देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOTRIMAZOLE
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
CLOTRIMAZOLE
15 ml
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ZOLE TOPICAL SOLUTION (CLOTRIMAZOLE 1% W/V) Clotrimazole (1% w/v) 1 WHAT IS IN THIS LEAFLET 1. What Zole is used for 2. How Zole works 3. Before you use Zole 4. How to use Zole 5. While you are using Zole 6. Side effects 7. Storage and disposal of Zole 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ZOLE IS USED FOR To treat cutaneous candidiasis (red, itchy rash), tinea corporis (ringworm), tinea cruris (jock itch), tinea pedis (Athlete's foot) and tinea versicolor (small, discolored patches). HOW ZOLE WORKS Clotrimazole has an anti-fungal activity which helps to treat fungal infection. BEFORE YOU USE ZOLE _- When you must not use it _ Do not use it when you have sensitivity to Clotrimazole. _-Before you start to use it_ To be used under medical advice and as directed by the attending physician. _-Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Not known drug interaction. HOW TO USE ZOLE _-How much to use _ Apply gently onto affected and surrounding skin area 2 or 3 times daily continuing for 2-4 weeks. _-When to use it _ Use as directed by your doctor or pharmacist. Apply thinly to the affected areas 2-3 times daily and rub in. _-How long to use it _ Continue taking Zole as your doctor recommended. _ _ _ _ _ _ _ _ _ _ _-If you forget to use it _ Consult your doctor or pharmacist on what you should do if you forget to use it. _ _ _-If you use too much (overdose) _ Acute overdose with topical application of Clotrimazole is unlikely and would not be expected to lead to a life- threatening situation. WHILE YOU ARE USING ZOLE _-Things you must do _ • Tell all the doctors, dentists and pharmacists treating you that you are using Zole. _ _ • Tell your doctor immediately if you become pregnant while taking this medication. _ _ _-Things you must not do _ • Do not take more than the rec पूरा दस्तावेज़ पढ़ें
ZOLE TOPICAL SOLUTION (CLOTRIMAZOLE 1% W/V) Name and Strength of Active Substance: Clotrimazole ………………………….. 1% w/v DESCRIPTION: PRODUCT DESCRIPTION Clear, colourless viscous liquid. PHARMACODYNAMICS The antifungal activity of imidazoles is due to their ability to increase fungal cell membrane permeability by interfering with the biosynthesis of sterols, particularly ergosterol. PHARMACOKINETICS When applied topically Clotrimazole penetrates the epidermis but there is little if any systemic absorption. Clotrimazole is metabolised in the liver to inactive compounds and excreted in the faeces and urine. INDICATIONS Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis and tinea versicolor. RECOMMENDED DOSE Apply gently onto affected and surrounding skin area 2 or 3 times daily continuing for 2-4 weeks. ROUTE OF ADMINISTRATION Topical CONTRAINDICATIONS Hypersensitivity to Clotrimazole. WARNING AND PRECAUTIONS If irritation or sensitivity develops with the use of Clotrimazole, treatment should be discontinued and appropriate therapy instituted. INTERACTIONS WITH OTHER MEDICAMENTS Not known. PREGNANCY & LACTATION There are, no adequate and well controlled studies in pregnant women during the first trimester of pregnancy because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman. ADVERSE EFFECTS / UNDESIRABLE EFFECTS Local reactions include irritation, burning sensation, contact dermatitis, blister, peeling of skin, pruritus, urticaria and stinging of skin. SYMPTOMS AND TREATMENT OF OVERDOSE Acute overdosage with topical application of Clotrimazole is unlikely and would not be expected to lead to a life-threatening situation. EFFECTS ON ABILITY TO DRIVE AND USE MACHINE Not Applicabl पूरा दस्तावेज़ पढ़ें