Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
UREA
Beiersdorf UK Limited
D02AX
UREA
10 %w/w
Cutaneous Emulsion
Product not subject to medical prescription
Other emollients and protectives
Marketed
2005-04-15
April 2018 Common PIL UK/IE Page 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EUCERIN INTENSIVE LOTION 10% W/W CUTANEOUS EMULSION 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. The name of your medicine is EUCERIN INTENSIVE LOTION 10% W/W CUTANEOUS EMULSION. In the rest of this leaflet it is called EUCERIN . WHAT IS IN THIS LEAFLET 1. What EUCERIN is and what it is used for 2. What you need to know before you use EUCERIN 3. How to use EUCERIN 4. Possible side effects 5. How to store EUCERIN 6. Contents of the pack and other information 1. WHAT EUCERIN IS AND WHAT IT IS USED FOR EUCERIN IS A HYDRATING AGENT. IT IS USED FOR THE TREATMENT OF: • ichthyosis (an inherited condition in which the skin is dry, rough and scaly because of a defect in cornification), • xeroderma, especially in the elderly (a mild form of ichthyosis in which the skin develops slight dryness and forms scales) and hyperkeratosis (thickening of the outer layer of the skin) • other chronic dry skin conditions such as atopic eczema (dermatitis). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EUCERIN DO NOT USE EUCERIN: • if you are allergic to urea or any of the other ingredients of this medicine (listed in section 6) • on broken, inflamed skin • on large areas of skin if you have kidney trouble OTHER MEDICINES AND EUCERIN Consult your doctor or pharmacist if you are using any other medicines on your skin, including those obtained without a prescription. EUCERIN may increase the penetration of some substances into the skin e.g.: • medicines known as corticosteroids • dithranol • fluorouracil Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Urea 10% w/w Contains castor oil, polyoxyl hydrogenated. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous emulsion. A white, shiny smooth viscous emulsion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of ichthyosis, xeroderma (especially in the elderly), hyperkeratosis and other chronic dry skin conditions such as atopic eczema (dermatitis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion should be applied twice daily or as directed by a doctor to the affected areas and gently massaged into the skin. It should not be allowed to come into contact with the eyes. It should not be applied on large areas in patients with renal insufficiency. The duration of use depends on the particular condition of the skin and should be established on an individual basis. 4.3 CONTRAINDICATIONS Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion should not be used in patients with a known hypersensitivity to any of the ingredients. It should not be used to treat excoriated acute inflammation of the skin. It should not be used on large areas in patients with renal insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE A doctor should be consulted if symptoms persist. Application of the product to broken skin should be avoided. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Urea may potentiate the release of active substances from topical preparations and their penetration into the skin. This is known in particular for corticosteroids, dithranol and fluorouracil. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Aqra d-dokument sħiħ