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BOOTS DRY COUGH RELIEF 2.5MG LOZENGES

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Dry Cough Relief 2.5mg Lozenges

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Dextromethorphan Hydrobromide BP mg/1oz 2.5

3.

PHARMACEUTICAL FORM Lozenge

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4.1

CLINICAL PARTICULARS
Therapeutic indications Cough suppressant for the relief of acute non-productive (dry, tickly) cough associated with respiratory tract infection. For oral administration.

4.2

Posology and method of administration Adults and children over 12 years: A lozenge should be sucked whenever the cough is troublesome. Not more than 10 lozenges should be taken in one day. The normal adult dose is still appropriate in the elderly. Children 6 to 12 years: Not more than 2 lozenges within any 4 hours, and not more than 7 in any one day.

This medicine is contraindicated in children under 6 years of age (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. Warning: Do not exceed the stated dose. Keep all medicines out of the sight and reach of children. 4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients. Dextromethorphan should not be given to subjects in, or at risk of developing respiratory failure. Should not be taken by patients with liver disease. Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5). Patients taking selective serotonin reuptake inhibitors (SSRI's, see section 4.5). Not to be used in children under the age of 6 years

4.4

Special warnings and precautions for use Should be used with caution in atopic children due to histamine release. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma or are suffering from an acute asthma attack or where cough is accompanied by excessive secretions. Do not take with any other cough and cold medicine. Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses. If symptoms do not go away talk to your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Not to be used in patients taking monoamine oxidase inhibitors or within 14 days of stopping treatment as there is a risk of serotonin syndrome (pyrexia, hypertension, arrhythmias) when MAOIs are taken in combination with dextromethorphan. (Severe and sometimes fatal reactions have been reported following administration of dextromethorphan to patients receiving MAOIs (see also section 4.3)). Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SRRIs, and thioridazine, should be borne in mind. Dextromethorphan might exhibit additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.

4.6

Pregnancy and lactation There is no or inadequate evidence of the safety of dextromethorphan in human pregnancy and therefore the lozenges should not be used during this period. No information is available on the secretion of dextromethorphan into breast milk and it is recommended that the product should not be used by breast feeding mothers.

4.7

Effects on Ability to Drive and Use Machines No adverse effects known.

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.

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. Other effects may include: abdominal discomfort, hallucinations, hypotension and ataxia. Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In severe overdosage the specific narcotic antagonist naloxone may be given. Information regarding children 6-12 years: Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight). 5. 5.1. PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Dextromethorphan is a cough suppressant.

5.2.

Pharmacokinetic Properties Dextromethorphan is well-absorbed from the gastrointestinal tract. metabolised in the liver and excreted as both unchanged drug and demethylated metabolites.

5.3.

Pre-clinical Safety Data There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. 6.1.

PHARMACEUTICAL PARTICULARS List of Excipients Star anise oil Strong capsicum tincture Levomenthol Natural blackcurrant flavour 3109382 Anthocyanin Sugar/glucose liquid sugar

6.2.

Incompatibilities None stated.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 30C.

6.5.

Nature and contents of container A card carton containing two blister push-through packs consisting of PVC/PVDC blisters heat sealed to hard temper aluminium foil. There are 12 lozenges on each blister and two trays in each carton.

6.6.

Instructions for use and handling Not applicable.

7.

MARKETING AUTHORISATION HOLDER The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

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MARKETING AUTHORISATION NUMBER PL 00014/0357

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

First authorisation: 20 January 1988 Last renewal: 20 January 1993

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DATE OF REVISION OF THE TEXT
14/11/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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