4.1. Therapeutic indications

Benylin Dry Coughs (Original) is indicated as an antitussive, for the relief of persistent, dry, irritating cough.

4.2. Posology and method of administration

Adults and children aged 12 years and over:

Oral. 10 ml syrup 4 times a day. Children under 12 years:

Benylin Dry Coughs (Original) is contraindicated in children under the age of 12 years (see section 4.3). The Elderly:

Normal adult dosage is appropriate, [See Pharmacokinetics in the Elderly].Do not exceed the stated dose.Keep out of the reach and sight of children.

4.3. Contraindications

Benylin Dry Coughs (Original) is contraindicated in individuals with known hypersensitivity to the product or any of its components.Benylin Dry Coughs (Original) is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.Dextromethorphan, in common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure.Not to be used in children under the age of 12 years.

4.4. Special warnings and precautions for use

This product may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. Subjects with moderate to severe renal or hepatic dysfunction should exercise caution when using this product (see pharmacokinetics).

4.5. Interaction with other medicinal products and other forms of interaction

The concomitant use of a dextromethorphan-containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma. [See Contraindications.] This product contains diphenhydramine and therefore may potentiate the effects of alcohol, and other CNS depressants. As diphenhydramine possess 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.

4.6. Pregnancy and lactation

Both diphenhydramine and dextromethorphan have been in widespread use for many years without apparent ill consequence. However, there is insufficient information on the effects of the administration of dextromethorphan during human pregnancy. In addition, it is not known whether dextromethorphan or its metabolites are excreted in breast milk. Diphenhydramine is known to cross the placenta and has also been detected in breast milk. BENYLIN Dry Coughs (Original) should therefore 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 product may cause drowsiness; if affected, individuals should not drive or operate machinery. This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told: • The medicine is likely to affect your ability to drive • Do not drive until you know how the medicine affects you • It is an offence to drive while under the influence of this medicine • However, you would not be committing an offence (called 'statutory defence') if: o The medicine has been taken to treat a medical or dental problem and o You have taken it according to the information provided with the medicine and o It was not affecting your ability to drive safely. Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

4.8. Undesirable effects

Diphenhydramine may cause: drowsiness; dizziness; gastrointestinal disturbance; dry mouth, nose and throat; difficulty in urination or blurred vision. Dextromethorphan: dizziness, nausea, vomiting, or gastro-intestinal disturbance may occur. Adverse reactions to menthol at the low concentration present in Benylin Dry Coughs (Original) are not anticipated.

4.9. Overdose

Symptoms and signs

The effects of acute toxicity of Benylin Dry Coughs (Original) may include drowsiness, hyperpyrexia, anticholinergic effects, lethargy, nystagmus, ataxia, respiratory depression, nausea, vomiting, and hyperactivity. With higher doses, and particularly in children, symptoms of CNS excitation including hallucinations and convulsions may appear; with massive doses, coma or cardiovascular collapse 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. The intravenous use of physostigmine may be efficacious in antagonising severe anticholinergic symptoms. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children. Convulsions may be controlled with diazepam and thiopental sodium.