מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOTRIMAZOLE
SPG PHARMA (MALAYSIA) SDN BHD
CLOTRIMAZOLE
1 x 6's vaginal Tablets
SIAM BHEASACH CO LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DEFUNGO (VAGINAL TABLET) Clotrimazole (0.1 g) _______________________________________________________________________________________________ 1/2 WHAT IS IN THIS LEAFLET 1. What DEFUNGO is used for 2. How DEFUNGO works 3. Before you use DEFUNGO 4. How to use DEFUNGO 5. While you are using DEFUNGO 6. Side effects 7. Storage and Disposal of DEFUNGO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT DEFUNGO IS USED FOR DEFUNGO is an antifungal agent used to treat infections vaginal discharge. HOW DEFUNGO WORKS DEFUNGO belongs to a class of medicines known as azoles. It works by preventing the growth of fungi which causes your infection. BEFORE YOU USE DEFUNGO _- When you must not use it _ Do not use DEFUNGO if you: ▪ are allergic to clotrimazole or any other ingredients listed at the end of this leaflet ▪ are having your menstrual period _- Before you start to use it _ Tell your doctor or pharmacist before using DEFUNGO if you: ▪ have known hypersensitivity to imidazoles or other vaginal antifungal product _- Taking other medicines _ Tell your doctor or pharmacist if you are taking or have recently taken any medicines, including traditional products bought without a prescription. Some medicines may interact with DEFUNGO such as tacrolimus or sirolimus (used after organ transplant). For pregnant and/or breastfeeding mother, please consult your doctor before using DEFUNGO. HOW TO USE DEFUNGO _- How much to use _ For vaginal use only. The medicine should be inserted as deeply as possible into the vagina, best achieved when lying back with legs bent up. _DEFUNGO 0.1G (VAGINAL _ _TABLET): _ First infection Insert 2 Defungo 0.1g (vaginal tablet) into the vagina for three consecutive nights. Reinfection Insert 1 Defungo 0.1g (vaginal tablet) into the vagina for six consecutive nights. If necessary, 2 Defungo 0.1g (vaginal tablet) can be used, 1 in the morning and 1 in the evening for 6-12 days. _- When t קרא את המסמך השלם
PRODUCT NAME DEFUNGO 0.1G (VAGINAL TABLET) NAME AND STRENGTH OF ACTIVE SUBSTANCE DEFUNGO 0.1G: Each vaginal tablet contains 0.1 g Clotrimazole PRODUCT DESCRIPTION DEFUNGO 0.1G: White, oblong and biconvex tablet engraved with the “ ” logo on one side and the letter “0.1” on the other side PHARMACODYNAMICS Pharmacotherapeutic group: gynaecological anti-infective and antiseptics - imidazole derivatives Mechanism of action Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action which includes dermatophytes, yeasts, moulds, etc. PHARMACOKINETICS Clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects. Pharmacokinetic investigations have shown that only a small amount of clotrimazole, about 3-10% of the dose is absorbed after vaginal application. INDICATION Infections of the genital region (vaginitis) caused by fungi (usually Candida) and superinfections caused by Clotrimazole-sensitive bacteria. DOSAGE AND ADMINISTRATION DEFUNGO 0.1G (VAGINAL TABLET): First infection Insert 2 Defungo 0.1g (vaginal tablet) into the vagina for three consecutive nights. Reinfection Insert 1 Defungo 0.1g (vaginal tablet) into the vagina for six consecutive nights. If necessary, 2 Defungo 0.1g (vaginal tablet) daily, 1 in the morning and 1 in the evening for 6-12 days. Instruction for use █ For vaginal use only. The medicine should be inserted as deeply as possible into the vagina, best achieved when lying back with the legs bent up █ Treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation █ Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product █ Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using this product the partner could become infected CONTRAINDICATI קרא את המסמך השלם