YODAFAR 300 micrograms tablets: each tablet contains 393 micrograms of potassium iodide, equivalent to 300 micrograms of iodine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Yodafar 200 micrograms tablets: round, biconvex, white tablets scored on one side. Yodafar 300 micrograms tablets: round, biconvex, white tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Yodafar is a supplement of potassium iodide indicated in: _Adults:_ Correction of nutritional deficiencies. _Pregnancy and lactation:_ Correction of nutritional deficiencies and the prevention of neural tube defects as well as fetal neurological disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended iodine dose is: • _Adults:_ 120-150 micrograms daily • _Pregnant and lactation:_ 200-300 micrograms daily. At the time of establishing the appropriate dose, the doctor will consider iodine needs and the use of potassium iodide in multivitamins. _Paediatric population _ It is not suitable for children under 12 years. Method of administration Administer the tablet orally, after meal with enough amount of liquid. 2 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Acute bronchitis. • Overt hyperthyroidism. • Latent hyperthyroidism if the dose exceeds 150 micrograms daily. • Thyroid adenoma. • Renal failure. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Urinary iodine should be used to evaluate the degree of iodine deficiency as well as monitoring and evaluating its correction. The adequate supply of iodine in the diet should be at least 150-300 micrograms daily. Since some people are very sensitive to iodine, the p Leer el documento completo