Ülke: İsveç
Dil: İsveççe
Kaynak: Läkemedelsverket (Medical Products Agency)
urea
Evolan Pharma AB
D02AE01
urea
50 mg/g
Kräm
propylenglykol Hjälpämne; etylparahydroxibensoat Hjälpämne; cetostearylalkohol Hjälpämne; metylparahydroxibensoat Hjälpämne; urea 50 mg Aktiv substans
Receptfritt
Förpacknings: Burk med pump, 500 g
Godkänd
2018-10-09
PACKAGE LEAFLET: INFORMATION FOR THE USER KARBAMID EVOLAN 50 MG/G CREAM Urea READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Karbamid Evolan is and what it is used for 2. What you need to know before you use Karbamid Evolan 3. How to use Karbamid Evolan 4. Possible side effects 5. How to store Karbamid Evolan 6. Contents of the pack and other information 1. WHAT KARBAMID EVOLAN IS AND WHAT IT IS USED FOR Karbamid Evolan is a white emollient cream containing 5 % urea. The water-binding ability of urea contributes to normalization of dry skin. Karbamid Evolan is used to moisturise dry skin of different origin and to prevent relapses of atopic eczema. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KARBAMID EVOLAN DO NOT USE KARBAMID EVOLAN - if you are allergic to urea or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS - Avoid application into eyes, nose, ears or to open wounds or mucous membranes. PREGNANCY AND BREAST-FEEDING Karbamid Evolan can be used during pregnancy and breast-feeding. DRIVING AND USING MACHINES Karbamid Evolan has no effect on the ability to drive or use machines. KARBAMID EVOLAN CONTAINS ETHYL AND METHYL PARAHYDROXYBENZOATE, CETOSTEARYL ALCOHOL AND PROPYLENE GLYCOL Ethyl and methyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Propylene glycol may cause skin irritation. Do not use this medicine in Belgenin tamamını okuyun
S UMMARY OF P RODUCT C HARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Karbamid Evolan 50 mg/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains: urea 50 mg. Excipient(s) with known effect Ethyl parahydroxybenzoate, methyl parahydroxybenzoate, cetostearyl alcohol, propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream White cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For moisturising of dry skin of different origin and for prevention of relapse of atopic eczema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For moisturising of dry skin of different origin: The cream can be applied when needed, preferably several times daily and always after contact with water. For prevention of relapse of atopic eczema: Apply at least twice daily and preferably after contact with water. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid application into eyes, nose, ears or to open wounds or mucous membranes. Karbamid Evolan cream contains ethyl and methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Karbamid Evolan cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). Karbamid Evolan cream contains propylene glycol, which may cause skin irritation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION Karbamid Evolan can be used during pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES There is no indication that Karbamid Evolan has any effect on the ability to drive or use machines. 4.8 UNDESIRABLE EFFECTS The cream can give transient, local sensation of burning and heat. The face is most sensitive. Common (>1/100) _Skin_ : Transient sensations of burning or heat Reporting of suspected adverse reactions Reporting suspected adverse reactions Belgenin tamamını okuyun