STREPSILS BLACKCURRANT FLAVOUR LOZENGES
Active substance(s): AMYLMETACRESOL / ASCORBIC ACID / DICHLOROBENZYL ALCOHOL / SODIUM ASCORBATE
NAME OF THE MEDICINAL PRODUCT
Strepsils Blackcurrant Flavour Lozenges
Strepsils Dry & Sore Throat Blackcurrant Flavour Lozenges
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ascorbic acid and sodium ascorbate equivalent to 100.0mg ascorbic acid
For a full list of excipients, see section 6.1.
Blackcurrent flavoured and coloured circular lozenge.
Strepsils brand icon is intagliated on both sides.
For the symptomatic relief of mouth and throat infections.
Posology and method of administration
Use the lowest dose for the shortest duration necessary to relieve symptoms.
One lozenge every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
Children over 6 years old:
As above for adults.
There is no need for dosage reduction in the elderly.
Children under 6 years old:
Not suitable for children under 6 years (see section 4.4).
Method of administration
For oral administration. To be dissolved slowly in the mouth.
Hypersensitivity to any of the ingredients.
Special warnings and precautions for use
Not to be given to children under 6 years
If symptoms persist, have not improved, or have worsened after 3 days,
consult a doctor or health care professional.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrose-isomaltose insufficiency should not take
Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.
Fertility, pregnancy and lactation
There are no or limited amount of data from the use of amylmetacresol and
As with all medicines care should be taken when using this product in
pregnancy and medical advice sought if necessary.
It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol or
metabolites are excreted in human milk. A risk to the newborns / infants
cannot be excluded.
No data are available regarding the effects on fertility.
Effects on ability to drive and use machines
No or negligible influence on the ability to drive and use machines.
The list of the following adverse effects relates to those experienced with 2,4dichlorobenzyl alcohol and amylmetacresol at OTC doses, in short term use..
Adverse events which have been associated with 2,4-dichlorobenzyl alcohol
and amylmetacresol are given below, tabulated by system organ class and
frequency. Frequencies are defined as: Very common (≥1/10); Common
(≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and
<1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the
available data). Within each frequency grouping, adverse events are presented
in order of decreasing seriousness.
System Organ Class
Not known Hypersensitivityab
Not known Glossodyniaab, oral discomfortab
2,4-dichlorobenzyl alcohol bamylmetacresol
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.
Overdosage should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.
Pharmacotherapeutic group: Throat Preparations; Antiseptics; ATC Code:
R02AA03 Dichlorobenzyl alcohol.
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.
Preclinical safety data
List of excipients
Blackcurrant Flavour (contains Glycerol, Propylene Glycol)
36 months for lozenges packed in blister strips within a carton.
Special precautions for storage
Do not store above 25°C.
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.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT