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THE BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 165
Fax: +44 (0)1159 592 565

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 07/12/2011
SPC Boots Sore Throat Relief Dual Action Lozenges Black Cherry Flavour


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1. NAME OF THE MEDICINAL PRODUCT

Boots Sore Throat Relief Dual Action Lozenges Black Cherry Flavour

Tesco Dual Action Cherry Flavour 2.4mg Lozenges


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol 2.4 mg per lozenge

For excipients see 6.1.


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3. PHARMACEUTICAL FORM

Lozenge.

Clear, red 3/4" diameter, round, biconvex, brittle lozenge with a glossy surface.


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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

For adults and children aged 6 years and over:

One lozenge dissolved slowly in the mouth every 3 hours or as required.

Do not take more than 12 lozenges in 24 hours.

Not to be given to children under 6 years.

For the elderly:

The normal adult dose may be taken.


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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

Labelling: Keep out of reach of children. If symptoms persist consult your doctor. Not to be given to children under 6 years.

Contains 2.4g sucrose and liquid glucose solids per lozenge. Unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

E122 can cause allergic-type reactions including asthma. Allergy is more common in those peolple who are allergic to aspirin.


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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 contraindicated in pregnancy and lactation. However,as with all medicines taken 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

Reports of hypersensitivity reaction, including rash, urticaria and angioedema, are extremely rare. There have been very rare reports of tongue soreness.


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4.9 Overdose

Hexylresorcinol overdose may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.


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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. The product base has a demulcent action.


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5.2 Pharmacokinetic properties

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharangeal cavity.


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5.3 Preclinical safety data

None available specific to the product.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Menthol

Cherry flavour 500880E

Carmoisine E122

Sucrose

Liquid Glucose


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6.2 Incompatibilities

Not applicable.


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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/blister.


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6.5 Nature and contents of container

Blister strips of 250µm PVC coated 40g/m2 PVDC with 20µm hard temper aluminium foil in a carton or laminate flowrap.

Pack sizes:

6, 8, 10,12, 16, 24, 30, 32, 36 lozenges.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co Ltd

High Street

Crediton

Devon

EX17 3AP,

UK


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00094/0038


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/03/2000


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10. DATE OF REVISION OF THE TEXT

July 2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22546/SPC/


Active Ingredients/Generics

 
   hexylresorcinol