- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
Oral gel containing:-
Choline salicylate 8.714%
Cetalkonium chloride 0.010%
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 also help fight minor mouth infection and aid the healing of sore spots and ulcers due to dentures and orthodontic devices.
Using a clean finger, massage approximately half an inch of the gel onto the sore area, not more than once every 3 hours.
Apply and leave at least 30 minutes before reinsertion of the dentures. Do no apply directly to the dentures.
Contraindicated in children under 16 years.
The CHM has advised that topical oral pain relief products containing salicylate salts should not be used in children under 16 years as a cautionary measure, due to the theoretical risk of Reye's syndrome.
Adolescents 16 years and over:
See adult dose.
Precautions and Warnings
Salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients.
Pregnancy at term (seePregnancy ).
If symptoms persist for more than seven days, advise the patient to consult a doctor or dentist.
Frequent application may led to salicylate poisoning.
The Commission on Human Medicines (CHM) has advised that topical oral pain relief products containing salicylate salts should not be used in children under 16 years as a cautionary measure, due to the theoretical risk of Reye's syndrome.
Pregnancy and Lactation
The manufacturer has noted that this medication is best avoided at term as there is clinical evidence of the safety of salicylates in pregnancy, but they may prolong bleeding and contribute to maternal and neonatal bleeding.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
The manufacturer has noted that this medication is unlikely to adversely affect the infant. Salicylates are excreted at low concentrations in breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
If symptoms persist for more than seven days, consult doctor or dentist.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Shelf Life and Storage
Do not store above 25 degrees C.
Last Full Review Date: January 2012.
British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.
BNF for Children (2011-2012) Pharmaceutical Press, London.
MHRA guidance issued 21/04/09 'New advice on oral salicylate gels in under 16s'.
Summary of Product Characteristics: Bonjela Gel, Reckitt Benckiser Healthcare (UK) Ltd, revised September 2009.
Summary of Product Characteristics: Bonjela Cool Mint Gel, Reckitt Benckiser Healthcare (UK) Ltd, revised November 2010.
(Summary of Product Characteristics for Pyralvex, Meda Pharmaceuticals, revised June 2011).
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