Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Urea
Galderma (UK) Ltd
D02AE01
Urea
100mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020100; GTIN: 5020465000273
u r e a C R E A M N U T R A P L U S TM 1 0 % W / W C RE A M PACKAGE LEAFLET: INFORMATION FOR THE USER NUTRAPLUS 10% W/W 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 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 Nutraplus is and what it is used for 2. What you need to know before you use Nutraplus 3. How to use Nutraplus 4. Possible side effects 5. How to store Nutraplus 6. Contents of the pack and other information 1. WHAT NUTRAPLUS IS AND WHAT IT IS USED FOR • Nutraplus is an emollient, a moisturising and protective cream for the treatment of dry or damaged skin. • The active substance in this product is urea, a natural substance found in healthy skin. • The presence of urea in the cream moisturises the skin. This helps bring back soft and supple skin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRAPLUS DO NOT USE NUTRAPLUS • If you are allergic to urea or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash or itching. • On large areas of skin if you have renal impairment, talk to your doctor before using. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Nutraplus. • If irritation occurs, discontinue use temporarily and consult your doctor. • Apply carefully only to damaged or inflamed skin or to the face • Avoid getting Nutraplus in your eyes, mouth, nose or ears (mucous membranes). Upon accidental contact, rinse the affected area with clean water. • Nutraplus should only be used under medical supervisi Διαβάστε το πλήρες έγγραφο
OBJECT 1 NUTRAPLUS CREAM Summary of Product Characteristics Updated 30-Aug-2017 | Galderma (U.K) Ltd 1. Name of the medicinal product Nutraplus 10% w/w Cream 2. Qualitative and quantitative composition Each gram of cream contains 100mg of Urea Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.8 mg/g, Propyl parahydroxybenzoate (E216) 0.9 mg/g, Propylene glycol 45mg/g, Cetearyl alcohol 18.0 mg/g – 22.5 mg/g For the full list of excipients see section 6.1 3. Pharmaceutical form Cream Smooth white, almost odourless cream (water in oil emulsion). 4. Clinical particulars 4.1 Therapeutic indications An emollient, moisturising and protective cream for the treatment of dry or damaged skin 4.2 Posology and method of administration Adults, paediatric population and older people Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The product should not be used extensively in patients with severe renal impairment. 4.4 Special warnings and precautions for use Avoid contact with the eyes and mucous membranes. If irritation occurs, discontinue use temporarily and consult a physician. Apply with caution only to damaged or inflamed skin or to the face. The product should be used under medical supervision in babies. 4.5 Interaction with other medicinal products and other forms of interaction Urea may enhance the efficacy of topical formulations of 5-fluorouracil and dithranol, and increase the release and the permeation into the skin of active ingredients from other topical products such as corticosteroids. 4.6 Fertility, pregnancy and lactation There are no clinical data available concerning use in pregnancy. There are no adequate experimental animal studies available concerning the effects on pregnancy, embryonic development, foetal development and/or post-natal development. Caution must be exercised for use during pregnancy. However, indicatio Διαβάστε το πλήρες έγγραφο