Drugs List

Therapeutic Indications

Uses

Treatment and prophylaxis of iron deficiency anaemia

Administration

Oral

Tablets may be crushed, chewed or swallowed whole
Capsules are to be swallowed whole.
Although iron is absorbed better on an empty stomach, to minimise any gastro-intestinal side effects it may be taken after food.

Contraindications

Haemochromatosis
Haemosiderosis
Active peptic ulcer
Repeated blood transfusions
Ulcerative colitis
Regional enteritis
Paroxysmal nocturnal haemoglobinuria
Hereditary fructose intolerance - some liquid preparations contain sugar

Ineffective in anaemias due to causes other than iron deficiency.

Precautions and Warnings

Not all formulations are suitable for use in children under 12 years.

Elderly - may cause constipation and faecal impaction in older patients
History of peptic ulcer
Pregnancy - especially first trimester, when folic acid supplementation is also recommended

Caution should be exercised in patients with the following conditions as diarrhoea may be exacerbated:
Inflammatory bowel disease
Gastrointestinal diverticula
Gastrointestinal stricture

Exclude any serious underlying cause of anaemia, particularly in male patients, before starting treatment.

The haemoglobin concentration should rise about 1 - 2g/litre per day or 20g/litre over 3 - 4 weeks; when the normal range is reached treatment should be continued for about 3 months to replenish the iron stores.

Maximum treatment duration of uncomplicated iron deficiency anaemia should not exceed 6 months, and no longer than 3 months after reversal of anaemia has been achieved.

Some post gastrectomy patients may show poor absorption of iron.

Anaemia due to combined iron and vitamin B12 or folate deficiency may be microcytic in type. Patients with microcytic anaemia resistant to treatment with iron alone should be screened for vitamin B12 or folate deficiency.

Liquid iron formulations may discolour teeth, advise patients to dilute and swallow through a straw or rinse mouth after use.

Some liquid preparations contain sugar, use with caution in glucose-galactose malabsorption syndrome and when treating diabetic patients.

May discolour faeces black.

Reduce dose or switch to an alternative iron salt if side effects occur.

Advise the patient to keep the medicine out of the reach of children as overdose may be fatal.

Pregnancy and Lactation

Pregnancy

The adult dose is appropriate if required during pregnancy if clinically indicated.

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

No adverse effects have been reported in breastfed infants of treated mothers. Ferrous fumarate can be used during breastfeeding if clinically indicated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Gastro-intestinal disturbances
Nausea
Vomiting
Epigastric pain
Diarrhoea
Constipation
Faecal impaction
Darkening of faeces
Black discolouration of teeth (liquid preparation)

The oral solution contains sodium metabisulfite. Susceptible individuals may show allergic reactions such as urticaria and difficulty in breathing.

Presentation

Tablets containing 210mg of ferrous fumarate, equivalent to 65-70mg of elemental iron
Tablets containing 322mg of ferrous fumarate, equivalent to 100mg of elemental iron
Capsules containing 305mg of ferrous fumarate, equivalent to 100mg elemental iron
Oral solution containing 140mg of ferrous fumarate equivalent to 45mg of elemental iron in 5ml

Drugs List

Therapeutic Indications

Uses

Treatment and prophylaxis of iron deficiency anaemia

Dosage

Duration of treatment should not exceed 3 months after correction of anaemia

Adults

Elderly

Children

Neonates

Patients with Hepatic Impairment

Administration

Oral

Tablets may be crushed, chewed or swallowed whole
Capsules are to be swallowed whole.
Although iron is absorbed better on an empty stomach, to minimise any gastro-intestinal side effects it may be taken after food.

Contraindications

Haemochromatosis
Haemosiderosis
Active peptic ulcer
Repeated blood transfusions
Ulcerative colitis
Regional enteritis
Paroxysmal nocturnal haemoglobinuria
Hereditary fructose intolerance - some liquid preparations contain sugar

Ineffective in anaemias due to causes other than iron deficiency.

Precautions and Warnings

Not all formulations are suitable for use in children under 12 years.

Elderly - may cause constipation and faecal impaction in older patients
History of peptic ulcer
Pregnancy - especially first trimester, when folic acid supplementation is also recommended

Caution should be exercised in patients with the following conditions as diarrhoea may be exacerbated:
Inflammatory bowel disease
Gastrointestinal diverticula
Gastrointestinal stricture

Exclude any serious underlying cause of anaemia, particularly in male patients, before starting treatment.

The haemoglobin concentration should rise about 1 - 2g/litre per day or 20g/litre over 3 - 4 weeks; when the normal range is reached treatment should be continued for about 3 months to replenish the iron stores.

Maximum treatment duration of uncomplicated iron deficiency anaemia should not exceed 6 months, and no longer than 3 months after reversal of anaemia has been achieved.

Some post gastrectomy patients may show poor absorption of iron.

Anaemia due to combined iron and vitamin B12 or folate deficiency may be microcytic in type. Patients with microcytic anaemia resistant to treatment with iron alone should be screened for vitamin B12 or folate deficiency.

Liquid iron formulations may discolour teeth, advise patients to dilute and swallow through a straw or rinse mouth after use.

Some liquid preparations contain sugar, use with caution in glucose-galactose malabsorption syndrome and when treating diabetic patients.

May discolour faeces black.

Reduce dose or switch to an alternative iron salt if side effects occur.

Advise the patient to keep the medicine out of the reach of children as overdose may be fatal.

Pregnancy and Lactation

Pregnancy

The adult dose is appropriate if required during pregnancy if clinically indicated.

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

No adverse effects have been reported in breastfed infants of treated mothers. Ferrous fumarate can be used during breastfeeding if clinically indicated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

There are no known effects that may impair the ability to drive or operate machinery.

Counselling

Advise the patient to keep the medicine out of the reach of children as overdose may be fatal.

Side Effects

Gastro-intestinal disturbances
Nausea
Vomiting
Epigastric pain
Diarrhoea
Constipation
Faecal impaction
Darkening of faeces
Black discolouration of teeth (liquid preparation)

The oral solution contains sodium metabisulfite. Susceptible individuals may show allergic reactions such as urticaria and difficulty in breathing.

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 ).

Shelf Life and Storage

Storage conditions may vary see individual product requirements.

Further Information

Last Full Review Date: September 2012

Reference Sources

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Ferrrous fumarate 140mg/5ml Syrup. Mercury Pharmaceuticals Ltd. Revised April 2012.

Summary of Product Characteristics: Ferrrous fumarate 210mg tablets. Mercury Pharmaceuticals Ltd. Revised September 2012.

Summary of Product Characteristics: Galfer capsules. Thornton and Ross Ltd. Revised January 2007.

Summary of Product Characteristics: Galfer Syrup. Thornton and Ross Ltd. Revised May 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 31 August 2017