Robitussin Dry Cough Medicine
Active Ingredient
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.
Oral administration.
Adults, the elderly and children over 12 years: One 10ml measure 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.
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.
Keep out of the sight and reach of children.
Do not exceed recommended dose.
Excipient warnings:
- 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.
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 product.
Quinidine can increase serum concentrations of dextromethorphan markedly and some patients have experienced symptoms of dextromethorphan toxicity when the two agents have been used together.
Amiodarone appears to be able to increase serum concentrations of dextromethorphan.
Although dextromethorphan has been in widespread use for many years without apparent illconsequence, 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.
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 medicine and
o It was not affecting your ability to drive safely
Adverse effects are rare, however the following side effects may be associated with dextromethorphan hydrobromide:
Gastrointestinal Disorders
Rare: Gastrointestinal upset
Nervous System Disorders
Rare: Dizziness
Immune System Disorders
Hypersensitivity
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.
Symptoms:
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.
Management:
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.
Dextromethorphan
Pharmacotherapeutic group: Cough suppressant
ATC code: R05DA09
Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan, which has some cough suppressant activity.
There is no relevant information additional to that already contained elsewhere in the SmPC or of relevance to the prescriber.
Glycerol
Sodium Carboxymethyl Cellulose
Sodium Benzoate
Disodium Edetate
Maltitol (E965)
Ethanol (96%)
Citric Acid Anhydrous
Amaranth (E123)
Caramel (E150)
Levomenthol
Cherry/Grenadine Flavour
Sorbitol Solution 70%
Sodium Cyclamate
Acesulfame Potassium Salt
Purified Water
Do not store above 25°C.
Keep out of reach and sight of children.
PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.
A clear polypropylene measuring cap also included.
Pfizer Consumer Healthcare Ltd
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
