Reckitt Benckiser Ireland Limited
Strepsils Extra Blackcurrant Lozenges
1. NAME OF THE MEDICINAL PRODUCT
Strepsils Extra Blackcurrant Lozenges
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains hexylresorcinol 2.4 mg.
Excipients: Each lozenge contains 1.4g sucrose, 1.1g glucose and 0.13mg Carmoisine (E122).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lozenge
Circular 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
Posology
Adults: One lozenge every three hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days.
Paediatric Population:
Children of 6 years and over: Same as for adults.
Not to be given to children under 6 years.
Elderly Population:
No dosage adjustment is considered necessary in the elderly.
Method of administration
For oral administration. Allow the lozenge to dissolve slowly in the mouth.
4.3 Contraindications
Hypersensitivity to hexylresorcinol or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
If symptoms do not improve or worsen within 3 days, consult a healthcare professional.
The label will convey:
Keep out of the sight and reach of children.
If symptoms persist consult your doctor.
Not to be given to children under 6 years.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product may cause allergic reactions.
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 and in animals, but hexylresorcinols has been widely used in lozenges for many years without apparent ill consequence.
Pregnancy
The product should be used with caution during pregnancy. There are no or limited amount of data from the use of hexylresorcinol in pregnant women. No effects during pregnancy are anticipated.
Breast-feeding
The product should be used with caution during breast-feeding. It is unknown whether hexylresorcinol/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated.
Fertility
There are no data available regarding the use of hexylresorcinol on male or female fertility. No effects on fertility are anticipated.
4.7 Effects on ability to drive and use machines
The product has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
None known.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie
4.9 Overdose
Symptoms
Hexylresorcinol over-dosage may cause minor gastrointestinal irritation.
Management
Treatment would be withdrawal of the product and symptomatic measures as appropriate.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Throat preparations, antiseptics; ATC Code: R02AA12
Hexylresorcinol is a phenol derivative and local anaesthetic for topical use on the mucous membranes of the mouth and throat. The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects. 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 pre-clinical data of relevance additional to those already included in other section of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquid Glucose
Liquid Sucrose
Blackcurrant flavour (containing propylene glycol)
Levomenthol
Carmoisine edicol (E122)
Patent Blue V (E131)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 30°C. Store in the original packaging.
6.5 Nature and contents of container
Blister packs of 250 micron PVC coated 40 gsm PVdC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVDC blister.
24 lozenges in two blister strips in a carton.
6.6 Special precautions for disposal and other handling
No special requirements
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Ireland Ltd.,
7 Riverwalk,
Citywest Business Campus,
Dublin 24
8. MARKETING AUTHORISATION NUMBER(S)
PA 979/42/1
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 10 June 2005
Date of last renewal: 10 June 2010
10. DATE OF REVISION OF THE TEXT
December 2016