STREPSILS CITRUS FLAVOUR LOZENGES
Active substance(s): 2 4-DICHLOROBENZYL ALCOHOL / AMYLMETACRESOL
NAME OF THE MEDICINAL PRODUCT
Strepsils Citrus Flavour Lozenges
Strepsils Dry Throat Lozenges
QUALITATIVE AND QUANTITATIVE COMPOSITION
2,4-Dichlorobenzyl alcohol 1.2mg/lozenge
For a full list of excipients, see section 6.1
A white to pale yellow, circular lozenge with a characteristic lemon taste and
the Strepsils brand icon intagliated on both sides.
As an antiseptic for the relief of sore throat and its associated pain.
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.
Strepsils Citrus Flavour Lozenges are contraindicated in persons who have previously
shown 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, or if
symptoms are accompanied by a high fever or headache consult a doctor or health
Contains isomaltitol and maltitol syrup, which may have a mild laxative effect
if several are taken a day. Patients with rare hereditary problems of fructose
intolerance should not take this medicine.
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
There are no or limited amount of data from the use of amylmetacresol and 2,4dichlorbenzyl alcohol.
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
Immune System Disorders
Glossodynia , oral discomfort
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.
In view of the nature and presentation of Strepsils Citrus Flavour Lozenges,
accidental or deliberate overdosage is highly unlikely.
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.
An oral bioavailability study conducted on Strepsils lozenges demonstrated a
rapid release of 2,4-dichlorobenzyl alcohol and amylmetacresol into saliva
with peak levels achieved within 3-4 minutes of sucking the lozenge. A
doubling of saliva volume was observed within a minute* and levels above
baseline were maintained whilst the lozenge dissolved over approximately 6
minutes. Quantifiable amounts of actives were expectorated up to 20-30
minutes post dose; net recovery of actives was suggestive of a prolonged
residency in mouth and throat mucosa.
Preclinical safety data
There are no preclinical data available specific to the product.
List of excipients
Saccharin sodium Ph Eur (E954)
Isomalt (Isomaltitol E 953)
Maltitol syrup (E965)
Special precautions for storage
Do not store above 25°C
Nature and contents of container
The lozenges are contained in a strip pack containing either 6, 8, 12, 16, 18,
20, 22, 24, 32 or 36 lozenges packed into a cardboard carton. Not all pack
sizes may be marketed.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT