1. Name Of The Medicinal Product
Strepsils Honey and Lemon
2. Qualitative And Quantitative Composition
Amylmetacresol BP 0.6mg
2,4
For excipients, see 6.1
3. Pharmaceutical Form
A yellow 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
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 Honey and Lemon during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects are known.
4.8 Undesirable Effects
Occasionally 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
5.2 Pharmacokinetic Properties
None available.
5.3 Preclinical Safety Data
None available.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Honey
Tartaric acid
Peppermint oil
Terpeneless lemon oil
Quinoline yellow
Liquid sugar
Liquid glucose
6.2 Incompatibilities
Not applicable.
.
6.3 Shelf Life
36 months for lozenges packed in blister strips within a carton.
36 months for lozenges packed in polypropylene tube, with an in use shelf-life of 'use within 3 months of opening'.
18 months for blister packs attached to a stencilled card.
6.4 Special Precautions For Storage
Carton or Stencilled card - Do not store above 25°C.
Polypropylene tube – No storage restrictions
6.5 Nature And Contents Of Container
A blister push through pack consisting of hard temper aluminium foil heat
Sample packs consisting of two, four or six individual lozenge blister strips attached to a card.
A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a 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.
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.
20 lozenges consisting of a bundled pack of 2 tubes of 10 lozenges each.
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) Ltd
Slough
SL1 3UH
8. Marketing Authorisation Number(S)
PL 00063/0397
9. Date Of First Authorisation/Renewal Of The Authorisation
19th March 2010
10. Date Of Revision Of The Text
March 2010
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