Last Updated on eMC 12-07-2018 View medicine  | Reckitt Benckiser Healthcare (UK) Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:05-07-2018

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes to Section 4.1, 4.2, 4.4

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:06-10-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

$0Section 5.1$0$0$0$0$0The followingtext has been deleted:$0$0Localanaesthetic /analgesic - antiseptic.$0$0The followingtext has been added:$0$0Pharmacotherapeuticgroup: Lidocaine,combinations; ATC Code: N01BB52$0$0Lidocaine is alocal anaesthetic of the amide type, acting to produce reversible loss ofsensation by preventing or diminishing the generation and transmission ofsensory nerve impulses near the site of application. Depolarisation of theneuronal membrane and ion exchange are reversibly inhibited.$0$0Cetylpyridinium chlorideis a quaternary pyridinium antiseptic with actions and uses similar to those ofother cationic surfactants. $0$0 $0$0Section 5.2$0$0 $0$0The followingtext has been deleted:$0$0Not applicable.$0$0The followingtext has been added:$0$0Lidocaine is readily absorbed through the mucousmembranes and is hydrolysed mainly by the liver.$0

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-12-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



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.

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.


4.8         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

Hypersensitivity

Not known

Skin and subcutaneous tissue disorders

Contact dermatitis

Not known

4.9       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.





 

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:GSL

Black Triangle (CHM): NO