Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
TACROLIMUS
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
D11AH01
TACROLIMUS 0.1 % (W/W)
OINTMENT
TACROLIMUS 0.1 % (W/W)
POM
OTHER DERMATOLOGICAL PREPARATIONS
Withdrawn
2018-01-04
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER TACROLIMUS 0.1% OINTMENT Tacrolimus 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 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 Tacrolimus ointment is and what it is used for 2. What you need to know before you use Tacrolimus ointment 3. How to use Tacrolimus ointment 4. Possible side effects 5. How to store Tacrolimus ointment 6. Contents of the pack and other information 1. WHAT TACROLIMUS OINTMENT IS AND WHAT IT IS USED FOR The active substance of Tacrolimus ointment, tacrolimus monohydrate, is an immunomodulating agent. Tacrolimus 0.1% 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. 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 Tacrolimus 0.1% ointment twice weekly. In atopic dermatitis, an over-reaction of the skin’s immune system causes skin inflammation (itchiness, redness, dryness). Tacrolimus ointment alters the abnormal immune response and relieves the skin inflammation and the itch. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TACROLIMUS OINTMENT DO NOT USE TACROLIMUS OINTMENT - If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacrolimus ointment (listed in secti Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS _ _ 1. NAME OF THE MEDICINAL PRODUCT Tacrolimus 0.1 % ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g ointment contains tacrolimus monohydrate corresponding to 1.0 mg tacrolimus. 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 Tacrolimus 0.1 % ointment is indicated in adults and adolescents (16 years of age and above) 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. 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 Tacrolimus treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Tacrolimus is available in two strengths, tacrolimus 0.03 % and tacrolimus 0.1 % ointment. _Posology _ Flare treatment Tacrolimus can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis. Tacrolimus treatment should begin at the first appearance of signs and symptoms. Each affected region of the skin should be treated with Tacrolimus ointment until lesions are cleared, almost cleared or mildly affected. Thereafter, patients are considered suitable for maintenance treatment (see below). At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. _ _ Page 2 of 13 _ _ _Adults and adolescents (16 years of age and above)_ Treatmen Διαβάστε το πλήρες έγγραφο