Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tacrolimus
LEO Pharma A/S
D11AH01
tacrolimus
Other dermatological preparations
Dermatitis, Atopic
Flare treatmentAdults and adolescents (16 years of age and above)Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.Children (two years of age and above)Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatmentMaintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Revision: 26
Authorised
2002-02-27
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE USER PROTOPIC 0.03% OINTMENT tacrolimus monohydrate 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 Protopic is and what it is used for 2. What you need to know before you use Protopic 3. How to use Protopic 4. Possible side effects 5. How to store Protopic 6. Contents of the pack and other information 1. WHAT PROTOPIC IS AND WHAT IT IS USED FOR The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent. Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03% ointment twice weekly. In atopic dermatitis, an over-reaction of the skin’s immune system causes skin inflammation (itchiness, redness, dryness). Protopic alters the abnormal immune response and relieves the skin inflammation and the itch. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROTOPIC DO NOT USE PROTOPIC • If you are allergic to tacrolimus or any of the other ingredi Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Protopic 0.03% ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%). Excipient with known effect Butylhydroxytoluene (E321) 15 micrograms/g ointment. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment A white to slightly yellowish ointment. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. Flare treatment _Adults and adolescents (16 years of age and above)_ Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. _Children (2 years of age and above) _ Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment. Posology Flare treatment Protopic can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis. Protopic treatment should begin at the first appearance of signs and symptoms. Each affected region of the skin should be treated with Protopic until lesions are cleared, almost cleared or mildly a Прочетете целия документ