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BONJELA JUNIOR GEL

Active substance(s): CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE / CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE / CETYLPYRIDINIUM CHLORIDE / LIDOCAINE HYDROCHLORIDE

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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
Blood and lymphatic
system disorders
Immune System
Disorders
Skin and subcutaneous
tissue disorders
4.9

Preferred Term
Frequency
Methaemoglobinaemia Not known
Hypersensitivity

Not known

Contact dermatitis

Not known

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

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
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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