COMPOSITION:
Polymalt-F (Iron (Ill) hydroxide polymaltose complex and Folic acid) 100mg +
0.35mg chewable tablets:
Each chewable tablet contains:
Iron
(Il) Hydroxide Polymaltose Complex MS equivalent to elemental
ION.......
..........100mg
Folic acid USP.......0.35mg
Mfg. Specs.: HIGH-Q
PROPERTIES:
Polymalt-F chewable tablets are combination preparation containing iron and folic acid for the treatment of iron deficiency and the prevention of iron and folic acid deficiency before, during and after pregnancy (during lactation). In Polymalt-F chewable tablets, the content of folic acid is according to WHO guidelines. Folic acid is an important vitamin for the development of the unborn child. Folic acid deficiency in the first weeks of pregnancy can lead to malformations in the child. Iron is an important constituent of haemoglobin, myoglobin and the enzymes which contain iron. Iron deficiency is particularly frequent during pregnancy & lactation, it manifests itself as chronic fatigue, lack of concentration, irritability, nervousness, headache, loss of appetite, susceptibility to stress and infection, paleness, cracks at the corners of the mouth (rhagades), dry skin, brittle hair and nails. The iron in Polymalt-F chewable tablets exists as Iron (III) Hydroxide Complex, where individual particles are embedded into a carbohydrate polymer (polymaltose). This prevents the iron from causing any harm in the gastrointestinal system. This protection inhibits the interaction of iron with food. Moreover, it ensures the bioavailability of iron. The structure of IPC is similar to ferritin, the naturally occurring iron storage protein. Due to this similarity, iron is absorbed through natural mechanism. IPC has no pro-oxidative properties unlike bivalent iron salts.
INDICATIONS:
Treatment of latent and manifest iron deficiency and prevention of iron and folic acid deficiency before, during and after pregnancy (during lactation).
DOSAGE:
Dosage and duration of therapy are dependent upon the extent of iron deficiency.
Manifest iron deficiency:
One chewable tablet two or three times daily until normalization of haemoglobin.
Afterwards the therapy should be continued with one chewable tablet daily atleast until the end of pregnancy to replenish iron stores.
Latent iron deficiency and prevention of iron and folic acid deficiency:
One chewable tablet daily.
ADMINISTRATION:
The daily dose can be divided into separate doses or can be taken at once.
Polymalt-F chewable tablets can be chewed or swallowed whole and should be taken during or immediately after meal.
In case of immediate iron need such as low Hb, concomitant EPO treatment etc., parenteral iron preparations should be used as iron substitute so that iron is more rapidly available.
CONTRAINDICATIONS:
Iron overload (e.g. haemochromatosis,
haemosiderosis) or disturbance in iron
utilization (e.g. lead anaemia, sidero-achrestic anaemia, thalassaemia) and anaemia not caused by iron deficiency (e.g. haemolytic anaemia).
WARNINGS AND PRECAUTIONS:
Note to diabetics: 0.04 bread units per chewable tablet.
In cases of anaemia due to infections or malignancy, the substituted iron is stored in the reticuloendothelial system, from which it is mobilized and utilized only after curing the primary disease.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTIONS:
Until now interactions have not been observed. Since the iron is complex-bound, ionic interactions with food components (phytin, oxalates,
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 so there is no need to interrupt iron therapy.
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 mothers and neonates. There is no evidence of a risk during the first trimester and a negative influence on the foetus is unlikely.
The administration of Polymalt-F chewable tablets is unlikely to cause undesirable effects to the nursed child. During pregnancy and lactation Polymalt-F chewable tablets should be used only after consulting a medical doctor or pharmacist.
UNDESIRABLE EFFECTS:
Occasional gastrointestinal irritations such as sensation of repletion, pressure in the epigastric region, nausea, constipation or diarrhoea can occur. A dark coloration of stool due to iron is of no clinical significance. Polymalt-F chewable tablets do not cause teeth staining.
OVERDOSAGE:
In case of overdosage neither intoxication nor iron overload have been reported till date.
INSTRUCTIONS:
Store below 30°C.
Protect from light and moisture.
Keep all medicines out of the reach of children.
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