BOOTS COMPANY PLC

1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone: +44 (0)1159 595 306
Fax: +44 (0)1159 592 565


Summary of Product Characteristics last updated on the eMC: 08/12/2011
SPC Boots Sore Throat Relief Dual Action Lozenges Blackcurrant Flavour


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1. NAME OF THE MEDICINAL PRODUCT

Boots Sore Throat Relief Dual Action Lozenges Blackcurrant Flavour


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol B.P. 2.4mg per lozenge

For excipients see section 6.1.


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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 and local anaesthetic for the relief of sore throat and its associated pain.


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4.2 Posology and method of administration

Adults, the Elderly, and Children aged 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 & sight of children. If symptoms persist consult your doctor. Not to be given to children under 6 years.

Contains a total of 2.4g of sucrose and liquid glucose solids per lozenge. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.


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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 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

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 overdosage 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

There is no preclinical data available specific to the product.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Sucrose

Liquid Glucose

Citric Acid Anhydrous

Menthol

Propylene Glycol

Blackcurrant Flavour 545071E

Ponceau 4R E124

Brilliant Black E151


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6.2 Incompatibilities

None known


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6.3 Shelf life

2 years.


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6.4 Special precautions for storage

Do not store above 25°C. Store in the original packaging.


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6.5 Nature and contents of container

Blister packs of 250µm PVC coated 40g/m2 PVDC with 20µm hard temper aluminium foil packed in a carton or flow wrapped flexible laminate pack.

Pack sizes: 8 (1x8), 12 (1x12) 16 (2x8), 24 (2x12), 36 (3x12) lozenges.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

None specific to the product/pack


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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)

PL0094/0018


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22 November 1993 - 5 August 1999 – 05/02/2009


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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/21968/SPC/


Active Ingredients/Generics

 
   hexylresorcinol