Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Terbinafine Hydrochloride
Y.S.P. INDUSTRIES (M) SDN BHD
Terbinafine Hydrochloride
20gm mcg/mL; 20gm mcg/mL; 15gm mcg/mL; 10gm mcg/mL; 10gm mcg/mL; 15gm mcg/mL; 500 gm
Y.S.P. INDUSTRIES (M) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DERMAFIN ® CREAM Terbinafine Hydrochloride (10mg/g) 1 WHAT IS IN THIS LEAFLET This leaflet contains information below: 1. What DERMAFIN ® CREAM is used for 2. How DERMAFIN ® CREAM works 3. Before you use DERMAFIN ® CREAM 4. How to use DERMAFIN ® CREAM 5. While you are using DERMAFIN ® CREAM 6. Side effects 7. Storage and disposal of DERMAFIN ® CREAM 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DERMAFIN ® CREAM IS USED FOR DERMAFIN ® CREAM is used for fungal infections of the skin such as below: • athlete’s foot (tinea pedis) - especially when it occurs between the toes • jock itch (tinea cruris) - itchy rash with a clear border which often occurs on the groin and inner thigh area. • ringworm (tinea corporis) - circular patches of red rash which may appear scaly. • pityriasis (tinea) versicolor - skin infection caused by yeast, causing scaly patches that become white areas due to loss of skin pigmentation. DERMAFIN ® CREAM is for external use only. HOW DERMAFIN ® CREAM WORKS Terbinafine is a fungicidal medication which kills certain dermatophytes, mould, fungi and fungistatic (inhibit growth of fungi) for some yeast that causes the infection. BEFORE YOU USE DERMAFIN ® CREAM _-When you must not use it _ DERMAFIN ® CREAM is not recommended for pregnant and breastfeeding women. Do not use DERMAFIN ® CREAM if you have allergy towards terbinafine or any components in this cream preparation. Do not use this medicine after the expiry date or if the tube is leaking or tube nozzle cover is broken. _-Before you start to use it _ Tell your doctor or pharmacist if you are allergic to terbinafine or any components of this preparation. _-Taking other medicines _ Seek advice from your doctor or pharmacist if you intend to use DERMAFIN ® CREAM together with other medication. HOW TO USE DERMAFIN ® CREAM _-How much to use _ Apply a thin layer and rub lightly to the affected skin and surrounding area once Přečtěte si celý dokument
ATTACHMENT 1 DERMAFIN CREAM INGREDIENT(S): Each gram contains: Terbinafine Hydrochloride ......................................... 10mg PRESERVATIVE(S): Methyl Paraben........................................................... 1mg Propyl Paraben............................................................ 1mg PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS): Terbinafine is an allylamine with a range of antifungal activity its action being fungicidal against dermatophytes, moulds and certain dimorphic fungi, and either fungicidal or fungistatic against yeast, depending on the species. Terbinafine interferes with fungal ergosterol biosynthesis at an early stage. This leads to a deficiency in ergosterol and to intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine does not affect the metabolism of hormones or other drugs. INDICATION(S): Fungal infections of the skin caused by dermatophytes, eg. _Tricophyton, _ _Microsporum _ _canis_ and _Epidermophyton _ _floccosum_; yeast infections of the skin, principally those caused by the genus Candida; _Pityriasis (tinea) versicolor_ due to _Pityrosporum orbiculare._ DOSAGE AND ADMINISTRATION: Apply a thin layer and rub lightly to the affected skin and surrounding area once or twice daily. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal), the application may be covered with gauze strip, especially at night. Duration of treatment: Tinea pedis, cruris, corporis: 1 week of treatment will normally suffice if the cream is applied once daily. Cutaneous Candidiasis: 1 -2 weeks Pityriasis (tinea) versicolor: 2 weeks CONTRAINDICATION(S): Hypersensitivity to terbinafine. PRECAUTION(S) / WARNING(S): Terbinafine cream is for external use only. Contact with the eyes should be avoided. It is not recommended for pregnant and breastfeeding women DRUG INTERACTION(S): There are no known drug interactions involving terbinafine cream. SIDE EFFECT(S) / ADVERSE REACTION(S): Occasional redness or itching. SYMPTOMS Přečtěte si celý dokument