Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
UREA ; LACTIC ACID
Galderma (UK) Ltd
D02AE01
UREA ; LACTIC ACID
%w/w
Cream
Product not subject to medical prescription
carbamide
Marketed
1978-07-28
® UREA 10% LACTIC ACID 5% 1 0 % / 5 % W / W C R E A M _LAUNCHING DEPARTMENT - Z.I. Galderma_ _74540 ALBY-SUR-CHERAN - FRANCE_ PMS 432U DIELINES Artwork approved by: Date: Signature: This approval applies to WHOLE TEXT, including barcodes, pre-printed mentions and legal or special labelling constraints. PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT. Product code: P20615-12 Product description: CALMURID CRE Market: GBR Article: Leaflet Flat size: 135x210 Fold size: 135x26,25 Pharmacode: 1418 Font size: 8 pt PACKAGE LEAFLET: INFORMATION FOR THE USER CALMURID 10%/ 5% W/W CREAM Urea 10% w/w Lactic Acid 5% w/w 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 or pharmacist 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 or pharmacist. 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 Calmurid is and what it is used for 2. What you need to know before you use Calmurid 3. How to use Calmurid 4. Possible side effects 5. How to store Calmurid 6. Contents of the pack and other information 1. WHAT CALMURID IS AND WHAT IT IS USED FOR • Your doctor or pharmacist has recommended this cream for use as a moisturising cream for the treatment of dry, rough, scaly skin such as eczema and similar conditions. • The active substances in Calmurid are urea and lactic acid which act as moisturisers. This helps make your skin soft and supple. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CALMURID DO NOT USE CALMURID: • If you are allergic to urea or lactic acid or any of the other ingredients of this medicine (listed in section 6). Please seek immediate medical attention if you experience symptoms of a Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calmurid 10%/ 5% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 100 mg of Urea (10% w/w) and 50 mg of Lactic acid (5% w/w). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. A homogenous, white, oil-in-water cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of dermatoses characterised by hyperkeratosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external use only. Adults, paediatric population and older people Application: twice daily or as directed by the physician, ideally after washing. 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 Calmurid is acidic and hypertonic and can cause smarting if applied to raw areas, fissures or mucous membranes. Where this is a barrier to therapy the use of Calmurid diluted 50% with aqueous cream B.P. for one week should result in freedom from smarting upon use of Calmurid. Avoid contact with the eyes and surrounding area and do not apply Calmurid on inflamed skin or open wounds. Because of potential transcutaneous penetration of urea, the product should not be used extensively in subjects with severe renal impairment without medical supervision. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Low pH of the cream might affect stability of other drugs. Urea may enhance the penetration of other active substances into the skin. This is particularly well-known for corticosteroids, dithranol and 5-fluoruracil. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Διαβάστε το πλήρες έγγραφο