Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOTRIMAZOLE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
CLOTRIMAZOLE
0.2gm3Tablet Tablets
GLENMARK PHARMACEUTICALS LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CANDID V3 VAGINAL INSERT Clotrimazole (200mg) Page 1 of 2 WHAT IS IN THIS LEAFLET 1. What Candid V3 is used for 2. How Candid V3 works 3. Before you use Candid V3 4. How to use Candid V3 5. While you are using it 6. Side effects 7. Storage and Disposal of Candid V3 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CANDID V3 IS USED FOR Candid V3 is indicated for the treatment of vaginal thrush. It is inserted into the vagina for treatment at the site of infection. Only use this product if you have been diagnosed by your doctor as having vaginal thrush. HOW CANDID V3 WORKS The active substance in Candid V3 is clotrimazole. Clotrimazole belongs to a group of medicines called azoles which is an antifungal agent that fights the infections causing vaginal thrush. BEFORE YOU USE CANDID V3 _-_ _ _ _When you must not use it _ If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Candid V3. _-_ _ _ _Before you start to use it _ Tell your pharmacist or doctor if: You are unsure whether you have thrush or this is the first time you have had these symptoms. You have ever had an allergic reaction or sensitivity caused with the use of Candid V3 or other vaginal antifungal products. Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast-feeding before using any medicine This is because Candid V3 may not be the right treatment for you. _-_ _ _ _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. HOW TO USE CANDID V3 _-_ _ _ _How much to use _ Non-pregnant women: Insert one tablet into vagina once a day. Pregnant women: Intravaginal, 100mg once a day. _-_ _ _ _When to use it _ If Candid V3 has been prescribed for you by your doctor, follow any instructions he/she may have given you. If you purchased this product withou Læs hele dokumentet
SAME SIZE ARTWORK LEAFLET SIZE: 88 mm x 186 mm SAME SIZE ARTWORK LEAFLET SIZE: 88 mm x 186 mm Manufactured by: Plot no. E-37, 39, D-Road, MIDC, Satpur, Nashik - 422 007, Maharashtra State, India. Trade Mark PRODUCT REGISTRATION HOLDER: Glenmark Pharmaceuticals (Malaysia) Sdn Bhd (660397-W) D-31-02, Menara Suezcap 1, No. 2, Jalan Kerinchi, 59200 Kuala Lumpur, Malaysia PE00000 MY PE56459 MY 24 mm COMPOSITION Each uncoated tablet contains: Clotrimazole USP 200 mg PRESERVATIVES: Methyl Paraben USP NF 0.8 mg Propyl Paraben USP NF 0.2 mg THERAPEUTIC CLASS T0130 DESCRIPTION A printed carton with an insert, an applicator (s) and a printed aluminium strip (s) containing 3 white, biconvex vaginal, uncoated tablets with monogram on one side and V3 on the other side. ACTIONS AND MODE OR MECHANISM OF ACTION Clotrimazole is an imidazole antifungal agent. Clotrimazole exerts its activity on the cell membrane of the fungus. It appears that the drug inhibits protein synthesis and so influences the utilisation and the incorporation of the acylated amino acids essential for fungi. PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS) PHARMACODYNAMICS Clotrimazole has a wide spectrum of activity against Dermatophytes (Trichophyton, Microsporum, Epidermophyton), Yeasts (Candida sp., Torulopsis sp.), Mould fungi and other fungi (Aspergilus sp.,Malassezia furfur, Nocardia sp., etc.). It also has action against Trichomonas and some strains of Gram - positive bacteria (Streptococci, Staphylococci and Corynebacterium minitissimum) and Gram - negative bacteria (Bacteroides and Haemophilus vaginalis). PHARMACOKINETICS Following topical and vaginal administration , however, Clotrimazole appears to 14 be minimally absorbed . Following intravaginal administration of 100 mg C- Clotrimazole vaginal inserts to nine adult females, an average peak serum level, corresponding to only 0.03 µg equivalents/mL of Clotrimazole, was reached 1 to 2 days after application. INDICATIONS Vulvoginal Candidiasis. CONTRAINDICATIONS Except for possible h Læs hele dokumentet