Tcp Sore Throat Lozenge
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.
5.2.
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.
1st 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
7th March 2005
10 DATE OF REVISION OF THE TEXT
05/08/2014