Elamal
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Elamal 40 mg/g cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains 40 mg lidocaine.
Excipients: Propylene glycol 75 mg
Hydrogenated soy lecithin 73.2 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Cream
White to yellowish cream.
4. Clinical particulars
4.1 Therapeutic indications
Topical anaesthesia of the skin in association with needle insertions.
Elamal is indicated in children aged 6 to 12 years and adolescent over 12 years and adults.
4.2 Posology and method of administration
A thick, even layer of cream should be applied to the skin area being treated.
Paediatric Population
Children from 6 to 12 years:
The single application dose is 2-3g. The maximum daily dose is 10 grams. Recommended application time is 60 minutes, but no longer than two hours.
Adolescents over 12 years and Adults:
The single application dose is 2-3g. The maximum daily dose is 20 grams. Recommended application time is 60 minutes, but no longer than two hours.
Children from 2 to 6 years:
As there are insufficient data Elamal is not recommended in this age group.
Children from 0 to 2 years:
As there are no data available Elamal should not be used in this age group.
1 g of cream corresponds to a strand of approximately 2.5 cm.
A dressing is recommended to avoid the cream coming off before the application time is up.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to local anaesthetics of the amide type, to soya or peanuts.
Pre-term new born infants born before the 37th full week of pregnancy.
4.4 Special warnings and precautions for use
In acute inflammation of the middle ear when puncturing the eardrum is necessary, or in other surgical procedures in the auditory canal or inner ear, as there is a risk of damage to the inner ear.
Extensive use should be avoided in patients with serious underlying conditions; in particular impairment of cardiac conduction, non-compensated cardiac insufficiency or cardiogenic or hypovolaemic shock. Patients treated with antiarrhythmics class I and III (e.g. tocainide, mexiletine and amiodarone) should be closely supervised and ECG monitoring should be considered, as the cardiac effects of lidocaine and these antiarrhythmics can be additive.
There are currently no clinical studies of Elamal in the treatment of wounds, mucous membranes and skin areas of atopic dermatitis. Elamal should therefore only be used on undamaged skin.
Elamal should be used with caution near the eyes, as lidocaine may cause eye irritation. In addition, with the loss of protective reflexes, corneal irritation or grazes may occur. If Elamal comes into contact with the eyes, they should be rinsed immediately with water or sodium chloride solution and protected until sensation returns.
In order to prevent reduced efficacy of live vaccines, such as BCG, vaccines should not be administered in areas where Elamal has already been applied.
Due to an increased risk of high plasma concentrations of lidocaine, Elamal should be used with caution in patients with severe hepatic impairment.
Frequent use of high doses of lidocaine is not recommended.
Elamal contains propylene glycol, which may cause skin irritations.
4.5 Interaction with other medicinal products and other forms of interaction
Increased systemic toxicity should be taken into account if Elamal is coadministered with lidocaine therapy given in high doses, as well as other local anaesthetics or substances with similar structure (e.g. class I antiarrhythmic agents such as tocainide and mexiletine).
Specific interaction studies of local anaesthetics and antiarrhythmic active substances class III (e.g. amiodarone) have not been performed but caution is advised.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no adequate data of pregnant women treated with Elamal. Animal studies are incomplete in regard to pregnancy, embryonic/foetal development, delivery and postnatal development (see section 5.3). Lidocaine crosses the placenta barrier and may be absorbed in amniotic fluid. The risk to humans is not known. With temporary use of Elamal during pregnancy, the benefit is considered to outweigh the possible risks. The lowest possible dose of Elamal should be used for the shortest possible time during pregnancy.
Lactation
Lidocaine is excreted in breast milk in small quantities. It is thought unlikely, however, that Elamal affects the child. Breast feeding can therefore continue during treatment.
4.7 Effects on ability to drive and use machines
Elamal has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Skin and subcutaneous tissue disorders:
Uncommon (≥1/1000 to <1/100)
Local skin reactions, such as pallor and redness in the treated area. These symptoms are caused by a direct effect of the local anaesthetic on the blood vessels and are usually transient and mild.
Skin irritations such as itching and burning may occur, particularly in the beginning of treatment. These symptoms are transient.
Immune system disorders:
Rare (≥1/10 000 to <1/1000)
Allergic contact eczema
Very rare (<1/10 000)
Allergic reactions (in severe cases, anaphylactic shock) to
- local anaesthetic of amide type
- hydrogenated soy lecithin
4.9 Overdose
Systemic toxicity is extreme unlikely with normal use of Elamal. However, if signs of an overdose are observed, it is to be expected that the symptoms are similar to those described for other local anaesthetics e.g. excitatory CNS symptoms and, in severe cases, CNS depression and myocardial depression. Topical administration of 8.6 – 17.2 mg/kg of lidocaine caused very severe intoxication in small children.
If signs of acute systemic toxicity should occur, administration of the local anaesthetic should be discontinued immediately. Severe neurological reactions (convulsions, CNS depression) require symptomatic treatment such as respiratory supportive and anticonvulsive therapy. In regard to chronic systemic absorption, a patient with symptoms of toxicity should be observed for several hours after treatment of these symptoms.
Accidental oral intake of the cream by children may cause toxic symptoms, depending on the dose.
There is no specific antidote for lidocaine.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Local anaesthetics: amides
ATC code: N01BB02
Elamal is a local anaesthetic for surface anaesthesia of the skin in topical surgical procedures.
The active substance, lidocaine, is a local anaesthetic of the amide type. Topical anaesthesia occurs after application through the release of lidocaine in the skin's epidermal and dermal layers, near the pain receptors in the skin and nerve endings. Blocking of the sodium ion channels subsequently occurs, preventing initiation and conduction of the nerve impulse.
The degree of anaesthesia depends on the application time and dose.
Elamal causes a transient local peripheral vasoconstriction or vasodilatation in the treated area of skin.
Lidocaine has bactericidal and virus suppressing properties in concentrations above 0.5 – 2 %.
5.2 Pharmacokinetic properties
There are no data on the bioavailability of lidocaine in Elamal. The systemic absorption depends on the amount of cream, application time, skin thickness (varies in different parts of the body) and the general condition of the skin.
Absorption of lidocaine after application of Elamal on intact skin is very low and increased absorption can therefore be expected after application on mucous membrane of previously damaged skin. There are also insufficient data on the use of Elamal on wounds and mucous membranes.
In studies in which Elamal was used in children of different ages (3-15 years), the plasma levels of the active substance were very low (0.3 micrograms/ml or less). This was well below toxic plasma levels of the active substance. There are no pharmacokinetics data for Elamal in children under 2 years.
The plasma elimination half life of lidocaine is 1.5 – 2 hours after absorption from the tissues.
The distribution volume is 1.5 l/kg and the plasma protein binding is approx. 65 %.
90 – 95 % is metabolised in the liver to the main metabolite 4-hydroxy-2,6-dimethylaniline. The amount of formed 2,6-xylidine, the intermediate metabolite, has not been established. 5 – 10 % of the dose is excreted renally in unchanged form.
The elimination half life in patients with renal insufficiency is 2 – 3 hours and accumulation of active metabolites may occur. In hepatic impairment, the rate of metabolism may decrease from half to 1/10 of the normal.
5.3 Preclinical safety data
Reproduction toxicology
In studies of embryonic/foetal development in which rats or rabbits were dosed during organ development, no teratogenic effects were observed. Embryotoxicity was seen in rabbits at a dose toxic to the mother. In rats, reduced postnatal survival was seen in the young of mothers treated during late pregnancy and lactation with doses which were toxic and influenced the length of the pregnancy.
Genotoxicity and carcinogenicity
Genotoxic studies of lidocaine were negative. 2,6-xylidine, a metabolite of lidocaine has, however, shown genotoxic potential in vitro. In a carcinogenicity study of rats exposed in utero, postnatally and throughout life to 2,6-xylidine, tumours were observed in the nasal cavity, the liver and subcutaneously. High doses of 2,6-xylidine were needed to induce tumours in animal studies. The clinical relevance of the tumour inducing effect of this lidocaine metabolite after intermittent use as a local anaesthetic is unknown.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Purified water
Propylene glycol
Hydrogenated soy lecithin
Benzyl alcohol
Polysorbate 80
Carbomer 940
Trolamine
Cholesterol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
After first opening: 6 months
6.4 Special precautions for storage
Do not store above 30C.
Keep the tube tightly closed
6.5 Nature and contents of container
Aluminium tube: 5 g, 10 g, 20 g, 30 g, 40 g or 50 g cream
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
For Sweden:
Scharper S.P.A.
Viale Ortles, 12
20139 Milano
Italy
Phone: +39 022629161
8. MARKETING AUTHORISATION NUMBER
21496
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27 April 2007/27 April 2012
10. DATE OF REVISION OF THE TEXT
17 April 2014
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