País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Fluconazole 150mg; Fluconazole 150mg
Viatris Limited
Fluconazole 150 mg
150 mg
Capsule
Active: Fluconazole 150mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Pregelatinised maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide Active: Fluconazole 150mg Excipient: Gelatin Hydrated silica Lactose monohydrate Magnesium stearate Maize starch Sodium laurilsulfate TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide
Blister pack, PVC/PVDC/Al, 1 capsule
Restricted
Restricted
Mylan Laboratories Limited
Fluconazole is indicated for the treatment of vaginal candidiasis.
Package - Contents - Shelf Life: Blister pack, PVC/Al or PVC/PVDC/Al - 1 capsules - 36 months from date of manufacture stored at or below 25°C
2004-09-03
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION FLUCAZOLE ® _FLUCONAZOLE CAPSULES 150 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Flucazole. This leaflet answers some common questions about Flucazole. It does not contain all the information available on this medicine. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Flucazole against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT FLUCAZOLE IS TAKEN FOR AND HOW IT WORKS Your Flucazole capsule contains fluconazole. It belongs to a group of medicines known as antifungals. Flucazole is used to treat vaginal thrush infections. It works by preventing the growth of fungal and yeast organisms. 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. Flucazole is available over the counter at a pharmacy or with a doctor’s prescription. BEFORE YOU TAKE FLUCAZOLE _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE FLUCAZOLE IF YOU HAVE AN ALLERGY TO THE FOLLOWING: • ANY MEDICINE CONTAINING FLUCONAZOLE • MEDICINES RELATED TO FLUCONAZOLE SUCH AS MICONAZOLE, KETOCONAZOLE, ITRACONAZOLE, CLOTRIMAZOLE OR VORICONAZOLE • 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) Leia o documento completo
Page 1 of 14 NEW ZEALAND DATA SHEET FLUCAZOLE ® 1. PRODUCT NAME Flucazole, 150 mg, capsule. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg of fluconazole. Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 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. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Flucazole 150 mg, given orally, is indicated for vaginal candidiasis. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE Fluconazole 150mg capsules are administered orally. For vaginal candidiasis, fluconazole 150 mg should be administered as a single oral dose. The median time to onset of symptom relief following a 150 mg oral dose for the treatment of vaginal candidiasis is one day. The range of time to onset of symptoms relief is one hour to nine days. SPECIAL POPULATIONS _RENAL IMPAIRMENT _ Fluconazole is predominantly excreted in the urine as unchanged medicine. No adjustments in single-dose therapy are necessary in patients with minor to moderate renal impairment. _PAEDIATRIC _ Single dose fluconazole is not recommended for use in children under 18 years of age except under doctor supervision. Page 2 of 14 _4.3_ _CONTRAINDICATIONS_ Flucazole 150 mg capsules should not be used in patients with known sensitivity to fluconazole; to related azole compounds; or to any of its excipients. 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). Co-administration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study. _4.4_ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE_ Fluconazole should be administered with caution to patients Leia o documento completo