Summary of Product Characteristics

1. NAME OF THE MEDICINAL PRODUCT

Lloydspharmacy Double Action Throat Lozenges Blackcurrant Superdrug Blackcurrant Sore Throat Dual Action Lozenges Morrisons Dual Action Antiseptic Throat Lozenges Blackcurrant Flavour.

Boots Sore Throat Relief Double Action 2.4 mg Lozenges Blackcurrant Flavour Mac Dual Action Blackcurrant Flavour

Asda Dual Action Blackcurrant Flavour 2.4 mg Throat Lozenges

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol B.P. 2.4mg per lozenge For excipients see section 6.1.

3. PHARMACEUTICAL FORM

Lozenge

4 CLINICAL PARTICULARS

4.1    Therapeutic indications

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

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.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

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.

4.5 Interactions with other Medicaments and other forms of Interaction

None known.

4.6    Fertility, pregnancy and lactation

Pregnancy

There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown.

In the absence of sufficient data, the use during pregnancy is not recommended. Lactation

It is not known whether the active ingredients of this product are excreted in human breast milk.

In the absence of sufficient data, the use during lactation is not recommended.

Fertility

Studies on the effects on fertility have not been investigated.

4.7    Effects on Ability to Drive and Use Machines

None known.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Overdose

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

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.

The product base has a demulcent action.

5.2    Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

There is no preclinical data available specific to the product.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sucrose Liquid Glucose Citric Acid Monohydrate Menthol

Propylene Glycol Blackcurrant Flavour 545071E Ponceau 4R E124 Brilliant Black E151

6.2    Incompatibilities

None Known

6.3    Shelf life 2 years.

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

6.5    Nature and contents of container

Blister packs of 250pm PVC coated 60g/m2 PVDC with 20pm 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.

6.6    Instructions for Use/Handling

None specific to the product/pack

7.    MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co. Ltd.

High Street, Crediton Devon, EX17 3AP, UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 00094/0018

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/02/2009

10    DATE OF REVISION OF THE TEXT

10/09/2015