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4.1. Therapeutic indications
dry, irrtant cough deleted
non-productive cough (dry cough) added
common cold and influenza deleted
upper respiratory tract infection added
4.3. Contra-indications
Patients receiving replaced with taking monoamine oxidase inhibitor therapy (MAOIs) or within
14 days of stopping such treatment (see section 4.5) added
or who have taken a monoamine oxidase inhibitor within the last two weeks deleted
Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5) added
4.4. Special warnings and precautions for use
chronic or persistent cough added
Keep out of reach of children deleted
Keep out of reach and sight of children added
Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses added
4.5. Interactions with other medicaments and other forms of interaction
Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs added
4.5. Interactions with other Medicaments and other forms of Interaction
see section 4.3 regarding maoi therapy. deleted
Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome (pyrexia, hypertension, arrhythmias) when MAOIs are taken in combination with dextromethorphan. (SEE SECTION 4.3) added
Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs, and thioridazine, should be borne in mind. added
4.6. Pregnancy and Lactation
there is no literature evidence of hazard due to dextromethorphan but use is not recommended during the first trimester and during breast feeding deleted
Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician. added
4.7. Effects on Ability to Drive and Use Machines
None expected, but added
or drowsiness added
4.8. Undesirable Effects
In general no severe undesirable effects are expected.
Nervous system disorders:
Drowsiness or dizziness may occur rarely.
Gastrointestinal disorders:
Gastrointestinal disturbances that may rarely occur include nausea, vomiting and diarrhoea.
Skin and subcutaneous disorders:
Skin rashes have rarely been reported with dextromethorphan. added
reactions are uncommon, but may include dizziness, excitation, mental confusion and gastrointestinal disturbances. deleted
4.9. Overdose
Symptoms
These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression added
mild to moderate overdosage may cause dizziness, excitation, mental confusion and gastrointestinal disturbances deleted
very high doses may produce respiratory depression deleted
Treatment of overdose
Treatment of overdose 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) added
gastric lavage and general supportive measures deleted
6.1. List of excipients
Lactic acid deleted
Citric acid monohydrate deleted
Potassium hydroxide deleted
Eucalyptus oil deleted
6.4. Special precautions for storage
Do not store above 25oC added
Store below 25oC deleted
10. Date of (partial) revision of the text
December 2010 deleted
20/03/2012 added
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