Drugs List

Administration

For oral administration.

Tablets should be taken before food and swallowed whole.

Contraindications

Intestinal obstruction
Intestinal diverticular disease

Haemosiderosis
Haemochromatosis
Repeated blood transfusions
Concurrent parenteral iron therapy

Children under 12 years

Precautions and Warnings

Exclude any serious underlying cause of anaemia before starting treatment.

To be used with caution in the following :
Inflammatory bowel disease - may exacerbate diarrhoea
Elderly patients - constipation may lead to faecal impaction.

Advise patient to keep out of reach of children .

Advise patient that stools may be discoloured, black. This may interfere with tests used for detection of occult blood in the stools. The guaiac test occasionally yields false positive tests for blood.

The inert tablet matrix will be excreted unchanged in the stools. This may represent a safety hazard in the elderly and others with delayed intestinal transit.

Pregnancy and Lactation

Pregnancy

This medication is inappropriate in pregnancy for the prevention of neural tube defects as there is no folic acid contained in it. Folic acid supplementation is required pre-conception to the end of the first trimester.

Plasma volume expansion during pregnancy results in a physiological decrease in haemoglobin concentrations which typically fall in the second trimester and then rise to approach pre-pregnancy levels at term. Mean Cell Volume (MCV) is unaffected during pregnancy and offers a better indicator of iron-deficiency anaemia. Iron treatment of low haemoglobin in the absence of other signs of deficiency is seldom required.

Adverse outcomes in pregnancy such as low birth-weight, pre-term birth and perinatal death in states of mild to moderate anaemia have been found in studies, although the causality and also preventability by iron supplements remain unclear. Additionally, iron supplements have been shown to result in an increase in low birth-weight and pre-term delivery.

Iron should be given if there is evidence of deficiency in the first trimester and later based on haemoglobin below 10g/dL or MCV below 82fL.

Iron supplements should be considered in women with increased risk of iron deficiency anaemia such as those who have had recent menorrhagia, repeated closely spaced pregnancies or miscarriages and those with poor dietary intake.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Drugs List

Dosage

Adults

Elderly

Children

Administration

For oral administration.

Tablets should be taken before food and swallowed whole.

Contraindications

Intestinal obstruction
Intestinal diverticular disease

Haemosiderosis
Haemochromatosis
Repeated blood transfusions
Concurrent parenteral iron therapy

Children under 12 years

Precautions and Warnings

Exclude any serious underlying cause of anaemia before starting treatment.

To be used with caution in the following :
Inflammatory bowel disease - may exacerbate diarrhoea
Elderly patients - constipation may lead to faecal impaction.

Advise patient to keep out of reach of children .

Advise patient that stools may be discoloured, black. This may interfere with tests used for detection of occult blood in the stools. The guaiac test occasionally yields false positive tests for blood.

The inert tablet matrix will be excreted unchanged in the stools. This may represent a safety hazard in the elderly and others with delayed intestinal transit.

Pregnancy and Lactation

Pregnancy

This medication is inappropriate in pregnancy for the prevention of neural tube defects as there is no folic acid contained in it. Folic acid supplementation is required pre-conception to the end of the first trimester.

Plasma volume expansion during pregnancy results in a physiological decrease in haemoglobin concentrations which typically fall in the second trimester and then rise to approach pre-pregnancy levels at term. Mean Cell Volume (MCV) is unaffected during pregnancy and offers a better indicator of iron-deficiency anaemia. Iron treatment of low haemoglobin in the absence of other signs of deficiency is seldom required.

Adverse outcomes in pregnancy such as low birth-weight, pre-term birth and perinatal death in states of mild to moderate anaemia have been found in studies, although the causality and also preventability by iron supplements remain unclear. Additionally, iron supplements have been shown to result in an increase in low birth-weight and pre-term delivery.

Iron should be given if there is evidence of deficiency in the first trimester and later based on haemoglobin below 10g/dL or MCV below 82fL.

Iron supplements should be considered in women with increased risk of iron deficiency anaemia such as those who have had recent menorrhagia, repeated closely spaced pregnancies or miscarriages and those with poor dietary intake.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Counselling

Advise patient to keep out of reach of children. Acute iron poisoning occurs rarely in adults, however, it could happen if children swallow this medication.

Advise patient that spent matrix will be excreted in the stools.

Inform patient that treatment might cause darkening of the stools.

Advise patients not to take this medicine within one hour before or two hours after ingestion of the following medicines or food: antacids, calcium supplements, oxalates or phosphates, tea, coffee, milk or milk products, eggs or whole grains.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Ferrograd C Tablets. Teofarma S.r.l. Revised December 2005

Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.