1. Name Of The Medicinal Product
BENYLIN CHILDREN'S NIGHT COUGHS
2. Qualitative And Quantitative Composition
BENYLIN CHILDREN'S NIGHT COUGHS contains -
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3. Pharmaceutical Form
A clear colourless syrup with no insoluble matter.
4. Clinical Particulars
4.1 Therapeutic Indications
BENYLIN CHILDREN'S NIGHT COUGHS is indicated for the relief of cough and its congestive symptoms, runny nose and sneezing, and in the treatment of hay fever and other allergic conditions affecting the upper respiratory tract. It is specially formulated for children and contains no artificial dyes or sucrose.
4.2 Posology And Method Of Administration
Route of Administration: Oral
Children under 6 years:
BENYLIN CHILDREN'S NIGHT COUGHS is contraindicated in children under the age of 6 years (see section 4.3).
Children 6 to 12 years:
Two 5 ml spoonfuls every 6 hours
No more than four doses should be given in any 24 hours.
Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
BENYLIN CHILDREN'S NIGHT COUGHS is contraindicated in individuals with known hypersensitivity to the product or any of its constituents.
BENYLIN CHILDREN'S NIGHT COUGHS should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOI) or those patients who have received treatment with MAOIs within the last two weeks (see section 4.5).
Not to be used in children under the age of 6 years.
4.4 Special Warnings And Precautions For Use
Diphenhydramine should not be taken by patients with susceptibility to angle-closure glaucoma or symptomatic prostatic hypertrophy unless directed by a doctor.
Alcohol or other potential sedating medicines should not be used concurrently with Benylin Children's Night Coughs
Patients with hepatic or moderate to severe renal dysfunction or urinary retention should exercise caution when using this product (see Pharmacokinetics - Renal/Hepatic Dysfunction).
The product may cause drowsiness. This product should not be used to sedate a child.
The label will state:
Do not use to sedate a child.
Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Ask a doctor before use if your child suffers from a chronic or persistent cough, if he/she has asthma, is suffering from an acute asthma attack or where cough is accompanied by excessive secretions.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
CNS depressants: may enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.
Antimuscarinic drugs: may have an additive muscarinic action with other drugs, such as atropine and some antidepressants.
MAOIs: Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.
4.6 Pregnancy And Lactation
Diphenhydramine crosses the placenta and has been detected in breast milk. BENYLIN CHILDREN'S NIGHT COUGHS should only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus or suckling infant.
4.7 Effects On Ability To Drive And Use Machines
This preparation may cause drowsiness, dizziness or blurred vision. If affected, the patient should not drive or operate machinery.
4.8 Undesirable Effects
Common side effects:
CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headache, psychomotor impairment.
Antimuscarinic effects: Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions.
Rare side effects:
Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions, blood disorders and liver dysfunction.
Adverse reactions to menthol at the low concentration present in BENYLIN CHILDREN'S NIGHT COUGHS are not anticipated.
4.9 Overdose
Signs and Symptoms:
Drowsiness, hyperpyrexia and anticholinergic effects. In children, CNS excitation, including hallucinations and convulsions may appear; with larger doses, coma or cardiovascular collapse may follow.
Treatment
Treatment of overdose with BENYLIN CHILDREN'S NIGHT COUGHS is likely to involve supportive care and rapid gastric emptying with Syrup of Ipecac induced emesis or gastric lavage. In cases of acute poisoning, activated charcoal may be useful. Seizures may be controlled with Diazepam or Thiopental Sodium. In addition to supportive care, the intravenous use of Physostigmine may be efficacious in antagonising severe anticholinergic symptoms.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Diphenhydramine is a potent antihistamine and antitussive with anticholinergic properties. Recent experiments have shown that the antitussive action is discrete from H1-receptor blockade and is located in the brain stem.
Menthol has mild local anaesthetic and decongestant properties.
5.2 Pharmacokinetic Properties
Diphenhydramine is well absorbed from the gastrointestinal tract. Peak serum levels are reached at between 2-2.5 hours after an oral dose. Duration of activity is between 4 - 8 hours. The drug is widely distributed throughout the body, including the CNS, and some 78% is bound to plasma proteins. Estimates of the volume of distribution lie in the range 3.3 - 6.8 l/kg.
Diphenhydramine experiences extensive first-pass metabolism, undergoing two successive N-Demethylations; the resultant amine is then oxidised to a carboxylic acid. Values for plasma clearance lie in the range 600 - 1300 ml/min and the terminal elimination half life lies in the range 3.4 - 9.3 hours. Little unchanged drug is excreted in the urine.
Pharmacokinetic studies in elderly subjects indicate no major differences in drug distribution or elimination compared with younger adults.
Menthol: After absorption, menthol is conjugated in the liver and excreted both in urine and bile as the glucuronide.
Renal Dysfunction
The results of a review on the use of diphenhydramine in renal failure suggest that in moderate to severe renal failure, the dose interval should be extended by a period dependent on Glomerular filtration rate (GFR).
Hepatic Dysfunction
After intravenous administration of 0.8 mg/kg diphenhydramine, a prolonged half-life was noted in patients with chronic liver disease which correlated with the severity of the disease. However, the mean plasma clearance and apparent volume of distribution were not significantly affected.
5.3 Preclinical Safety Data
Not applicable
6. Pharmaceutical Particulars
6.1 List Of Excipients
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6.2 Incompatibilities
None stated
6.3 Shelf Life
36 months unopened
6.4 Special Precautions For Storage
Store below 30ºC
6.5 Nature And Contents Of Container
125.000 ml, 30.000 ml Round amber glass bottles with roll-on-pilfer-proof (ROPP) aluminium caps containing melinex-faced pulpboard wad
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3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad or polyethylene/expanded polyethylene laminated wad
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2 piece plastic child resistant, tamper evident closure fitted with a PET wad.
6.6 Special Precautions For Disposal And Other Handling
Not applicable
Administrative Data
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0044
9. Date Of First Authorisation/Renewal Of The Authorisation
Date granted: 16 June 1997
10. Date Of Revision Of The Text
5th March 2010
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