SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Thornton & Ross Bronchial Balsam Syrup

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Dextromethorphan Hydrobromide BP    7.5mg/5ml

Menthol BP    2.5mg/5ml

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 in people with diabetes.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Syrup

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 out of the reach and sight of children.

If symptoms persist consult your doctor.

Thornton & Ross Bronchial Balsam Syrup 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 sucrase-isomaltase insufficiency should not take this medicine.

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

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 Thornton & Ross Bronchial Balsam Syrup 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.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

•    The medicine is likely to affect your ability to drive

•    Do not drive until you know how the medicine affects you

•    It is an offence to drive while under the influence of this medicine

•    However, you would not be committing an offence (called “Statutory defence”) if:

° The medicine had been prescribed to treat a medical or dental problem and

° You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and ° It was not affecting your ability to drive safely

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 combated 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

Pharmacotherapeutic group: Cough suppressants and expectorants, combinations.

ATC Code: RO5F

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

Citric acid monohydrate (E330)

Peppermint oil Anise oil

Capsicum tincture Macrogol cetostearyl ether Caramel (E150)

Glycerol (E422)

Diethyl ether Cineole Chloroform Syrup

6.2    Incompatibilities

No major incompatibilities are known

6.3    Shelf life

150ml: 36 months unopened

6.4    Special precautions for    storage

Do not store above 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

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

7    MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd Huddersfield HD75QH England

8    MARKETING AUTHORISATION NUMBER(S)

PL 00240/0365

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25/08/2010

10 DATE OF REVISION OF THE TEXT

29/05/2014