Covonia Original Bronchial Balsam Syrup

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.

Contains 3.07g sucrose per 5ml dose, to be taken into account with diabetes

For full list of excipients, see section 6.1

Linctus

For the symptomatic relief of non-productive coughs such as those associated with the common cold and bronchitis.

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.

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.

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.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Contains 3.07g sucrose, to be taken into account in people with diabetes.

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.

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.

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.

At the stated dose constipation, gastrointestinal discomfort, nausea, vomiting, dizziness and drowsiness may occur rarely.

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.

Pharmacotherapeutic Group: Cough suppressant and expectorants, Combinations

ATC Code: R05F

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.

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.

None

Water purified

Citric acid monohydrate

Peppermint oil

Anise oil

Capsicum tincture

Macrogol cetostearyl ether

Caramel

Glycerol

Diethyl ether

Cineole

Chloroform

Syrup

No major incompatibilities are known.

150ml: 36 months unopened.

Store below 25°C.

150ml flat sloping shoulder amber glass bottle, with 28mm tamper evident child resistant closure with EPE/ Saranex liner.

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

Thornton & Ross Ltd

Huddersfield

HD7 5QH

England

PL 00240/5033R

29^th October 1997

10/04/2012