Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Fluconazole 100mg; Fluconazole 100mg
Viatris Limited
Fluconazole 100 mg
100 mg
Capsule
Active: Fluconazole 100mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Patent blue V Pregelatinised maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide Active: Fluconazole 100mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Maize starch Patent blue V Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide
Blister pack, PVC/PVDC/Al 28's, 28 capsules
Prescription
Prescription
Mylan Laboratories Limited
1. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. 2. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated. 3. Mucosal candidiasis. These include oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated. 4. Vaginal candidiasis, acute or recurrent. 5. Prevention of fungal infection in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant 6. Fluconazole 50 mg & 150 mg capsules are also indicated for the treatment of dermatomycoses including tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor & candidiasis.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al 28's - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al 28's - 28 capsules - 36 months from date of manufacture stored at or below 25°C
2002-06-24
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION FLUCONAZOLE _FLUCONAZOLE 50 MG, 150 MG AND 200 MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fluconazole 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 using Fluconazole capsules against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLUCONAZOLE IS USED FOR AND HOW IT WORKS Your Fluconazole capsules contain fluconazole. It belongs to a group of medicines known as antifungals. Fluconazole is used to treat certain fungal and yeast infections. 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. Fluconazole is only available with a doctor's prescription. BEFORE YOU TAKE FLUCONAZOLE _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE FLUCONAZOLE IF YOU HAVE AN ALLERGY TO THE FOLLOWING: 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. Do not take this medicine if you are taking any of the following medicines: CISAPRIDE (a medicine used to treat stomach problems) ASTEMIZOLE (an antihistamine used to treat allergies) ERYTHROMYCIN (an antibiotic used in the treatment of infections) PIMOZIDE (an antipsychotic medicine) QUINIDINE (a medicine used to treat an irregular heartbeat) TERFENADINE (an antih Read the complete document
Page 1 of 19 NEW ZEALAND DATA SHEET FLUCONAZOLE 1. PRODUCT NAME Fluconazole, 50 mg, 100 mg, 150 mg and 200 mg, capsule. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg, 100 mg, 150 mg or 200 mg of fluconazole. Fluconazole capsules contain lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Fluconazole 50 mg: Size 4 hard gelatin capsule with white opaque body and dark blue opaque cap. The body has "FC 50" and the cap has "G" printed in black. The capsule contains white to off-white powder. Fluconazole 100 mg: Size 2 hard gelatin capsule with white opaque body and blue opaque cap. The body has “FC 100” and the cap has “G” printed in black. The capsule contains white to off- white powder. Fluconazole 150 mg: Size 1 hard gelatin capsule with white opaque body and white opaque cap. The body has "FC 150" and the cap has "G" printed in black. The capsule contains white to off- white powder. Fluconazole 200 mg: Size 0 hard gelatin capsule with white opaque body and blue opaque cap. The body has "FC 200" and the cap has "G" printed in black. The capsule contains white to off- white powder. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Fluconazole is indicated for the treatment of the following conditions: 1. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. 2. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candida infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candida infections may be treated. Page 2 of 19 3. Mucosal candidiasis. These incl Read the complete document