This information is intended for use by health professionals

1. Name of the medicinal product

Bonjela Junior gel

2. Qualitative and quantitative composition

Lidocaine hydrochloride 0.5% w/w

Cetylpyridinium chloride 0.025% w/w

Excipients with known effect:

Ethanol 96%

Banana Flavour (contains Propylene glycol)

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Oromucosal gel

4. 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).

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

None

4.8 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.

5. 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.

6. Pharmaceutical particulars
6.1 List of excipients

Ethanol 96%

Glycerol

Banana Flavour (contains Propylene glycol)

Sodium Saccharin

Carbomer

Triethanolamine

Water

6.2 Incompatibilities

None known.

6.3 Shelf life

Two years

6.4 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 filled into an aluminium collapsible tube, internally lacquered, with an aluminium membrane at the nozzle, sealed with latex, fitted with a white polyethylene flower pot 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.

7. Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Limited,

Wellcroft House,

Wellcroft Road,

Slough,

SL1 4AQ

United Kingdom

8. Marketing authorisation number(s)

PL 00063/0657.

9. Date of first authorisation/renewal of the authorisation

22 January 1988 / 04 Feburary 2000

10. Date of revision of the text

03/04/2019