SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

BENYLIN CHILDREN’S NIGHT COUGHS

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

BENYLIN CHILDREN’S NIGHT COUGHS contains -

Active Ingredient    Mg/5 ml

Diphenhydramine Hydrochloride    7.0 mg

Levomenthol    0.55 mg

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.

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 Hi-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% are 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 adminstration 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 Pre-clinical Safety Data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate Citric acid monohydrate Sodium citrate Saccharin sodium

Sodium carboxymethylcellulose 7MXF Glycerol

Sorbitol 70% (non crystalline) Concentrated raspberry essence Ethanol 96%

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf Life

36 months unopened

6.4    Special Precautions for Storage

Store below 30°C

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 or

3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad or polyethylene/expanded polyethylene laminated wad or

2 piece plastic child resistant, tamper evident closure fitted with a PET wad

6.6    Instructions for Use/Handling Not applicable

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

05/03/2010