- Approval Id
- dec6ac506a76d168
- Drug Approval Emc Name
- Bonjela Cool Mint Gel
- Drug Name
- Bonjela Cool Mint Gel
- Company Address
- RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
- Company Website
- http://www.reckittbenckiser.com
- Company Telephone
- 0333 2005 345
- Company Medical Info Direct Line
- 0333 2005 345
- Company Customer Care Direct Line
- 0333 2005 345
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU87DS
United Kingdom
- Authorisation Number
- PL 00063/0122
- Authorisation Date
- 24/11/2000 / 23/02/2009
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU87DS
United Kingdom
- Instruction Authorisation Number
- PL 00063/0122
- Instruction Authorisation Date
- 24/11/2000 / 23/02/2009
- Instruction Composition
- | | |
| --- | --- |
| \*\*Active ingredient\*\* | \*\*%w/w\*\* |
| Choline salicylate\\* | 8.714 |
| Cetalkonium chloride | 0.010 |
| | |
| --- | --- |
| \\*Added as choline salicylate solution prepared from: | |
| Choline bicarbonate solution Salicylic acid | |
Excipients with known effect:
Ethanol 46.83 mg/dose
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Gel
- Instruction Clinical Particulars
- 4.1 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 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 pregnancy4.4 Special warnings and precautions for use
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 ethanol (alcohol) 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 product contains salicylate and should not be used with Acetylsalicylic Acid (Aspirin) or other salicylates except under the direction of a doctor.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 Fertility, pregnancy and lactation
\*\*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.4.7 Effects on ability to drive and use machines
None known4.8 Undesirable effects
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.4.9 Overdose
Salicylate toxicity can result if the stated dose is exceeded.
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning. Patients should be given supportive therapy or treatment for salicylate poisoning as necessary. This may include treatment like activated charcoal, urinary alkalinisation and in severe cases haemodialysis.
- Instruction Pharmacology
- 5.1 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.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Alcohol (96% v/v), glycerol, menthol, hypromellose 4500, mint flavour, sodium saccharin and purified water.6.2 Incompatibilities
None known6.3 Shelf life
Two years.6.4 Special precautions for storage
Do not store above 25° C6.5 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
Or
In a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap.
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 and other handling
No special requirements
- Instruction Content
- ## Composition
| | |
| --- | --- |
| \*\*Active ingredient\*\* | \*\*%w/w\*\* |
| Choline salicylate\\* | 8.714 |
| Cetalkonium chloride | 0.010 |
| | |
| --- | --- |
| \\*Added as choline salicylate solution prepared from: | |
| Choline bicarbonate solution Salicylic acid | |
Excipients with known effect:
Ethanol 46.83 mg/dose
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Gel
## Clinical Particulars
4.1 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 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 pregnancy4.4 Special warnings and precautions for use
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 ethanol (alcohol) 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 product contains salicylate and should not be used with Acetylsalicylic Acid (Aspirin) or other salicylates except under the direction of a doctor.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 Fertility, pregnancy and lactation
\*\*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.4.7 Effects on ability to drive and use machines
None known4.8 Undesirable effects
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.4.9 Overdose
Salicylate toxicity can result if the stated dose is exceeded.
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning. Patients should be given supportive therapy or treatment for salicylate poisoning as necessary. This may include treatment like activated charcoal, urinary alkalinisation and in severe cases haemodialysis.
## Pharmacological Properties
5.1 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.
## Pharmaceutical Particulars
6.1 List of excipients
Alcohol (96% v/v), glycerol, menthol, hypromellose 4500, mint flavour, sodium saccharin and purified water.6.2 Incompatibilities
None known6.3 Shelf life
Two years.6.4 Special precautions for storage
Do not store above 25° C6.5 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
Or
In a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap.
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 and other handling
No special requirements
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
