Strepsils Orange with Vitamin C 100mg

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Prieinama:

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

ATC kodas:

R02AA03

INN (Tarptautinis Pavadinimas):

AMYLMETACRESOL 0.6 mg ASCORBIC ACID 100 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg

Vaisto forma:

LOZENGE

Sudėtis:

AMYLMETACRESOL 0.6 mg ASCORBIC ACID 100 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg

Recepto tipas:

OTC

Gydymo sritis:

THROAT PREPARATIONS

Autorizacija statusas:

Authorised

Leidimo data:

2006-02-28

Pakuotės lapelis

PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON)
1. NAME OF THE MEDICINAL PRODUCT
Strepsils Orange with Vitamin C Lozenges
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Active Ingredients: Amylmetacresol 0.6mg, 2,4-Dichlorobenzyl Alcohol
1.2mg and Vitamin C (as Sodium
Ascorbate / Ascorbic Acid) 100mg.
3. LIST OF EXCIPIENTS
Each lozenge contains 0.97 g glucose and 1.44 g sucrose 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 19.36 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.
Each lozenge contains 3 mg propylene glycol.
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 skin
reactions and bronchospasm.
The orange flavour contains citral, citronellol, d-Limonene, geraniol
and linalool, which may cause allergic
reactions.
The Azo colouring agents Ponceau 4R (E124) and Sunset Yellow (E110)
may cause allergic reactions.
Also contains Tartaric Acid and Menthol.
4. PHARMACEUTICAL FORM AND CONTENTS
Lozenge
24 lozenges
36 lozenges
Strepsils Orange with Vitamin C 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. 100mg Vitamin C to help boost
levels of Vitamin C which is beneficial
during an infection.
5. METHOD AND ROUTE(S) OF ADMINISTRATION
6. SPECIAL WARNING: THAT THE MEDICINAL PRODUCT MUST BE
STORED 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

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
Strepsils Orange with Vitamin C Lozenges
Amylmetacresol 0.6mg
2, 4-Dichlorobenzyl Alcohol 1.2mg
Vitamin C 100mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.6 mg Amylmetacresol, 1.2 mg 2,
4-Dichlorobenzyl Alcohol and 100 mg
Vitamin C (as Ascorbic Acid and Sodium Ascorbate).
Excipients with known effects:
Glucose 0.97 g (968 mg)/lozenge.
Sucrose 1.44 g (1438 mg)/lozenge.
Propylene glycol 3 mg/lozenge.
Wheat Starch (containing gluten present in liquid glucose) 19.36
micrograms/lozenge.
Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.124
ppm/lozenge.
Orange flavour fragrances containing citral, citronellol, d-Limonene,
geraniol and linalool.
Colouring agents Ponceau 4R (E124) and Sunset yellow (E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lozenge
An orange flavoured and coloured circular lozenge. Embossed on both
sides with strepsils brand
icon.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of mouth and throat infection.
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 POPULATIONS:
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 WARNINGS AND SP