País: Suécia
Língua: sueco
Origem: Läkemedelsverket (Medical Products Agency)
järn(II)glycinsulfat
Cogmill Pharma AB
B03AA01
iron (II) glycinsulfat
100 mg
Enterokapsel, hård
järn(II)glycinsulfat 567,66 mg Aktiv substans; natriumlaurilsulfat Hjälpämne
Receptfritt
Järn(II)glycinsulfat
Avregistrerad
2008-12-04
1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER NIFEREX 100MG GASTRO-RESISTANT CAPSULES, HARD iron (Fe 2+ ) [FOR MEDICINES AVAILABLE ONLY ON PRESCRIPTION] 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 your 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. See section 4. [FOR MEDICINES AVAILABLE WITHOUT A PRESCRIPTION] 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 doctor if you do not feel better or if you feel worse. <[To be completed nationally]> WHAT IS IN THIS LEAFLET : 1. What X is and what it is used for 2. What you need to know before you take X 3. How to take X 4. Possible side effects 5. How to store X 6. Contents of the pack and other information 1 WHAT X IS AND WHAT IT IS USED FOR X is a form of iron that can be taken by mouth to treat or prevent iron deficiency. Iron is essential for transport of oxygen and for energy transfer in the body. The capsules are called gastro-resistant because they do not release their contents in the stomach. They deliver the iron to your gut where it can be absorbed. Niferex is used for the treatment of iron deficiency. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE X DO NOT TAKE X Leia o documento completo
1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Niferex 100mg gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 capsule contains: Ferrous (II) glycine-sulphate complex 567.7 mg (equivalent to 100 mg Fe 2+ ). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Hard gelatine capsule size 0 (approximately 21.7 mm x 7.5 mm) with a chocolate-brown, opaque, unprinted cap and an orange, opaque, unprinted body Capsule content: grey-brownish, enteric, coated pellets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Iron deficiency. <[To be completed nationally]> is indicated in adults and children from 6 years (min. 20 kg BW). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For all ages, body weights and dosing groups the posology should be adjusted to suit the patient’s needs and the response of the clinical variables (e.g. haemoglobin, ferritin and transferrin) should be monitored. A daily dose of 5mg Fe 2+ /kg BW should not be exceeded (see section 4.9). Children from age 6 years (from a body weight of 20 kg), adolescents and adults Bodyweight (kg) Capsules per intake Frequency of intake Total Fe 2+ dose (mg) ≥ 20 1 1 time daily 100 Adolescents from age 15 years (from a body weight of 50 kg) and adults In adolescents from age 15 years and adults the following dosage is recommended at the beginning of therapy in cases of pronounced iron deficiency: Bodyweight (kg) Capsules per intake Frequency of intake Total Fe 2+ dose (mg) 50 - ˂ 60 1 2 times daily 200 ≥ 60 1 2 - 3 times daily 200 - 300 _Elderly patients _ No clinical data on the need to adjust the dosage in elderly patients are available (see section 4.4). 2 Patients with impaired renal or hepatic function No clinical data on the need to adjust the dosage in patients with impaired renal or hepatic function are available (see section 4.4). _Paediatric population:_ X is contraindicated in children aged less than 6 years (see section 4.3). Children from 6 y Leia o documento completo