País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
fluconazole, Quantity: 150 mg
Arrotex Pharmaceuticals Pty Ltd
Fluconazole
Capsule, hard
Excipient Ingredients: titanium dioxide; maize starch; sodium lauryl sulfate; colloidal anhydrous silica; patent blue V; lactose monohydrate; Gelatin; purified talc
Oral
one capsule
(S3) Pharmacist Only Medicine
Treatment of vaginal candidiasis.
Visual Identification: Hard gelatin capsules of size '1' with sky blue opaque body and cap.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2008-06-10
APO-FLUCONAZOLE ONE _Fluconazole_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about fluconazole. It does not contain all the available information. It does not take the place of talking to your pharmacist. All medicines have risks and benefits. Your pharmacist has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Fluconazole is used to treat a fungal infection known as vaginal thrush (vaginal candidiasis). Fluconazole belongs to a group of medicines known as azole antifungals. Vaginal thrush is an infection caused by a yeast-like fungus called Candida. Candida is one of the many organisms that live in the vagina and its growth is normally balanced by your body's immune system. If this natural balancing is upset, Candida can multiply in the vagina to cause the symptoms of thrush. _HOW IT WORKS_ Fluconazole works by preventing the growth of the fungi causing your infection. ASK YOUR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your pharmacist may have prescribed this medicine for another reason This medicine is available without a doctor's prescription, but your pharmacist's advice is required. This medicine is not addictive. This medicine is not recommended for children under 18 years of age, except under doctor advice. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • fluconazole • any other azole antifungals e.g. clotrimazole • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body Llegiu el document complet
1 AUSTRALIAN PRODUCT INFORMATION – APO-FLUCONAZOLE ONE CAPSULE (FLUCONAZOLE) 1 NAME OF THE MEDICINE Fluconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg fluconazole, as its active ingredient. EXCIPIENTS WITH KNOWN EFFECT Each capsule contains sugars (as lactose) and sulfites. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Fluconazole is available as a hard gelatin capsule of size ‘1’ with sky blue body and cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of vaginal candidiasis. 4.2 DOSE AND METHOD OF ADMINISTRATION Fluconazole is intended for oral administration. ADULTS One capsule (150 mg fluconazole) should be administered as a single oral dose. USE IN RENAL IMPAIRMENT Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single-dose therapy are necessary in patients with minor or moderate renal impairment. CHILDREN Fluconazole is not recommended in children under 18 years of age except under medical, advice. 2 4.3 CONTRAINDICATIONS • Known sensitivity to fluconazole; to related azole compounds or to any of the excipients of this product. • Co-administration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400mg/day or higher based upon results of a multiple dose interaction study • 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 in patients receiving fluconazole (see 4.5- Interactions with other medicines and other forms of interactions). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Anaphylaxis has been reported in rare instances. 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. Llegiu el document complet