מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
Pfizer Limited
N05AE04
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
80 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Antipsychotics
Authorised
2002-03-08
Page 1 of 8 2015-0009549 IE GE 142 PACKAGE LEAFLET: INFORMATION FOR THE USER GEODON™ 20 MG, 40 MG, 60 MG, 80 MG CAPSULES, HARD ZIPRASIDONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Geodon capsules are and what they are used for 2. What you need to know before you use Geodon capsules 3. How to take Geodon capsules 4. Possible side effects 5. How to store Geodon capsules 6. Contents of the pack and other information 1. WHAT GEODON CAPSULES ARE AND WHAT THEY ARE USED FOR Geodon capsules belong to a group of medicines called antipsychotics. Geodon capsules are used for the treatment of schizophrenia in adults - a mental disorder characterised by the following symptoms: to hear, see and feel things that do not exist, to believe in something not true, to feel unusual suspicions, to be absent and have difficulty in establishing social relationships, nervousness, depression or anxiety. Geodon capsules are also used for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in adults and children and adolescents aged 10-17 years - a mental disorder characterised by alternate stages of euphoric (mania) or depressed mood states. During mania episodes, the most characteristic symptoms are: elated behaviour, exaggerated self-esteem, increase in energy, decreased need for sleeping, lack of concentration or hyperactivity and repeated high risk- taking behaviour. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GEODON CAPSULES DO NOT TAKE GEODON CAPSULES - if you are allergic to ziprasi קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geodon 80mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 80 mg, of ziprasidone Excipient(s) with known effects: Each 80 mg capsule contains 175.65 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard 80 mg – No 2, blue/white capsules, marked “Pfizer” and ZDX 80 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziprasidone is indicated for the treatment of schizophrenia in adults. Ziprasidone is indicated for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in adults, children and adolescents aged 10-17 years(prevention of episodes of bipolar disorder has not been established - see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended dose, in acute treatment of schizophrenia and bipolar mania, is 40 mg twice daily taken with food. 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. _It is of particular importance not to exceed the maximum dose as the safety profile above 160 mg/day has not been_ _confirmed and ziprasidone is associated with dose-related prolongation of the QT interval (see sections 4.3 and 4.4)._ In maintenance treatment of schizophrenia patients, ziprasidone should be administered at the lowest effective dose; in many cases, a dose of 20 mg twice daily may be sufficient. _Elderly_ A lower starting dose is not routinely indicated but should be considered for those 65 and over when clinical factors warrant. _Patients with renal impairment_ No dose adjustment is required in patients with impaired renal function (see section 5.2). _Patients with hepatic impairment_ In patients with hepatic insufficiency, lower doses should be considered (see sections 4.4 קרא את המסמך השלם