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FERRUM HAUSMANN SYRUP

Information leaflet

                                                               Irish Medicines Board




                                              IRISH MEDICINES BOARD ACTS 1995 AND 2006

                    MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007

                                                                (S.I. No.540 of 2007)




 PA0949/003/001
 Case No: 2064627

 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to

 Vifor France SA

 7-13 Boulevard Paul-Emile Victor, 92200 Neuilly-sur-Seine, France

 an authorisation, subject to the provisions of the said Regulations, in respect of the product

 Ferrum Hausmann Syrup 50mg / 5ml oral solution.

 The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
 may be specified in the said Regulations as listed on the reverse of this document.

 This authorisation, unless previously revoked, shall continue in force from 12/06/2009.

 Signed on behalf of the Irish Medicines Board this




 ________________

 A person authorised in that behalf by the said Board.




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Date Printed 12/06/2009                               CRN 2064627                                         page number: 1
                                                   Irish Medicines Board




                                                       Part II
                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Ferrum Hausmann Syrup 50mg / 5ml oral solution.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each 5 ml dose of oral solution contains:
 Iron 50 mg as Iron (III)-ydroxide polymaltose complex

 Excipients: Each 5ml of oral solution contains 1g sucrose, 2.0g sorbitol 70% (non-crystallising), 2.915mg methyl
 parahydroxybenzoate, 0.835mg propyl parahyroxybenzoate and 16.25mg ethanol.

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Oral solution
 Dark brown, flavoured oral solution.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 In the treatment of anaemia due to iron deficiency. Treatment and prophylactic therapy of iron deficiency during
 pregnancy. This product should only be used in pregnancy after the first thirteen weeks.

 4.2 Posology and method of administration

 Adults:
 100 to 200mg (10 ml to 20ml) Iron daily.

 Children aged 1-12 years:
 50 to 100mg (5 to 10ml) Iron daily.

 Depending on the severity of the anaemia.

 The supplied measuring cup is used for an exact administration of the dosage.

 Ferrum Hausmann syrup can be mixed with fruit and vegetable juices or with bottle-feed. The slight colouration does
 not affect either the taste or the efficacy.

 Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these
 symptoms may reflect an underlying disease process.

 Route of Administration:
 Oral.




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Date Printed 12/06/2009                               CRN 2064627                                         page number: 2
                                                     Irish Medicines Board




 4.3 Contraindications

 1. Use in patients with iron storage or assimilation diseases.
 2. Use in patients with a known hypersensitivity to the active ingredient.
 3. Use in individuals with haemochromatosis and iron overload syndromes.

 4.4 Special warnings and precautions for use

 1. All medications containing iron should be kept out of reach of children.
 2. The response to iron therapy should be regularly monitored.
 3. The additional requirements for folic acid should be borne in mind when treatment with iron is carried out
    during pregnancy.
 4. In cases of anaemia due to infection or malignancy, the substituted iron is stored in the reticulo-endothelial
    system, from which it is mobilised and utilised only after curing the primary disease.
 5. Caution is advised in individuals with a family history of haemochromatosis or an iron overload syndrome.
    It should be noted that these conditions may be under diagnosed.
 6. Overdose may be fatal.
 7. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrose-
 isomaltase insufficiency should not take
    this medicine.

 4.5 Interaction with other medicinal products and other forms of interaction

 Until now interactions have not been observed. Since the iron is complex-bound, ionic interaction with food
 components (phytin, oxalates, tannin etc) and concomitant administration of medicaments (tetracyclines, antacids) are
 unlikely to occur.

 The haemoccult test (selective for Hb) for the detection of occult blood is not impaired and therefore there is no need to
 interrupt iron therapy.

 4.6 Pregnancy and lactation

 This product should only be used in pregnancy after the first thirteen weeks.

 Pregnancy Category A
 Reproduction studies in animals did not show any foetal risk. Controlled studies in pregnant women after the first
 trimester have not shown any undesirable effects on mother and neonates. There is no evidence of a risk during the first
 trimester and a negative influence on the foetus is unlikely.

 Breast milk naturally contains iron bound to lactoferrin. It is not known how much iron from the complex is passed into
 breast milk. The administration of Ferrum Hausmann syrup is unlikely to cause undesirable effects to the nursed child.
 During pregnancy and lactation Ferrum Hausmann syrup should be used only after consulting a physician.

 4.7 Effects on ability to drive and use machines

 None stated.

 4.8 Undesirable effects

 Very rarely gastro-intestinal discomfort, vomiting, constipation or diarrhoea can occur.

 A dark colouration of the stool is of no clinical significance.




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Date Printed 12/06/2009                               CRN 2064627                                         page number: 3
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