1. Name Of The Medicinal Product
Strepsils Strawberry Sugar Free Lozenges
2. Qualitative And Quantitative Composition
Amylmetacresol BP 0.6mg/lozenge
2,4-Dichlorobenzyl alcohol 1.2mg/lozenge
For excipients, see 6.1
3. Pharmaceutical Form
Lozenge
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
For oral administration
Adults and children (over 6 years old)
One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
Not suitable for children under 6 years.
Elderly
There is no need for dosage reduction in the elderly
4.3 Contraindications
Strepsils Strawberry Sugar Free Lozenges are contraindicated in persons who have previously shown hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach and sight of children.
Not to be given to children under 6 years.
If symptoms persist consult your doctor.
Warning: Do not exceed the stated dose.
Consult your doctor if symptoms persist or are accompanied by a high fever or headache.
Contains isomaltitol 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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
The product is not contraindicated during pregnancy and lactation. However, as with all medicines during this period, caution should be exercised.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
Occasional hypersensitivity reactions.
4.9 Overdose
In view of the nature and presentation of Strepsils Strawberry Sugar Free Lozenges, accidental or deliberate overdosage is highly unlikely.
Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.
5.2 Pharmacokinetic Properties
No data available.
5.3 Preclinical Safety Data
There are no preclinical data available specific to the product.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Flav P Strawberry Flavour
Ponceau 4R (E124)
Saccharin sodium Ph Eur (E954)
Tartaric acid Ph Eur
Isomalt (Isomaltitol E953)
Maltitol syrup (E965)
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
Do not store above 25°C
6.5 Nature And Contents Of Container
The lozenges are contained in a strip pack containing either 6, 8, 12, 16, 20, 24, 32 or 36 lozenges packed into a cardboard carton.
The lozenges are contained in a strip pack containing 8 lozenges packed into a wrap around cardboard carton with tamper-evident seal.
Not all pack sizes may be marketed
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8. Marketing Authorisation Number(S)
PL 00063/0395
9. Date Of First Authorisation/Renewal Of The Authorisation
6th April 2010
10. Date Of Revision Of The Text
April 2010.
No comments:
Post a Comment