COVONIA ORIGINAL BRONCHIAL BALSAM

Oral. Recommended doses Adults and children over 12 years: 10ml. Elderly: as adults dose with caution. Dosage schedule The dose may be repeated after 4 hours if required.

At the stated dose constipation, gastrointestinal discomfort, nausea, vomiting, dizziness and drowsiness may occur rarely. Drug dependence and drug withdrawal syndrome may also occur (frequency unknown). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

Warning:

Do not take more medicine than the label tells you to. Keep all medicines away from children. If symptoms persist consult your doctor. Covonia normally works without causing drowsiness, but care should be taken initially as rare exceptions can occur.

Use with caution in a history of asthma.

Label states:

Consult a doctor or pharmacist before use if you have a history of asthma. Do not give to children under 12 years. Can cause addiction. This medicine may cause opioid-like effects when used at high doses. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6.

The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan.

5). Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , major depression). Drug withdrawal syndrome The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.

Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

Serotonin Syndrome Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.

Contraindicated in patients with liver disease and/or known hypersensitivity to dextromethorphan hydrobromide, and menthol. Patients being treated with monoamine oxidase inhibitors should avoid using the product. Persistent or productive cough.

Dextromethorphan should not be administered to patients in or at risk of developing respiratory failure or during an acute asthma attack. Do not use within 2 weeks of discontinuation of MAOI use. Children under 12 years of age.