Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
MEDORPHAN is indicated in adults and children 12 years and older, for the relief of an unproductive cough.
10 ml syrup (15 mg dextromethorphan) 4 times a day.
Maximum daily dose: 40 ml syrup (60 mg dextromethorphan)
Children aged 12 years and over: As for adults above.
Children under 12 years: [Product name] is not intended in children under the age of 12 years.
As for adults above.
Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of moderate to severe hepatic impairment (see section 5.2).
Do not exceed the stated dose.
Oral.
Treatment should not exceed a period longer than 2-3 weeks.
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.
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.
36 months.
After first opening: 3 years.
This medicinal product does not require any special storage conditions.
150 ml or 200 ml Type III (Ph.Eur) brown glass bottles closed with one of the following caps:
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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