- 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
1. Name of the medicinal product
Boots Dry Cough Relief 2.5mg Lozenges
2. Qualitative and quantitative composition
|Dextromethorphan Hydrobromide BP||2.5|
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
Cough suppressant for the relief of acute non-productive (dry, tickly) cough associated with respiratory tract infection.For oral administration.
4.2 Posology and method of 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.
4.4 Special warnings and precautions for use
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.If symptoms do not go away talk to your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
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 is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SRRIs, and thioridazine, should be borne in mind.Dextromethorphan might exhibit additive CNS depressant effects when co-administered with alcohol, antihistamines, psychotropics, and other CNS depressant drugs.
4.6 Pregnancy and lactation
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.
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 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).
5. Pharmacological properties
5.1 Pharmacodynamic properties
Dextromethorphan is a cough suppressant.
5.2 Pharmacokinetic properties
Dextromethorphan is well-absorbed from the gastrointestinal tract, metabolised in the liver and excreted as both unchanged drug and demethylated metabolites.
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
Star anise oil Strong capsicum tincture LevomentholNatural blackcurrant flavour 3109382 Anthocyanin Sugar/glucose liquid sugar
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
The Boots Company PLC1 Thane Road WestNottingham NG2 3AA
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
|Date of first authorisation:||20 January 1988|
|Date of last renewal:||20 January 2003|
10. Date of revision of the text
THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA
+44 (0)1159 592 565
+44 (0)1159 595 165