Consumer medicine information

Mucosoothe

Lidocaine (lignocaine) hydrochloride

BRAND INFORMATION

Brand name

Mucosoothe Oral Gel

Active ingredient

Lidocaine (lignocaine) hydrochloride

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Mucosoothe.

What is in this leaflet

This leaflet answers some of the common questions people ask about Mucosoothe. It does not contain all the information that is known about Mucosoothe.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Mucosoothe is for

Mucosoothe is indicated for the topical anaesthesia and relief of pain and discomfort of mucous membranes of the mouth, throat and upper gastrointestinal tract.

The active ingredient, lignocaine belongs to a group of medicines called local anaesthetics. It works by making the nerves unable to pass messages to the brain.

Your doctor will have explained why you are being treated with Mucosoothe and told you what dose you should use.

Follow all directions given to you carefully. They may differ from the information contained in this leaflet.

Your doctor or pharmacist may recommend this medicine for another use. Ask them if you want more information.

Mucosoothe is not addictive.

Before you use Mucosoothe

When you must not use it

Do not use Mucosoothe if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved. Lignocaine has been widely used during pregnancy and there have been no reports of any ill effects on the baby.

When used correctly, it is unlikely that any Mucosoothe will get into your breast milk if you are breastfeeding.

Do not use Mucosoothe for teething pain.

Do not use Mucosoothe after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not use Mucosoothe if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor or pharmacist tells you to.

Do not give this medicine to anyone else.

Before you start to use it

You must tell your doctor if:

  1. you have any allergies to
  • other local anaesthetics
  • ingredients listed at the end of this leaflet
  • any other substances
If you have an allergic reaction, you may get a skin rash, hayfever, breathing difficulties or feel faint.
  1. you have any of these medical conditions
  • epilepsy
  • heart problems
  • liver problems
  • kidney problems
  • open wounds or infection where the solution will be used
It may not be safe for you to take Mucosoothe if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including

  • ones to control your heartbeat
  • ones for blood pressure (anti-hypertensives)
  • ones for epilepsy or fits
  • cimetidine
  • any medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Mucosoothe works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor or pharmacist about any of these things, tell them before you use any Mucosoothe.

Using Mucosoothe

How to use it

Shake the bottle well before use.

Adults
The dose is 15mL, not more often than every three hours as required. For anaesthesia (numbing) of the mouth swish the gel for 30 seconds and then spit out.

For anaesthesia (numbing) of the upper gastrointestinal tract and throat, the gel should be gargled and may be swallowed.

Children 3-12 years
No more than 4mg/kg (0.2mL/kg) of bodyweight or 5mL (100mg lignocaine HCl), whichever is lower, should be used as above, not more often than every three hours, as required. No more than 4 doses should be given in a 24 hour period.

Children under 3 years
No more than 4mg/kg (0.2mL/kg) of bodyweight or 1.25mL (25mg lignocaine HCl), whichever is lower, should be accurately measured and applied with a cotton swab to the area, not more often than every three hours, as required. No more than 4 doses should be given in a 24 hour period.

Overdose

Telephone your doctor or the Poisons Information Centre (13 11 26) or go to casualty at your nearest hospital immediately if you think that you or anybody else may have taken too much Mucosoothe even if there are no signs of discomfort or poisoning.

The lignocaine in Mucosoothe can be absorbed into the blood, therefore it is important to use the correct amount of this medicine to avoid an overdose.

The first signs of overdose are dizziness, blurred vision, tremor or nervousness. In the rare case of problems occurring, you will be watched closely by medical staff.

While you are using it

Things to be careful of

Be careful driving or operating machinery after you have been given Mucosoothe. You may be drowsy and your reflexes may be slow.

You should not exceed the recommended dose unless your doctor tells you to. This may cause serious side effects if too much Mucosoothe is taken.

You must not eat or drink anything within 60 minutes of using Mucosoothe in the mouth or throat area. You may swallow your food the wrong way, or burn or bite your mouth.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

If you show signs of systemic toxicity (eg. lethargy, shallow breathing, seizure activity), emergency medical attention should be sought immediately and no additional product should be administered.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Mucosoothe.

Mucosoothe will help to relieve pain and discomfort in most people, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • skin rash or irritation
  • drowsiness

These are all mild side effects of Mucosoothe.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • wheezing or difficulty breathing
  • chest pain
  • severe rash or itching
  • increased sweating
  • numbness

These are all serious side effects. You may need urgent medical attention.

Serious side effects are rare.

Lignocaine can pass into the bloodstream, and in high doses can rarely cause more serious side effects. These may include:

  • fits
  • unconsciousness
  • breathing problems
  • low blood pressure
  • slow heartbeat
  • collapse

These are very serious side effects. You will need urgent medical attention or hospitalisation.

All of these side effects are very rare.

Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while taking Mucosoothe.

Storage

Keep your Mucosoothe in the bottle until it is time to use it. Keep tightly closed after use.

Keep it in a cool place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave it in the car on hot days.

Disposal

Ask your pharmacist what to do with any solution you have left over if your doctor tells you to stop using it, or you find that the expiry date has passed. Unused product should be discarded in a manner that prevents possible exposure to children and pets.

Product Description

Mucosoothe is a pink viscous solution, with a blackcurrant odour, packaged in a 200mL bottle.

Each mL contains:

  • 21.3 mg lidocaine (lignocaine) hydrochloride monohydrate [equivalent to 20 mg of lidocaine (lignocaine) hydrochloride]
  • Sodium methyl hydroxybenzoate
  • Sodium propyl hydroxybenzoate
  • Amaranth
  • Blackcurrant flavour
    (PI number: 367)
  • Carmellose sodium
  • Purified water

Sponsor

Orion Laboratories Pty Ltd T/A
Perrigo Australia
25-29 Delawney Street
Balcatta WA 6021

This leaflet was prepared in September 2015

Date of last amendment March 2020

Australian Registration Number:

Mucosoothe AUST R 239126

®Mucosoothe is a registered trademark of Orion Laboratories Pty Ltd

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Mucosoothe Oral Gel

Active ingredient

Lidocaine (lignocaine) hydrochloride

Schedule

S2

 

1 Name of Medicine

Lidocaine (lignocaine) hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Each mL of Mucosoothe oral gel contains lidocaine (lignocaine) hydrochloride monohydrate 21.3 mg (equivalent to lidocaine (lignocaine) hydrochloride 20 mg).
Contains 189 mg of sodium per 120 mL (maximum recommended daily dose).
Contains: Sodium methyl hydroxybenzoate and Sodium propyl hydroxybenzoate as preservatives.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Oral topical gel presented as a pink viscous solution, with a blackcurrant odour.

4 Clinical Particulars

4.1 Therapeutic Indications

Mucosoothe is indicated for the relief of pain and discomfort of mucous membranes of the mouth, pharynx and upper gastrointestinal tract.

4.2 Dose and Method of Administration

As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated, acutely ill or elderly patients and children should be given doses commensurate with their age, weight and physical condition.
Shake the bottle well before use.
For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around the mouth for approximately 30 seconds and spat out. For use on the pharynx, the solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours.

Maximum dosage.

Although the incidence of adverse effects with lidocaine (lignocaine) is quite low, caution should be exercised when using large amounts.

Adults.

No more than 15 mL (300 mg lidocaine (lignocaine) HCl) every 3 hours or 120 mL in a 24 hour period.

Children over 3 years of age.

No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 5 mL (100 mg lidocaine (lignocaine) HCl), whichever is lower. No more than 4 doses should be given in a 24 hour period. The dose should not be administered at intervals of less than three hours. It is recommended that excess solution is spat out.

Children under 3 years of age.

No more than 4 mg/kg (0.2 mL/kg) of bodyweight or 1.25 mL (25 mg lidocaine (lignocaine) HCl) whichever is lower, accurately measured and applied only to the affected area with a cotton swab. No more than 4 doses should be given in a 24 hour period. This dose should not be administered at intervals of less than three hours.
At the present time there is not enough documentation to allow recommendations for a more prolonged use of Mucosoothe in children under the age of 3 years.
The solution should not be administered to sooth teething pain in infants and children because of safety concerns.

4.3 Contraindications

Known history of hypersensitivity to lidocaine (lignocaine) or other local anaesthetics of the amide type or to other components of the viscous solution.
Hypersensitivity to sodium methyl and/or sodium propyl hydroxybenzoate or to their metabolite para aminobenzoic acid.

4.4 Special Warnings and Precautions for Use

Warning.

Excessive dosage, or short intervals between doses, can result in high levels of lidocaine (lignocaine) or its metabolites and serious adverse effects. In order to prevent serious adverse effects, patients should be instructed to strictly adhere to the recommended dosage and administration guidelines. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen and other resuscitative drugs (see Section 4.9 Overdose).
Patients should not exceed the recommended dose or use Mucosoothe for prolonged periods except on the advice of their physician.
The lowest dose that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient.
Excessive dosage or short intervals between doses may result in high plasma levels and serious adverse effects. Following too high or repeated doses, including accidental ingestion of viscous lidocaine (lignocaine) in infants and children under the age of three years, serious side effects have been reported involving the cardiovascular and central nervous systems including fatal outcomes. Patients should be instructed to adhere strictly to the recommended dosage. This is especially important in children where the doses vary with weight.

Dosage reduction.

Debilitated, elderly patients or patients with partial or complete heart block and/or acutely ill patients, and children should be given reduced doses commensurate with their age, weight and physical status.

Excessive absorption.

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Because of the possibility of significant systemic absorption, Mucosoothe should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application.
In order to prevent serious adverse effects, if the dose or site of administration is likely to result in high blood levels, lidocaine (lignocaine), in common with other local anaesthetics, should be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic function, in severe shock, the elderly, patients in poor general health and patients with severe renal dysfunction.
Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive.

Eating and drinking.

The use of topical anaesthetic agents in the oral cavity may interfere with swallowing and thus enhance the danger of aspiration of food or drink. For this reason, food or drink should not be ingested within 60 minutes of using local anaesthetics in the mouth or throat area. Numbness of the tongue or buccal mucosa may increase the danger of biting or heat trauma. Food, chewing gum or hot drinks should not be taken while the mouth or throat area is anaesthetised.

Malignant hyperthermia.

Many drugs used during the conduct of anaesthesia are considered potential triggering agents for familial malignant hyperthermia. It has been shown that the use of amide local anaesthetics in malignant hypothermia patients is generally safe, but cases of malignant hyperthermia have occasionally documented after use.

Porphyric patients.

Mucosoothe is probably porphyrinogenic and should only be used on patients with acute porphyria where there are strong or urgent indications. Appropriate precautions should be taken for all porphyric patients.

Use in the elderly.

Care is required with elderly patients who should be given reduced doses relative to their age and physical status.

Paediatric use.

Post-marketing cases of seizures, cardiopulmonary arrest and death in patients under the age of 3 years have been reported with use of lidocaine viscous 2% products when it was not administered in strict adherence to the dosing and administration recommendations.
Mucosoothe should not be administered to infants and children for teething pain. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Mucosoothe, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the bottle safely out of reach of children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Antiarrhythmic drugs.

Lidocaine (lignocaine) 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.
Specific interaction studies with lidocaine (lignocaine) and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised.

Enzyme inducing drugs.

Cimetidine or betablockers have been shown to cause potentially toxic plasma concentrations when lidocaine (lignocaine) is given in repeated high doses over a long period of time. Therefore, caution should be taken if lidocaine (lignocaine) was administered at higher than recommended doses over extended period of time.
Phenytoin and other antiepileptic drugs such as phenobarbitone, primidone and carbamazepine appear to enhance the metabolism of lidocaine (lignocaine) but the significance of this effect is not known. Phenytoin and lidocaine (lignocaine) have additive cardiac depressant effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Lidocaine crosses the placental barrier and may be taken up by foetal tissues. When used for surface anaesthesia, lidocaine blood levels following normal administration are low thus minimal drug is available for placental transfer.
There are, however, no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in rats at doses of 500 mg/kg/day and have revealed no evidence of harm to the foetus caused by lidocaine (lignocaine).
It is reasonable to assume that a large number of pregnant women and women of child-bearing age have used lidocaine (lignocaine). No specific disturbances to the reproduction process have so far been reported.

Labour and delivery.

Lidocaine (lignocaine) is not contraindicated in labour and delivery.
 Lidocaine enters the breast milk, however in such small quantities at therapeutic dose levels that there is generally no risk when breastfeeding.

4.7 Effects on Ability to Drive and Use Machines

Depending on the dose, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and co-ordination.

4.8 Adverse Effects (Undesirable Effects)

Systemic adverse reactions are rare and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or reduced tolerance on the part of the patient. Such reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system.

Central nervous system.

CNS reactions are excitatory and/or depressant and may be characterised by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness and possibly respiratory arrest. The excitatory reactions may be brief or may not occur at all, in which case the first manifestations of toxicity may be drowsiness, progressing to unconsciousness and respiratory arrest.
Drowsiness following administration of lidocaine (lignocaine) is usually an early sign of a high blood level of the drug and may occur as a result of rapid absorption.

Cardiovascular.

Cardiovascular reactions are usually depressant and may be characterised by hypotension, myocardial depression, bradycardia and possibly cardiac arrest.

Allergic reactions.

Allergic reactions may occur as a result of sensitivity either to the local anaesthetic agent or to other ingredients in the formulation. Allergic reactions as a result of sensitivity to lidocaine (lignocaine) are rare (< 0.1%). The detection of sensitivity by skin testing is of doubtful value.
The extremely rare cases of allergy to local anaesthetic preparations have included bronchospasm, chest pain, dyspnoea, pruritus, rash, rhinitis, increased sweating, urticaria, sleepiness, dizziness, paraesthesia, oedema, and in the most severe instances anaphylactic shock. Several cases of contact dermatitis have been reported with the use of lidocaine (lignocaine).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Management of local anaesthetic emergencies.

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anaesthetic administration. At the first sign of change, oxygen should be administered.

Treatment.

Should symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes. Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anti-convulsive drugs.
If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Lidocaine (lignocaine), the active ingredient of Mucosoothe, stabilises the neuronal membrane and prevents the initiation and conduction of nerve impulses, thereby effecting local anaesthetic action.
The onset of action of Mucosoothe occurs within 3-5 minutes on mucous membranes. Its low surface tension ensures an even film over the surface of the mucous membrane so that the Mucosoothe comes into intimate contact with the total surface. High viscosity ensures sufficiently prolonged contact with the mucous membrane. It is ineffective when applied to intact skin.
Excessive blood levels may cause changes in cardiac output, total peripheral resistance and mean arterial pressure. These changes may be attributable to a direct depressant effect of the anaesthetic agent on various components of the cardiovascular system.
Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine (lignocaine) required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 microgram free base/mL. In the rhesus monkey arterial blood levels of 18 to 21 microgram/mL have been shown to be the threshold for convulsive activity.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Lidocaine (lignocaine) may be absorbed following topical administration to mucous membranes, its rate of absorption and amount of dose absorbed depending upon concentration and total dose administered, the specific site of application and duration of exposure. In general, the rate of absorption occurs most rapidly after intratracheal administration.
Lidocaine (lignocaine) is well absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of bio transformation in the liver.

Distribution.

The plasma binding of lidocaine (lignocaine) is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 microgram of free base/mL, 60 to 80% of lidocaine (lignocaine) is protein bound. Binding is also dependent on the plasma concentrations of the alpha-1-acid glycoprotein.
Lidocaine (lignocaine) crosses the blood-brain and placental barriers, presumably by passive diffusion.

Metabolism.

Lidocaine (lignocaine) is metabolised rapidly by the liver.
Studies of lidocaine (lignocaine) metabolism following IV bolus injection have shown that the elimination half-life is usually 1.5 to 2 hours. The half-life may be prolonged 2-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine (lignocaine) kinetics, but may increase the accumulation of metabolites.
Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation. The pharmacological / toxicological actions of the metabolites are similar to, but not less potent than, those of lidocaine (lignocaine).

Excretion.

Metabolites and unchanged drug are excreted by the kidney.
Approximately 90% of lidocaine (lignocaine) is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4hydroxy-2,6-dimethylaniline.

5.3 Preclinical Safety Data

Genotoxicity.

Genotoxicity tests with lidocaine are inconclusive. In genotoxicity studies, the metabolite of lidocaine, 2,6-xylidine, showed evidence of activity in some tests but not in other tests.

Carcinogenicity.

The metabolite: 2,6-xylidine has been shown to have carcinogenic potential (nasal and subcutaneous tumours) in preclinical toxicological studies evaluating chronic exposure.

6 Pharmaceutical Particulars

6.1 List of Excipients

Mucosoothe also contains the following inactive ingredients: Amaranth, Carmellose sodium, Blackcurrant Flavour (PI 367), Purified water, Sodium methyl hydroxybenzoate and Sodium propyl hydroxybenzoate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Mucosoothe is packaged into a 200 mL HDPE bottle and closed with a Child resistant closure.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

6108-05-0.

7 Medicine Schedule (Poisons Standard)

S2.

Summary Table of Changes