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STREPSILS BLACKCURRANT FLAVOUR LOZENGES

Active substance(s): AMYLMETACRESOL / ASCORBIC ACID / DICHLOROBENZYL ALCOHOL / SODIUM ASCORBATE / AMYLMETACRESOL / ASCORBIC ACID / DICHLOROBENZYL ALCOHOL / SODIUM ASCORBATE / AMYLMETACRESOL / ASCORBIC ACID / DICHLOROBENZYL ALCOHOL / SODIUM ASCORBATE

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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

For a full list of excipients, see section 6.1.

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
Posology
Use the lowest dose for the shortest duration necessary to relieve symptoms.
Adults:
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.
Elderly:
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.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

4.4

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
this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.

4.6

Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of amylmetacresol and
2,4-dichlorbenzyl alcohol.
As with all medicines care should be taken when using this product in
pregnancy and medical advice sought if necessary.
Breast-feeding
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.
Fertility
No data are available regarding the effects on fertility.

4.7

Effects on ability to drive and use machines
No or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects
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

Frequency

Adverse Events

Immune System
Not known Hypersensitivityab
Disorders
Gastrointestinal
Not known Glossodyniaab, oral discomfortab
Disorders
a
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.

4.9

Overdose
Overdosage should not present a problem other than gastrointestinal discomfort.
Treatment should be symptomatic.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

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
31/03/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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