Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE VALERATE; FUSIDIC ACID
DKSH MALAYSIA SDN BHD
BETAMETHASONE VALERATE; FUSIDIC ACID
5gm mcg/mL; 15gm mcg/mL
LEO Laboratories Ltd
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FUCICORT ® CREAM Fusidic acid / Betamethasone (20mg/g / 1mg/g) ____________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Fucicort ® Cream is used for 2. How Fucicort ® Cream works 3. Before you use Fucicort ® Cream 4. How to use Fucicort ® Cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Fucicort ® Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT FUCICORT ® CREAM IS USED FOR Fucicort ® Cream is used to treat conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria). HOW FUCICORT ® CREAM WORKS Fucicort ® Cream contains two different types of medicine. One medicine is called Fusidic acid. It is a type of antibiotic. The other medicine is called betamethasone valerate. It is a type of corticosteroid (steroid). Fucicort ® Cream works by the antibiotic killing germs that cause infections and corticosteroid help to reduce any swelling, redness or itchiness of your skin. Your doctor may have prescribed this medication for another reason. Ask your doctor if you have any questions about why this medication has been prescribed for you. BEFORE YOU USE FUCICORT ® CREAM - _When you must not use it _ • If you are allergic (hypersensitive) to Fusidic acid or betamethasone valerate • If you are allergic (hypersensitive) to any of the other ingredients in this medicine. • If you have perioral dermatitis. This is a red spotty rash around your mouth or chin • If you have skin conditions caused by a virus such as cold sores or chickenpox • If you have skin condition caused by fungus • If you have a skin condition called acne rosacea. This is the redness and inflammation over your nose and cheeks. Ask your doctor if y Baca dokumen lengkap
Fucicort® Cream C omposition Each gramme contains: Fusidic acid 20 mg Betamethasone as valerate 1 mg Preserved with chlorocresol Product Description White cream P roperties Fucicort ® combines the potent topical antibacterial action of fusidic acid with the antiinflammatory and antipruritic effects of betamethasone. Betamethasone valerate is a topical steroid with rapid effect in inflammatory dermatoses. Even refractory conditions can often be treated successfully. When applied topically, fusidic acid is effective against Staphylococci, Streptococci, Corynebacteria, Neisseria and certain Clostridia and Bacteroides. The antibacterial activity of fusidic acid is not diminished in the pre sence of betamethasone. Indications Fucicort® is indicated in inflammatory dermatoses where bacterial infection is present or likely to occur. Inflammatory d ermatoses include atopic eczema, discoid eczema, stasis eczema, seborrhoeic , dermatitis, contact dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus. Dosage Uncovered lesions: 2–3 daily applications. Covered lesions: Less frequent application may be adequate. C ontra -indications Hypersensitivity to fusidic acid/sodium fusidate, betamethasone valerate or to any of the Excipients. Due to the content of corticosteroid, Fucicort® is contraindicated in the following conditions: Systemic fungal infections Primary skin infections caused by fungi, virus or bacteria, either untreated or uncontrolled by appropriate treatment (see Special Warnings and Precautions for Use) Skin manifestations in relation to tuberculosis, either untreated or uncontrolled by appropriate t herapy. Perioral dermatitis and rosacea Special Warnings and Precautions for Use Long- term continuous topical therapy with Fucicort® should be avoided. Depending on the application site, possible systemic absorption of betamethasone valerate should always be considered during treatment with Fucicort®. Due to the content of corticosteroid, Fucicort® should be used with care near the eyes Baca dokumen lengkap