- Approval Id
- e4eccddf2f6af65b
- Drug Approval Emc Name
- Bonjela Junior Gel
- Drug Name
- Bonjela Junior 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
- Atc Code
- N01BB52
- Legal Category
- General Sales List
- Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited,
Wellcroft House,
Wellcroft Road,
Slough,
SL1 4AQ
United Kingdom
- Authorisation Number
- PL 00063/0657.
- Authorisation Date
- 22 January 1988 / 04 Feburary 2000
- Instruction Authorisation Holder
- Reckitt Benckiser Healthcare (UK) Limited,
Wellcroft House,
Wellcroft Road,
Slough,
SL1 4AQ
United Kingdom
- Instruction Authorisation Number
- PL 00063/0657.
- Instruction Authorisation Date
- 22 January 1988 / 04 Feburary 2000
- Instruction Composition
- Lidocaine hydrochloride 0.5% w/w
Cetylpyridinium chloride 0.025% w/w
Excipients with known effect:
Ethanol 96% 242.2 mg/1g
Fragrances containing allergens (Eugenol)\\*
\\*in banana flavour
For a full list of excipients, see section 6.1.
- Instruction Dosage Form
- Oromucosal gel
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the relief of pain from common mouth ulcers and denture irritation.4.2 Posology and method of administration
Route of Administration: Oromucosal
\*\*Adults, the elderly and children over 5 months:\*\*
Apply a little gel to the sore area with either a clean fingertip or swab. This may be repeated after twenty minutes and then every three hours.4.3 Contraindications
Hypersensitivity to lidocaine or to any of the excipients listed in section 6.1.
Known hypersensitivity to local anaesthetics of the amide type.
Babies under 5 months.
In patients who have a history of or are suspected to have methaemoglobinaemia (see section 4.8).4.4 Special warnings and precautions for use
To be used with caution in patients with hepatic or cardiac dysfunction.
Do not exceed the stated dose. Not recommended for infants under five months.
Keep out of the reach and sight of children. If symptoms persist consult your doctor or dentist.
Excessive dosage, short intervals between doses or use on traumatised mucosa may result in high plasma levels and serious adverse effects (see Section 4.9).
\*\*Warnings related to Excipients:\*\*
This medicine contains 242.2 mg of alcohol (ethanol) per 1g. The amount in each 1g of this medicine is equivalent to less than 7 ml beer or 3 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 1g, that is to say essentially 'sodium-free'.
This medicine contains fragrance with Eugenol. Eugenol may cause allergic reactions.4.5 Interaction with other medicinal products and other forms of interaction
Concurrent use of either cimetidine or propranolol increases the risk of lidocaine toxicity. Lidocaine is antagonised by those diuretics which cause hypokalaemia.
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. antiarrhythmic drugs such as mexiletine, since the toxic effects may be additive.
In patients taking erythromycin the toxicity of oral lidocaine may be increased.
In patients taking itraconazole, the toxicity of oral lidocaine may be increased.4.6 Fertility, pregnancy and lactation
Pregnancy:
The safety of this medicinal product for use in human pregnancy has not been established. The product is, therefore, not recommended during pregnancy.
Lactation/Breastfeeding:
Lidocaine enters breast milk, but in such small quantities there is generally no risk of the child being affected at therapeutic dose levels.
No adverse effects have been seen in breastfed infants whose mothers were receiving lidocaine and it is therefore usually compatible with breast feeding.
Fertility:
No data on human fertility are available.4.7 Effects on ability to drive and use machines
None4.8 Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1,000 to < 1/100
Rare: ≥ 1/10,000 to <1/1,000
Very Rare: < 1/10,000
Not known: Frequency unable to be classified from available data.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| System Organ Class | Preferred Term | Frequency |
| Blood and lymphatic system disorders | Methaemoglobinaemia | Not known |
| Immune System Disorders | Hypersensitivity | Not known |
| Skin and subcutaneous tissue disorders | Contact dermatitis | Not known |
\*\*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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Overdose is highly unlikely given the size of the pack. No experience of overdosage.
It is most unlikely, even with misuse or excessive application of the gel, that the large amounts of lidocaine hydrochloride or cetylpyridinium chloride required to produce clinically-relevant toxic effects would be reached. In the event of overdose, use should be discontinued and a doctor consulted.
The toxic effects of lidocaine are directly related to blood concentrations. Symptoms are dizziness, cyanosis due to methaemoglobinaemia, muscular tremors, convulsions, coma, irregular and weak breathing, cardiac standstill, bronchial spasm, severe hypotension, asystole, bradycardia, apnoea, seizures, coma, cardiac arrest, respiratory arrest, and death.
\*\*Management\*\*
In the unlikely event of overdose with this product, immediate treatment should be sought which should be symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Lidocaine, combinations\*\*; ATC Code:\*\* N01BB52
Lidocaine is a local anaesthetic of the amide type, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.
Cetylpyridinium chloride is a quaternary pyridinium antiseptic with actions and uses similar to those of other cationic surfactants.5.2 Pharmacokinetic properties
Lidocaine is readily absorbed through the mucous membranes and is hydrolysed mainly by the liver.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Ethanol 96%
Glycerol
Fragrances containing allergens (Eugenol)\\*
\\*in banana flavour
Sodium Saccharin
Carbomer
Triethanolamine
Water6.2 Incompatibilities
None known.6.3 Shelf life
Two years6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
10g of product is filled into a 16 x 101mm aluminium collapsible tube internally lacquered with a 9mm membrane nozzle with spiked cap.
15g of product is contained in a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap. The tube is then packed into a carton.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
Lidocaine hydrochloride 0.5% w/w
Cetylpyridinium chloride 0.025% w/w
Excipients with known effect:
Ethanol 96% 242.2 mg/1g
Fragrances containing allergens (Eugenol)\\*
\\*in banana flavour
For a full list of excipients, see section 6.1.
## Pharmaceutical Form
Oromucosal gel
## Clinical Particulars
4.1 Therapeutic indications
For the relief of pain from common mouth ulcers and denture irritation.4.2 Posology and method of administration
Route of Administration: Oromucosal
\*\*Adults, the elderly and children over 5 months:\*\*
Apply a little gel to the sore area with either a clean fingertip or swab. This may be repeated after twenty minutes and then every three hours.4.3 Contraindications
Hypersensitivity to lidocaine or to any of the excipients listed in section 6.1.
Known hypersensitivity to local anaesthetics of the amide type.
Babies under 5 months.
In patients who have a history of or are suspected to have methaemoglobinaemia (see section 4.8).4.4 Special warnings and precautions for use
To be used with caution in patients with hepatic or cardiac dysfunction.
Do not exceed the stated dose. Not recommended for infants under five months.
Keep out of the reach and sight of children. If symptoms persist consult your doctor or dentist.
Excessive dosage, short intervals between doses or use on traumatised mucosa may result in high plasma levels and serious adverse effects (see Section 4.9).
\*\*Warnings related to Excipients:\*\*
This medicine contains 242.2 mg of alcohol (ethanol) per 1g. The amount in each 1g of this medicine is equivalent to less than 7 ml beer or 3 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 1g, that is to say essentially 'sodium-free'.
This medicine contains fragrance with Eugenol. Eugenol may cause allergic reactions.4.5 Interaction with other medicinal products and other forms of interaction
Concurrent use of either cimetidine or propranolol increases the risk of lidocaine toxicity. Lidocaine is antagonised by those diuretics which cause hypokalaemia.
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics, e.g. antiarrhythmic drugs such as mexiletine, since the toxic effects may be additive.
In patients taking erythromycin the toxicity of oral lidocaine may be increased.
In patients taking itraconazole, the toxicity of oral lidocaine may be increased.4.6 Fertility, pregnancy and lactation
Pregnancy:
The safety of this medicinal product for use in human pregnancy has not been established. The product is, therefore, not recommended during pregnancy.
Lactation/Breastfeeding:
Lidocaine enters breast milk, but in such small quantities there is generally no risk of the child being affected at therapeutic dose levels.
No adverse effects have been seen in breastfed infants whose mothers were receiving lidocaine and it is therefore usually compatible with breast feeding.
Fertility:
No data on human fertility are available.4.7 Effects on ability to drive and use machines
None4.8 Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1,000 to < 1/100
Rare: ≥ 1/10,000 to <1/1,000
Very Rare: < 1/10,000
Not known: Frequency unable to be classified from available data.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| System Organ Class | Preferred Term | Frequency |
| Blood and lymphatic system disorders | Methaemoglobinaemia | Not known |
| Immune System Disorders | Hypersensitivity | Not known |
| Skin and subcutaneous tissue disorders | Contact dermatitis | Not known |
\*\*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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
\*\*Symptoms\*\*
Overdose is highly unlikely given the size of the pack. No experience of overdosage.
It is most unlikely, even with misuse or excessive application of the gel, that the large amounts of lidocaine hydrochloride or cetylpyridinium chloride required to produce clinically-relevant toxic effects would be reached. In the event of overdose, use should be discontinued and a doctor consulted.
The toxic effects of lidocaine are directly related to blood concentrations. Symptoms are dizziness, cyanosis due to methaemoglobinaemia, muscular tremors, convulsions, coma, irregular and weak breathing, cardiac standstill, bronchial spasm, severe hypotension, asystole, bradycardia, apnoea, seizures, coma, cardiac arrest, respiratory arrest, and death.
\*\*Management\*\*
In the unlikely event of overdose with this product, immediate treatment should be sought which should be symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic group:\*\* Lidocaine, combinations\*\*; ATC Code:\*\* N01BB52
Lidocaine is a local anaesthetic of the amide type, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.
Cetylpyridinium chloride is a quaternary pyridinium antiseptic with actions and uses similar to those of other cationic surfactants.5.2 Pharmacokinetic properties
Lidocaine is readily absorbed through the mucous membranes and is hydrolysed mainly by the liver.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
## Pharmaceutical Particulars
6.1 List of excipients
Ethanol 96%
Glycerol
Fragrances containing allergens (Eugenol)\\*
\\*in banana flavour
Sodium Saccharin
Carbomer
Triethanolamine
Water6.2 Incompatibilities
None known.6.3 Shelf life
Two years6.4 Special precautions for storage
Do not store above 25°C.6.5 Nature and contents of container
10g of product is filled into a 16 x 101mm aluminium collapsible tube internally lacquered with a 9mm membrane nozzle with spiked cap.
15g of product is contained in a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap. The tube is then packed into a carton.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/reckitt-benckiser-healthcare-uk-ltd
