Country: Malta
Language: English
Source: Medicines Authority
lidocaine 2.5 % (w/w), prilocaine 2.5 % (w/w)
AstraZeneca AB
N01BB20
lidocaine, prilocaine
cream
Authorised
2005-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER EMLA 5% W/W CREAM (FOR 5 X 5 G PACK) lidocaine/prilocaine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What EMLA Cream is and what it is used for 2. What you need to know before you use EMLA Cream 3. How to use EMLA Cream 4. Possible side effects 5. How to store EMLA Cream 6. Contents of the pack and other information 1. WHAT EMLA CREAM IS AND WHAT IT IS USED FOR EMLA Cream contains two active substances called lidocaine and prilocaine. These belong to a group of medicines called local anaesthetics. EMLA Cream works by numbing the surface of the skin for a short time. It is put on the skin before certain medical procedures. This helps to stop pain on the skin; however you may still have the feelings of pressure and touch. ADULTS, ADOLESCENTS AND CHILDREN It can be used to numb the skin before: • Having a needle put in (for example, if you are having an injection or a blood test). • Minor skin operations. ADULTS AND ADOLESCENTS It can also be used: • To numb the genitals before: o Having an injection. o Medical procedures such as removal of warts. A doctor or nurse should supervise the use of EMLA Cream on the genitals. ADULTS Read the complete document
1. NAME OF THE MEDICINAL PRODUCT EMLA 5% w/w Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains: Lidocaine 2.5% w/w (25 mg) Prilocaine 2.5% w/w (25 mg) Excipients with known effect: Contains macrogolglycerol hydroxystearate (19 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream A white, soft, homogeneous aqueous cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EMLA Cream is indicated for: • Topical anaesthesia of the skin in connection with: o needle insertion, e.g. intravenous catheters or blood sampling; o superficial surgical procedures; in adults and in the paediatric population. • Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥ 12 years. • Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents _ _ _ The details of the Indications or Procedures for use, with Dosage and Application Time are provided in Tables 1 and 2. Page 1 of 14 For further guidance on the appropriate use of the product in such procedures, please refer to _Method of administration_. TABLE 1 ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE INDICATION/PROCEDURE DOSAGE AND APPLICATION TIME SKIN Minor procedures, e.g. needle insertion and surgical treatment of localised lesions. 2 g (approx. half a 5 g tube) or approx. 1.5g/10 cm 2 for 1 to 5 hours 1) . Dermal procedures on newly shaven skin of large body areas, e.g. laser hair removal (self- application by patient) Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm 2 for a minimum of 1 h Read the complete document