STREPSILS TRIPLE ACTION HONEY AND LEMON FLAVOUR 2.4 MG LOZENGES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Strepsils Triple Action Honey & Lemon Flavour 2.4mg Lozenges

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexylresorcinol Ph Eur 2.4mg

Also contains the following excipients:

Propylene Glycol (E1520)

Liquid Sucrose

Liquid Glucose (Wheat starch (containing Gluten) and Sulphites – Sulphur Dioxide (E220))

Honey and Lemon Flavour (containing Bergamot oil (containing bergapten), Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool).

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Lozenge

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

As an antiseptic, demulcent 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:

Do not exceed the stated dose.

Keep out of the reach of children.

Not to be given to children under 6 years.

This product is unsuitable hereditary fructose intolerance, glucose-galactose

malabsorption syndrome, or sucrase-isomaltase deficiency.

Important information about some of the ingredients of this medicine:

This medicine contains Glucose (1125 mg per lozenge) and Sucrose (1413 mg per lozenge). Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains Sulphites – Sulphur Dioxide present in liquid glucose which may rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘gluten-free’ and is very unlikely to cause problems if you have coeliac disease. One lozenge contains no more than 22.50 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.

This medicine contains 3.12 mg Propylene glycol in each lozenge.

This medicine contains fragrance with Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool. Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool may cause allergic reactions.

This medicine contains Bergamot oil (present in Lemon and Honey flavour) which may increase sensitivity to UV light (natural and artificial sunlight).

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Pregnancy and lactation

There is a lack of evidence of safety of the product in human pregnancy, 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 No adverse effects known.

4.8 Undesirable effects

1 Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

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

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 oropharyngeal cavity.

5.3 Preclinical safety data

There are no pre-clinical data available specific to the product.

6.1 List of Excipients

Liquid Sucrose, Liquid Glucose (containing wheat starch (containing Gluten), and sulphites -Sulphur Dioxide (E220)), Propylene Glycol (E1520), Honey and Lemon Flavour (containing Bergamot oil (containing bergapten), Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool).

6.2 Incompatibilities

Not applicable

24 months

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Blister packs of 250 micron PVC coated 90 gsm PVDC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVDC blister containing 6, 8, 10, 12, 16, 20, 24, 32 or 36 lozenges in a carton.

6.6 Special precautions for disposal

None specific to the product/ pack

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0394