Summary of medicine characteristics - STREPSILS EXTRA TRIPLE ACTION BLACKCURRANT LOZENGES, STREPSILS EXTRA BLACKCURRANT LOZENGES, STREPSILS EXTRA STRENGTH BLACKCURRANT LOZENGES
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
Excipient(s) with known effect:
Glucose
Fragrance containing allergens – d-Limonene and Linalool**
Carmoisine (E122)
Sucrose
Sulphites – Sulphur Dioxide (E220)
Wheat starch (containing Gluten)
Propylene glycol **
* present in liquid glucose
* * present in blackcurrant flavour
For excipients see Section 6.1
Lozenge
A round purple lozenge
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.
Important information about some of the ingredients of this medicine
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 22.42 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
This medicine contains fragrance with d-Limonene and Linalool. d-Limonene and Linalool may cause allergic reactions.
This medicine contains carmoisine (E122) which may cause allergic reactions
This medicine contains Sulphites – Sulphur Dioxide (E220) – present in liquid glucose which may rarely cause severe hypersensitivity reactions and bronchospasm.
Patients with rare glucose-galactose malabsorption should not take this medicine
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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.
4.8 Undesirable effects
| System Organ Class | Frequency | Adverse Events |
| Immune System Disorders | Not known | Hypersensitivity1 |
| 1 Hypersensitivity reactions may includ | e rash, urticaria and angioedema, | |
which may include swelling of the face, neck, throat or tongue that could affect breathing.
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
4.9 OverdoseHexylresorcinol 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 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.
6.1 List of excipients
Liquid sucrose
Liquid glucose (prepared from wheat starch (containing gluten) and Sulphites -Sulphur Dioxide)
Blackcurrant flavour (containing Propylene glycol, d-Limonene and Linalool) Levomenthol
Carmoisine (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. Keep in the outer carton.
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
6.6 Special precautions for disposalNone specific to the product/pack.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH