McNeil Healthcare (Ireland) Ltd

Benylin Children's Dry Coughs Syrup

Diphenhydramine Hydrochloride 7mg/5ml

Levomenthol 0.55mg/5ml

Contains Diphenhydramine Hydrochloride 7mg and Levomenthol 0.55mg in each 5ml.

Excipients

5ml contains:

Sorbital 2.525g

Sodium 17g

Ethanol 96% 0.260ml

For a full list of excipients, see section 6.1

Syrup

Clear, colourless syrup

In the symptomatic relief of non-productive cough and of allergic conditions and reactions.

Children aged 6 years and over:

Oral. 10 ml syrup 3 or 4 times a day.

Maximum daily dose: 40 ml syrup

Use only when simple measures have failed to provide adequate relief.

Use for more than five consecutive days is not recommended.

Children under 6 years:

Benylin Children's Dry Coughs is not suitable for administration to children under 6years of age. [See Section 4.3]

The Elderly:

Not applicable

Hepatic & Renal dysfunction

It may be prudent to increase the dosage interval in subjects with moderate to severe hepatic and/or renal dysfunction, [See Pharmacokinetics].

Benylin Children's Dry Coughs is contraindicated in individuals with known hypersensitivity to the product or any of its components.

Benylin Children's Dry Coughs is contraindicated in children under 6 years.

Benylin Children's Dry Coughs may cause drowsiness. Children receiving the product should be carefully supervised in order to avoid accidental mishap.

Caution should be exercised if moderate to severe renal and/or hepatic impairment is present, [See Pharmacokinetics].

Benylin Children's Dry Coughs should not be administered to patients with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years.

This product contains diphenhydramine and therefore may potentiate the effects of alcohol and other CNS depressants.

As diphenhydramine possesses some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

This product should not be used during pregnancy unless considered essential by the physician.

This product may cause drowsiness and patients receiving it should not drive or operate machinery unless it has been shown that their physical and mental capacity remains unaffected.

Diphenhydramine may cause: drowsiness; dizziness; gastrointestinal disturbance; dry mouth, nose and throat; difficulty in urination; blurred vision or headache.

Adverse reactions to menthol at the low concentration present in Benylin Children's Dry Coughs are not anticipated.

Symptoms and signs

This product may act as a cerebral stimulant in children and occasionally in adults.

The symptoms and signs of Benylin Children's Dry Coughs overdose may include insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions. With higher doses, and particularly in children, symptoms of cardiovascular collapse and CNS excitation including hallucinations and convulsions may appear; with massive doses, coma may follow.

Treatment

Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying (with syrup of ipecac-induced emesis or gastric lavage) and, in cases of acute poisoning, the use of activated charcoal, may be useful.

Diphenhydramine posseses antitussive, antihistaminic, and anticholinergic properties. Experiments have shown that the antitussive effect (resulting from an action on the brainstem) is discrete from its antihistaminic effect.

The duration of activity of diphenhydramine is between 4 and 8 hours.

Menthol has mild local anaesthetic and decongestant properties.

Absorption

Diphenhydramine and menthol are well absorbed from the gut following oral administration. Peak serum levels of diphenhydramine are reached at between 2 and 2.5 hrs following a 50 mg oral dose.

Distribution

Diphenhydramine is widely distributed throughout the body, including the CNS. Following a 50 mg oral dose of diphenhydramine, the volume of distribution is in the range 3.3 - 6.8 L/kg, and it is some 78% bound to plasma proteins.

Metabolism and elimination

Diphenhydramine undergoes extensive first pass metabolism. Two successive N-demethylations occur, with the resultant amine being oxidised to a carboxylic acid. Values for plasma clearance of a 50 mg oral dose of diphenhydramine 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. Menthol is hydroxylated in the liver by microsomal enzymes to p-methane -3,8 diol. This is then conjugated with glucuronide and excreted both in urine and bile as the glucuronide.

Pharmacokinetics in the Elderly

Pharmacokinetic studies indicate no major differences in distribution or elimination of diphenhydramine compared to younger adults.

Pharmacokinetics in 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).

Pharmacokinetics in 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.

Mutagenicity

The results of a range of tests suggest that neither diphenhydramine or menthol have mutagenic potential.

Carcinogenicity

There is insufficient information to determine the carcinogenic potential of diphenhydramine or menthol, although such effects have not been associated with these drugs in animal studies.

Teratogenicity

The results of a number of studies suggest that the administration of either diphenhydramine or menthol does not produce any statistically significant teratogenic effects in rats, rabbits and mice.

Fertility

There is insufficient information to determine whether diphenhydramine has the potential to impair fertility, although a diminished fertility rate has been observed in mice in one study.

Sodium benzoate

Citric acid monohydrate

Sodium citrate

Saccharin sodium

Carmellose sodium

Glycerol

Sorbitol 70 % (Non crystalline)

Concentrated raspberry essence (Double strength)

Ethanol 96%

Purified water

Not Applicable

3 years.

Do not store above 30^oC

125 ml amber glass bottle with ROPP aluminium cap containing Melinex faced pulpboard wad or with a 3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad or polyethylene/expanded polyethylene laminated wad

Or a two pieces Child resistant cap consisting of an external white plastic cap in Polypropylene or an inner plastic cap including a tamper evident ring in High Density Polyethylene. This CRC cap is fitted with a PET wad.

No special requirements

McNeil healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/21/1

Date of first authorisation: 24^th August 1992

Date of last renewal: 24^th August 2002

April 2011