SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Vicks Cough Syrup with Honey for Dry Coughs

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

ACTIVE INGREDIENTS

%w/v Specification

Dextromethorphan hydrobromide 0.133 Ph. Eur.

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

Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician.

4.7. Effects on Ability to Drive and Use Machines

None expected.

Undesirable effects

In general no severe undesirable effects are expected.

Nervous system disorders:

Drowsiness or dizziness may occur rarely.

Gastrointestinal disorders:

Gastrointestinal disturbances that may rarely occur include nausea, vomiting and diarrhoea.

Skin and subcutaneous disorders:

Skin rashes have rarely been reported with dextromethorphan.

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).

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 25°C.

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, 30m1, 100ml, 120m1, 180m1 and 250ml of product are available.

6.6. Instruction for Use/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

PL 00129/0079

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

31 June 1984 / 13 February 1995

10 DATE OF REVISION OF THE TEXT

30/04/2011