Country: Svíþjóð
Tungumál: sænska
Heimild: Läkemedelsverket (Medical Products Agency)
ziprasidonhydrokloridmonohydrat
Paranova Läkemedel AB
N05AE04
ziprasidone hydrochloride monohydrate
40 mg
Kapsel, hård
ziprasidonhydrokloridmonohydrat Aktiv substans; propylenglykol Hjälpämne; laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne
Apotek
Receptbelagt
Ziprasidon
Avregistrerad
2005-07-27
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ZELDOX 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 Zeldox capsules are and what they are used for 2. What you need to know before you use Zeldox capsules 3. How to take Zeldox capsules 4. Possible side effects 5. How to store Zeldox capsules 6. Contents of the pack and other information 1. WHAT ZELDOX CAPSULES ARE AND WHAT ARE THEY USED FOR Zeldox capsules belong to a group of medicines called antipsychotics. Zeldox 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. Zeldox 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 ZELDOX CAPSULES DO NOT TAKE ZELDOX CAPSULES - if you are allergic to ziprasidone or any of the Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zeldox 20 mg capsules, hard Zeldox 40 mg capsules, hard Zeldox 60 mg capsules, hard Zeldox 80 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone Excipient(s) with known effects: Each 20 mg capsule contains 66.1 mg lactose monohydrate. Each 40 mg capsule contains 87.83 mg lactose monohydrate. Each 60 mg capsule contains 131.74 mg lactose monohydrate. 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 20 mg – No 4, blue/white capsules, marked “Pfizer” and ZDX 20 40 mg – No 4, blue capsules, marked “Pfizer” and ZDX 40 60 mg – No 3, white capsules, marked “Pfizer” and ZDX 60 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 and 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 admini Lestu allt skjalið