MEDORPHAN Oral solution Ref.[27869] Active ingredients: Demorphan

Posology

Adults and children aged 12 years and over

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

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

Paediatric population

Children under 12 years

MEDORPHAN 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).

Method of administration

Oral use.

Do not exceed the stated dose.

Keep out of the reach and sight of children.

Signs and symptoms

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.

Treatment

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.

24 months.

Store below 25°C in the original package.

150 ml and 200 ml Type III (Ph.Eur) brown glass bottles closed with caps (aluminium sheet; liner – EPE sealing disk: hot-foamed polyethylene).

Not all pack sizes may be marketed.

None applicable.

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