SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Strepsils Extra Blackcurrant Lozenges

Strepsils Extra Triple Action Blackcurrant Lozenges

Strepsils Extra Strength Blackcurrant Lozenges

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains Hexylresorcinol 2.4mg For excipients see Section 6.1

3    PHARMACEUTICAL FORM

Lozenge

A round purple 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

For oral administration.

Adults, the 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 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

The label will convey:

Keep out of the reach and sight of children.

If symptoms persist consult your doctor.

Not to be given to children under 6 years.

This product is unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltase deficiency.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

There is lack of evidence of safety of the product in human pregnancy and in animals, but hexylresorcinol has been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None known.

Undesirable effects

None known.

4.9 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-pharyngeal cavity.

5.3 Preclinical safety data

There are no preclinical data of relevance additional to those already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid sucrose, Liquid glucose, Blackcurrant flavour (containing propylene glycol), Levomenthol, Carmoisine edicol (E122), Patent blue V (E131).

6.2    Incompatibilities

Not applicable

6.3    Shelf life

36 months for the unopened blister pack

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Blister packs of 250 micron PVC/coated 40gsm PVDC with 20 micron hard temper aluminium foil heat-sealed to the PVC/PVDC blister. The tray contains an appropriate number of lozenges to give a pack sizes of 2, 4, 6, 12, 16, 24, 32, 36 and 48.

8 lozenges in a blister in a carton or a flow wrap outer composed of PET/aluminium foil/polyethylene.

6.6 Special precautions for disposal

None specific to the product/pack.

7    MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL13UH

8    MARKETING AUTHORISATION NUMBER(S)

PL 00063/0392

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/03/2010

10    DATE OF REVISION OF THE TEXT

13/05/2014