Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
UREA ; HYDROCORTISONE ; LACTIC ACID
Galderma (UK) Ltd
D07XA01
UREA ; HYDROCORTISONE ; LACTIC ACID
10/1/5 %w/w
Cream
Product subject to prescription which may be renewed (B)
hydrocortisone
Not Marketed
1978-04-01
CALMURID HC 10%/5%/1% W/W CREAM U RE A 1 0 % W / W - L A C T I C A C I D 5 % W / W - H Y D RO C O R T I S O N E 1 % W / W PMS 432U DIELINES Artwork approved by: Date: Signature: Product code: MOCK UP Product description: CALMURID HC CRE Market: IRL Article: Leaflet Flat size: 135x210 Fold size: 135x26,25 Font size: 8 pts Pharmacode: TBD _LAUNCHING DEPARTMENT - Z.I. Galderma_ _74540 ALBY-SUR-CHERAN - FRANCE_ 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. PACKAGE LEAFLET: INFORMATION FOR THE USER CALMURID HC 10%/5%/1% W/W CREAM Urea 10% w/w Lactic Acid 5% w/w Hydrocortisone 1% w/w 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 Calmurid HC is and what it is used for 2. What you need to know before you use Calmurid HC 3. How to use Calmurid HC 4. Possible side effects 5. How to store Calmurid HC 6. Contents of the pack and other information 1. WHAT CALMURID HC IS AND WHAT IT IS USED FOR • This medicine is for the treatment of eczema and other similar conditions where the skin is inflamed, sore, dry, rough, scaly, irritated or itchy. • The active substances contained in Calmurid HC are urea (10% w/w), lactic acid (5% w/w), both of which are found in healthy skin, and hydrocortisone (1% w/w), which is a mild steroid. • The urea and lactic acid in Calmurid HC have moisturising and antibacterial properties, as well as helping to relieve itching, and to soften Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calmurid HC 10%/5%/1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Cream. A smooth white, oil-in-water cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of dermatoses characterised by hyperkeratosis and inflammation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external use only. Apply twice daily to the affected areas or as directed by the physician. 4.3 CONTRAINDICATIONS 1. Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. 2. Use in acne rosacea or in perioral dermatoses. 3. Use in plaque psoriasis. 4. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Continuous treatment longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation. 2. Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressings may suppress adrenocortical function. 3. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilation, particularly on the face. Urea 10.0 % w/w Lactic acid 5.0 % w/w Hydrocortisone 1.0 % w/w For the full list of excipients, see section 6.1. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _2_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _3_ _C_ _R_ _N_ _ _ _2_ _1_ _4 Lugege kogu dokumenti