ESRACAIN CREAM 5 %

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

LIDOCAINE

Disponible des:

RAFA LABORATORIES LTD

Codi ATC:

D04AB01

formulario farmacéutico:

CREAM

Composición:

LIDOCAINE 5 %

Vía de administración:

TOPICAL

tipo de receta:

Not required

Fabricat per:

RAFA LABORATORIES LTD, JERUSALEM

Grupo terapéutico:

LIDOCAINE

Área terapéutica:

LIDOCAINE

indicaciones terapéuticas:

Topical anesthetic.

Data d'autorització:

2021-06-30

Informació per a l'usuari

Patient Leaflet According to the Pharmacists’ Regulations
(Preparations) - 1986
Please read the entire leaflet carefully before using this medicine
ESRACAIN
CREAM
COMPOSITION:
Active ingredient
Lidocaine 5%
Inactive ingredients
Emulsifying wax, cetyl alcohol, glycerin, methyl hydroxybenzoate,
propyl
hydroxybenzoate, water, lactic acid.
THERAPEUTIC GROUP:
Local anesthetic of the amide group.
THERAPEUTIC ACTIVITY:
This medicine is indicated as a topical anesthetic
and as local pain relief of the skin and mucous membranes, due to
cuts,
abrasions and hemorrhoids and before local skin procedures.
WHEN SHOULD THIS MEDICINE NOT BE USED?
Do not use this medicine if you are hypersensitive to any of its
ingredients,
or to another local anesthetic of the amide group.
Do not use on festering sores, open wounds, burns or large areas of
skin.
Frequent usage of this medicine on large skin areas or for a long
period of
time, including use before cosmetic procedures, may result in severe
side
effects due to excessive absorption. Those effects are detailed below
in
the side effects section.
This medicine is not intended for use in the eyes.
DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A DOCTOR BEFORE
STARTING TREATMENT, IN THE FOLLOWING CASES:
If you are pregnant
or breastfeeding. If you suffer or have suffered in the past from
impaired
function of the: liver, kidneys, heart and/or vascular system, or if
you are
a geriatric patient.
WARNINGS:
Do not take this medicine frequently or for a long period without
consulting
your doctor.
If you are sensitive to any type of food or medicine, inform your
doctor
before starting treatment with this medication.
DRUG INTERACTIONS:
If you are taking any other medications including non-prescription
drugs
and nutrition supplements, or if you have recently finished treatment
with
another drug, please notify your doctor in order to prevent any
potential
risks
or
a
potential
reduction
in
efficacy
that
may
result
from
drug
interactions. In particular, medicines of the following therapeutic
groups
m

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Esracain® Cream 5%
1.1
Qualitative and quantitative composition
Lidocaine 5%
1 gram of cream contains 50 mg lidocaine.
Excipients with known effect: cetyl alcohol, methylhydroxybenzoate and
propyl
hydroxybenzoate.
1 gram of cream contains 50 mg cetyl alcohol, 3 mg
propylhydroxybenzoate and 2 mg
methylhydroxybenzoate.
For the full list of excipients, see 6 DOSAGE FORMS, STRENGTHS,
COMPOSITION AND
PACKAGING.
1.2 Pharmaceutical form
White cream
2
THERAPEUTIC INDICATIONS
Topical anesthetic.
Esracain® Cream 5% is indicated as a topical anesthetic and as local
pain relief of the skin and
mucous membranes, due to cuts, abrasions and hemorrhoids and before
local skin procedures.
3
CONTRAINDICATIONS
•
Lidocaine is contraindicated in patients who are hypersensitive to the
active substance
or to any of the excipients of the cream or components of the
container. For a
complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND
PACKAGING.
•
Lidocaine is contraindicated in patients with a known history of
hypersensitivity to local
anesthetics of the amide type or to other components of the cream (see
6 DOSAGE
FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
•
Lidocaine is contraindicated in patients with congenital or idiopathic
methemoglobinemia and patients with glucose-6-phosphate dehydrogenase
deficiency, which are more susceptible to drug-induced
methemoglobinemia.
•
Lidocaine is contraindicated in infants who require treatment with
methemoglobin
inducing agents, e.g., sulfonamides and are 12 months of age or
younger (see 9 DRUG
INTERACTIONS).
2
4
DOSAGE AND ADMINISTRATION
4.1
Recommended Dose and Dosage Adjustment
This medicine is usually not intended for infants under the age of two
years.
Children 2-12 years of age: do not apply more than 0.1 grams of cream
for each kg of body
weight (application of approximately 3 cm of cream for each 10 kg of
body weight), up to 3
times per day (every 8 hours).
Adults and children over 12 years of age: d