Drugs List

Therapeutic Indications

Uses

Symptomatic relief of chesty cough

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Hereditary fructose intolerance
Pregnancy

Precautions and Warnings

Asthma
Benign prostatic hyperplasia
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Narrow angle glaucoma
Renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Oral liquid contains propylene glycol
Preparation contains sucrose
Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
Should not be taken with other cough or cold medicine
Advise patient to avoid alcohol during treatment
Advise patient not to exceed stated dose
Advise patient to consult a doctor if symptoms persist despite treatment

MHRA/CHM advice (February 2009)
Cough and cold remedies containing diphenhydramine 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

The combination of diphenhydramine hydrochloride with ammonium chloride and levomenthol oral solution is contraindicated in pregnancy.

The manufacturers note that as the safety of this combination is not known in human pregnancy and in view of potential risks versus small benefits, this medication should not be used in 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

The combination of diphenhydramine hydrochloride with ammonium chloride and levomenthol oral solution is contraindicated in breastfeeding.

The manufacturers note that as the safety of this combination is not known in breastfeeding and in view of potential risks versus small benefits, this medication should not be used in 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

Arrhythmias
Blood disorders
Blurred vision
Confusion
Convulsions
Depression
Dizziness
Drowsiness
Dry mouth
Excitement (paradoxical)
Extrapyramidal effects
Gastro-intestinal symptoms
Headache
Hepatic impairment
Hypersensitivity reactions
Hypotension
Palpitations
Psychomotor impairment
Sleep disturbances
Thickening of bronchial secretions
Tremor
Urinary retention

Presentation

Oral solution containing diphenhydramine hydrochloride, ammonium chloride and levomenthol.

Drugs List

Therapeutic Indications

Uses

Symptomatic relief of chesty cough

Dosage

Adults

Children

Contraindications

Children under 12 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Hereditary fructose intolerance
Pregnancy

Precautions and Warnings

Asthma
Benign prostatic hyperplasia
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Narrow angle glaucoma
Renal impairment
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Oral liquid contains propylene glycol
Preparation contains sucrose
Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
Should not be taken with other cough or cold medicine
Advise patient to avoid alcohol during treatment
Advise patient not to exceed stated dose
Advise patient to consult a doctor if symptoms persist despite treatment

MHRA/CHM advice (February 2009)
Cough and cold remedies containing diphenhydramine 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

The combination of diphenhydramine hydrochloride with ammonium chloride and levomenthol oral solution is contraindicated in pregnancy.

The manufacturers note that as the safety of this combination is not known in human pregnancy and in view of potential risks versus small benefits, this medication should not be used in 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

The combination of diphenhydramine hydrochloride with ammonium chloride and levomenthol oral solution is contraindicated in breastfeeding.

The manufacturers note that as the safety of this combination is not known in breastfeeding and in view of potential risks versus small benefits, this medication should not be used in 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

Arrhythmias
Blood disorders
Blurred vision
Confusion
Convulsions
Depression
Dizziness
Drowsiness
Dry mouth
Excitement (paradoxical)
Extrapyramidal effects
Gastro-intestinal symptoms
Headache
Hepatic impairment
Hypersensitivity reactions
Hypotension
Palpitations
Psychomotor impairment
Sleep disturbances
Thickening of bronchial secretions
Tremor
Urinary retention

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: October 2017

Reference Sources

Summary of Product Characteristics: Histalix Syrup. Wallace Manufacturing Chemists Ltd. Revised March 2017.

Summary of Product Characteristics: Unicough Oral Solution. Infirst Healthcare Limited. Revised August 2015.

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: 25.08.16