1. Name Of The Medicinal Product
Boots Dry Cough Syrup 6 Years +
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Oral solution
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
No adverse effects known.
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.
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 flav DA 13624
Vanilla bean extract AD 17342
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: 150ml, 100ml
6.6 Special Precautions For Disposal And Other Handling
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
May 2009
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