Drugs List

Therapeutic Indications

Uses

Hayfever
Symptomatic relief of chesty cough
Symptomatic relief of nasal congestion

Contraindications

Children under 6 years
Asthma
Excessive bronchial secretions

Precautions and Warnings

Children 6 to 12 years
Benign prostatic hyperplasia
Breastfeeding
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Moderate hepatic impairment
Moderate renal impairment
Narrow angle glaucoma
Pregnancy
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain glucose
Some formulations contain sucrose
Should not be taken with other cough or cold medicine
Advise patient to avoid alcohol during treatment
Advise patient not to exceed stated dose

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

Diphenhydramine with levomenthol should be used with caution in pregnancy.

Animal data and published human experience suggest that diphenhydramine does not cause complications in pregnancy. There is one report of a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.

The manufacturer notes that the medication should only be use when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus.

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

Diphenhydramine with levomenthol should be used with caution in breastfeeding.

Diphenhydramine is excreted into human breast milk, however the levels are not thought to be that high as to affect the infant.

The manufacturer notes that the medication should only be use when the potential benefit of treatment to the mother exceeds any possible hazards to the breastfeeding 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

Angioedema
Arrhythmias
Blood disorders
Blurred vision
Convulsions
Depression
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Erythema
Excitement (paradoxical)
Extrapyramidal effects
Gastro-intestinal disturbances
Headache
Hepatic impairment
Hypersensitivity reactions
Hypotension
Palpitations
Paraesthesia
Psychomotor impairment
Rash
Sleep disturbances
Thickening of bronchial secretions
Tremor
Urinary retention
Urticaria

Presentation

Oral solution containing diphenhydramine hydrochloride and levomenthol

Drugs List

Therapeutic Indications

Uses

Hayfever
Symptomatic relief of chesty cough
Symptomatic relief of nasal congestion

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

Children under 6 years
Asthma
Excessive bronchial secretions

Precautions and Warnings

Children 6 to 12 years
Benign prostatic hyperplasia
Breastfeeding
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Moderate hepatic impairment
Moderate renal impairment
Narrow angle glaucoma
Pregnancy
Urinary retention

Advise patient drowsiness may affect ability to drive or operate machinery
Not all available brands are licensed for all indications
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain glucose
Some formulations contain sucrose
Should not be taken with other cough or cold medicine
Advise patient to avoid alcohol during treatment
Advise patient not to exceed stated dose

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

Diphenhydramine with levomenthol should be used with caution in pregnancy.

Animal data and published human experience suggest that diphenhydramine does not cause complications in pregnancy. There is one report of a statistical association with cleft palate following first trimester exposure. Premature infants exposed within two weeks of birth may be at risk of toxicity.

The manufacturer notes that the medication should only be use when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus.

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

Diphenhydramine with levomenthol should be used with caution in breastfeeding.

Diphenhydramine is excreted into human breast milk, however the levels are not thought to be that high as to affect the infant.

The manufacturer notes that the medication should only be use when the potential benefit of treatment to the mother exceeds any possible hazards to the breastfeeding 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

Angioedema
Arrhythmias
Blood disorders
Blurred vision
Convulsions
Depression
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dry throat
Dryness of nose
Erythema
Excitement (paradoxical)
Extrapyramidal effects
Gastro-intestinal disturbances
Headache
Hepatic impairment
Hypersensitivity reactions
Hypotension
Palpitations
Paraesthesia
Psychomotor impairment
Rash
Sleep disturbances
Thickening of bronchial secretions
Tremor
Urinary retention
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: November 2016

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Benylin Children's Night Coughs. McNeil Products Limited. Revised March 2010.

Summary of Product Characteristics: Benylin Chesty Coughs (Original). McNeil Products Limited. Revised July 2014.

Reference:
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: 24th November 2016