Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
fluconazole, Quantity: 150 mg
Arrotex Pharmaceuticals Pty Ltd
Fluconazole
Capsule, hard
Excipient Ingredients: brilliant blue FCF; pregelatinised maize starch; Gelatin; colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; purified talc; lactose monohydrate; purified water; titanium dioxide
Oral
1 and 4 capsules
(S4) Prescription Only Medicine
Fluconazole, given orally, is indicated for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. Note. Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aquired immune deficiency syndrome (AIDS). Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B. Note. It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice. Vaginal candidiasis, when topical therapy has failed. Treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. Usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks
Visual Identification: White free flowing powder filled in empty hard gelatin capsule of size '1' with a blue cap and a blue body; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-08-17
FLUZOLE- Consumer Medicine Information Page 1 of 4 FLUZOLE fluconazole CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FLUZOLE 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 FLUZOLE capsules against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLUZOLE IS USED FOR FLUZOLE capsules are used to treat certain fungal and yeast infections. This medicine belongs to a group of medicines called azole antibiotics. It works by preventing the growth of the fungal and yeast organisms causing your infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. This medicine is not addictive. BEFORE YOU TAKE IT When you must not take it DO NOT TAKE FLUZOLE IF YOU HAVE AN ALLERGY TO: • any medicine containing fluconazole • medicines related to fluconazole such as miconazole, ketoconazole or clotrimazole • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. FLUZOLE SHOULD NOT BE GIVEN IF YOU ARE TAKING CISAPRIDE (A MEDICINE USED TO TREAT STOMACH PROBLEMS). DO NOT TAKE THIS MEDICINE IF THE EXPIRY DATE PRINTED ON THE PACKAGING HAS PASSED OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING THIS MEDICINE, TALK TO YOUR DOCTOR. Before you start to take it TELL Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION FLUZOLE (FLUCONAZOLE) CAPSULES 1 NAME OF THE MEDICINE Fluconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluzole capsules come in three strengths and contain 50 mg, 150 mg or 200 mg of fluconazole. Fluconazole is a white to off-white crystalline powder which is sparingly soluble in water and saline. The capsules also contain lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM FLUZOLE 50 Blue and white, opaque, hard gelatin capsules. Each capsule contains 50 mg of fluconazole. FLUZOLE 150 Blue, opaque, hard gelatin capsules. Each capsule contains 150 mg of fluconazole. FLUZOLE 200 Violet and white, opaque, hard gelatin capsules. Each capsule contains 200 mg of fluconazole. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Orally for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B. NOTE. Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis. Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (AIDS). Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients. Secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (HIV) infection. Serious and life-threatening _Candida_ infections in patients who are unable to tolerate amphotericin B. NOTE. It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life-threatening _Candida_ infections. Until such data are available, amphotericin B remains the drug of choice. 2 Vaginal candidiasis, when topical therapy has failed. Treatment of extensive _Tinea corporis_, extensive _Tinea cruris_ and extensive _Tinea pedis_ infections in immunocompetent patients in whom topical therapy is not a practical treatment option. Usually, topical therapy should Przeczytaj cały dokument