1. Name Of The Medicinal Product
Vicks Cough Syrup with Honey for Dry Coughs
2. Qualitative And Quantitative Composition
ACTIVE INGREDIENTS
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3. Pharmaceutical Form
Syrup for oral administration.
4. Clinical Particulars
4.1 Therapeutic Indications
Cough suppressant to relieve acute non-productive cough associated with upper respiratory tract infection and soothe the throat
4.2 Posology And Method Of Administration
Adults and children over 12 years: 3 x 5ml spoonfuls
Children (6-12 years): 1 x 5ml spoonful
Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor, seek medical attention if the child's condition deteriorates during treatment.
Vicks Cough Syrup with Honey for Dry coughs is contraindicated under 6 years of age (see section 4.3)
Keep out of reach and sight of children
Repeat every 6 hours as needed.
No more than 4 doses a day
Do not exceed the stated dose
4.3 Contraindications
Not to be used in children under the age of 6 years
Hypersensitivity to the active substance(s) or to any of the excipients.
Severe liver disease.
Patients currently receiving monoamine oxidase inhibitors (MAOIs) or within 14days of stopping such treatment
Patients with a productive cough.
Patients in, or at risk of developing respiratory failure.
Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5)
4.4 Special Warnings And Precautions For Use
Do not exceed the stated dose.
Ask a doctor before use if you suffer from liver disease, chronic or persistent cough, if you have asthma, suffering from an acute asthma attack or where cough is accompanied by excessive secretions
Should be used with caution in atopic children due to histamine release
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 persist, consult your doctor.
Keep out of reach and sight of children.
Children age 6-12: do not take with any other cough and cold medicine
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Not to be used in patients taking MAOIs 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.
Dextromethorphan is primarily metabolised by the cytochrome P450 isoenzyme CYP2D6; the possibility of interactions with inhibitors of this enzyme, including amiodarone, haloperidol, propafenone, quinidine, SSRIs, 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 literature evidence of hazard due to dextromethorphan hydrobromide but, as with all medicines, use is not recommended during the first trimester and during breast feeding.
4.7 Effects On Ability To Drive And Use Machines
None expected.
4.8 Undesirable Effects
Reactions are rare but the following side effects may be associated with the use of dextromethorphan:
occasional drowsiness, dizziness, and gastrointestinal disturbances (nausea, vomiting and diarrhoea).
Hypersensitivity: rarely, skin reactions including rash may occur
Excitation, mental confusion, respiratory depression or convulsions may occur very rarely under normal conditions of use or after overdosage (see Section 4.9)
4.9 Overdose
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.
Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully to reverse central or peripheral opioid effects of dextromethorphan in children (0.01mg/kg body weight).
4.9.1 Symptoms
Mild to moderate overdose may cause dizziness and gastrointestinal disturbances. Very high doses may produce excitation, confusion, and respiratory depression.
4.9.2 Management of an overdose
Treatment involves gastric lavage and general supportive measures. Intravenous naloxone is a specific antidote. 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 hydrobromide is a cough suppressant with a central action on the cough centre of the medulla.
5.2 Pharmacokinetic Properties
Dextromethorphan HBr is well absorbed from the gastrointestinal tract, metabolised in the liver and is excreted in the urine as unchanged dextromethorphan and demethylated metabolites.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance which are additional to that already included in other sections of the SmPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose.
Sodium saccharin.
Propylene glycol.
Ethanol 96%.
Sodium citrate, hydrous.
Citric acid, anhydrous.
Carboxymethylcellulose sodium.
Polyethylene oxide.
Honey flavour L-166952
Menthoxypropanediol (TK10).
Polyoxyl 40 stearate.
Sodium benzoate.
Verveine Flavour
Purified water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Shelf life (unopened): 2 years
6.4 Special Precautions For Storage
Do not store above 25oC.
6.5 Nature And Contents Of Container
Amber cylindrical glass bottle (pharmaceutical type III) with a high density polyethylene screw thread closure.
Bottles containing 15ml, 30ml, 100ml, 120ml, 180ml and 250ml of product are available.
6.6 Special Precautions For Disposal And Other Handling
No specific instructions required.
7. Marketing Authorisation Holder
Procter & Gamble (Health & Beauty Care) Ltd.,
The Heights,
Brooklands,
Weybridge,
Surrey,
KT13 0XP.
8. Marketing Authorisation Number(S)
PL 0129/0079
9. Date Of First Authorisation/Renewal Of The Authorisation
13 February 1995
10. Date Of Revision Of The Text
July 2009
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