देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
fluconazole, Quantity: 150 mg
Sun Pharma ANZ Pty Ltd
Fluconazole
Capsule, hard
Excipient Ingredients: Gelatin; colloidal anhydrous silica; maize starch; titanium dioxide; lactose monohydrate; magnesium stearate; purified water; sodium lauryl sulfate; patent blue V; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
1 capsule per pack
(S3) Pharmacist Only Medicine
For the treatment of vaginal candidiasis, when topical therapy has failed.
Visual Identification: Blue/blue hard gelatin, self locked capsules of size '1' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2006-10-06
OZOLE _Fluconazole 150 mg Capsule _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OZOLE (fluconazole 150 mg) capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking OZOLE against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with this medicine. You may need to read it again. WHAT OZOLE IS USED FOR OZOLE contains the active ingredient fluconazole. It is used to treat vaginal thrush in women, when topical treatment has failed. If this is the first time you have had symptoms, talk to your doctor before using any treatment. _TREATING VAGINAL THRUSH IN _ _WOMEN _ Taken by mouth, OZOLE treats the yeast infection, vaginal thrush, which is caused by a yeast called Candida albicans. Most women have vaginal thrush some time during their lives. Many women have this yeast living harmlessly within their bodies. However, the natural balance that keeps Candida albicans under control can be upset by other factors, e.g. antibiotics, diabetes, the Pill, wearing tight clothing, or using perfumed soaps, bath additives and vaginal deodorants. When the levels of yeast become too high, thrush develops. You may have one or more of these common symptoms: • Vaginal itching • Vaginal burning and redness • Pain during intercourse • A white, curdy, odourless discharge from the vagina (like cottage cheese) Rubbing and scratching can aggravate the soreness and itching. Also, the salt in urine can sting the sore tissue. BEFORE YOU TAKE OZOLE DO NOT USE OZOLE: • If you are pregnant, suspect you might be pregnant or are trying to become pregnant or are breast- feeding • If you are allergic to any of the ingredients in OZOLE or other thrush treatments such as miconazole, clotrimazole or ketoconazole • If you are tak पूरा दस्तावेज़ पढ़ें
AUSTRALIAN PRODUCT INFORMATION OZOLE (FLUCONAZOLE) CAPSULE 1 NAME OF THE MEDICINE Fluconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each OZOLE capsule contains fluconazole 150 mg as the active ingredient. Other ingredients: lactose. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM OZOLE capsules are a size 1, hard gelatin capsule, with a blue opaque body and a blue opaque cap. The body and the cap has RANBAXY printed in black edible ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OZOLE, given orally, is indicated for vaginal candidiasis. 4.2 DOSE AND METHOD OF ADMINISTRATION OZOLE is administered orally. ADULTS For vaginal candidiasis, fluconazole 150 mg (OZOLE) should be administered as a single oral dose. USE IN RENAL IMPAIRMENT Impaired Renal Function. Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single-dose therapy are necessary in patients with minor to moderate renal impairment. PAEDIATRIC USE Children. Single-dose fluconazole is not recommended for use in children under 18 years of age except under physician supervision. Version 3, dated 21 Aug 2018 Page 1 of 13 4.3 CONTRAINDICATIONS OZOLE is contraindicated in patients with known sensitivity to fluconazole, related azole compounds or any of the excipients of OZOLE. Co-administration of other drugs known to prolong the QT interval and which are metabolised via the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide and quinidine are contraindicated (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In rare cases, as with other azoles, anaphylaxis has been reported. Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are more prone to the development of serious cutaneous reactions to many drugs. Fluconazole should not be used again if a rash develops which is attributa पूरा दस्तावेज़ पढ़ें