Boots Dry Cough

Boots Dry Cough Syrup 6 Years +

For the full list of excipients, see section 6.1.

Syrup

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

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.

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.

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 If signs and symptoms suggestive of these reactions appear, Boots Dry Cough Syrup 6 Years + should be withdrawn immediately.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.

Cross-reactivity leading to serious allergic reactions (anaphylaxis) have been reported between pholcodine and NMBAs (Neuromuscular Blocking Agents). A precise at-risk period of time between the exposures of pholcodine and NMBAs has not been determined. Clinicians should be aware of this potential in case of future anaesthetic procedures involving NMBAs.

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.

Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

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

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).

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.

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

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

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.

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

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.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Maltitol liquid

Sodium citrate

Citric acid monohydrate

Sodium benzoate (E 211)

Blackcurrant Flavour QL80001

Vanilla Flavour Mixture QL78307

Purified water

Hydroxyethylcellulose

Glycerin

Acesulfame K

None stated

36 months

Do not store above 30°C.

An amber PET bottle with a child resistant polypropylene cap fitted with an expanded polyethylene liner.

Pack size: 150ml, 100ml

Not applicable.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/0523

16 July 1996

11/07/2022