País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
ferric maltol
Shield TX (UK) Limited
B03AB
ferric maltol
Antianemic preparations
Anemia, Iron-Deficiency
Feraccru is indicated in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD).
Authorised
2016-02-18
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FERACCRU 30 MG HARD CAPSULES Iron (as ferric maltol) 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. Do not pass it onto 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 Feraccru is and what it is used for. 2. What you need to know before you take Feraccru. 3. How to take Feraccru. 4. Possible side effects. 5. How to store Feraccru. 6. Contents of the pack and other information. 1. WHAT FERACCRU IS AND WHAT IT IS USED FOR Feraccru contains iron (as ferric maltol). Feraccru is used in adults to treat low iron stores in your body. Low iron causes anaemia (too few red blood cells). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FERACCRU DO NOT TAKE FERACCRU: - If you are allergic to ferric maltol or any of the other ingredients of this medicine (listed in section 6). - If you have any illness causing iron overload or a disturbance in how your body uses iron. - If you have received multiple blood transfusions. WARNINGS AND PRECAUTIONS Before starting treatment, your doctor will use a blood test to make sure that your anaemia is not severe or caused by anything other than iron deficiency (low iron stores). You should avoid taking Feraccru if you are experiencing a “flare” of your IBD. CHILDREN AND ADOLESCENTS Do not give Feraccru to children or adolescents 17 years and under as it has not been studied in this age group. Too much iron is dangerous in young children and can be life-threatening. OTHER MEDICINES AND FERACCRU Tell your doctor or pharmacist if you are taking any other medicines. You shoul Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg iron (as ferric maltol). Excipient(s) with known effect: Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard. Red capsule (19 mm long x 7 mm diameter). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Feraccru is indicated in adults for the treatment of iron deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one capsule twice daily, morning and evening, on an empty stomach (see section 4.5). Treatment duration will depend on the severity of iron deficiency but generally at least 12-weeks treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests. _Paediatric population_ The safety and efficacy of Feraccru in children (17 years and under) has not yet been established. No data are available (see section 4.4). _The elderly and patients with hepatic or renal impairment _ No dose adjustment is needed in elderly patients. No clinical data on the need to adjust the dosage in patients with impaired hepatic or renal function are available (see section 4.4). _ _ Method of administration Oral use. Feraccru capsules should be taken whole on an empty stomach (with half a glass of water), as the absorption of iron is reduced when Feraccru is taken with food (see section 4.5). 3 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Haemochromatosis and other iron overload syndromes. • Patients receiving repeated blood transfusions. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBD- patients with haemoglobin (Hb) <9.5 g/dl. Iron preparat Llegiu el document complet