Summary of Product Characteristics (SmPC) - Strepsils Triple Action Honey and Lemon Flavour 2.4 mg lozenges
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, glucose-galactose 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
| System Organ Class | Frequency | Adverse Events | ||||||||
| Immune System | Not known | Hypersensitivity1 | ||||||||
| Disorders | ||||||||||
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 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 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
6.3 Shelf life
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
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/04/2010
10 DATE OF REVISION OF THE TEXT
09/03/2021