FERRUM HAUSMANN SYRUP 50 MG/5ml Oral Drops Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-06-2016
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Active ingredient:
FERRIC HYDROXIDE POLYMALTOSE COMPLEX
Available from:
Vifor France
ATC code:
B03AB04
INN (International Name):
FERRIC HYDROXIDE POLYMALTOSE COMPLEX
Dosage:
50 MG/5ml
Pharmaceutical form:
Oral Drops Solution
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Iron trivalent, oral preparations
Authorization status:
Authorised
Authorization date:
2005-09-16
Summary of Product characteristics
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 09/06/2016_
_CRN 2178377_
_page number: 1_
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 indi
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