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BOOTS DRY COUGH SYRUP 6 YEARS +

Active substance(s): PHOLCODINE / PHOLCODINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Dry Cough Syrup 6 Years +

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

mg/5ml

Pholcodine Ph Eur

2.0

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1

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

4.2

Posology and method of administration
Children 6-12 years: Two 5ml spoonfuls three times a day.
Not more than 3 doses should be given in any 24 hours.
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.
For oral administration
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
Pholcodine should not be given to subjects in, or at risk of developing respiratory
failure, (may depress respiration).
Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum
retention
Patients with renal or hepatic failure
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping
such treatment (see also 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 patients with liver or renal disease
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 give with any other cough and cold medicine.
Use of pholcodine with alcohol or other CNS depressants may increase the effects on
the CNS and cause toxicity in relatively smaller doses.
If symptoms persist consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Not to be used in patients taking MAOIs or within 14 days of stopping treatment.
Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.
The reduction in blood pressure caused by antihypertensives may accentuate the
hypotensive effects of pholcodine. Diuretics may have the same effect. Pholcodine
may enhance the sedative effect of central nervous system depressants including

alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers
(phenothiazines and tricyclic antidepressants).

4.6

Pregnancy and lactation
The safety of pholcodine during pregnancy and lactation has not been established.
Based on the available data for morphine, it would seem likely that use of pholcodine
during pregnancy would not be associated with congenital defects and that use of
pholcodine during lactation would not be contraindicated. However, its use should be
carefully assessed by consideration of small benefits versus potential risk to the foetus
or neonate.

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 pholcodine:
Occasional drowsiness, dizziness, excitation, confusion, sputum retention,
vomiting, gastrointestinal disturbances (nausea and constipation) and skin
reactions including rash.
Immune system disorders have been noted including hypersensitivity reactions
and anaphylaxis.
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, drowsiness, restlessness, excitement, ataxia and
respiratory depression.
Management: Treatment of overdose should be symptomatic and supportive. Gastric
lavage may be of use. In cases of severe poisoning the specific narcotic antagonist
nalaxone may be used.
Information for children:
Nalaxone has been used successfully to reverse central or peripheral opioid effects in
children (0.01mg/kg body weight). Other treatment option is activated charcoal
(1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided
the airway can be protected.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pholcodine is a cough suppressant with mild sedative but little analgesic activity.

5.2

Pharmacokinetic properties
Maximum plasma concentrations are attained at 4 to 8 hours after an oral dose. The
elimination half life ranges from 32 to 43 hours and volume of distribution is 30-49
l/kg.
Pholcodine is protein bound to the extent of 23.5%.
Pholcodine is metabolised in the liver but undergoes little conjugation.
There is little or no metabolism of pholcodine to morphine and this may account for
the lack of analgesic activity, morphine-like side-effects and addictive potential.

5.3

Preclinical 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
Maltitol liquid
Sodium citrate

Citric acid monohydrate
Sodium benzoate
Blackcurrant Flavour QL80001
Vanilla Flavour Mixture QL78307
Purified water
Hydroxyethylcellulose
Glycerin
Acesulfame K

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
An amber PET bottle with a child resistant polypropylene cap fitted with an expanded
polyethylene liner.
Pack size: 100ml, 150ml.

6.6

Special precautions for disposal
Not applicable.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0523

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16 July 1996

10

DATE OF REVISION OF THE TEXT
14/07/2015

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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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