1. Name Of The Medicinal Product
Strepsils Extra Citrus Menthol Lozenges
STREPSILS Extra Strength Lemon Menthol Lozenges
2. Qualitative And Quantitative Composition
Hexylresorcinol Ph Eur 2.4mg
For excipients, see 6.1.
3. Pharmaceutical Form
Lozenge.
4. Clinical Particulars
4.1 Therapeutic Indications
As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.
4.2 Posology And Method Of Administration
For oral administration.
Adults, the elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 6 years.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
The label will convey:
Do not exceed the stated dose.
Keep out of the reach of children.
Not to be given to children under 6 years.
This product is unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltase deficiency.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
There is a lack of evidence of safety of the product in human pregnancy, but hexylresorcinol has been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
None known.
4.9 Overdose
Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.
The product base has a demulcent action.
5.2 Pharmacokinetic Properties
Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharangeal cavity.
5.3 Preclinical Safety Data
There are no pre-clinical data available specific to the product.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Liquid Sucrose,
Liquid Glucose,
Propylene Glycol,
Levomenthol,
Lemon Flavour,
Quinoline Yellow (E104),
Indigo Carmine (E132).
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original packaging. Keep in the outer carton.
6.5 Nature And Contents Of Container
Blister packs of 250 micron PVC coated 40 gsm PVDC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVDC blister containing 6, 8, 10, 12, 16, 20, 24, 32 or 36 lozenges in a carton.
6.6 Special Precautions For Disposal And Other Handling
None specific to the product/pack.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8. Marketing Authorisation Number(S)
PL 00063/0394
9. Date Of First Authorisation/Renewal Of The Authorisation
6th April 2010
10. Date Of Revision Of The Text
April 2010
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