מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Urea; Lactic acid
Mawdsley-Brooks & Company Ltd
D02AE51
Urea; Lactic acid
100mg/1gram ; 50mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020100
PATIENT INFORMATION LEAFLET CALMURID® 10% / 5% W/W CREAM (urea 10% lactic acid 5%) 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. Your medicine is called Calmurid Cream but will be referred to as Calmurid throughout this leaflet. 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 an allergic reaction. Signs or symptoms of a severe allergic reaction may include a rash, with or without itching, swelling of the face, eyelids or lips and difficulty in breathing. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Calmurid. • Avoid contact with the eyes, eyelids, lips and other mucous surfaces. Upon accidental contact, rinse the affected area with clean water. • Calmurid may cause stinging if קרא את המסמך השלם
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 and 50 mg of Lactic acid For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream for topical (cutaneous) use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To be applied topically for the correction of hyperkeratosis and dryness in ichthyosis and allied conditions characterised by dry, rough, scaly skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external use only. Adults, elderly and children: A thick layer of Calmurid is applied twice daily after washing the affected area. The cream is left on the skin for 3-5 minutes and then rubbed lightly in. Excess cream should be wiped off the skin with a tissue, not washed off. Frequency of application can be reduced as the patient progresses. In hyperkeratosis of the feet apply Calmurid as above after soaking the feet in warm water for 15 minutes and drying with a rough towel. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Calmurid should not be used extensively in patients with severe renal impairment. 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Low pH of 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. 4.6. FERTILITY, PREGNANCY AND LACTATION There is no specific data available regarding the us קרא את המסמך השלם