BOOTS DRY COUGH SYRUP 6 YEARS + - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Dry Cough Syrup 6 Years +

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient                               ­mg/5ml

Pholcodine Ph Eur                             ­2.0

Excipients with known effect

Maltitol liquid

Sodium benzoate (E 211)

For the full list of excipients, see section 6.1.

3 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.

Severe cutaneous adverse reactions (SCARs) including acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in patients treated with pholcodine-containing products, most likely in the first week. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Boots Dry Cough Syrup 6 Years + should be withdrawn immediately.

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.

Caution is needed in patients with a history of drug abuse. Pholcodine is an opioid and addiction is observed with opioids as a class.

This product contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This product contains 10 mg sodium benzoate in each 5ml spoonful.

This medicine contains less than 1 mmol sodium (23 mg) per 5ml spoonful, that is to say essentially ‘sodium-free’.

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, and gastrointestinal disturbances (nausea and constipation).

Skin and subcutaneous tissue disorders:

Skin reactions including rash

Acute generalized exanthematous pustulosis (see section 4.4) (frequency unknown)

Immune system disorders have been noted including hypersensitivity reactions and anaphylaxis.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store

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.

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 (E 211)

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

16 July 1996