Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TACROLIMUS
DKSH MALAYSIA SDN BHD
TACROLIMUS
30gm mcg/mL; 10gm 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. 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 scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin). • If you have a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication after undergoing a bone marrow transplant). • If you have swollen lymph nod Lue koko asiakirja
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) _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 topicalcorticosteroids. 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 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 lesion are cleared, almost cleared or mildly affected. 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) _ Treatment should be started with PROTOPIC® 0.1% twice a day and treatment should be continued until clearance of the lesion. If symptoms recur, twice daily treatment with PROTOP Lue koko asiakirja