Strepsils Pain Relief Plus
SUMMARY 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.
For a full list of excipients, see section 6.1.
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
Posology
Use the lowest dose for the shortest duration necessary to relieve symptoms.
Adults
One lozenge every two hours as required. No more than 8 to be sucked in any 24 hours.
Paediatric population Children over 12 years As above for adults.
Children under 12 years
Not recommended for children under 12 years (see section 4.3).
Elderly
There is no need for dosage reduction in the elderly.
Method of administration
For oral administration. To be sucked slowly.
4.3 Contraindications
Strepsils Pain Relief Plus lozenges are contraindicated in persons who have previously shown hypersensitivity to any of the active ingredients or to any of the excipients listed in section 6.1.
A history of allergy to local anaesthetics of the amide-type.
In patients who have a history of or are suspected to have methaemoglobinaemia. Patients suffering from asthma or bronchospasm.
Children under 12 years of age.
4.4 Special warnings and precautions for use
Consult your doctor if symptoms persist after 3 days, or are accompanied by a high fever or headache.
Consult your doctor before taking this product if you are pregnant or breast-feeding. Patients with rare glucose-galactose malabsorption should not take this medicine.
4.5
Interaction with other medicinal products and other forms of interaction
While a number of interactions are theoretically possible with lidocaine, these drug interactions are unlikely to become clinically significant to the safety of the patients as the product is administered topically.
The toxicity of oral lidocaine may be increased when the drug is taken in combination with the following drugs:
• Erythromycin
• Itraconazole
• Cimetidine
• Fluvoxamine
• Beta blockers
• Other antiarrhythmic drugs (e.g. Mexiletine)
4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of this medicinal product for use in human pregnancy has not been established. However, a moderate amount of data on pregnant women (between 3001000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of lidocaine. There are no or limited amount of data from the use of amylmetacresol and
2,4-dichlorobenzyl alcohol.
The product is therefore not recommended during pregnancy except under medical supervision.
Breast-feeding
Lidocaine/ metabolites are excreted in human milk, but at therapeutic doses of the product no effects on the breastfed newborns/ infants are anticipated. It is unknown whether amylmetacresol, 2,4-dichlorobenzyl alcohol or metabolites are excreted in human milk. A risk to newborns / infants cannot be excluded.
The product is therefore not recommended during lactation except under medical supervision.
Fertility
No data are available regarding the effects of the active substances on fertility.
4.7 Effects on ability to drive and use machines
No adverse effects are known.
4.8 Undesirable effects
Adverse events which have been associated with amylmetacresol, 2,4-dichlorobenzyl alcohol and lidocaine are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (>1/10); Common (>1/100 and <1/10); Uncommon (>1/1000 and <1/100); Rare (>1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdosage will initially only produce excessive anaesthesia of the upper alimentary tract. However lidocaine intoxication can result in severe hypotension, asystole, bradycardia, apnoea, seizures, coma, cardiac arrest, respiratory arrest and death.
In view of the nature and presentation of Strepsils Pain Relief Plus lozenges, accidental or deliberate overdosage is highly unlikely.
Treatment of potentially toxicological overdose should be symptomatic and supportive and conducted under medical supervision.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Throat
Preparations; Antiseptics; ATC Code: R02AA03 Dichlorobenzyl alcohol
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties. Lidocaine is a local anaesthetic of the amide type, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited. It provides an anaesthetic effect by blocking neuronal transmission.
5.2
estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
|
System Organ Class |
Frequency |
Adverse Events |
|
Immune System Disorders |
Not known |
Hypersensitivity1 |
|
Gastrointestinal Disorders |
Not known |
Abdominal pain, nausea, oral discomfort |
|
Skin and Subcutaneous Tissue Disorders |
Not known |
Rash |
Description of Selected Adverse Reactions
i Hypersensitivity reactions to lidocaine may present in the form of angioedema, urticarial, bronchospasms and hypotension with syncope.
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.
2,4-Dichlorobenzyl alcohol is metabolised by the liver to form hippuric acid which is excreted in the urine.
No data available on amylmetacresol metabolism and elimination.
5.3 Preclinical safety data
There are no preclinical safety data of relevance to the consumer.
6 PHARMACEUTICAL PARTICULARS
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
19/07/2016