Land: Israel
Språk: engelska
Källa: Ministry of Health
LIDOCAINE
RAFA LABORATORIES LTD
D04AB01
CREAM
LIDOCAINE 5 %
TOPICAL
Not required
RAFA LABORATORIES LTD, JERUSALEM
LIDOCAINE
LIDOCAINE
Topical anesthetic.
2021-06-30
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 Läs hela dokumentet
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 Läs hela dokumentet