Strepsils Dry & Sore Throat
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Blackcurrant Flavour Lozenges
Strepsils Dry & Sore Throat Blackcurrant Flavour Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol1.2mg
Ascorbic acid and sodium ascorbate equivalent to 100.0mg ascorbic acid
3 PHARMACEUTICAL FORM
Blackcurrent flavoured and coloured circular lozenge.
Strepsils brand icon is intagliated on both sides.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of mouth and throat infections.
4.2 Posology and method of administration
For oral administration.
Adults and children (over 6 years old):
One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
Not suitable for children under 6 years.
Elderly:
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep all medicines out of the reach of children.
If symptoms persist consult your doctor
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.
4.6 Fertility, pregnancy and lactation
The safety of Strepsils has not been established, but it is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects are known.
4.8 Undesirable effects
Occasionally hypersensitivity reactions.
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.
4.9 Overdose
Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.
Ascorbic acid provides a source of vitamin C, which may be beneficial during infection when vitamin C levels are believed to fall.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
None available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anthocyanins (E163)
Tartaric Acid Liquid Sucrose Liquid glucose
Blackcurrant Flavour (contains Glycerol, Propylene Glycol)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months for lozenges packed in blister strips within a carton.
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32 and 36 lozenges in a cardboard carton.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0692
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/03/2014
10 DATE OF REVISION OF THE TEXT
18/03/2014