Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Dried ferrous sulphate; Folic acid
Intapharm Labs Ltd
B03AD; B03AD03
Dried ferrous sulphate; Folic acid
150/0.5 milligram(s)
Modified-release capsule, hard
Iron in combination with folic acid; ferrous sulfate
Not marketed
1980-04-01
FEFOL SPANSULE 150 MG/ 0.5 MG MODIFIED RELEASE CAPSULES PACKAGE LEAFLET TEXT 29/10/2020 FEFOL SPANSULE CAPSULES 150 mg/0.5 mg MODIFIED RELEASE CAPSULES Dried Ferrous Sulphate and Folic Acid PATIENT INFORMATION LEAFLET This leaflet contains a summary of the information about Fefol Spansule Capsules. Please read it before using the capsules and do not throw it away until you have finished your course of treatment; you may wish to read it again. If you have any questions about this medicine, please ask your doctor or pharmacist. WHAT IS IN YOUR MEDICINE? The name of your medicine is Fefol Spansule 150 mg/0.5 mg Modified Release Capsules. The capsules are clear and green with red, yellow and white pellets inside. The box contains 30 capsules. Each hard capsule contains 150 mg dried ferrous sulphate (equivalent to 47mg iron) and 0.5 mg folic acid as the active ingredients. Fefol Spansule Capsules also contain, sucrose, maize starch, talc, heavy kaolin, gelatin, titanium dioxide (E171), red iron oxide (E172), povidone 30, glycerol monostearate,white beeswax, calcium sulphate dihydrate, quinoline yellow (E104) and patent blue V (E131). Fefol Spansule Capsules are one of a group of medicines known as haematinics, which improve the blood's ability to carry oxygen. They do this by increasing the amount of haemoglobin which is carried in the red blood cells. MARKETING AUTHORISATION HOLDER Intapharm Labs Ltd Achamon 25 Lakatamia 2305 Nicosia Cyprus MANUFACTURER Movianto Ltd, Progress Park Elstow, Bedford, MK42 9XE,UK WHAT IS YOUR MEDICINE USED FOR? Fefol Spansule Capsules are used to prevent iron and folic acid deficiency during pregnancy, after the first thirteen weeks. BEFORE USING THIS MEDICINE Fefol Spansule capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Before you use this medicine, please answer the following questions: FEFOL SPANSULE 150 MG/ 0.5 MG MODIFIED RELEASE CAPSULES PACKAGE LEAFLET TEXT 29/10/ Leggi il documento completo
Health Products Regulatory Authority 11 November 2021 CRN00CNTW Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fefol Spansule 150 mg/0.5 mg Modified Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release capsule contains 150 mg dried ferrous sulphate (equivalent to 47 mg elemental iron) and 0.5 mg folic acid. Excipients - contains Sucrose 105.0 mg per capsule. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release hard capsules Modified release capsule containing red, yellow and white pellets in size no.1 hard gelatin shells with clear bodies and transparent green caps. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fefol is a haematinic with added folic acid used for the prophylaxis of iron and folic acid deficiency, after the first 13 weeks of pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage: _Adults only:_ 1 capsule a day during pregnancy. Some pregnant patients may need a higher dose of iron because of dietary or other factors. _Children and elderly:_ Not recommended. Medical advice should be sought if symptoms do not improve after 4 weeks of use of this product as these symptoms may reflect an underlying disease process. Method of Administration: Oral. 4.3 CONTRAINDICATIONS Do not use in patients with a known hypersensitivity to any of the active ingredients. Use in patients with anaemias of undiagnosed aetiology. Individuals with haemochromatosis and iron overload syndromes. Health Products Regulatory Authority 11 November 2021 CRN00CNTW Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The label will state: “Important warning: Contains Iron. Keep out of reach and sight of children, as overdose may be fatal” This will appear on the front of the pack within a rectangle in which there is no other information. Caution is advised in individuals with a family history of haemochromatosis or iron overload syndromes. It should be noted that these conditions may be under diagnosed. Failure to respond Leggi il documento completo