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, cetylpyridinium chloride, 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.

While a number of interactions are theoretically possible with lidocaine, these drug interactions are unlikely to be clinically relevant to the use of the product, which is administered topically.

The toxicity of oral lidocaine may be increased when the product is taken in combination with the following drugs:

• Erythromycin

• Itraconazole

• Fluvoxamine

• Beta blockers e.g. propranolol, bisoprolol.

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:

A small amount of lidocaine enters breast milk, but there are no established data showing harmful effects at therapeutic doses. It is not known if cetylpyridinium chloride excretes into breast milk.

Patients should first consult a healthcare professional before using this product during breastfeeding.

Fertility:

No data on human fertility are available.

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

Hypersensitivity1

Not known

Skin and subcutaneous tissue disorders

Contact dermatitis

Not known

Description of Selected Adverse Reactions

1Hypersensitivity reactions may present in the form of angioedema, urticaria, bronchospasms and hypotension with syncope.

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.