Bonjela
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonjela
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active ingredient |
%w/w |
Specification |
|
Choline salicylate* |
8.7 14 |
Reckitt Benckiser |
|
Cetalkonium chloride |
0.0 10 |
Reckitt Benckiser |
|
*Added as choline salicylate solution prepared from: | ||
|
Choline bicarbonate solution |
Reckitt Benckiser | |
|
Salicylic acid |
Ph.Eur |
3 PHARMACEUTICAL FORM
Gel.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of pain, discomfort and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots due to orthodontic devices. To help to fight minor mouth infection and aid healing of sore spots and ulcers due to dentures and orthodontic devices.
4.2 Posology and method of administration
By topical application to the oral mucosa.
Adults and children over the age of 16: Using a clean finger massage approximately half an inch of the gel onto the sore area, not more than once every 3hours.
There is no indication that dosage need be modified in the elderly.
Denture irritation: Apply and leave at least 30 minutes before reinsertion of the dentures. Do not apply this product directly to the dentures.
4.3 Contraindications
Not to be used in children and adolescents under the age of 16. This is because there is a possible association between salicylates and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease which affects the brain and liver and can be fatal.
Not to be used in patients suffering from active peptic ulceration or known to be allergic to salicylates.
4.4 Special warnings and precautions for use
Label
warnings: Do not exceed the stated dose. If symptoms persist
for more than seven days consult your doctor or dentist. Keep out of the reach of children. Contains ethanol.
4.5 Interaction with other medicinal products and other forms of interaction
Salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics.
4.6 Pregnancy and lactation
There is clinical evidence of the safety of salicylates in pregnancy, but they may prolong bleeding and contribute to maternal and neonatal bleeding, and are best avoided at term. Salicylates are excreted at low concentrations in breast milk, but are unlikely to adversely affect the infant.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.
4.9 Overdose
Salicylate toxicity can result if the stated dose is exceeded.
The usual procedure for salicylate overdosage should be followed, including general supportive measures and gastric lavage if necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Choline salicylate is the choline salt of salicylic acid and its pharmacology is essentially that of salicylic acid. It has exhibited anti-inflammatory analgesic and antipyretic actions in animal models, and is taken orally or is applied topically in man for the relief of pain and inflammation. Like salicylic acid it has no antithrombotic activity and shows a low potential for production of gastrointestinal injury when given by the oral route. The pharmacological actions of choline salicylate are thought to be primarily mediated through inhibition of prostaglandin production, although effects on lukotriene pathways, kinin release and nerve conduction have been proposed.
Cetalkonium chloride is a quaternary ammonium antimicrobial agent, being bactericidal towards both Gram positive and Gram negative organisms, but with preference for the former.
5.2 Pharmacokinetic properties
Choline salicylate is absorbed from the gut and is likely to be absorbed across mucous membranes such as all buccal mucosa. Metabolism of salicylic acid is by glycine and phenolic or acyl glucuronate conjugation with small amounts undergoing hydroxylation. The plasma half-life of salicylic acid is 2-4 hours. Both metabolites and a small amount of intact salicylic acid are excreted, mainly in the urine. Salicylic acid is highly (80-90%) protein bound and although it has a low apparent volume of distribution of around 0.15 1/kg it is widely distributed throughout extracellular water and most tissues.
5.3 Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6.1 List of excipients
Alcohol (96% v/v), glycerol, levomenthol, hypromellose 4500, star anise oil EP, sodium saccharin and purified water.
6.2
Incompatibilities
None known.
Shelf life
6.3
Two years.
6.4. Special precautions for storage
Do not store above 25 °C
6.5 Nature and contents of container
Gel is contained in an extruded aluminium membrane tube with an internal lacquer, plastic neck insert and plastic tamper-evident closure Or
In a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap.
The 10g and 15g tubes are packed in a cardboard outer carton. The 3g tube is presented on a supporting card.
6.6 Special precautions for disposal
For topical application to the oral mucosa.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0121
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/05/2008
10 DATE OF REVISION OF THE TEXT
27/05/2015