Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TACROLIMUS
DKSH MALAYSIA SDN BHD
TACROLIMUS
10gm mcg/mL; 30gm mcg/mL
LEO Laboratories Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 PROTOPIC® OINTMENT Tacrolimus (0.03% w/w, 0.1% w/w) WHAT IS IN THIS LEAFLET 1. What Protopic® is used for 2. How Protopic® works 3. Before you use Protopic® 4. How to use Protopic® 5. While you are using it Side effects 6. Storage and Disposal of Protopic® 7. Product Description 8. Manufacturer and Product Registration Holder 10. Date of revision WHAT PROTOPIC® IS USED FOR Protopic® 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. Only Protopic® 0.03% is used to treat children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. Protopic® is also used to treat moderate to severe atopic dermatitis (eczema) for the prevention of flares and 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 maximum 6 weeks treatment of twice daily Protopic® ointment. HOW PROTOPIC® WORKS The active substance of Protopic®, tacrolimus monohydrate, is an immunomodulating agent. 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. BEFORE YOU USE PROTOPIC® _-_ _ _ _When you must not use it _ If you are allergic to tacrolimus or any of the other ingredients of this medicine or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin). _-_ _ _ _Before you start to use it _ Talk to your doctor • If you have liver failure. • If you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause. • If you have an inherited skin barrier disease such as Netherton’s syndrome, lamellar ichthyosis (extensive sca Læs hele dokumentet
PROTOPIC ® NAME OF THE MEDICINAL PRODUCT PROTOPIC® ointment 0.03% PROTOPIC® ointment 0.1% QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of PROTOPIC® 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%). 1 g of PROTOPIC® 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%). For the full list of excipients, see List of Excipients. PHARMACEUTICAL FORM Ointment. A white to slightly yellowish ointment. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS PROTOPIC® 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. PROTOPIC® 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. _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). 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 Læs hele dokumentet