Drugs List

Therapeutic Indications

Uses

Irritable bowel syndrome

Contraindications

Children under 10 years
Paralytic ileus

Precautions and Warnings

Breastfeeding
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Pregnancy

Not all available brands are licensed for all age groups
Some formulations contain sucrose

Pregnancy and Lactation

Pregnancy

Mebeverine hydrochloride should be used with caution in pregnancy.

There have been no detailed studies on the use of mebeverine during pregnancy. Animal studies are insufficient with respect to reproductive toxicity.

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

Mebeverine hydrochloride should be used with caution during breastfeeding.

There is a small risk that suppression of milk production could occur with anticholinergic drugs, although there is no published evidence to support this (UK Drugs in Lactation Advisory Service).

It is unknown whether mebeverine is excreted in human milk. The excretion of mebeverine in milk has not been studied in animals.

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

Allergic reaction
Anaphylactic reaction
Angioedema
Exanthema
Facial oedema
Hypersensitivity reactions
Urticaria

Presentation

Modified release capsules containing mebeverine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Irritable bowel syndrome

Dosage

Adults

Children

Contraindications

Children under 10 years
Paralytic ileus

Precautions and Warnings

Breastfeeding
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Pregnancy

Not all available brands are licensed for all age groups
Some formulations contain sucrose

Pregnancy and Lactation

Pregnancy

Mebeverine hydrochloride should be used with caution in pregnancy.

There have been no detailed studies on the use of mebeverine during pregnancy. Animal studies are insufficient with respect to reproductive toxicity.

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

Mebeverine hydrochloride should be used with caution during breastfeeding.

There is a small risk that suppression of milk production could occur with anticholinergic drugs, although there is no published evidence to support this (UK Drugs in Lactation Advisory Service).

It is unknown whether mebeverine is excreted in human milk. The excretion of mebeverine in milk has not been studied in animals.

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

Allergic reaction
Anaphylactic reaction
Angioedema
Exanthema
Facial oedema
Hypersensitivity reactions
Urticaria

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: March 2018

Reference Sources

Summary of Product Characteristics: Aurobeverine MR 200 mg modified-release capsules, hard. Milpharm Limited. Revised April 2017.

Summary of Product Characteristics: Colofac MR. Mylan Products Limited. Revised August 2016.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 March 2018

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 20 March 2018