Strepsils Pain Relief Plus
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Pain Relief Plus.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active Ingredients |
Quantity |
Specification |
|
Amylmetacresol |
0.6mg |
BP |
|
2,4-Dichlorobenzyl alcohol |
12mg |
HSE |
|
Lidocaine hydrochloride |
10.0mg |
Ph Eur |
|
(Lidocaine base |
8.11mg) |
Ph Eur |
An overage of 2.5% is added for amylmetacresol, 5.0% for 2,4-Dichlorobenzyl alcohol and 4% for Lidocaine hydrochloride.
3 PHARMACEUTICAL FORM
Pale blue-green circular, translucent lozenge with an icon intagliated on both sides of the lozenge. The lozenge has a mint taste.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Strepsils Pain Relief Plus lozenges are indicated for the symptomatic relief of mouth and throat infections including severe sore throat.
Strepsils Pain Relief Plus is indicated in adults, children and adolescents aged 12 to 18 years of age.
4.2 Posology and method of administration
Adults and children over 12 years
One lozenge to be sucked slowly every two hours as required. No more than 8 to be sucked in any 24 hours.
Children under 12 years
Not recommended for children under 12 years.
Elderly
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Strepsils Pain Relief Plus lozenges are contraindicated in persons who have previously shown hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Not recommended for children under 12 years.
Warning: Do not exceed the stated dose.
Keep all medicines out of the reach of children.
Consult your doctor if symptoms persist or are accompanied by a high fever or headache.
Consult your doctor before taking this product if you are pregnant or breast-feeding.
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 this medicinal product for use in human pregnancy has not been established. The product is therefore not recommended during pregnancy and lactation except under medical supervision.
4.7 Effects on ability to drive and use machines
No adverse effects are known.
4.8 Undesirable effects
Occasional hypersensitivity reactions.
4.9 Overdose
In view of the nature and presentation of Strepsils Pain Relief Plus lozenges, accidental or deliberate overdosage is highly unlikely.
Overdosage will initially produce excessive anaesthesia of the upper alimentary tract. Treatment of potentially toxicological overdose should be symptomatic and supportive and conducted under medical supervision.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties. Lidocaine is a local anaesthetic of the amide type.
5.2 Pharmacokinetic properties
Lidocaine is readily absorbed from mucous membranes. The plasma elimination half life is about 2 hours.
Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.
No data available on amylmetacresol and 2,4-dichlorobenzyl alcohol.
5.3 Preclinical safety data
There are no preclinical safety data of relevance to the consumer.
6.1 List of excipients
Tartaric acid Sodium saccharin Levomenthol Peppermint oil Star Anise oil Quinoline yellow (E104) Indigo carmine (E132)
Liquid sugar for confectionery Liquid glucose
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
The lozenges are contained in a strip pack. The tray contains an appropriate number of lozenges to give pack sizes of 24, 32 and 36 lozenges in a cardboard carton.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser healthcare (UK) limited
103-105 bath road
Slough
Berkshire
SL13UH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0427
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
5th January 1995
10 DATE OF REVISION OF THE TEXT
14/11/2013