BENYLIN DRY COUGHS Syrup Ref.[7731] Active ingredients: Demorphan Diphenhydramine Menthol

Adults and Children aged 12 years and over:

Posology

10 ml syrup (15 mg dextromethorphan) 4 times a day.

Maximum daily dose: 40 ml syrup (60 mg dextromethorphan).

Children under 12 years

This product is contraindicated in children under the age of 12 years (see section 4.3).

The Elderly (over 65 years)

As for adults above.

Hepatic/renal dysfunction

Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of moderate to severe hepatic impairment (see Pharmacokinetics).

Do not exceed the stated dose.

Keep out of the sight and reach of children.

Method of Administration

For oral use.

Signs and symptoms

Dextromethorphan is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms of overdose may include: mydriasis, nausea and vomiting, CNS depression, excitation, lethargy, nystagmus, psychomotor hyperactivity, serotonin syndrome, somnolence (drowsiness), dizziness, dysarthria (slurred speech), mental confusion, psychotic disorder (psychosis), and respiratory depression.

Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability.

In the event of massive overdose the following symptoms may be observed: coma, respiratory depression, convulsions.

Management

Treatment should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight).

Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of dextromethorphan within the preceding hour.

For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses for treatment of opioid overdose, can be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome can be used.

3 years.

Store below 30°C.

125 or 150 ml amber glass bottles with a 2 piece or a 3 piece plastic child resistant, tamper evident closure fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.