Strepsils Extra Blackcurrant Lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hexylresorcinol

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AA12

INN (International Name):

Hexylresorcinol

Dosage:

2.4 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

hexylresorcinol

Authorization status:

Marketed

Authorization date:

2005-06-10

Patient Information leaflet

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON)
1.
NAME OF THE MEDICINAL PRODUCT
Strepsils Extra Blackcurrant Lozenges
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each lozenge contains the active ingredient: Hexylresorcinol Ph Eur
2.4mg.
3.
LIST OF EXCIPIENTS
Strepsils Extra Blackcurrant Lozenges contain:
Glucose & Sucrose: 1.121 g glucose and 1.408 g sucrose per lozenge.
This should be taken into account in
patients with diabetes mellitus. If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Wheat Starch: This medicine contains only very low levels of gluten
(from wheat starch). It is regarded as
‘gluten free’ and very unlikely to cause problems if you have
coeliac disease. One lozenge contains no more
than 22.42 micrograms of gluten. If you have wheat allergy (different
from coeliac disease) you should not
take this medicine.
Propylene glycol: This medicine contains 10.8 mg propylene glycol per
lozenge.
Sodium: Contains less than 1 mmol sodium (23 mg) per lozenge, that is
to say essentially ‘sodium-free’.
Sulphur Dioxide (E220) which may rarely cause severe hypersensitivity
reactions and bronchospasm.
Contains fragrances with d-Limonene and linalool which may cause
allergic reactions.
Azo colouring agent Carmoisine (E122) may cause allergic reactions.
Also contains Levomenthol.
4.
PHARMACEUTICAL FORM AND CONTENTS
Lozenge
24 lozenges
Strepsils Extra Blackcurrant Lozenges are formulated to bring
effective relief from painful sore throats. The
active ingredient in Strepsils Extra Blackcurrant is an antiseptic
which combats the bacteria which can cause
sore throat conditions and also has a local anaesthetic action which
brings relief from pain and discomfort.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use.
6.
SPECIAL WARNING: THAT THE MEDICINAL PRODUCT MUST BE STORED
OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNINGS: IF NECESSARY

Remember young children

Summary of Product characteristics

Health Products Regulatory Authority
13 August 2021
CRN00C5NR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Extra Blackcurrant Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains hexylresorcinol 2.4 mg.
Excipients with known effects:
Each lozenge contains Glucose 1.121 g, Sucrose 1.408 g, Propylene
Glycol 10.8 mg, Wheat Starch 22.42 µg, Sulphur Dioxide
(E220) 0.143 ppm and Carmoisine (E122) 0.130 ppm.
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.
This medicine contains only very low levels of gluten (from wheat
starch). It is regarded as 'gluten-free' and is very unlikely to
cause problems if you have coeliac disease. One lozenge contains no
more than 22.42 micrograms of gluten. If you have a
wheat allergy (different from coeliac disease) you should not take
this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that
is to say essentially 'sodium free'.
This medicine also contains 1.121 g glucose and 1.408 g sucrose per
lozenge. This should be taken into account in patients
with diabetes