Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
fluoxetine hydrochloride, Quantity: 22.36 mg (Equivalent: fluoxetine, Qty 20 mg)
Alphapharm Pty Ltd
Capsule, hard
Excipient Ingredients: maize starch; purified talc; sodium lauryl sulfate; lactose monohydrate; Gelatin; colloidal anhydrous silica; magnesium stearate; brilliant blue FCF; titanium dioxide; erythrosine; quinoline yellow; indigo carmine; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
28 capsules
(S4) Prescription Only Medicine
Indicated for the treatment of major depression. Obsessive Compulsive Disorder (OCD).
Visual Identification: Size 3 capsule with light green opaque body and purple opaque cap, printed "FL20" on the body and the greek alpha symbol on the cap in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
1995-11-13
ZACTIN _fluoxetine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZACTIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking ZACTIN against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ZACTIN IS USED FOR ZACTIN is used to treat • depression • obsessive compulsive disorder (OCD) ZACTIN belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). SSRIs are thought to work by their action on brain chemicals called amines which are involved in controlling mood. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZACTIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed ZACTIN for another reason. ZACTIN is available only with a doctor's prescription. ZACTIN is not recommended for use in children and adolescents under 18 years of age. BEFORE YOU TAKE ZACTIN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ZACTIN IF YOU ARE ALLERGIC TO: • any other medicines containing fluoxetine (such as Prozac and Lovan) • 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 or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE ZACTIN IF YOU ARE TAKING, OR HAVE TAKEN WITHIN THE LAST 14 DAYS, ANOTHER MEDICINE FOR DEPRESSION CALLED A MONOAMINE OXIDASE INHIBITOR (MAOI). CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE UNSURE AS TO WHETHER OR NOT YOU ARE TAKING A MAOI. IF YOU DO TAKE ZACTIN WHILE YOU ARE TAKING A MAOI, YOU MAY EXPERIENCE SHAKING (TREMOR), SHIVERING, MUSCLE STIFFNESS, FEVER, RAPID PULSE, RAPID BREATHING OR CONFUSION. DO NOT TAKE ZACTIN IF YOU ARE TAKIN Lesen Sie das vollständige Dokument
AUSTRALIAN PRODUCT INFORMATION ZACTIN _Fluoxetine hydrochloride _ 1 NAME OF THE MEDICINE Fluoxetine (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Zactin capsule contains fluoxetine hydrochloride equivalent to fluoxetine 20 mg (64.7 micromol). Excipients with known effect: sulfites and sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Zactin : Fluoxetine 20 mg capsule: light green body printed with "FL20" in black and purple cap printed with "α" in black 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of: • Major depression • Obsessive Compulsive Disorder (OCD). 4.2 DOSE AND METHOD OF ADMINISTRATION DEPRESSION The usual recommended initial dose of fluoxetine in the treatment of depression is 20 mg/day, taken in the morning. A dose increase may be considered after several weeks if no clinical improvement is observed. Doses more than 20 mg/day should be administered twice daily (morning and noon) and should not exceed a maximum daily dose of 80 mg (see Section 5.2 PHARMACOKINETIC PROPERTIES - CLINICAL ISSUES RELATED TO ACCUMULATION AND SLOW ELIMINATION). As with other antidepressant agents, the full antidepressant effect may be delayed until 4 or more weeks of therapy (see Section 5.2 PHARMACOKINETIC PROPERTIES - CLINICAL ISSUES RELATED TO ACCUMULATION AND SLOW ELIMINATION). As with many other medications, patients with renal and/or hepatic impairment should be given a lower or less frequent dosage. A lower or less frequent dosage should also be considered for patients, such as the elderly, with concurrent disease or on multiple medications. OBSESSIVE COMPULSIVE DISORDER _Initial treatment -_ A dose of 20 mg/day, administered in the morning, is recommended as the initial dose. If insufficient clinical improvement is observed, a dose increase may be considered after several weeks. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Doses above 20 mg/day may be administered on a once a day (i Lesen Sie das vollständige Dokument