1. Name Of The Medicinal Product
Strepsils Sore Throat and Blocked Nose
Strepsils Sore Throat and Cough
2. Qualitative And Quantitative Composition
|
|
|
|
|
|
3. Pharmaceutical Form
A blue circular lozenge with a characteristic taste.
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of mouth and throat infections, dry, irritating cough associated with the common cold and nasal congestion.
4.2 Posology And Method Of 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.
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 Sore Throat and Blocked Nose during pregnancy and lactation has not been established, but is not considered to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects are known.
4.8 Undesirable Effects
Occasionally hypersensitivity reactions and soreness of the tongue are a possibility.
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.
Menthol has a mild local anaesthetic action on the throat and also relieves the symptoms of nasal congestion.
5.2 Pharmacokinetic Properties
None available.
5.3 Preclinical Safety Data
None available.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Tartaric acid gran 572 GDE
Eucalyptus oil
Indigo carmine BP '73 (E132)
Liquid Sucrose
Liquid Glucose
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months for lozenges packed in blister strips within a carton.
18 months for blister pack 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 hard temper aluminium foil heat sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32 and 36 lozenges in a cardboard carton.
A blister push-through pack consisting of hard-temper aluminium foil heat-sealed to a PVC/PVDC blister. Two, four or six blisters are attached to a stencilled card.
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 00063/0398
9. Date Of First Authorisation/Renewal Of The Authorisation
6th April 2010
10. Date Of Revision Of The Text
April 2010
No comments:
Post a Comment