SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dextromethorphan Hydrobromide 10mg/5ml Oral Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient Each 5ml contains

Dextromethorphan Hydrobromide Ph Eur 10mg For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

A limpid red solution for oral administration.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of persistent dry irritant coughs.

4.2 Posology and method of administration

For oral administration.

Adults and children over 12: Take 10-20mg every 4-6 hours (1-2 spoonful of 5ml), up to a maximum of 80 mg/day. Do not exceed the 4 daily intakes.

Children under 12 years: Do not use

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Dextromethorphan should not be given to patients in, or at risk of developing respiratory failure (for example during an acute asthma attack or in patients with Chronic Obstructive Pulmonary Disease).

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

Patient taking serotonin reuptake inhibitors (SSRIs, see section 4.5) or medications for depression, psychiatric, or emotional conditions or parkinson’s disease.

If you are not sure if your prescription medication contains one of these medicines, ask a doctor or pharmacist before taking this product. (See section 4.5).

Not to be used in children under 12years.

4.4 Special warnings and precautions for use

Patients suffering from chronic cough as occurs with smoking, asthma or patients suffering from an acute asthma attack where cough is accompanied by excessive secretions should be advised to consulta Healthcare Professional before use.

Do not exceed the recommended dose. (see section 4.2)

Keep out of the sight and reach of children.

Use with caution in patients with hepatic dysfunction.

Not to be taken with any other cough and cold medicine.

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/ treated. Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache. These could be signs of serious conditions.

Excipient warnings:

Dextromethorphan Hydrobromide 10mg/5ml Oral Solution contains Liquid Maltitol Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This product contains Amaranth (E123), which may cause allergic reactions.

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.

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription medication contains one of these drugs, ask a doctor or pharmacist before taking this product.

Quinidine can increase serum concentrations of dextromethorphan markedly and some patients have experienced symptoms of dextromethorphan toxicity when the two agents have been used together.

Amiodarone appears to be able to increase serum concentrations of dextromethorphan.

Dextromethorphan might exhibit additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics and other CNS depressants.

4.6 Pregnancy and lactation

Although dextromethorphan has been in widespread use for many years without apparent illconsequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment against any possible hazards. It is not known whether dextromethorphan or its metabolites are excreted in human milk.

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.

Dextromethorphan Hydrobromide 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 has 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

Gastrointestinal Disorders

Rare: Gastrointestinal upset Nervous System Disorders Rare: Dizziness,

Hypersensitivity

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.mhra.gov.uk/yellowcard.

4.9    Overdose

Symptoms:

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

Management:

Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Cough suppressant ATC code: R05DA09

Dextromethorphan hydrobromide is a cough suppressant which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.

5.2 Pharmacokinetic properties

Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan, which has some cough suppressant activity.

5.3 Preclinical safety data

There is no relevant information additional to that already contained elsewhere in the SPC or of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Benzoate

Anhydrous citric acid Liquid maltitol Saccharin sodium Propylene glycol

Strawberry flavour (containing propylene glycol and alpha-tocopherol) Contramarum flavouring (containing propylene glycol and benzyl alcohol) Amaranth (E123)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original container. Keep the container tightly closed.

6.5 Nature and contents of container

Dextromethorphan Hydrobromide 10mg/5ml oral solution is packed into amber coloured polyethylene terephthalate (PET) bottle, closed by a child-resistant high density polyethylene (HDPE) white coloured closure along with 1.25, 2.5 and 5 ml polypropylene doubled spoon with EC mark.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

BRISTOL LABORATORIES LIMITED

Unit 3, Canalside, Northbridge Road Berkhamsted, Hertfordshire,

HP4 1EG United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 17907/0314

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/01/2012

10    DATE OF REVISION OF THE TEXT

18/08/2014