SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Vicks Cough Lozenges with Honey 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient	%	Mg/Lozenge	Reference Standard
Dextromethorphan	0.204	7.33	USP

3.    PHARMACEUTICAL FORM

Lozenge for oral administration.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Cough suppressant for the relief of acute non-productive cough (dry cough) associated with upper respiratory tract infection.

4.2.    Posology and Method of Administration

Adults and Children over 12;

2 lozenges dissolved in the mouth consecutively. repeat every 6 hours as needed. no more than 8 lozenges per day.

4.3. Contraindications

Known hypersensitivity to dextromethorphan or to any ingredient of the lozenge. Patients suffering from severe liver disease.

Patients taking monoamine oxidase inhibitors therapy (MAOIs) or within 14 days of stopping such treatment (see section 4.5).

Patients taking selective serotonin reuptake inhibitors (SSRIs, see section 4.5). Patients with a productive cough.

Special warnings and precautions for use

Patients suffering from asthma, chronic or persistent cough, liver disease, or impaired respiratory function should consult their doctor before taking this product.

Do not administer to children under 12 years.

If symptoms persist consult your doctor.

Do not exceed the stated dose.

Keep out of reach and sight of children.

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

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. (SEE 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, SSRIs, and thioridazine, should be borne in mind.

Dextromethorphan might exhibit additive CNS depressant effects when coadministered 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, but patients suffering from the undesirable effects of dizziness, or drowsiness (see section 4.8) should not drive or operate machinery.

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.

4.9    Overdose

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 of an overdose: 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 is a non-opioid dextro-isomer of morphine. The drug's cough suppressant action is mediated by a central action on the cough centre in the medulla oblongata of the brain, raising the threshold for coughing.

5.2. Pharmacokinetic Properties

Dextromethorphan base is well absorbed from the gastrointestinal tract, but there is extensive first-pass metabolism. Metabolism occurs in the liver by demethylation, and the drug is excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan which has some cough suppressant activity. There is no faecal elimination. Urinary excretion is negligible. Variation in capacity to metabolise dextromethorphan exists between individuals and the clinical implications of this are not fully understood.

5.3. Pre-clinical Safety Data

N/A.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose Glucose syrup Levomenthol Honey

Honey flavour l-134515 Water

6.2. Incompatibilities

None known.

6.3. Shelf-Life

Shelf life (unopened):    3 years

Shelf life (after opening blister pack):    as for unopened product

6.4 Special precautions for storage

Do not store above 25°C

6.5. Nature and Contents of Container

Polypropylene blister foil, white in colour, with backing foil (paper/aluminium/polypropylene based adhesive) containing 12 lozenges.

Or

Polyvinylchloride/polyvinylidene chloride blister foil, white in colour, with backing foil (paper/aluminium/polyvinylidene based adhesive) containing 12 lozenges.

6.6. Instructions for Use, Handling and Disposal

None.

7. MARKETING AUTHORISATION HOLDER

Procter & Gamble (Health & Beauty Care) Limited

The Heights

Brooklands

Weybridge

Surrey

KT13 0XP

UK

8. MARKETING AUTHORISATION NUMBER(S)

PL 0129/0129

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

09 July 1997

10 DATE OF REVISION OF THE TEXT

20/03/2012