Strepsils Strawberry Sugar Free Lozenges

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL

Disponible depuis:

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

Code ATC:

R02AA20

DCI (Dénomination commune internationale):

2,4 DICHLOROBENZYL ALCOHOL 1.2 mg AMYLMETACRESOL 0.6 mg

forme pharmaceutique:

LOZENGE

Composition:

2,4 DICHLOROBENZYL ALCOHOL 1.2 mg AMYLMETACRESOL 0.6 mg

Type d'ordonnance:

OTC

Domaine thérapeutique:

THROAT PREPARATIONS

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-02-28

Notice patient

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON)
1.
NAME OF THE MEDICINAL PRODUCT
Strepsils Strawberry Sugar Free Lozenges
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Active Ingredients: Amylmetacresol 0.6mg, 2,4-Dichlorobenzyl Alcohol
1.2mg
3.
LIST OF EXCIPIENTS
Each lozenge contains 1.83 g isomalt and 0.458 g maltitol liquid. If
you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicinal product. May have a
mild laxative effect. Calorific value 2.34 kcal/g.
Contains less than 1 mmol sodium (23 mg) per dose, that is to say
essentially ‘sodium-free’.
Contains 7.30 mg propylene glycol (present in strawberry flavour) in
each lozenge.
Fragranced with Benzyl Alcohol which may cause allergic reactions.
Also contains Pink Antho (E163), Sodium Saccharin and Tartaric Acid.
4.
PHARMACEUTICAL FORM AND CONTENTS
Lozenge
16 lozenges
Strepsils Strawberry Sugar Free 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. Strepsils Strawberry Sugar Free
Lozenge are suitable for use by people
with Diabetes.
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
Reckitt Benckiser
0005 MA 096/01102 CCDS/Excipient Update
1.3.1 Outer Packaging Clean
Strepsils SSF AMC DCBA 0333206 eCTD
Page 1
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 medicine can cause side effects, although not
everybody gets them. Side
effects may include rash, stomach pain, feeling sick, oral discomfort,
allergic reaction.
If you are allergic to any ingredients listed, do not take this
product.
Consult your doctor if symptoms persist or anything unusual happens.
Do not take for more than 3 days unless told to do so by yo

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT
CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Strepsils Strawberry Sugar Free
Lozenges Amylmetacresol 600
micrograms
2,4-Dichlorobenzyl alcohol 1.2mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lozenge contains amylmetacresol 600 micrograms and
2,4-Dichlorobenzyl alcohol
1.2 mg. Excipients with known effects:
Propylene Glycol 7.30
mg/lozenge. Isomalt (E 953)
1.83 g (1830 mg)/lozenge.
Maltitol liquid (E 965) 0.458 g (458 mg)/lozenge.
Benzyl Alcohol (present in Strawberry flavour) 0.0028
mg/lozenge. For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lozenge.
Pink, circular lozenge with a characteristic strawberry taste,
embossed on both sides with
Strepsils brand icon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Strepsils Sugar Free are indicated for the symptomatic relief of mouth
and throat
infections including sore throat.
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 every 2-3 hours. Do not take more than 12 lozenges in 24
hours.
PAEDIATRIC POPULATION:
CHILDREN OVER 6 YEARS OF AGE:
As above for adults.
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CHILDREN UNDER 6 YEARS OF AGE:
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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
Strepsils Strawberry Sugar Free Lozenges are contraindicated in
persons who have previously
shown hypersensitivity to the active substances or to any of the
excipients listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product is not recommended for young children due to a risk of
choking.
Consult your doctor if symptoms persist or if anything unusual
happens.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that
is to say