Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Ferrous fumarate; Folic acid
Clonmel Healthcare Ltd
B03AD; B03AD02
Ferrous fumarate; Folic acid
305 mg/0.35 milligram(s)
Capsule, hard
Iron in combination with folic acid; ferrous fumarate
Not marketed
1976-06-04
CF/REG/96/2 PRODUCT NAME Galfer FA 305mg/0.35mg Hard Capsules PACKAGING TYPE Leaflet CATEGORY/PL NO. PA 610/13/1 TEXT REVISION NO. 0 PAGE # 1 of 4 COMPONENT PACK SIZE IG CODE: CURRENT V#: NEW V#: REVISED BY: DATE: AUTHORISED BY: DATE: Leaflet 28’s 9279682 1803 1903 CRN DESCRIPTION 15907 Transfer license to Clonmel for Brexit PACKAGE LEAFLET: INFORMATION FOR THE USER GALFER FA 305MG/0.35MG HARD CAPSULES ferrous fumarate folic acid READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Galfer FA Capsules carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need any more information or advice. You must contact your doctor if your symptoms worsen or do not improve. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Galfer FA Capsules are and what they are used for 2. Before you take Galfer FA Capsules 3. How to take Galfer FA Capsules 4. Possible side effects 5. How to store Galfer FA Capsules 6. Further information 1. WHAT GALFER FA CAPSULES ARE AND WHAT THEY ARE USED FOR Galfer FA Capsules contain ferrous fumarate which is used to replace low levels of iron in the blood. They also contain folic acid. They are used to treat and prevent anaemia during pregnancy caused by iron deficiency. They can also be used to prevent megaloblastic anaemia caused by deficiencies in vitamin B 12 or folic acid after the first 13 weeks of pregnancy. 2. BEFORE YOU TAKE GALFER FA CAPSULES DO NOT TAKE THE MEDICINE IF YOU HAVE…. An ALLERGY to any of the ingredients listed in section 6. Other PROBLEMS WITH IRON IN THE BLOOD (including conditions that lead to iron building up in soft tissues, or problems with red blood cells). A STOMACH ULCER or other STOMACH OR BOWEL PROBLEM. Had REPEATED BLOOD TRANSFUSIONS in the Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 09 July 2019 CRN008YWN Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Galfer FA 305 mg / 0.35 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Per Capsule Ferrous Fumarate 305.0 mg (Equivalent to 100mg elemental iron) Folic Acid 350 micrograms For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule Scarlet/yellow hard gelatin capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of iron deficiency anaemia in pregnancy and for the prevention of megaloblastic anaemia of pregnancy, after the first 13 weeks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults only: One capsule daily after the first 13 weeks of pregnancy and the first month post partum. 4.3 CONTRAINDICATIONS 1. Use in non-pregnant patients. 2. Use in children. 3. The diagnosis of pernicious anaemia should be excluded before use of this preparation. 4. Use in patients with megaloblastic anaemia due to vitamin B 12 deficiency. 5. Use in patients with anaemias other tan those due to iron deficiency. 6. Hypersensitivity to any of the ingredients. 7. Use in patients with haemosiderosis, haemochromatosis and haemoglobinopathies. 8. Use in patients with inflammatory bowel disease, including regional enteritis and ulcerative colitis, intestinal strictures and diverticulae. 9. Concomitant use with parenteral iron. 10. Use in patients with active peptic ulcer. Health Products Regulatory Authority 09 July 2019 CRN008YWN Page 2 of 5 11. Use in patients who require repeated blood transfusion. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools. 2. Iron preparations should be used with caution in patients with erythropoietic protoporphyria. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS 1. The absorption of iron salts is decreased in the Olvassa el a teljes dokumentumot