Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ziprasidone hydrochloride, Quantity: 87.2 mg
Arrotex Pharmaceuticals Pty Ltd
Ziprasidone hydrochloride
Capsule, hard
Excipient Ingredients: macrogol 6000; titanium dioxide; lactose monohydrate; sodium starch glycollate type B; Gelatin; ammonium chloride; indigo carmine; sodium lauryl sulfate; purified water; sucrose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
60
(S4) Prescription Only Medicine
Ziprasidone is indicated for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy. Ziprasidone is indicated as monotherapy for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder.
Visual Identification: Blue/White size '0' hard gelatin capsules imprinted in black ink with "CL65" on the cap and "80mg" on the body; filled with pale pink coloured powder.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-08-13
APO-ZIPRASIDONE 1 APO-ZIPRASIDONE _Contains the active ingredient ziprasidone hydrochloride _ 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 this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is APO- Ziprasidone. It contains the active ingredient ziprasidone (as ziprasidone hydrochloride). It is used to treat schizophrenia and bipolar disorder. Ziprasidone belongs to a group of medicines called atypical antipsychotics/neuroleptics. 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. ZIPRASIDONE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. SCHIZOPHRENIA Schizophrenia is a mental illness. It varies from person to person, but can involve: • hallucinations: the person sees, hears, feels, smells or tastes something that is not actually there; most commonly a person may hear voices • delusions: a delusion is a false belief held by a person which is not held by others of the same cultural background • disturbed or disorganised thinking • poor memory and concentration • loss of emotion and expression • loss of motivation and energy • difficulty interacting with others, leading to social isolation. BIPOLAR DISORDER Bipolar disorder is a mental illness where a person cycles through: • 'manic' phases - with symptoms such as over-activity, irritability, elation and limited need for sleep • 'depressive' phases - with symptoms such as depressed mood, anxie Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION APO-ZIPRASIDONE (ZIPRASIDONE HYDROCHLORIDE) CAPSULES 1 NAME OF THE MEDICINE Ziprasidone hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg, 40 mg, 60 mg or 80 mg ziprasidone (as hydrochloride) as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Contains sugars (as lactose) and sulfites. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 20 MG CAPSULES: Blue/White size ‘4’ hard gelatin capsules imprinted in black ink with “CL62” on the cap and “20 mg” on the body; filled with pale pink coloured powder. 40 MG CAPSULES: Blue/Blue size ‘2’ hard gelatin capsules imprinted in black ink with “CL63” on the cap and “40 mg” on the body; filled with pale pink coloured powder. 60 MG CAPSULES: White/White size ‘1’ hard gelatin capsules imprinted in black ink with “CL64” on the cap and “60 mg” on the body; filled with pale pink coloured powder. 80 MG CAPSULES: Blue/White size ‘0’ hard gelatin capsules imprinted in black ink with “CL65” on the cap and “80 mg” on the body; filled with pale pink coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziprasidone is indicated: • for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy; • as monotherapy for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Ziprasidone capsules are intended for oral administration. APO-Ziprasidone capsules should be taken with food and swallowed whole without chewing, crushing or opening beforehand. 2 SCHIZOPHRENIA The recommended dose in treatment of schizophrenia is 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days. Read the complete document