BONJELA

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.

The list of the following adverse effects relates to those experienced with topical oral salicylates at OTC doses, in short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Adverse events which have been associated with salicylates are given below, listed 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) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse events are presented in order of decreasing seriousness. System Organ Class Frequency Adverse Event Respiratory, Thoracic and Mediastinal Disorders Not known Bronchospasm, and asthma1. Immune System Disorders Not known Hypersensitivity 1Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.

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. uk/yellowcard.

Label warnings:

Do not exceed the stated dose. Consult your doctor or dentist before use if you are in the first or second trimester of pregnancy or when symptoms persist for more than seven days. Keep out of the reach of children. 83 mg of alcohol (ethanol) in each dose.

The amount in each dose of this medicine is equivalent to less than 2 ml beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. It may cause burning sensation on damaged skin. This medicine contains less than 1 mmol sodium (23 mg) in each dose, that is to say essentially ‘sodium-free’.

This medicine contains fragrance with d-limonene, anisyl alcohol and linalool. d-Limonene, anisyl alcohol and linalool may cause allergic reactions. This product contains salicylate and should not be used with acetylsalicylic acid (aspirin) or other salicylates except under the direction of a doctor.

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. Not to be used in patients with hypersensitivity to salicylates, Acetylsalicylic Acid (Aspirin) or other NSAIDs, or to any of the excipients. Salicylates and Acetylsalicylic acid: doses > 100 mg/day during the third trimester of pregnancy