BONJELA TEETHING GEL - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Bonjela Teething Gel.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1Equivalent to 0.27% w/w of Lidocaine base.

Excipients:

Also contains Ethanol (33.45%w/w)

Fragrances containing allergens (in Banana flavour)

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Water soluble viscous gel.

4.1 Therapeutic Indications

For the relief of pain and discomfort associated with teething in children from 5 months of age, where nonpharmacological treatments have failed to provide sufficient relief.

4.2 Posology and Method of Administration

Topical application to the gums.

Children from 5 months of age:

Apply a pea-sized amount (0.2 grams) of Bonjela Teething gel with a clean finger to the affected area of gum.

The dose may be repeated if necessary after 3 hours, up to a maximum of 6 doses in 24 hours.

Treatment should be stopped once symptoms have resolved.

Not to be used for more than 7 days.

Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.

In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately. The dose may be repeated if necessary after 3 hours.

Adults and elderly: Not intended for adult use.

4.3 Contraindications

Known hypersensitivity to anaesthetics of the amide type.

Hypersensitivity to any of the active ingredients or to any of the excipients.

4.4 Special warnings and precautions for use

Do not use more than one product containing lidocaine at the same time.

To be used with caution in patients with hepatic or cardiac dysfunction.

This medicine contains 28.77 mg of alcohol (ethanol) in each dose.

The amount in each dose of this medicine is equivalent to less than 1 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 medicine contains fragrance with Eugenol.

Eugenol may cause allergic reactions.

Label warnings: Do not use more than every 3 hours. Do not exceed the stated dose. Do not give this medicine, if your child is under 5 months old. Keep out of reach and sight of children. If symptoms persist consult your doctor.

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 Pregnancy and Lactation

Not applicable.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable Effects

There have been a few cases of contact dermatitis and methaemoglobi­naemia.

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

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 (0.1mg/kg    i.v.) or

succinylcholine chloride (10–50mg 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 Bonjela Teething Gel. Such an effect has been reported in an adult who gargled and swallowed 5 ml of a 2% Lidocaine hydrochloride solution (equivalent to 100mg of Lidocaine).However, assuming proportionality of body surface area and pharyngeal surface area, this dose would be equivalent to a single dose of 5.4 g of Bonjela Teething Gel for a three month old child.

It is most unlikely, even with misuse or excessive application of Bonjela Teething Gel, that the large amounts of Lidocaine hydrochloride or cetalkonium chloride required to produce clinically-relevant toxic effects would be reached. In the event of overdose, use should be discontinued and a doctor consulted.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

ATC Code: A01AB

Lidocaine hydrochloride is an established local anaesthetic agent which produces tissue insensitivity by virtue of its ability to impede the inward flux of sodium ions, thus preventing transmission of the nerve impulse.

Cetalkonium chloride is a quatemary ammonium antimicrobial agent, being bactericidal towards both gram positive and gram negative organisms but with preference for the former.

5.2. Pharmacokinetic Properties

Lidocaine is highly lipophilic resulting in rapid passage through mucous membranes, which is confirmed by human studies showing a Tmax of approximately 50 minutes following application of a 2% solution to the intact oral mucosa.

Metabolism is virtually complete by the hepatic route, undergoing three transformations, oxidative-n-dealkylation, hydrolysis and hydroxylation.

In neonates a T^ of 3–5 hours has been reported following intrathecal administration of Lidocaine to the mother; the elimination following topical application to the oral mucosa is likely to be of the same order.

5.3. Pre-clinical Safety Data

No preclinical findings of relevance have been reported.

6.1 List of excipients

Ethanol 96%, glycerol, hypromellose 4500, sodium cyclamate 1969, banana flavour, (contains fragrances containing allergens) and purified water.

6.2. Incompatibilities

None known.

6.3. Shelf-Life

Two years.

6.4. Special Precautions for Storage

Store below 25°C.

6.5 Nature and contents of container

Internally lacquered collapsible aluminium tube with membrane seal fitted with a polyethylene wadless cap. Pack size: 10g.

6.6. Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS

United Kingdom