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HSA Approval

MALTOFER FILM-COATED TABLETS 100MG

SIN14981P

MALTOFER FILM-COATED TABLETS 100MG

MALTOFER FILM-COATED TABLETS 100MG

April 6, 2016

VIFOR PHARMA ASIA PACIFIC PTE. LTD.

VIFOR PHARMA ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantVIFOR PHARMA ASIA PACIFIC PTE. LTD.
Licence HolderVIFOR PHARMA ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

TABLET, FILM COATED

**How to use Maltofer®?** Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The recommended dose - Treatment of iron deficiency with reduced number of red blood cells in children over 12 years and adults 1 to 3 tablets once daily or divided into separate doses for about 3 to 5 months. After normalisation of the red blood pigment (haemoglobin) value, continue with 1 tablet once daily for several weeks. This will replenish the iron stores. - Treatment of iron deficiency with reduced number of red blood cells in pregnancy 2 to 3 tablets once daily or divided into separate dose. After normalisation of the red blood pigment value, continue with 1 tablet once daily until, at least, the end of pregnancy. This will replenish the iron stores and provide the increased amount of iron required during pregnancy. - Treatment of iron deficiency with normal number of red blood cells in children over 12 years, adults and pregnancy, and prevention of iron deficiency in pregnancy 1 tablet once daily for 1 to 2 months. Method of use: The daily dose can be divided into separate doses or can be taken at once. Take Maltofer® during or immediately after a meal. Maltofer® film-coated tablets should be swallowed whole. Duration of use: This depends upon the degree of iron deficiency. If you stop taking Maltofer®: Do not discontinue sooner than recommended as this may reduce the success of therapy. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

ORAL

Medical Information

**What is Maltofer® used for?** Maltofer® is used to: - treat iron deficiency - prevent iron deficiency, during pregnancy

**When should you not take Maltofer®?** Do not take Maltofer®, if you are/have - allergic to iron(III)-hydroxide polymaltose complex or any of the other ingredients of Maltofer® - an iron overload in the body - disturbed use of iron by the body - reduced number of red blood cells (anaemia), not caused by iron deficiency, such as due to - increased red blood cell breakdown - vitamin B12 deficiency

B03AB05

ferric oxide polymaltose complexes

Manufacturer Information

VIFOR PHARMA ASIA PACIFIC PTE. LTD.

Vifor SA

Active Ingredients

Iron(III)-hydroxide polymaltose complex 357mg eqv iron (III)

100mg

Iron polymaltose

Documents

Package Inserts

Maltofer_PI_Approved.pdf

Approved: September 11, 2018

Download

Patient Information Leaflets

Maltofer Tablets PIL.pdf

Approved: July 21, 2020

Download

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MALTOFER FILM-COATED TABLETS 100MG - HSA Approval | MedPath