BOOTS DRY COUGH Syrup Ref.[9336] Active ingredients: Pholcodine

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 If signs and symptoms suggestive of these reactions appear, Boots Dry Cough Syrup 6 Years+ should be withdrawn immediately.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

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, 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.

None stated.