1. Name Of The Medicinal Product
Strepsils
2. Qualitative And Quantitative Composition
|
|
|
|
3. Pharmaceutical Form
A red circular lozenge.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of mouth and throat infections.
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
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach of children.
If symptoms persist consult your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions are known.
4.6 Pregnancy And Lactation
The safety of Strepsils Original Flavour has not been established, but is not expected to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects are known.
4.8 Undesirable Effects
Occasional hypersensitivity reactions.
4.9 Overdose
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
None available.
5.3 Preclinical Safety Data
None available.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Star Anise oil
Peppermint oil
Menthol natural or menthol synthetic
Tartaric acid gran 571 GDE
Ponceau 4R edicol E124
Carmoisine edicol E122
Liquid Sucrose
Liquid Glucose
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months for lozenges packed in blister strips within a carton.
24 months for blister packs attached to a stencilled card.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 18, 20, 22, 24, 32, 36 and 720 lozenges in a cardboard carton or a flow wrap composed of PET/aluminium foil/polyethylene
A blister push-through pack consisting of 15 or 20µm hard-temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. Two, four or six blisters are attached to a stencilled card.
Jar of polypropylene/ethyl-vinyl hydroxide (EVOH) barrier/ polypropylene laminate with a polypropylene cap fitted with an aluminium faced pulpboard liner, or a HDP jar with a tinplate cap fitted with an aluminium faced pulpboard liner. Pack size 1800 lozenges.
A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges in a wrap around cardboard carton with tamper-evident seal.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8. Marketing Authorisation Number(S)
PL 00063/0396
9. Date Of First Authorisation/Renewal Of The Authorisation
19th March 2010
10. Date Of Revision Of The Text
March 2010
No comments:
Post a Comment