Strepsils Honey & Lemon Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl alcohol 1.2mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DICHLOROBENZYL ALCOHOL, AMYLMETACRESOL

Available from:

Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland

ATC code:

R02AA03

INN (International Name):

2,4 DICHLOROBENZYL ALCOHOL 1.2 mg AMYLMETACRESOL 0.6 mg

Pharmaceutical form:

LOZENGE

Composition:

2,4 DICHLOROBENZYL ALCOHOL 1.2 mg AMYLMETACRESOL 0.6 mg

Prescription type:

OTC

Therapeutic area:

THROAT PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-02-28

Patient Information leaflet

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON)
1.
NAME OF THE MEDICINAL PRODUCT
Strepsils Honey & Lemon Lozenges
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Active Ingredients: Amylmetacresol 0.6mg and 2,4-Dichlorobenzyl
Alcohol 1.2mg.
3.
LIST OF EXCIPIENTS
Each lozenge contains 0.98 g glucose, 1.44 g sucrose and 100.9 mg
invert sugars (honey) which 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.
Each lozenge contains no more than 19.52 micrograms of gluten (from
wheat starch) and is regarded as
'gluten-free' and very unlikely to cause problems if you have coeliac
disease. If you have a wheat allergy
(different from coeliac disease) you should not take this medicine.
Contains less than 1 mmol sodium (23 mg) per dose, that is to say
essentially ‘sodium-free’.
Contains sulphur dioxide (E220) which may rarely cause severe
hypersensitivity reactions and bronchospasm.
The lemon flavour contains citral, d-Limonene, geraniol and linalool,
which may cause allergic reactions.
Also contains Tartaric Acid, Peppermint Oil and Quinoline Yellow
(E104).
4.
PHARMACEUTICAL FORM AND CONTENTS
Lozenge
24 lozenges
36 lozenges
Strepsils Honey & Lemon Lozenges provide fast, soothing and effective
relief from the discomfort of sore
throats. Each lozenge contains a combination of 2 anti-bacterials to
help kill the bacteria which can cause sore
throats and mouth infections. Natural honey with lemon for an extra
soothing effect on the throat.
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use.
Reckitt Benckiser
0004 MA 190/00504 CCDS/Excipient Update
1.3.1 Outer Packaging Clean
Strepsils Honey and Lemon HZ2PZ eCTD
Page 1
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 can choke on lozenges.
Like all medicines, this medic

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Strepsils Honey and Lemon Lozenges
Amylmetacresol 0.6mg
2,4-Dichlorobenzyl Alcohol 1.2mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains Amylmetacresol 600 micrograms and
2,4-Dichlorobenzyl alcohol 1.2mg
Excipients with known effects:
Glucose 0.98 g (976 mg)/lozenge.
Sucrose 1.44 g (1441 mg)/lozenge.
Invert Sugar (honey) 100.9 mg/lozenge.
Wheat Starch (containing gluten present in liquid glucose) 19.52
micrograms/lozenge.
Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.125
ppm/lozenge.
Lemon flavour fragrance containing citral, d-Limonene, geraniol and
linalool.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lozenge
A yellow circular lozenge with a taste of honey and lemon, embossed on
both sides with
Strepsils brand icon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of mouth and throat infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms. It is recommended that the product should be used for a
maximum of 3 days.
ADULTS
:
One lozenge to be dissolved slowly in the mouth every 2 – 3 hours.
Do not take more
than 12 lozenges in 24 hours.
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PAEDIATRIC POPULATION:
CHILDREN OVER 6 YEARS OF AGE
: As above for adults.
CHILDREN UNDER 6 YEARS OF AGE:
Not suitable for children under 6 years (see section 4.4.
ELDERLY
: There is no need for dosage reduction in the elderly.
METHOD OF ADMINISTRATION
For oromucosal administration. To be dissolved slowly in the mouth.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Patients
with
rare
hereditary
problems
of
fructose
intolerance,
glucose,
galactose
malabsorption or sucrose-isomaltase insufficiency should not take this
medicine.
4.4
SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE
This product is not recommended for young child