Drugs List

Therapeutic Indications

Uses

For the symptomatic treatment of irritable bowel syndrome and other conditions such as chronic irritable colon, spastic constipation, mucous colitis, spastic colitis.

Not all brands are licensed for all indications. Restrictions apply to 'P' products.

Administration

For oral administration, preferably 20minutes before food.

Contraindications

Paralytic ileus
Children under 3 years

Precautions and Warnings

Breastfeeding (see 'Lactation' section)

Pregnancy (see 'Pregnancy' section)

Children aged 3 to 10 years - See Dosage - Children.

Some formulations contain lactose. Should not be taken by patients with galactosaemia. Caution in use in patients with glucose-galactose malabsorption syndrome and lactose intolerance.

Some formulations contain sucrose. Should not be taken by patients with hereditary fructose intolerance. Caution in use in patients with glucose-galactose malabsorption syndrome.

'P' products only
Additional restrictions apply to 'P' products. Patients should see their doctor as soon as possible if any of the following apply:

-age 40 years or over
-blood passed from the bowel
-feeling sick or vomiting
-looking pale or feeling tired
-suffering from severe constipation
-having a fever
-recently travelled abroad
-pregnant or may be pregnant
-abnormal vaginal bleeding or discharge
-difficulty or pain passing urine

Patients should consult their doctor if they develop new symptoms, or if their symptoms worsen, or if they do not improve after 2 weeks treatment.

Pregnancy and Lactation

Pregnancy

Use 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

Contraindicated
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 reactions
Urticaria
Angioedema
Erythematous rash
Facial oedema
Hypersensitivity

Presentation

Tablets containing mebeverine hydrochloride 135mg.
Sugar free oral suspension containing mebeverine pamoate equivalent to mebeverine hydrochloride 50mg per 5ml.

Drugs List

Therapeutic Indications

Uses

For the symptomatic treatment of irritable bowel syndrome and other conditions such as chronic irritable colon, spastic constipation, mucous colitis, spastic colitis.

Not all brands are licensed for all indications. Restrictions apply to 'P' products.

Dosage

Adults

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration, preferably 20minutes before food.

Contraindications

Paralytic ileus
Children under 3 years

Precautions and Warnings

Breastfeeding (see 'Lactation' section)

Pregnancy (see 'Pregnancy' section)

Children aged 3 to 10 years - See Dosage - Children.

Some formulations contain lactose. Should not be taken by patients with galactosaemia. Caution in use in patients with glucose-galactose malabsorption syndrome and lactose intolerance.

Some formulations contain sucrose. Should not be taken by patients with hereditary fructose intolerance. Caution in use in patients with glucose-galactose malabsorption syndrome.

'P' products only
Additional restrictions apply to 'P' products. Patients should see their doctor as soon as possible if any of the following apply:

-age 40 years or over
-blood passed from the bowel
-feeling sick or vomiting
-looking pale or feeling tired
-suffering from severe constipation
-having a fever
-recently travelled abroad
-pregnant or may be pregnant
-abnormal vaginal bleeding or discharge
-difficulty or pain passing urine

Patients should consult their doctor if they develop new symptoms, or if their symptoms worsen, or if they do not improve after 2 weeks treatment.

Pregnancy and Lactation

Pregnancy

Use 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

Contraindicated
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

Effects on Ability to Drive and Operate Machinery

None known.

Counselling

'P' products only
Patients should consult their doctor if they develop new symptoms, or if their symptoms worsen, or if they do not improve after 2 weeks treatment.

Side Effects

Allergic reactions
Urticaria
Angioedema
Erythematous rash
Facial oedema
Hypersensitivity

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 requirements vary according to the brand.

Further Information

Last Full Review Date: July 2012

Reference Sources

Summary of Product Characteristics: Colofac Tablets 135mg. Abbot Healthcare Products Limited. Revised May 2012.

Summary of Product Characteristics: Mebeverine 50mg/5ml Sugar Free Oral Suspension. Essential Generics. Revised October 2008.

Summary of Product Characteristics: Mebeverine Tablets 135mg. Teva UK Limited. Revised January 2012.

Summary of Product Characteristics: IBS Relief 135mg tablets. Generics (UK). Revised January 2010.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 September 2017