SUMMARY OF PRODUCT CHARACTERISTICS

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

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, denture irritation and infant teething pain.

4.2    Posology and method of administration

Route of Administration: Oromucosal

Adults, the elderly and children over 3 months:

Apply a little gel to the sore area with either a clean finger tip or swab. This may be repeated after twenty minutes and then every three hours.

4.3    Contraindications

Known hypersensitivity to anaesthetics of the amide type.

Hypersensitivity to any of the active ingredients or excipients.

Babies under 3 months.

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 three months. Keep out of the reach and sight of children. If symptoms persist consult your doctor or dentist.

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.

4.6    Fertility, pregnancy and lactation

Pregnancy:

The safety of the product for use in human pregnancy has not been established. The product is, therefore, not recommended during pregnancy.

Lactation/Breastfeeding:

Lidocaine is distributed into breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels. No adverse effects have been seen in breast-fed 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

4.9 Overdose

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, fall of blood pressure, muscular tremors, convulsions, coma, irregular and weak breathing, cardiac standstill and bronchial spasm. Removal of the ingested drug by induced emesis followed by activated charcoal is only useful if the patient is seen within 30 minutes of ingestion. The airway must be maintained and artificial respiration with oxygen given until convulsions or depression are controlled and blood pressure and pulse return to normal.

Convulsions can be controlled with diazepam (0.1 mg/kg i.v.) or succinylcholine chloride (10-50 mg i.v. slowly). Perform artificial respiration with oxygen until convulsions are controlled and continue giving oxygen until blood pressure and pulse return to normal. Adequate arterial oxygen saturation must be maintained. If convulsions are not continuous the administration of oxygen may be sufficient to maintain the patient until the blood level of lidocaine falls. Do not give stimulants. The methaemoglobinaemia can be treated by methylene blue (1%, 0.1 ml/kg, i.v. over ten minutes). Treat fall in blood pressure by postural means (head down, feet raised, supine position) or with i.v. saline or blood transfusion if shock threatens. The critical period does not exceed one hour.

Suppression of pharyngeal sensation with concomitant effects on swallowing may theoretically result from excessive topical oral use of the gel. Such an effect has been reported in an adult who gargled and swallowed 5 ml of a 2% lidocaine hydrochloride solution (equivalent to 100 mg of lidocaine). However, assuming proportionality of body surface area and pharyngeal surface area, this dose would be equivalent to a single dose of 3.6 g of the gel for a three month old child.

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

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

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

06/10/2015