NAME OF THE MEDICINAL PRODUCT

Tussabron Syrup

Numark Adult Dry Cough Linctus Asda Strong Dry Tickly Cough Syrup Tesco Dry Cough Linctus Superdrug Adult Dry Cough Linctus Tussabron for Dry Coughs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains:

Dextromethorphan Hydrobromide 10.000mg For excipients see 6.1

3. PHARMACEUTICAL FORM

Oral Solution

CLINICAL PARTICULARS

4.1 Therapeutic indications

Cough suppressant for relief of acute non-productive cough associated with    upper

respiratory tract infection.

4.2 Posology and method of administration

Oral Administration

Adults:    Two 5ml spoonfuls, up to four times daily.

Children: 6 to 12 years: One 5ml spoonful, up to four times daily Elderly (over 65 years): As for Adults

This medicinal product is contraindicated in children under the age of 6 years (see section 4.3)

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.

Do not exceed the stated dose.

Keep out of the sight and reach of children.

4.3 Contraindications

Known hypersensitivity to dextromethorphan and propylene glycol, liver disease

and ventilatory failure, not to be used during acute exacerbation of asthma.

Dextromethorphan should not be given to subjects in, or at risk of developing respiratory failure.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see section 4.5)

Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5)

•    Hypersensitivity to the active substance(s) or to any of the excipients

•    Not to be used in children under the age of 6 years

Special warnings and precautions for use

1.    Should be used with caution by patients with liver disease

2.    Should be used with caution in atopic children due to histamine release.

3.    Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

4.    Do not take with any other cough and cold medicine.

5.    Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used in patients taking monoamine inhibitors or within 14 days of stopping treatment as there is a risk of serotonin syndrome (pyrexia, hypertension, arrhythmias) when MOAI are taken in combination with dextromethorphan.

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.

Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.

Pregnancy and lactation

Problems concerning use in pregnancy and lactation have not been documented. However, as with all medication during pregnancy risk-benefit must be considered before administration.

4.7. Effects on ability to drive and use machines

Dextromethorphan hydrobromide may cause drowsiness and dizziness. Patients affected should not drive or operate machinery.

4.8 Undesirable effects

The following side effects may be associated with the use of dextromethorphan:

Occasional drowsiness, dizziness, excitation, mental confusion, convulsions, respiratory depression, vomiting, gastrointestinal disturbances (nausea and diarrhoea) and skin reactions including rash.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.yellowcard.mhra.gov.uk.

4.9 Overdose

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms: These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression.

Management: 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).

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Dextromethorphan hydrobromide suppresses the cough reflex by a direct action on the cough centre in the medulla of the brain. Its potency is nearly equal to that of codeine. Compared to codeine, dextromethorphan produces fewer subjective and gastro-intestinal side-effects.

In therapeutic doses, the drug does not inhibit ciliary activity and its antitussive effects persist for 5 to 6 hours.

5.2. Pharmacokinetic properties

Dextromethorphan hydrobromide is well absorbed from the gastro-intestinal tract. It is metabolized in the liver and excreted as unchanged dextromethorphan and demethylated morphinan compounds.

Preclinical safety data

None available

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Glucose Syrup Propylene Glycol Sorbitol Solution Menthol

Orange Juice Flavour FC4590 Ponceau 4R (E124)

Saccharin Sodium Purified Water Anhydrous Citric Acid.

6.2. Incompatibilities

None.

36 months Unopened.

6.4. Special precautions for storage

6.5    Nature and contents of container

Bottle: Amber (Type III) glass

Closures: Child resistant closure (CRC) fitted with low density polyethylene EPE/AL/PET liner.

100 ml, 200 ml.

30 ml CE marked polypropylene measuring cup with 2.5 ml, 3.3 ml 4 ml, 5 ml,

7.5 ml, 10 ml, 15 ml, 20 ml and 25 ml graduations.

(May not be included in all marketed products)

6.6    Instructions for use and handling

None

7.    MARKETING AUTHORISATION HOLDER

Bell, Sons & Co (Druggists) Ltd

Gifford House

Slaidbum Crescent Southport Merseyside PR9 9AL

8. MARKETING AUTHORISATION NUMBER

PL 03105/0076

Date of Grant: 15th January 2001.

10 DATE OF REVISION OF THE TEXT

25/11/2016