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Chefaro UK Ltd

4th Floor, Hamilton House, Mabledon Place, Bloomsbury, London, WC1H 9BB, UK
Telephone: +44 (0)207 554 8791
Medical Information e-mail: enquiries@chefaro.co.uk
Customer Care direct line: +44 (0)1748 828 860

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Summary of Product Characteristics last updated on the eMC: 24/02/2011
SPC Buttercup Max Strength Sore Throat Lozenge


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1. NAME OF THE MEDICINAL PRODUCT

TCP Sore Throat Lozenge

Buttercup Max Strength Sore Throat Lozenge


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains hexylresorcinol 2.4mg.


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3. PHARMACEUTICAL FORM

Lozenge


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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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.


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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4.4 Special warnings and 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).


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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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.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

None known.


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4.9 Overdose

Hexylresorcinol overdosage may cause minor gastro-intestinal irritation.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

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


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5.3 Preclinical safety data

No specific data.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Menthol Laevo

Eucalyptus Oil

Quinoline Yellow E104

Acid Brilliant Green BS E142

Sucrose/Liquid Glucose Solids


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6.2 Incompatibilities

Hexylresorcinol is incompatible with acids and alkalis.


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6.3 Shelf life

36 months.


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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.


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6.5 Nature and contents of container

Blister strip of clear PVC/PVDC plastic laminate with aluminium foil in a cardboard carton

Pack size: 24 lozenges


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6.6 Special precautions for disposal and other handling

Not applicable


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7. MARKETING AUTHORISATION HOLDER

Chefaro UK Ltd,

4th Floor, Hamilton House,

Mabledon Place, Bloomsbury,

LONDON, WC1H 9BB

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 02855/0018


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

7th March 2005


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10. DATE OF REVISION OF THE TEXT

14th November 2010



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21967/SPC/


Active Ingredients/Generics

 
   hexylresorcinol