- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Boots Dry Cough Relief 2.5mg Lozenges
Dextromethorphan Hydrobromide BP
Cough suppressant for the relief of acute non-productive (dry, tickly) cough associated with respiratory tract infection.
For oral administration.
Adults and children over 12 years: A lozenge should be sucked whenever the cough is troublesome. Not more than 10 lozenges should be taken in one day.
The normal adult dose is still appropriate in the elderly.
Children 6 to 12 years: Not more than 2 lozenges within any 4 hours, and not more than 7 in any one day.
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.
Warning: 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.
Dextromethorphan should not be given to subjects in, or at risk of developing respiratory failure.
Should not be taken by patients with liver disease.
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).
Patients taking selective serotonin reuptake inhibitors (SSRI's, see section 4.5).
Not to be used in children under the age of 6 years.
Should be used with caution in atopic children due to histamine release.
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 take with any other cough and cold medicine.
Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.
Cases of dextromethorphan abuse have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan. Caution should therefore be exercised in patients who are slow metabolisers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).
If symptoms do not go away talk to your doctor.
Not to be used in patients taking monoamine oxidase inhibitors or within 14 days of stopping treatment as there is a risk of serotonin syndrome (pyrexia, hypertension, arrhythmias) when MAOIs are taken in combination with dextromethorphan.
(Severe and sometimes fatal reactions have been reported following administration of dextromethorphan to patients receiving MAOIs (see also section 4.3)).
Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.
Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels multifold higher than normal. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome. Potent CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent. Amiodarone, flecaninde and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dextromethorphan dose may need to be reduced.
There is no or inadequate evidence of the safety of dextromethorphan in human pregnancy and therefore the lozenges should not be used during this period. No information is available on the secretion of dextromethorphan into breast milk and it is recommended that the product should not be used by breast feeding mothers.
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 dextromethorphan; occasional drowsiness, dizziness, excitation, mental confusion, convulsions, respiratory depression, vomiting, gastrointestinal disturbances (nausea and diarrhoea) and skin reactions including rash.
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.
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 and vomiting, CNS depression, dizziness, dysarthria (slurred speech), nystagmus, somnolence (drowsiness), excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression. Other effects may include: abdominal discomfort, hallucinations, hypotension and ataxia.
Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In severe overdosage the specific narcotic antagonist naloxone may be given.
Information regarding children aged 6-12 years:
Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight).
Dextromethorphan is a cough suppressant.
Dextromethorphan is well-absorbed from the gastrointestinal tract, metabolised in the liver and excreted as both unchanged drug and demethylated metabolites.
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers.
It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine.
Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals metabolism proceeds more slowly and unchanged dextromethorphan predominated in the blood and urine.
There are no preclinical data of relevance to the prescriber which are additional to that already included.
Star anise oil
Strong capsicum tincture
Natural blackcurrant flavour 3109382
Sugar/glucose liquid sugar
Do not store above 30°C.
A card carton containing two blister push-through packs consisting of PVC/PVDC blisters heat sealed to hard temper aluminium foil. There are 12 lozenges on each blister and two trays in each carton.
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
Date of first authorisation:
20 January 1988
Date of last renewal:
20 January 2003
22 November 2016
THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA
+44 (0)1159 592 565
+44 (0)1159 595 165