Drugs List

Therapeutic Indications

Uses

Cough (dry or painful)

Contraindications

Children under 6 years
Within 2 weeks of discontinuing MAOIs
Bronchiectasis
Chronic bronchitis
Chronic obstructive pulmonary disease
Respiratory failure
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Children 6 to 12 years
Asthma
Breastfeeding
Hepatic impairment
Hereditary fructose intolerance
Pregnancy
Renal impairment
Respiratory disease

Advise patient dizziness may affect ability to drive or operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all age groups
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations may contain alcohol
Monitor patients with a history of alcoholism and drug abuse
May cause sputum retention
May potentiate effect of CNS depressants
Should not be taken with other cough or cold medicine
Advise patient that the effects of alcohol may be potentiated
Advise patient to consult a doctor if symptoms persist despite treatment

MHRA/CHM advice (February 2009)
Cough and cold remedies containing pholcodine should no longer be used in children under 6 as the balance of benefits and risk has not been shown to be favourable.
Medicines to treat cough and colds in older children (6 to 12) can be considered after basic principles of best care have been tried.
Products for children from 6 to 12 will continue to be available in pharmacies where advice can be given.

MHRA/CHM advice (March 2008)
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.

Pregnancy and Lactation

Pregnancy

Manufacturer recommends use with caution. The safety in pregnancy has not been established.

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

Pholcodine is not generally recommended in breastfeeding mothers due to a lack of data available. However, one of the manufacturer's note that "pholcodine has been detected in human milk but in amounts unlikely to affect the suckling infant".

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

Anaphylaxis
Angioedema
Confusion
Constipation
Dizziness
Drowsiness
Excitation
Gastrointestinal disorder
Hypersensitivity reactions
Nausea
Rash
Sputum retention
Vomiting

Presentation

Oral solutions of pholcodine.

Drugs List

Therapeutic Indications

Uses

Cough (dry or painful)

Dosage

Adults

Elderly

Children

Adolescents

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Children under 6 years
Within 2 weeks of discontinuing MAOIs
Bronchiectasis
Chronic bronchitis
Chronic obstructive pulmonary disease
Respiratory failure
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Children 6 to 12 years
Asthma
Breastfeeding
Hepatic impairment
Hereditary fructose intolerance
Pregnancy
Renal impairment
Respiratory disease

Advise patient dizziness may affect ability to drive or operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all age groups
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations may contain alcohol
Monitor patients with a history of alcoholism and drug abuse
May cause sputum retention
May potentiate effect of CNS depressants
Should not be taken with other cough or cold medicine
Advise patient that the effects of alcohol may be potentiated
Advise patient to consult a doctor if symptoms persist despite treatment

MHRA/CHM advice (February 2009)
Cough and cold remedies containing pholcodine should no longer be used in children under 6 as the balance of benefits and risk has not been shown to be favourable.
Medicines to treat cough and colds in older children (6 to 12) can be considered after basic principles of best care have been tried.
Products for children from 6 to 12 will continue to be available in pharmacies where advice can be given.

MHRA/CHM advice (March 2008)
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.

Pregnancy and Lactation

Pregnancy

Manufacturer recommends use with caution. The safety in pregnancy has not been established.

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

Pholcodine is not generally recommended in breastfeeding mothers due to a lack of data available. However, one of the manufacturer's note that "pholcodine has been detected in human milk but in amounts unlikely to affect the suckling infant".

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 patient not to take medication with any other cough and cold medicine.

Advise patient do not use and consult a doctor if the cough is chronic or persistent, or where the cough is accompanied by excessive secretions.

Advise patient pholcodine may cause drowsiness, dizziness and nausea. If affected do not drive or operate machinery.

Side Effects

Anaphylaxis
Angioedema
Confusion
Constipation
Dizziness
Drowsiness
Excitation
Gastrointestinal disorder
Hypersensitivity reactions
Nausea
Rash
Sputum retention
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: January 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2012-2013) Pharmaceutical Press, London.

Dear Healthcare Professional Letter. Medicines and Healthcare products Regulatory Agency. 28th February 2009.
https://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON038904&RevisionSelectionMethod=LatestReleased
Last accessed: 29th January 2013.

Summary of Product Characteristics: Benylin Children's Dry Coughs. McNeil Products Ltd. Revised September 2012.

Summary of Product Characteristics: Covonia Dry Cough Sugar Free. Thornton & Ross Ltd. Revised March 2013.

Summary of Product Characteristics: Galenphol Paediatric Linctus. Thornton & Ross Ltd. Revised August 2011.

Summary of Product Characteristics: Galenphol Linctus. Thornton & Ross Ltd. Revised July 2012.

Summary of Product Characteristics: Galenphol Strong Linctus. Thornton & Ross Ltd. Revised August 2011.

Summary of Product Characteristics: Hill's Balsam Dry Cough Liquid. Boston Healthcare Limited. Authroised February 2005.

Summary of Product Characteristics: Pavacol-D. Alliance Pharmaceuticals. Revised November 2012.