Reckitt Benckiser Ireland Limited

Bonjela Oromucosal Gel

Choline Salicylate 8.714%

Cetalkonium Chloride 0.010%

Excipients: Ethanol 33.45% w/w

For a full list of excipients, see section 6.1.

Oromucosal gel.

Clear, colourless gel.

For the relief of pain and discomfort of common mouth ulcers, cold sores, denture sore spots, infant teething and mouth ulcers, and sore spots due to orthodontic devices in children.

To aid healing of sore spots and ulcers due to dentures in adults and orthodontic devices in children.

By topical application to the oral mucosa.

Adults: Using a clean finger, massage approximately one centimeter of the gel onto the sore area, not more than once every 3 hours.

Children (from four months): Using a clean finger, massage a pea size amount of gel onto the sore area, not more than once every 3 hours. Do not apply more than six doses in any 24 hour period. Not suitable for infants under four months.

Do not exceed the stated dose.

Orthodontic devices: Apply to the sore area as described above, not more than once every 3 hours.

Denture irritation: Apply and leave at least 30 minutes before re-insertion of the dentures. Do not apply this product directly to the dentures.

There is no indication that dosage need be modified in the elderly.

Not to be used in infants under four months. Not to be used in patients with hypersensitivity to salicylates, aspirin or other NSAIDs, or to any of the excipients.

This product contains salicylate and should not be used with aspirin or other salicylates except under the direction of a doctor.

Do not use this product if you have a stomach ulcer.

Do not use if you are currently suffering from varicella (chicken pox) or influenza infection.

Consult your doctor if you are pregnant or breastfeeding.

If there is no improvement after 7 days or there is aggravation of the condition, the doctor should be consulted.

Caution: frequent application, especially in children, may give rise to salicylate poisoning (see section 4.9).

Salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics.

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, and may adversely affect the infant in very rare cases.

None known.

Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients. They can cause stomatitis, burns, allergic reactions, transient numbing and stinging.

There have been post-marketing reports of cases of suspected Reyes syndrome and possible salicylate toxicity in children who had a history of use of choline salicylate gels but causality has not been established.

i) Dealing with the potential for toxicity with local application, especially in infants:

As choline salicylate is absorbed across the buccal mucosa, the possibility exists for toxicity, especially in infants hence the need for caution not to exceed the stated dose and monitor for any signs of suggested salicylism.

Symptoms: Nausea, vomiting, tinnitus, hyperventilation, high fever, confusion, dehydration, disorientation, dizziness, coma and/or convulsions are common. Gastrointestinal haemorrhage is frequent. Some degree of acid-base disturbance is present in most cases.

ii) Dealing with overdose in the event of accidental ingestion of product:

Serum salicylate levels above 3.6 mmol/l in adults (2.2 mmol/l in children) are likely to be toxic and levels of 5.4 mmol/l or above are fatal.

Treatment: Drug absorption can be stopped by induced vomiting or gastric lavage within an hour of ingestion. Activated charcoal is to be given by mouth if the patient is suspected of ingesting more than 120mg/kg of salicylate within 1 hour of presentation to enhance excretion. The plasma salicylate concentration should be measured if ingestion of more than 12mg/kg of salicylate is suspected.

Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urinary pH should also be monitored.

Haemodialysis may be used for severe poisoning in patients with plasma salicylate concentrations >700mg/L or in patients with severe clinical or metabolic symptoms. Vulnerable patients such as children or the elderly may require dialysis at an earlier stage.

ATC code: N02BA03 / Salicylic acid and derivatives

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.

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 0.151 l/kg it is widely distributed throughout extracellular water and most tissues.

No preclinical findings of relevance to the prescriber have been reported.

Ethanol (96% w/w), glycerol, levomenthol, hypromellose 4500, star anise oil, saccharin sodium and purified water.

Not applicable.

2 years.

This medicinal product does not require any special storage conditions.

Gel is contained in a collapsible aluminium tube with an internal lacquer, plastic neck insert and plastic tamper-evident closure. The 10 g and 15 g tubes are packed in a cardboard outer carton. The 3 g tube is presented on a supporting card.

Do not store above 25^oC

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/1/1.

Date of first authorisation: 1st April, 1983

Date of last renewal: 1st April, 2008

July 2010.