מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ARIPIPRAZOL
PharmaSwiss Ceská republika s.r.o.
N05AX12
ARIPIPRAZOLE
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468),
Oraal gebruik
Aripiprazole
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468);
2015-09-07
Common Technical Document Aripiprazole Tablets M1.3.1_03.ARZ.tab.100.03 Page 1 of 7 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER APRIZEXEN 15 MG, TABLETTEN APRIZEXEN 30 MG, TABLETTEN aripiprazole 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 Aprizexen is and what it is used for 2. What you need to know before you take Aprizexen 3. How to take Aprizexen 4. Possible side effects 5. How to store Aprizexen 6. Contents of the pack and other information 1 WHAT APRIZEXEN IS AND WHAT IT IS USED FOR APRIZEXEN CONTAINS THE ACTIVE SUBSTANCE ARIPIPRAZOLE AND BELONGS TO A GROUP OF MEDICINES CALLED ANTIPSYCHOTICS. It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense. Aprizexen is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with Aprizexen. _ _ Common Technical Document Aripiprazole Tablets M1.3.1_03.ARZ.tab.100.03 Page 2 of 7 2 WHAT YOU NEED TO KNOW BEFORE קרא את המסמך השלם
Common Technical Document Aripiprazole Tablets M1.3.1_01.ARZ.tab.100.03 .core Page 1 of 22 1.3.1 Summary of Product Characteristics - Core 1. NAME OF THE MEDICINAL PRODUCT Aprizexen 15 mg, tabletten Aprizexen 30 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Aprizexen 15 mg tablet contains 15 mg of aripiprazole. Each Aprizexen 30 mg tablet contains 30 mg of aripiprazole. Excipient with known effect: _ [15 mg tablets] _ 99.8 mg lactose monohydrate per tablet _ [30 mg tablets] _ 199.5 mg lactose monohydrate per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet _[15 mg tablets] _ Round (approximately 7 mm) and yellow, with possible darker spots, engraved with “ARZ” and “15” on one side. _ [30 mg tablets] _ Round (approximately 9 mm) and pink, with possible darker spots, engraved with “ARZ” and “30” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aprizexen is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aprizexen is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). Aprizexen is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1). Common Technical Document Aripiprazole Tablets M1.3.1_01.ARZ.tab.100.03 .core Page 2 of 22 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Schizophrenia: the recommended starting dose for Aprizexen is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. Aprizexen is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose. The קרא את המסמך השלם