Țară: Malta
Limbă: engleză
Sursă: Malta Medicines Authority
Laboratoire Innotech International 22 Avenue Aristide Briand, Arcueil 94110, France
B03AD05
FERROUS GLUCONATE 60 mg FOLIC ACID 0.40 mg
FILM-COATED TABLET
FERROUS GLUCONATE 60 mg FOLIC ACID 0.40 mg
OTC
ANTIANEMIC PREPARATIONS
Authorised
2023-07-31
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER TOTYLEM 60 MG/0.4 MG, FILM-COATED TABLET iron/folic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What TOTYLEM is and what it is used for 2. What you need to know before you take TOTYLEM 3. How to take TOTYLEM 4. Possible side effects 5. How to store TOTYLEM 6. Contents of the pack and other information 1. WHAT TOTYLEM IS AND WHAT IT IS USED FOR TOTYLEM contains iron and folic acid as active substances. This medicinal product belongs to a group of medicines used to treat iron deficiency disorders. TOTYLEM is used for the prophylaxis and treatment of iron deficiency with increased need for folic acid during pregnancy, after delivery and while breastfeeding. Medicinal product for women only during pregnancy, after delivery and while breastfeeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOTYLEM DO NOT TAKE TOTYLEM - If you are allergic to iron, folic acid or any of the other ingredients of this medicine (listed in section 6), - If you suffer from iron overload, - If you have anaemia that is not due to iron deficiency (e.g. due to Vitamin B12 deficiency), - If you receive frequent blood transfusions. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking TOTYLEM - If you have difficulties swallowing. You may be at risk of ulceration of the throat or the oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs), if the tablet enters the airwa Citiți documentul complet
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TOTYLEM 60 mg/0.4 mg, film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Iron (as ferrous gluconate hydrate) ...........................................................................................60.000 mg Folic acid (as folic acid hydrate) .................................................................................................0.400 mg For one film-coated tablet. Excipient with known effect: each film-coated tablet contains 158 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pearly pink, round film-coated tablet of 12 mm diameter and 7 mm thickness. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of iron deficiency with increased need for folic acid during pregnancy, postpartum and breastfeeding. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 tablet daily (60 mg iron and 0.4 mg folic acid). _ _ _Duration of the treatment_ In case of prophylactic treatment, pregnant women should be treated for 6 months, or, if 6 months of treatment cannot be achieved during the pregnancy, continue the prophylaxis during postpartum period (6 to 12 weeks after childbirth). In case of iron deficiency, duration of use should be long enough to restore the iron stores (serum iron, serum transferrin receptor and transferrin saturation coefficient). Serum hemoglobin and ferritin levels should be checked 8 weeks after treatment initiation. The need of any subsequent monitoring is left to the discretion of the physician. In pregnant women, these tests should be repeated at least once during the second trimester. _Children and adolescents _ The product is not intended for use in the pediatric population as only indicated in women during pregnancy, postpartum and breastfeeding. _Elderly patients _ The product is not intended for use in the elderly population as only indicated in women during pregnancy, postpartum and breastfeeding. _Patients wit Citiți documentul complet