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BONJELA COOL MINT GEL

Active substance(s): CETALKONIUM CHLORIDE / CHOLINE SALICYLATE / CETALKONIUM CHLORIDE / CHOLINE SALICYLATE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Bonjela Cool Mint Gel

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Choline salicylate* Cetalkonium chloride *Added as choline salicylate solution prepared from: Choline bicarbonate solution Salicylic acid %w/w 8.714 0.010

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PHARMACEUTICAL FORM
Gel

4
4.1

CLINICAL PARTICULARS
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 Reyes syndrome when given to children. Reyes 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.

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5.1

PHARMACOLOGICAL PROPERTIES
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 l/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.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Alcohol (96% v/v), glycerol, menthol, hypromellose 4500, mint flavour, sodium saccharin and purified water.

6.2

Incompatibilities
None known

6.3

Shelf life
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. The 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

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MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU87DS United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 00063/0122

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/11/2000 / 23/02/2009

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DATE OF REVISION OF THE TEXT
01/02/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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