Maltofer Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Fe (III) hydroxide polymaltose complex

Indications/Uses

FC tab: Fe deficiency. Prevention of Fe deficiency during pregnancy. Oral drops: Fe deficiency w/o anaemia & Fe deficiency anaemia. To cover recommended daily dietary allowances during pregnancy & lactation, for childn, adolescents & adults (eg, vegetarians & elderly).

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Dosage/Direction for Use

FC tab Adult & childn >12 yr Fe deficiency w/ reduced number of RBC 1-3 tab once daily or divided into separate doses for 3-5 mth, continue w/ 1 tab once daily for several wk after normalisation of red blood pigment value. Fe deficiency w/ reduced number of RBC in pregnancy 2-3 tab once daily or divided into separate doses, continue w/ 1 tab once daily after normalisation of red blood pigment value, until at least the end of pregnancy. Fe deficiency w/ normal number of RBC in adult, childn >12 yr & pregnancy & prevention of Fe deficiency in pregnancy 1 tab once daily for 1-2 mth. Oral drops Fe deficiency anaemia Therapy duration: 3-5 mth. Adult & childn >12 yr 40-120 drops daily. Childn 1-12 yr 20-40 drops daily. Infant (up to 1 yr) 10-20 drops daily. Pregnant woman 80-120 drops daily. Fe deficiency w/o anaemia Therapy duration: 1-2 mth. Adult & childn >12 yr 20-40 drops daily. Childn 1-12 yr 10-20 drops daily. Infant (up to 1 yr) 6-10 drops daily. Pregnant woman 40 drops daily. Prophylactic therapy Adult & childn >12 yr, childn 1-12 yr 4-6 drops daily. Infant (up to 1 yr) 2-4 drops daily. Pregnant woman 20-40 drops daily. Fe deficiency anaemia (dosage based on body wt) Adult & childn >30 kg 100-300 mg Fe daily. Childn 15-30 kg 50-100 mg Fe daily. Infant <15 kg & premature births 2.5-5 mg Fe/kg daily. Treatment & prevention of Fe deficiency w/o anaemia (dosage based on body wt) Adult & childn >30 kg 50-100 mg Fe daily. Childn 15-30 kg 25-50 mg Fe daily. Infant <15 kg & premature births 2.5 mg Fe/kg daily.

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Overdosage

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Administration

Should be taken with food: Take during or immediately after a meal. May be mixed w/ fruit, veg juices, other liqds or w/ bottle-feed.

Contraindications

Hypersensitivity. Fe overload (eg, haemochromatosis, haemosiderosis). Disturbances in Fe utilisation (eg, anaemia from lead-poisoning, sidero-achrestic anaemia, thalassaemia). Anaemia not caused by Fe deficiency (eg, haemolytic anaemia or megaloblastic anaemia due to vit B₁₂ deficiency).

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Special Precautions

Infections or tumours may cause anaemia; a benefit/risk evaluation is advisable since Fe can only be utilized after correcting the primary disease. May cause dark discolouration of faeces (stools) during treatment. Should only be taken by pregnant & lactating women after consulting a doctor. Oral drops: Contains Na & sucrose. Not to be used by patients w/ rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Na methyl hydroxybenzoate & Na propyl hydroxybenzoate may cause allergic, or even delayed reactions.

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Use In Pregnancy & Lactation

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Adverse Reactions

Discoloured faeces. Diarrhoea, nausea, constipation, abdominal pain (including dyspepsia, epigastric discomfort, abdominal distension).

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Drug Interactions

Concomitant administration w/ parenteral Fe is not recommended.

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Storage

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Description

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Action

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MIMS Class

Vitamins & Minerals (Pre & Post Natal) / Antianemics

ATC Classification

B03AB05 - ferric oxide polymaltose complexes ; Belongs to the class of oral iron trivalent preparations. Used in the treatment of anemia.

Regulatory Classification

GSL

Presentation/Packing

Form

Maltofer FC tab 100 mg

Packing/Price

100's;30's

Form

Maltofer oral drops 50 mg/mL

Packing/Price

30 mL x 1's

Maltofer

iron polymaltose

Manufacturer:

Vifor Pharma

Distributor:

Zuellig Pharma