Drugs List

Therapeutic Indications

Uses

Treatment of iron deficiency anaemia

Contraindications

Children under 18 years
Haemoglobin concentration below 9.5g/dl
Acute inflammatory bowel disease
Galactosaemia
Haemochromatosis
Haemosiderosis
Repeated blood transfusions

Precautions and Warnings

Breastfeeding
Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy

Exclude non-iron deficiency anaemia
Contains lactose
Contains sunset yellow (E110) - may cause allergic reaction
Additional iron supplement under strict medical supervision only
Diagnosis of iron deficiency must be based on appropriate laboratory tests

Pregnancy and Lactation

Pregnancy

Ferric maltol should be used with caution during pregnancy.

There are no data from the use of ferric maltol in pregnant women. Ferric maltol is not systemically available. Definitive animal studies are not available for maltol with respect to reproductive toxicity.

As a precautionary measure the manufacturer states that it is preferable not to use ferric maltol during pregnancy.

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 to 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

Ferric maltol should be used with caution in breastfeeding.

Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk. No clinical studies are available to date. As a precautionary measure, it is preferable to avoid the use of ferric maltol during breastfeeding.

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

Abdominal discomfort
Abdominal distension
Abdominal pain
Acne
Constipation
Diarrhoea
Elevated TSH
Erythema
Extremity pain
Flatulence
Gamma glutamyl transferase (GGT) increased
Headache
Increase in serum alkaline phosphatase (reversible)
Intestinal bacterial overgrowth
Nausea
Stiffness
Thirst
Vomiting

Presentation

Oral formulations of ferric maltol.

Drugs List

Therapeutic Indications

Uses

Treatment of iron deficiency anaemia

Dosage

Adults

Contraindications

Children under 18 years
Haemoglobin concentration below 9.5g/dl
Acute inflammatory bowel disease
Galactosaemia
Haemochromatosis
Haemosiderosis
Repeated blood transfusions

Precautions and Warnings

Breastfeeding
Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy

Exclude non-iron deficiency anaemia
Contains lactose
Contains sunset yellow (E110) - may cause allergic reaction
Additional iron supplement under strict medical supervision only
Diagnosis of iron deficiency must be based on appropriate laboratory tests

Pregnancy and Lactation

Pregnancy

Ferric maltol should be used with caution during pregnancy.

There are no data from the use of ferric maltol in pregnant women. Ferric maltol is not systemically available. Definitive animal studies are not available for maltol with respect to reproductive toxicity.

As a precautionary measure the manufacturer states that it is preferable not to use ferric maltol during pregnancy.

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 to 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

Ferric maltol should be used with caution in breastfeeding.

Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk. No clinical studies are available to date. As a precautionary measure, it is preferable to avoid the use of ferric maltol during breastfeeding.

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

Counselling

Advise patients that iron is best absorbed when taken on an empty stomach.

Side Effects

Abdominal discomfort
Abdominal distension
Abdominal pain
Acne
Constipation
Diarrhoea
Elevated TSH
Erythema
Extremity pain
Flatulence
Gamma glutamyl transferase (GGT) increased
Headache
Increase in serum alkaline phosphatase (reversible)
Intestinal bacterial overgrowth
Nausea
Stiffness
Thirst
Vomiting

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 ).

Further Information

Last Full Review Date: September 2018

Reference Sources

Summary of Product Characteristics: Feraccru 30mg hard capsules. Shield TX (UK) Ltd. Revised July 2018.