Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tacrolimus monohydrate
Alliance Healthcare (Distribution) Ltd
D11AH01
Tacrolimus monohydrate
1mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050300
TACROLIMUS 0.1% 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 1. WHAT TACROLIMUS 0.1% OINTMENT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TACROLIMUS 0.1% OINTMENT 3. HOW TO USE TACROLIMUS 0.1% OINTMENT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TACROLIMUS 0.1% OINTMENT 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT TACROLIMUS 0.1% OINTMENT IS AND WHAT IT IS USED FOR The active substance of Tacrolimus 0.1 % 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 0.1 % Ointment alters the abnormal immune response and relieves the skin inflammation and the itch. WHAT YOU NEED TO KNOW BEFORE YOU USE TACROLIMUS 0.1% OINTMENT DO NOT USE TACROLIMUS 0.1 % OINTMENT • If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacrolimus 0.1% Ointment (listed in section 6) or to Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tacrolimus Teva 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 Teva 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 Teva 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 Teva can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis. Tacrolimus Teva treatment should begin at the first appearance of signs and symptoms. Each affected region of the skin should be treated with Tacrolimus Teva 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. _Adults and adolescents (16 years of age and above)_ Treatme Lees het volledige document