UK Edition. Click here for US version.
ROBITUSSIN DRY COUGH MEDICINE
Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / DEXTROMETHORPHAN HYDROBROMIDE / DEXTROMETHORPHAN HYDROBROMIDE
NAME OF THE MEDICINAL PRODUCT
Robitussin Dry Cough Medicine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextromethorphan Hydrobromide Ph Eur 7.5mg per 5ml
For full list of excipients see section 6.1
Bright pink clear liquid for oral administration
For the relief of persistent dry irritant coughs
Posology and method of administration
Adults, the elderly and children over 12 years: 10ml up to four times daily
Children under 12 years: Do not use
Hypersensitivity to any of the ingredients.
Taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin
reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or
emotional conditions, or Parkinson's disease, or for 2 weeks after stopping the
medication. If you are not sure if your prescription medication contains one of these
medicines, ask a doctor or pharmacist before taking this product. (See section 4.5).
Use in children under 12 years.
Special warnings and precautions for use
Patients suffering from chronic cough as occurs with smoking, asthma or patients
suffering from an acute asthma attack, or where cough is accompanied by excessive
secretions should be advised to consult a Healthcare Professional before use.
Causes of chronic cough should be excluded if symptoms are persistent. Any
accompanying symptoms should be actively sought and appropriately investigated/
treated. Stop use and ask your healthcare professional if your cough lasts more than 7
days, comes back or is accompanied by a fever, rash or persistent headache. These
could be signs of serious conditions.
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
metabolizers of CYP2D6 or use CYP2D6 inhibitors (see also section 4.5).
Keep out of the sight and reach of children.
Do not exceed recommended dose.
Patients with rare hereditary problems of fructose intolerance should not take
this medicine because this product contains Sorbitol and Maltitol.
This product contains Amaranth (E123), which may cause allergic reactions.
This medicinal product contains 2.5% v/v ethanol (alcohol), up to196 mg per
dose, (equivalent to approx 1.6 ml wine per dose). Harmful for those suffering
from alcoholism. To be taken into account in pregnant or breast-feeding
women and high-risk groups such as patients with liver disease, or epilepsy.
Interaction with other medicinal products and other forms of interaction
Do not use if you are now taking a prescription monoamine oxidase inhibitor
(MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for
depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2
weeks after stopping the medication. If you are not sure if your prescription
medication contains one of these drugs, ask a doctor or pharmacist before taking this
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, flecainide 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.
Pregnancy and lactation
Although dextromethorphan has been in widespread use for many years
without apparent ill-consequence, there are no specific data on its use during
pregnancy. Caution should therefore be exercised by balancing the potential
benefit of treatment against any possible hazards. It is not known whether
dextromethorphan or its metabolites are excreted in human milk.
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 taking 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 ‘statutory defence’) if:
o The medicine has been prescribed taken to treat a medical problem and
o You have taken it according to the information provided with the
o It was not affecting your ability to drive safely
4.8. Undesirable effects
Adverse effects are rare, however the following side effects may be associated with
Rare: Gastrointestinal upset
Nervous System Disorders
Immune System Disorders
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.
These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred
speech), myoclonus, nystagmus, somnolence (drowsiness), tremor, excitation, mental
confusion, psychotic disorder (psychosis), and respiratory depression.
Treatment of overdose should be symptomatic and supportive. Gastric lavage may be
of use. Naloxone has been used successfully as a specific antagonist to
dextromethorphan toxicity in children.
Dextromethorphan hydrobromide is a cough suppressant which has a central
action on the cough centre in the medulla. It has no analgesic properties and
little sedative activity.
Pharmacotherapeutic group: Cough suppressant
ATC code: R05DA09
Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract.
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
predominates in the blood and urine.
Preclinical safety data
There is no relevant information additional to that already contained elsewhere
in the SmPC or of relevance to the prescriber.
List of excipients
Sodium Carboxymethyl Cellulose
Citric Acid Anhydrous
Sorbitol Solution 70%
Acesulfame Potassium Salt
Special precautions for storage
Do not store above 25oC
Keep out of the sight and reach of children
Nature and contents of container
PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.
A clear polypropylene measuring cap also included.
Special precautions for disposal
No special requirements
MARKETING AUTHORISATION HOLDER
Pfizer Consumer Healthcare Ltd
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
01/09/1993 / 18/05/2010
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.