Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Ziprasidone hydrochloride monohydrate 90.6mg equivalent to 80 mg ziprasidone
Upjohn New Zealand ULC
Ziprasidone hydrochloride monohydrate 90.6 mg (equivalent to 80 mg ziprasidone)
80 mg
Capsule
Active: Ziprasidone hydrochloride monohydrate 90.6mg equivalent to 80 mg ziprasidone Excipient: Gelatin Lactose monohydrate Magnesium stearate Pregelatinised maize starch TekPrint black SW-9008
Blister pack, cold form alumi, 20 sample, 20 capsules
Prescription
Prescription
Pfizer Ireland Pharmaceuticals
Ziprasidone is indicated for the treatment of acute schizophrenia, and maintenance or continuation therapy.
Package - Contents - Shelf Life: Blister pack, cold form alumi, sample - 20 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, cold form alumi - 60 capsules - 48 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 60 capsules - 48 months from date of manufacture stored at or below 30°C
1997-08-13
ZELDOX ® 1 ZELDOX ® (ZELL-DOCKS) _ziprasidone hydrochloride (zi-pra-si-don hi-dro-klor-ride) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zeldox. 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 Zeldox 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 ZELDOX IS USED FOR _WHAT ZELDOX IS FOR _ Zeldox is used to treat schizophrenia and bipolar disorder. Your doctor may have prescribed Zeldox for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT ZELDOX OR WHY ZELDOX HAS BEEN PRESCRIBED FOR YOU. 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, anxiety, difficulty making decisions, concentrating and hopelessness. _HOW ZELDOX WORKS _ Zeldox belongs to a group of medicines called atypical antipsychotics/neuroleptics. It contains the ingredient ziprasidone. SCHIZOPHRENIA Researchers do not know exactly what causes schizophrenia, but they do know that man Soma hati kamili
Version: ujdzeldc11220 Supersedes: pfdzeldc11018 Page 1 of 19 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ZELDOX ® 20 mg, 40 mg, 60 mg and 80 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mg capsule contains 22.652 mg ziprasidone hydrochloride monohydrate equivalent to 20 mg ziprasidone Each 40 mg capsule contains 45.3 mg ziprasidone hydrochloride monohydrate equivalent to 40 mg ziprasidone Each 60 mg capsule contains 67.95 mg ziprasidone hydrochloride monohydrate equivalent to 60 mg ziprasidone Each 80 mg capsule contains 90.6 mg ziprasidone hydrochloride monohydrate equivalent to 80 mg ziprasidone EXCIPIENT(S) WITH KNOWN EFFECT • Lactose monohydrate For the full list of excipients, see section 6.1 – List of excipients. 3. PHARMACEUTICAL FORM 20 mg capsules - No. 4 blue/white capsules, marked “Pfizer” and ZDX 20. 40 mg capsules - No. 4 blue capsules, marked “Pfizer” and ZDX 40. 60 mg capsules - No. 3 white capsules, marked “Pfizer” and ZDX 60. 80 mg capsules - No. 2 blue/white capsules, marked “Pfizer” and ZDX 80. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziprasidone is indicated for the treatment of acute schizophrenia, and maintenance or continuation therapy. Ziprasidone is also indicated as a monotherapy for the short term treatment of acute manic or mixed episodes associated with bipolar 1 disorder. Version: ujdzeldc11220 Supersedes: pfdzeldc11018 Page 2 of 19 4.2 DOSE AND METHOD OF ADMINISTRATION USE OF ZELDOX CAPSULES For oral use. ZELDOX capsules should be taken with food and swallowed whole without chewing, crushing or opening beforehand. USE IN ADULTS _SCHIZOPHRENIA _ The recommended dose in treatment of schizophrenia is 40 mg twice daily to be taken with food (see Section 5.2 – Pharmacokinetic properties). Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment. _BIPOLAR MANIA _ The recommended dose in t Soma hati kamili