Orofer 47mg+0.5mg+22.5mg

Tablet
Iron Polymaltose Complex + Folic Acid + Zinc Sulfate
Unimed Unihealth MFG. Ltd

Other Strength:

Alternative:



Orofer
Presentation
Orofer Tablet: Maroon, oval shaped, film coated tablet; each tablet contains Iron (III) Hydroxide Polymaltose Complex INN equivalent to elemental Iron 47.00mg, Folic Acid BP 0.50mg and Zinc Sulfate USP equivalent to elemental Zinc 22.50mg.

Indications
Treatment of latent and manifest iron deficiency and prevention of iron and folic acid deficiency during and after pregnancy (during lactation). It is also indicated for folic acid and zinc deficiencies.

Dosage and administration
One tablet daily. Two tablets may be required a day in severe cases or as recommended by the physician. The daily dose can be divided into separate doses or can be taken at one time. Iron Polymaltose Complex tablet should be taken during or immediately after a meal.

Contra-indications, warnings, etc.
Contra-indications:
In conditions with iron overload (e.g. haemocromatosis, haemosiderosis) or disturbances of iron utilization (e.g, lead anaemia, sidero-achrestic anaemia, thalassaemias) and anaemia not caused by iron deficiency (e.g, haemolytic amaemia). Precautions: In cases of anaemia due to infection or malignancy, the substituted iron is stored in the reticulo-endothelial system, from which it is mobilized and utilized only after curing the primary disease.

Use in pregnancy and lactation:
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 the mother and neonates. There is no evidence of risk during the first trimester and a negative influence on the foetus is unlikely. The administration of Iron Polymaltose Complex tablet is unlikely to cause undesirable effects on the nursed child. During pregnancy and lactation Iron Polymaltose Complex tablet should be used only after consulting a medical doctor or pharmacist.

Side effects:
Occasionally gastrointestinal irritations such as a sensation of repletion, pressure in the epigastric region, nausea, obstipation or diarrhoea can occur. A dark colouration of the stool due to iron is of no clinical significance. Iron Polymaltose Complex tablet does not cause teeth staining.

Drug interaction:
Until now interactions have not been observed. Since, the iron is complex bound, ionic interactions 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.

Overdose:
Incase of overdosage neither intoxication nor iron overload have been reported to date. Pharmaceutical precautions Store in a cool and dry place, protected from light.

Packaging quantities
Orofer Tablet: Cartons containing 30 tablets in alu-PVDC blister.

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