1. Name Of The Medicinal Product
Strepsils Extra Blackcurrant Lozenges
STREPSILS Extra Triple Action Blackcurrant Lozenges
STREPSILS Extra Strength Blackcurrant Lozenges
2. Qualitative And Quantitative Composition
Each lozenge contains Hexylresorcinol 2.4 mg.
For excipients see Section 6.1.
3. Pharmaceutical Form
Lozenge
A round purple 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
Keep out of reach and sight of children.
If symptoms persist consult your doctor.
Not to be given to children under 6 years.
This product is unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltose deficiency.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
There is lack of evidence of safety of the product in human pregnancy and in animals, 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
None 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-pharyngeal cavity.
5.3 Preclinical Safety Data
There are no preclinical data of relevance additional to those already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Liquid sucrose, Liquid glucose, Blackcurrant flavour (containing propylene glycol), Levomenthol, Carmoisine Edicol (E122), Patent Blue V (E131).
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months for the unopened blister pack.
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 40gsm PVDC with 20 micron hard temper aluminium foil heat-sealed to the PVC/PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 2, 4, 6, 12, 16, 32 or 36.
24 lozenges in 2 blister strips in a carton.
8 lozenges in a blister in a carton or a flow wrap outer composed of PET/aluminium foil/polyethylene.
Blister packs of 250 micron PVC/coated 40gsm PVDC with 20 micron hard temper aluminium foil heat-sealed to the PVC/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
None specific to the product/pack.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 3UH
8. Marketing Authorisation Number(S)
PL 00063/0392
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