Medijel Pastilles
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MEDIJEL PASTILLES
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lignocaine Hydrochloride BP 0.25 % w/w
Aminacrine Hydrochloride BP 1968 0.025 %w/w
3 PHARMACEUTICAL FORM
Soft Pastille
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The quick effective relief from the pain of common mouth ulcers, soreness of gums and denture rubbing.
4.2 Posology and method of administration
Place pastille against affected area and let it dissolve slowly. Repeat as necessary.
Each pastille weighs approximately 1.2g, i.e. 3mg of Lignocaine Hydrochloride and 0.3mg of Aminacrine Hydrochloride.
Medijel Pastilles can be used as directed for adults and children.
4.3 Contraindications
Hypersensitivity to the active substances or to any other of the ingredients.
Contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.4 Special warnings and precautions for use
If symptoms persist longer than 7 days following the use of the product, a doctor or dentist should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
The safety of Medijel Pastilles during pregnancy and lactation has not been established, but is considered not to constitute a hazard.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Hypersensitivity reactions to Lignocaine have been reported on rare occasions.
4.9 Overdose
Maximum safe dosage for a 70kg adult is 750mg for Lignocaine (Goodman & Gilman, page 313). A pack of Medijel pastilles contains approximately 75mg of Lignocaine Hydrochloride - overdose is not a problem.
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PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Lignocaine Hydrochloride is well documented in Martindale 28th Edition page 900 - 904 and Goodman & Gilman, chapter 15 and pages 767 - 770.
Lignocaine Hydrochloride was first introduced in 1948 and is one of the most widely used local anaesthetics. However, it produces more prompt, more intense, longer lasting and more extensive anaesthesia than does an equal concentration of procaine (Peak anaesthesia within 2-5 minutes). Local anaesthetics are drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They have good powers of penetration and their action is reversible. Their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.
Aminacrine Hydrochloride is a slow acting disinfectant. It exerts germicidal action against bacteria and fungi. It is also used as a surgical and endodontic irrigant and to treat local infections of the ear, mouth and throat. Its exact mode of action is not known but it involves disruption of certain metabolic pathways.
5.2 Pharmacokinetic properties
Lignocaine is readily absorbed through mucous membranes. They exert their effects in the form of the non-ionised base. Lignocaine undergoes first-pass metabolism in the liver and bioavailablity is low after administration by mouth. It is rapidly de-ethylated to the active metabolite monoethyiglycinexylidide and then hydrolysed by amidases to various compounds, including glycineexylidide which has reduced activity but a longer elimination half-life. Less than 10% of a dose is excreted unchanged via the kidneys. The metabolic products are excreted in the urine.
Aminacrine Hydrochloride if administered systematically is rapidly eliminated through the kidney (0.2 g being eliminated from the blood in 30 minutes. Medijel Pastilles dose 0.15mg Aminacrine Hydrochloride)
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
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PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydroxypolyethoxydodecane HSE, Gelatin BP, Liquid Glucose BPC 1963, Sucrose EP,
Peppermint Oil BP, Levomenthol BP, Ethyl Vanillin NF, Standard Green SE 142,
Dextrose Monhydrate BP, Water (potable).
6.2 Incompatibilities
None encountered.
6.3 Shelf life
48 months.
6.4 Special precautions for storage
No special storage conditions.
6.5 Nature and contents of container
Aluminium Foil/Polyethylene laminate within coated boxboard carton.
Pack size: 30g
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Diomed Developments Ltd. T/A Dermal Laboratories
Tatmore Place Gosmore Hitchin Herts SG47QR
8 MARKETING AUTHORISATION NUMBER(S)
PL 00173/0409
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25th April 2011
10 DATE OF REVISION OF THE TEXT
16/05/2011