Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOTRIMAZOLE
SYNERRV SDN BHD
CLOTRIMAZOLE
1 Units
KUSUM HEALTHCARE PVT. LTD.
CANDIGO CLOTRIMAZOLE PESSARY 500 MG _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET _1._ _ _ What _is Candigo used for _ 2. How _Candigo _ works _3._ _ _ Before you use _Candigo _ _4._ _ _ How to use _Candigo _ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Candigo _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS _CANDIGO _IS USED FOR Clotrimazole belongs to a group of medicines called azoles and is an antifungal agent which fights the infections such as vaginitis (inflammation of vagina) caused by certain types of fungi (usually Candida) and superinfection caused by Clotrimazole sensitive bacteria. It is inserted into the vagina for treatment at the site of infection. HOW _CANDIGO _WORKS Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane of fungus BEFORE YOU USE _CANDIGO _ _- When you must not use it _ If you are under 16 or over 60 years of age. If you are in pain, feel sick, or have diarrhoea or a fever. Irregular vaginal bleeding. Abnormal vaginal bleeding or a blood-stained discharge. Lower abdominal pain or dysuria. Foul smelling vaginal discharge. _PREGNANCY AND LACTATION _ If you are pregnant or trying for a baby, tell your doctor or midwife before using _Candigo. _ If you have informed your doctor or midwife already, follow his/her instructions carefully. Do not use _Candigo _ if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _-Before you start use it _ Confirm if you are not hypersensitive to Clotrimazole or any of the excipients used in _Candigo_ . - _Taking other medicines _ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Inform your doctor if you are taking tacrolimus or sirolimus (used to reduc Aqra d-dokument sħiħ
CANDIGO ® CLOTRIMAZOLE PESSARY 500 MG GENERAL CHARACTERISTICS _GENERAL PHYSIO-CHEMICAL PROPERTIES:_ White to light yellow colour torpedo shaped pessary. COMPOSITION: Each pessary contains Clotrimazole BP ….….. 500 mg _EXCIPIENT _ Hard Fat PHARMACODYNAMIC PROPERTIES: PHARMACOTHERAPEUTIC GROUP: Anti-infective ATC CODE: G01A F02 _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 in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc. Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 μg/ml substrate. The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions PHARMACOKINETICS PROPERTIES: Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3- 10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites the resulting peak plasma concentrations of clotrimazole after vaginal application of a 500 mg dose were less than 10 mg/ml, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects. INDICATIONS: Infections of the genital region (vaginitis) caused by fungi (usually Candida) and superinfections caused by Clotrimazole-sensitive bacteria. DOSAGE AND ADMINISTRATION: Candigo ® Pessary should be inserted into the vagina, as high as possible with the help o Aqra d-dokument sħiħ