Addition in Green and deletions in Red

4.4.      Special warnings and precautions for use

This medicinal product contains chlorocresol and the azo dyes; amaranth (E123) and sunset yellow (E110), which may cause allergic reactions. in sensitive individuals.

This medicinal product contains 68vol% ethanol (alcohol). This medicine contains 151mg of alcohol (ethanol) in each dose (0.25 ml), which is equivalent to 604 mg/ml (65.6% w/v). The amount in 0.25 ml of this medicine is equivalent to less than 4 ml beer or 2 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects. i.e. up to 0.753 mg per ml equivalent to 15.1ml beer or 6.3ml wine per dose which may be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high risk groups, such as patients with liver disease, or epilepsy.

4.8.      Undesirable effects

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie..

6.1       List of Excipients

Ethanol 96% w/v  

10.       DATE OF REVISION OF THE TEXT

March 2019
16/07/202014/10/2021

Additions in Green and Deletions in Red to the below sections:

Important information about some of the ingredients

This medicine medicinal product contains chlorocresol and the azo dyes amaranth (E123) and sunset yellow (E110) which may cause allergic reactions. in sensitive individuals 

This medicine contains 151mg of alcohol (ethanol) in each dose (0.25 ml), which is equivalent to 604 mg/ml (65.6% w/v). The amount in 0.25 ml of this medicine is equivalent to less than 4 ml beer or 2 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

This medicinal product contains 68 vol % ethanol (alcohol), i.e. up to 0.753 mg per ml equivalent to 15.1 ml beer, 6.3 ml wine per dose which may be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high risk groups, such as patients with liver disease, or epilepsy. 

4. Possible Side effects

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.hpra.ie. ; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

The other ingredients are ethanol 96% w/v, levomenthol, glycerol, caramel colouring (comprised of quinoline yellow E104, amaranth E123, sunset yellow E110 and green S E142) and purified water.

Marketing Authorisation Holder and Manufacturer

This leaflet was last revised in January 2019October 2021.

File format update to PDF

4.9.      Overdose

Ingestion of the complete contents of the marketed pack would not be expected to cause any adverse effects.

Changes are highlighted below:

Update the IMB to HPRA and update the ADR reporting wording

6.5.      Nature and contents of container

Glass (type III) bottle with tamper evident HDPE screw threaded wadded plastic caps containing 6.5ml or 15ml of product.

Changes are highlighted in red text below:

4.1       Therapeutic indications

Anbesol Anaesthetic Antiseptic Oromucosal Solution is indicated in adults, the elderly and adolescents and children aged 10 to 18 years.

4.2.      Posology and method of administration

For patients of 10 years adults, the elderly and adolescents and children aged 10 to 18 yearsand over:

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 online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

4.1.        Posology and method of administration

 

Route of administration: oromucosal

 

For patients of 10 years and over:

Apply undiluted to the affected area with the fingertip.  Two applications immediately will normally be sufficient to obtain pain relief.  It should not be used more frequently than every 3 hours 3-4 times daily or as directed by the physician or dentist.

4.3.      Contraindications

 

Patients with a known history of hypersensitivity or allergic type reactions to any of the constituents of the product.

Hypersensitivity to the active substances, anaesthetics of the amide-type or to any of the excipients listed in section 6.1.

 

Lidocaine is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in animals.

 

4.4.      Special warnings and precautions for use

 

Excessive dosage, or short intervals between doses, may result in high plasma levels and serious adverse effects (see Section 4.9).  Anbesol should be used with caution in patients with wounds or traumatised mucosa in the region of the proposed application.  A damaged mucosa will permit increased systemic absorption resulting in systemic effects, such as convulsions, particularly if excessive quantities are used.

 

The label will contain the following statements:

1.If there is no improvement in 3 days, consult your doctor or dentist

1.                Do not persist with any medication if results seem unsatisfactory, except on doctor’s advice

1.Do not exceed the stated dose

1.Keep all medicines out of the sight and reach of children.

This medicinal product contains chlorocresol and the azo dyes; amaranth (E123) and sunset yellow (E110), which may cause allergic reactions in sensitive individuals.

 

 

This medicinal product contains 68vol% ethanol (alcohol) i.e. up to 0.753546 mg per ml equivalent to 15.110.9ml beer or 6.34.6ml wine per doseml which may be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high risk groups, such as patients with liver disease, or epilepsy.

This product contains chlorocresol which may cause allergic reactions.

 

4.5.      Interactions with other medicinal products and other forms of Interaction

 

None known.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 are additive.

 

In patients taking erythromycin the toxicity of oral lidocaine may be markedly increased.

 

In patients taking itraconazole, the toxicity of oral lidocaine may be markedly increased.

 

Antiarrhythmic drugs class III (e.g. amiodarone) may incur additive cardiac effects in combination with lidocaine.

 

Drugs that reduce the clearance of lidocaine (e.g. cimetidine or beta-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period.  Such interactions should therefore be of no clinical importance following short-term treatment with topical lidocaine (e.g. Anbesol) at the recommended dose.

 

Chlorocresol has long been recognised to be incompatible with a range of compounds including calcium chloride, codeine phosphate, diamorphine hydrochloride, papaveretum, quinine hydrochloride, methylcellulose and non-ionic surfactants such as cetomacrogol 1000 and polysorbate 80.

 

4.6.      Fertility, pPregnancy and lactation

 

None known.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:

Lidocaine enters the mother’s milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.

 

Fertility:

No data on human fertility is available.

 

4.8.      Undesirable effects

 

There have been reports of non-specific ulceration following oral cetylpyridinium chloride therapy.Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

 

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: cannot be estimated from the available data

 

System Organ Class	Undesirable Effect	Frequency
Immune system disorders	Allergic reactions	Not known
Gastrointestinal disorders	Non-specific ulceration	Not known
Skin and subcutaneous tissue disorders	Dermatitis	Not known

 

4.9.      Overdose

 

Ingestion of the complete contents of the marketed pack wshould not be expected to cause any adverse effects.

 

Lidocaine:

Systemic features:

CNS Symptoms: Increasing restlessness, visual disturbances, agitation, tinnitus, confusion, hallucinations, drowsiness, weakness, shivering, paraesthesia, and muscle twitching lead to convulsions, which are the major feature of toxicity.  Coma and apnoea may develop.

 

Cardiac Symptoms: Possibly transient hypertension and tachycardia followed by arrhythmias (including sinus bradycardia, AV nodal or ventricular arrhythmias, asystole).  The incidence of torsade de pointes is less than with other groups of antiarrhythmics.  Hypotension may result from depressed myocardial contractility and peripheral vasodilation.

 

GI Symptoms: Nausea and vomiting.

 

Allergic reactions occur rarely and may include urticaria, angioedema, contact dermatitis and pruritis.  Acute respiratory distress syndrome (ARDS) has been reported in severe allergic reactions.

 

Rarely methaemoglobinaemia may occur with excessive exposure to some local anaesthetics.  This is much more commonly seen with benzocaine and prilocaine (due to its metabolite o-toluidine) than with lidocaine.

 

Serious toxicity is usually due to inadvertent intravenous overdosage.  It is much less likely after oral administration because of extensive first pass metabolism but has been reported after ingestion of large amounts.  Lidocaine is readily absorbed across mucous membranes and through damaged skin. 

 

Systemic toxicity and death have been reported in children and adults following ingestion or aspiration of topical solutions or viscous preparations. The effect may also be due to absorption of high concentrations across the buccal mucosa causing systemic toxicity (see Section 4.4).

 

Potential toxic doses range from 800mg of gargled lidocaine solution (death), 1200mg ingestion (agitation and confusion) and 6g ingestion (death).  Toxicity may also arise from rectal or urethral instillation. 

 

Anaphylaxis or an anaphylactoid reaction has been reported following administration of 1% lidocaine solution for topical anaesthesia prior to fiberoptic bronchoscopy.

 

Signs of serious toxicity may occur at plasma concentrations greater than 5-8 microgram/mL (5-8mg/L).

 

Following ingestion bioavailability of lidocaine is 30-35% and peak levels occur within 40 minutes.  The elimination half-life is about 1-2 hours.  Metabolites of lidocaine have longer half-lives than lidocaine itself as well as antiarrhythmic activity.

 

All patients who have taken a deliberate overdose should be referred for assessment.  Children and adults who have ingested 6mg/kg or more lidocaine, or those who are symptomatic, should be referred for medical assessment.

 

Children and adults who have accidentally ingested less than 6mg/kg lidocaine and who have no new symptoms since the time of ingestion do not need to be referred for medical assessment.  Patients should be advised to seek medical attention if symptoms develop.

 

 

Chlorocresol:

Systemic features:

Nausea, vomiting, diarrhoea, hypotension, tachycardia, cardiac arrhythmias, metabolic acidosis, pallor, sweating and shock.  CNS stimulation is followed by drowsiness, respiratory depression, cyanosis, convulsions, coma, bronchospasm and rapid onset pulmonary oedema and death.  Methaemoglobinaemia is recognised.  Phenol may also cause renal and hepatic injury.

 

Chronic exposure is rare but has been associated with nausea, vomiting, diarrhoea, anorexia, weight loss, hypersalivation, headache, fainting, mental disturbances, weakness, muscle aches and pain, mouth sores, renal and hepatic injury.

 

Exposure by any route can cause irritation, burns and systemic effects.

 

Ingestion causes irritation of mucous membranes, and of the GI tract.  Significant ingestion is said to cause white/brown skin and mucosal burns which may be painless as phenol destroys the nerve endings.  Laryngeal oedema can occur, and oesophageal stricture may be a late complication.

 

Skin contact – even dilute solutions (1%) can cause irritation, dermatitis and burns to the skin following prolonged contact.  Often presents as relatively painless white or brown necrotic lesions; the brown colouration may remain after healing.

 

 

Management:

Wash area with soap and water.

Maintain a clear airway and ensure adequate ventilation.  Give oxygen if clinically indicated.

Observe for at least 4 hours after exposure. Perform 12 lead ECG. Monitor pulse, blood pressure and cardiac rhythm continuously for 4 hours if the ECG is abnormal or the patient is symptomatic.  Measure urea and electrolytes, arterial blood gases, liver and renal function in symptomatic cases and monitor in a critical care facility.

If cardiotoxicity is unresponsive to the above consider the use of a lipid emulsion. It is thought lipid may reduce free concentrations of active drug and therefore improve myocardial function, although other mechanisms are also postulated.

Correct acid base and metabolic disturbances as required.

Institute drug treatment of seizures as per local protocol.

 

 

Paediatric populations:

Lidocaine:

 

In children up to 6mg/kg lidocaine (with chlorhexidine in mouth paint) produced only minor symptoms.  A 5 month old child had a seizure after ingestion of 100mg (14mg/kg).  Severe toxicity in children is unlikely at doses less than 15mg/kg.

 

5.1.      Pharmacodynamic properties

 

Pharmacotherapeutic group: Amides – lidocaine, combinations

 

ATC code: N01BB52

6.6.      Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

No special requirements.

 

Any unused medicinal product or wasteter material should be disposed of in accordance with local requirements.