Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOTRIMAZOLE; HYDROCORTISONE BASE
HOE PHARMACEUTICALS SDN. BHD.
CLOTRIMAZOLE; HYDROCORTISONE BASE
450gm mcg/mL; 15gm mcg/mL; 5 gm mcg/mL
HOE PHARMACEUTICALS SDN. BHD.
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 CANDACORT CREAM Clotrimazole, Hydrocortisone (1.0% w/w, 1.0% w/w) _ _ WHAT IS IN THIS LEAFLET 1. What CANDACORT CREAM is used for 2. How CANDACORT CREAM works 3. Before you use CANDACORT CREAM 4. How to use CANDACORT CREAM 5. While you are using CANDACORT CREAM 6. Side effects 7. Storage and Disposal of CANDACORT CREAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision This leaflet answers some common questions about CANDACORT CREAM. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again WHAT CANDACORT CREAM IS USED FOR It is indicated for the topical treatment of fungal and candida infections, when these are accompanied by pronounced inflammatory symptoms and itching. HOW CANDACORT CREAM WORKS This medicine contains Clotrimazole which is a broad spectrum antifungal agent against a number of fungi causing infection to skin. The other active component of this product, Hydrocortisone is a topically active corticosteroid which has potent anti- inflammatory, anti-itching and blood vessel narrowing. BEFORE YOU USE CANDACORT CREAM _ _ _-When you must not use it: _ • If you are hypersensitive to Clotrimazole, Hydrocortisone or the excipients. The use of corticosteroid is contraindicated in most viral infections of the skin and also tuberculosis and acne rosacea. • On areas of damaged skin • On larger areas of skin (more than 5-10% of body surface) • On your face, eyes, mouth or around it • On any untreated bacterial skin infections, such as syphilis or tuberculosis _-Before you start use it _ Tell your doctor or pharmacist: • If you are pregnant, breast Olvassa el a teljes dokumentumot
NAME AND STRENGTH OF ACTIVE SUBSTANCES : Clotrimazole 1% w/w and Hydrocortisone 1% w/w. PRODUCT DESCRIPTION : A white cream. Other ingredients are Chlorocresol, White Soft Paraffin, Liquid Paraffin, Propylene Glycol, Macrogol Cetostearyl Ether, Cetostearyl Alcohol, Glycerin and Purified Water. PHARMACODYNAMICS : Clotrimazole is a broad-spectrum imidazole with potent anti-fungal against dermatophytes, including Epidermophytes, Microsporum, Trichophyton spp. and Malassezia furfur, and Candida species. It permeates the chitin of the fungal cell wall and increases the membrane permeability to various intracellular substances. Hydrocortisone is a topically active corticosteroid which has potent anti-inflammatory, anti-pruritic, and vasoconstrictive actions. PHARMACOKINETICS :When applied topically, clotrimazole penetrates the epidermis but there is little if any systemic absorption. It is metabolized in the liver to inactive compounds and excreted in the faeces and urine. When hydrocortisone is administered topically, particularly under occlusive dressings or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects. Corticosteroids are extensively bound to plasma proteins. Only unbound corticosteroid has pharmacological effects or is metabolized. They are metabolized in the liver and tissues, and the metabolites are excreted in the urine. INDICATIONS : For the topical treatment of fungal and candidal infections, when these are accompanied by pronounced inflammatory symptoms and itching. CONTRAINDICATIONS : Hypersensitivity to Clotrimazole, Hydrocortisone or any component in the base. The use of corticosteroid is contraindicated in most viral infections of the skin and also tuberculosis and acne rosacea. ADVERSE EFFECTS : Infrequent local adverse effects of Clotrimazole and Hydrocortisone include stinging, burning, oedema, desquamation, pruritus, and urticaria. Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids. PRECAUTI Olvassa el a teljes dokumentumot