SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

TCP Sore Throat Lozenge

Buttercup Max Strength Sore Throat Lozenge

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains hexylresorcinol 2.4mg.

3.    PHARMACEUTICAL FORM

Lozenge

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

As an antiseptic, demulcent and local anaesthetic for the relief of sore throat and its associated pain.

4.2.    Posology and Method of Administration

Route of administration: oral.

Adults, elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required.

Do not take more than 12 lozenges in 24 hours.

Not to be given to children under 6 years.

4.3.    Contra-Indications

Hypersensitivity to any of the ingredients.

4.4.    Special Warnings and Special Precautions for Use

Keep out of reach of children. If symptoms persist, consult your doctor. Not to be given to children under 6 years (warnings on the labelling).

4.5.    Interaction with other Medicinal Products and other Forms of Interaction

None known.

4.6.    Pregnancy and Lactation

The product is not contra-indicated during pregnancy and lactation. However as with all medicines during this period, caution should be exercised.

4.7.    Effects on Ability to Drive and Use Machines

None known.

4.8.    Undesirable Effects

None known.

4.9.    Overdose

Hexylresorcinol overdosage may cause minor gastro-intestinal irritation.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.

Pharmacokinetic Properties

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oropharyngeal cavity.

5.3. Pre-clinical Safety Data

No specific data.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Menthol Laevo Eucalyptus Oil Quinoline Yellow E104 Acid Brilliant Green BS E142 Sucrose/Liquid Glucose Solids

6.2. Incompatibilities

Hexylresorcinol is incompatible with acids and alkalis.

6.3. Shelf-Life

36 months.

6.4. Special Precautions for Storage

Do not store above 25°C. Store in the original package. Protect from humidity by keeping in a dry place.

6.5. Nature and Content of Container

Blister strip of clear PVC/PVDC plastic laminate with aluminium foil in a cardboard carton Pack size: 24 lozenges

6.6. Instructions for Use, Handling and Disposal

Not applicable

7. MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 02855/0018

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

7^th March 2005

10 DATE OF REVISION OF THE TEXT

05/08/2014