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BOOTS DRY COUGH RELIEF 2.5MG LOZENGES

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / DEXTROMETHORPHAN HYDROBROMIDE / 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

3.

mg/1oz
2.5

PHARMACEUTICAL FORM
Lozenge

4

CLINICAL PARTICULARS

4.1

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.

Cases of dextromethorphan abuse have been reported. Caution is particularly
recommended for adolescents and young adults as well as in patients with a
history of drug abuse or psychoactive substances.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The
activity of this enzyme is genetically determined. About 10% of the general
population are poor metabolisers of CYP2D6. Poor metabolisers and patients
with concomitant use of CYP2D6 inhibitors may experience exaggerated
and/or prolonged effects of dextromethorphan. Caution should therefore be
exercised in patients who are slow metabolisers of CYP2D6 or use CYP2D6
inhibitors (see also section 4.5).
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 might exhibit additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics, and other CNS
depressant drugs.
CYP2D6 inhibitors
Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass
metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can
increase the dextromethorphan concentrations in the body to levels multifold
higher than normal. This increases the patient’s risk for toxic effects of
dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and
respiratory depression) and development of serotonin syndrome. Potent
CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and
terbinafine. In concomitant use with quinidine, plasma concentrations of
dextromethorphan have increased up to 20-fold, which has increased the CNS
adverse effects of the agent. Amiodarone, flecaninde and propafenone,
sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and
thioridazine also have similar effects on the metabolism of dextromethorphan.
If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary,
the patient should be monitored and the dextromethorphan dose may need to
be reduced.

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
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 a ‘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
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.mhra.gov.uk/yellowcard.

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.

PHARMACOLOGICAL PROPERTIES

5.1.

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.
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the
liver after oral administration. Genetically controlled O-demethylation
(CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in
human volunteers.
It appears that there are distinct phenotypes for this oxidation process resulting
in highly variable pharmacokinetics between subjects. Unmetabolised
dextromethorphan, together with the three demethylated morphinan
metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3hydroxymorphinan and 3-methoxymorphinan have been identified as
conjugated products in the urine.
Dextrorphan, which also has antitussive action, is the main metabolite. In
some individuals metabolism proceeds more slowly and unchanged
dextromethorphan predominated in the blood and urine.

5.3.

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

6.

PHARMACEUTICAL PARTICULARS

6.1.

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 30°C.

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

8.

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

10

DATE OF REVISION OF THE TEXT
22/11/2016

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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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