1. Name Of The Medicinal Product
Strepsils Warm Lozenges
2. Qualitative And Quantitative Composition
Amylmetacresol 0.6 mg
2,4-Dichlorobenzyl alcohol 1.2mg
For excipients, see 6.1.
3. Pharmaceutical Form
A red to purple coloured circular lozenge with a characteristic taste of warm plum and ginger. Strepsils brand icon is intagliated on both sides.
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 upto a maximum of 12 lozenges in 24 hours.
Elderly: There is no need for dosage reduction in the elderly.
Not suitable for children under 6 years.
4.3 Contraindications
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.
If symptoms persist consult your doctor.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
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 Warm Lozenges during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects 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
Pharmacokinetically the active ingredients, when present in a dosage form such as a lozenge, will exert their desired effect locally on the oropharynx.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber, which are additional to that included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Anthocyanin (E163),
Fruity Plum Flavour (contains Propylene Glycol)
Soothing Cream Flavour (contains Glycerol and Propylene Glycol)
Tartaric acid ,
Warm Sensation Flavour
Warm Ginger Spice Flavour
Medium chain triglycerides
Sucrose,
Glucose.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
18 months for lozenges packed in blister strips within a carton.
24 months for lozenges packed in polypropylene tube, with an in use shelf-life of 'use within 3 months of opening'.
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 or PVC/90gms PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 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 or PVC/90gms 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.
An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).
The tube contains 10 lozenges.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Reckitt Benckiser healthcare (UK) Limited
103 – 105 Bath Road
Slough
Berkshire
SL1 3UK
UK.
8. Marketing Authorisation Number(S)
PL 00063/0468
9. Date Of First Authorisation/Renewal Of The Authorisation
3rd August 2007.
10. Date Of Revision Of The Text
August 2010
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