BONJELA Gel Ref.[49644] Active ingredients: Alkyldimethylbenzylammonium chloride Choline salicylate

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.

This medicinal product contains 46.83 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.

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

Pregnancy

Salicylates and Acetylsalicylic acid: low doses (up to 100 mg/day):

Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.

Breast feeding

Low quantities of salicylates and of their metabolites are excreted into the breast milk. Since adverse effects for the infant have not been reported up to now, short-term use of the recommended dose does not require suspending breastfeeding.

Fertility

There is no information on the effects of topical oral choline salicylate and fertility.

None known.

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.

¹ Salicylates 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.