Strepsils Children 6+ lozenges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amylmetacresol; Dichlorobenzyl alcohol

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

R02AA03

INN (International Name):

Amylmetacresol; Dichlorobenzyl alcohol

Dosage:

600microgram ; 1.2mg

Pharmaceutical form:

Lozenge

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030300; GTIN: 5000158103696

Patient Information leaflet

Package Leaflet: Information for the user
STREPSILS Children 6+ Lozenges
2,4-Dichlorobenzylalcohol,
Amylmetacresol
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you. This medicine is available without
prescription. However,
you still need to take Strepsils Children 6+ Lozenges carefully to get
the best results from it.
Strepsils Children 6+ Lozenges will be referred to as this medicine
throughout this leaflet.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your pharmacist. This includes
any possible side
effects not listed in the leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
What is in this leaflet:
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine contains two antiseptic ingredients for use in throat
medications. These are
used for the symptomatic relief of mouth and throat infections. These
ingredients are both
mild antiseptics which kill the bacteria associated with mouth and
throat
infections. The
action of sucking the lozenge allows the active ingredients to work in
the area
of the
discomfort and also helps lubricate and soothe the painful area. This
helps relieve the
soreness and discomfort of mouth and throat infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
This medicine is recommended for adults, children (over 6 years old)
and the elderly.
Children under 6 years old should not use this medicine.
Do not take this medicine if you:
•
are
allergic
(hypersensitive)
to
2,4-dichlorobenzyl
alcohol,
amylmetacresol,
isomaltitol, maltitol syrup or any of the other ingredients shown in
Section 6.
•
are

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Strepsils Children 6+ Lozenges
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Amylmetacresol 0.6mg/lozenge
2,4-Dichlorobenzyl alcohol 1.2mg/lozenge
Excipient(s) with known effect:
Propylene glycol (present in strawberry flavour)
Fragrance containing allergens – Benzyl Alcohol
Isomalt
Maltitol syrup
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A pink coloured circular lozenge with a characteristic taste of
strawberries. Strepsils
brand icon is intagliated on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an antiseptic for the relief of sore throat and its associated
pain.
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
Strepsils Children 6+ Lozenges are contraindicated in persons who have
previously
shown 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,
or if
symptoms are accompanied by a high fever or headache consult a doctor
or health
care professional.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THIS MEDICINE:
•
Contains isomalt 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.
•
This medicine contains 7.30 mg propylene glycol (present in strawberry
flavour) in each lozenge.
•
This medicine contains fragrance Benzyl Alcohol. Benzyl