Drugs List

Therapeutic Indications

Uses

Treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Administration

For oral use.

To be taken with or without food at any time of the day.

Contraindications

Children under 18 years

Renal impairment requiring dialysis

Breastfeeding (see 'Dosage; Lactation' section)

Pregnancy (see 'Dosage; Pregnancy' section)

Galactosaemia

Gastrointestinal obstruction or perforation

Obstructive ileus

Severe inflammatory disorders e.g. Crohn's disease, ulcerative colitis and toxic megacolon

Precautions and Warnings

Severe hepatic impairment (see 'Dosage; Hepatic impairment' section).

Severe renal impairment (see 'Dosage; Renal impairment' section).

Patients over 65years (see 'Dosage; Elderly' section)

Use with caution in ischaemic heart disease or history of cardiac arrhythmias.

Use with caution in patients with severe and clinically unstable concomitant disease e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS or other endocrine disorders) as these have not been studied.

Women of child bearing potential should use adequate contraception.

In the case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.

Tablets contain lactose. Use with caution in patients with lactose intolerance and glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Experience with prucalopride during pregnancy is limited. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

The manufacturer advises that prucalopride is not recommended during pregnancy.

Women of child bearing potential should use effective contraception during treatment with prucalopride.

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

Prucalopride is excreted in breast milk. At therapeutic doses however, prucalopride is not expected to cause a problem in breastfed newborns/infants.

However, in the absence of human data the manufacturer advises that prucalopride should not be used 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

Anorexia
Headache
Dizziness
Tremor
Palpitations
Nausea
Diarrhoea
Abdominal pain
Vomiting
Dyspepsia
Rectal haemorrhage
Flatulence
Abnormal bowel sounds
Pollakiuria
Fatigue
Fever
Malaise

Presentation

Film coated tablets containing 1mg prucalopride (as prucalopride succinate)

Film coated tablets containing 2mg prucalopride (as prucalopride succinate)

Drugs List

Therapeutic Indications

Uses

Treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For oral use.

To be taken with or without food at any time of the day.

Contraindications

Children under 18 years

Renal impairment requiring dialysis

Breastfeeding (see 'Dosage; Lactation' section)

Pregnancy (see 'Dosage; Pregnancy' section)

Galactosaemia

Gastrointestinal obstruction or perforation

Obstructive ileus

Severe inflammatory disorders e.g. Crohn's disease, ulcerative colitis and toxic megacolon

Precautions and Warnings

Severe hepatic impairment (see 'Dosage; Hepatic impairment' section).

Severe renal impairment (see 'Dosage; Renal impairment' section).

Patients over 65years (see 'Dosage; Elderly' section)

Use with caution in ischaemic heart disease or history of cardiac arrhythmias.

Use with caution in patients with severe and clinically unstable concomitant disease e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS or other endocrine disorders) as these have not been studied.

Women of child bearing potential should use adequate contraception.

In the case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.

Tablets contain lactose. Use with caution in patients with lactose intolerance and glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Experience with prucalopride during pregnancy is limited. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

The manufacturer advises that prucalopride is not recommended during pregnancy.

Women of child bearing potential should use effective contraception during treatment with prucalopride.

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

Prucalopride is excreted in breast milk. At therapeutic doses however, prucalopride is not expected to cause a problem in breastfed newborns/infants.

However, in the absence of human data the manufacturer advises that prucalopride should not be used 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

Effects on Ability to Drive and Operate Machinery

Prucalopride has been associated with dizziness and fatigue particularly during the first day of treatment. Patients should not drive or use machines if affected.

Counselling

Because prucalopride has been associated with dizziness and fatigue particularly during the first day of treatment patients should be advised not to drive or operate machinery if affected.

Women of child bearing potential should be advised to use effective contraception during treatment with prucalopride.

Advise women patients that in the case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.

Side Effects

Anorexia
Headache
Dizziness
Tremor
Palpitations
Nausea
Diarrhoea
Abdominal pain
Vomiting
Dyspepsia
Rectal haemorrhage
Flatulence
Abnormal bowel sounds
Pollakiuria
Fatigue
Fever
Malaise

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

Store in the original packaging in order to protect from moisture.

Further Information

Last Full Review Date: December 2012

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

Summary of Product Characteristics. Resolor 1mg film-coated tablets. Shire Pharmaceuticals Ltd. Revised May 2015.

Summary of Product Characteristics. Resolor 2mg film-coated tablets. Shire Pharmaceuticals Ltd. Revised May 2015.