1. Name Of The Medicinal Product
Covonia Original Bronchial Balsam
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Linctus
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of non-productive coughs such as those associated with the common cold and bronchitis.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
Do not exceed the stated dose.
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Cimetidine may delay the elimination of dextromethorphan. It is therefore imperative that the dose of Covonia is not exceeded when it is taken with other medicines. Dextromethorphan interacts with MAOI's.
4.6 Pregnancy And Lactation
There is no evidence of safety in human pregnancy. However, the drugs in the formulation have been widely used for many years without apparent ill consequence. No information is available on the excretion of dextromethorphan or its metabolites in breast milk. It is therefore best avoided during breastfeeding.
4.7 Effects On Ability To Drive And Use Machines
At the stated dose, no evidence has been found that the formulation has any effect on the ability to drive or use machinery however dextromethorphan hydrobromide may cause dizziness and drowsiness rarely.
4.8 Undesirable Effects
At the stated dose constipation, gastrointestinal discomfort, nausea, vomiting, dizziness and drowsiness may occur rarely.
4.9 Overdose
Serious overdoses have been reported with other dextromethorphan containing products. Taken in large doses, may cause drowsiness, dizziness, excitation, nausea, vomiting, gastro intestinal disturbance, blurred vision, nystagmus, ataxia, urinary retention, stupor, coma, facial oedema and urticaria. Very large doses may produce respiratory depression and some patients may be particularly sensitive to this. This may be combatted with trial small doses (1.5 – 3UG/KG to be repeated only if there is a response) of morphine antagonists such as naloxone. Symptoms arising from oral poisoning with menthol are, severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness and coma.
Treatment of overdose: acutely, gastric lavage: otherwise, general supportive measures should be used.
Dependence has been reported occasionally with dextromethorphan.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Dextromethorphan acts as a non-narcotic cough suppressant. The drug acts centrally to elevate the threshold for coughing.
Menthol relieves irritation, diminishes congestion, and checks excessive secretion of mucous membranes in the upper respiratory tract and is used for the treatment of the symptoms of bronchitis.
5.2 Pharmacokinetic Properties
Dextromethorphan is fully absorbed from the gastro-intestinal tract and passes via the portal vein to the liver before entering the general circulation. Dextromethorphan has three metabolites, principally dextrorphan which has approximately the same antitussive potency as dextromethorphan itself. Dextromethorphan is not metabolised to either morphine or codeine. In general, approximately 50% of dextromethorphan plus metabolites is excreted in the urine within 24 hours. Plasma levels of therapeutic doses are very low, due to metabolism in the liver. Plasma levels of the principal metabolite, dextrorphan, are higher than dextromethorphan, plasma levels reaching a peak 2 hours after administration. The plasma half life of dextrorphan has been determined as approximately 0.5 – 1.0 hour in the dog.
After absorption menthol is excreted in the urine and bile as a glucuronide.
5.3 Preclinical Safety Data
None
6. Pharmaceutical Particulars
6.1 List Of Excipients
Water purified EP
Citric acid monohydrate EP
Peppermint oil EP
Anise oil EP
Capsicum tincture BPC
Macrogol cetostearyl ether
Caramel BPC
Glycerol EP
Diethyl ether
Cineole BPC
Chloroform BP
Syrup BP.
6.2 Incompatibilities
No major incompatibilities are known.
6.3 Shelf Life
150ml: 36 months unopened
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
150ml flat sloping shoulder amber glass bottle, with 28mm tamper evident child resistant closure with EPE/ Saranex liner.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Thornton & Ross Ltd
Huddersfield
HD7 5QH
England
8. Marketing Authorisation Number(S)
PL 00240/5033R
9. Date Of First Authorisation/Renewal Of The Authorisation
29th October 1997
10. Date Of Revision Of The Text
17.02.2010
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