Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
aripiprazole
Otsuka Pharmaceutical Netherlands B.V.
N05AX12
aripiprazole
Psycholeptics
Schizophrenia
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Revision: 20
Authorised
2013-11-14
68 B. PACKAGE LEAFLET 69 PACKAGE LEAFLET: INFORMATION FOR THE USER ABILIFY MAINTENA 300 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION ABILIFY MAINTENA 400 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION aripiprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Abilify Maintena is and what it is used for 2. What you need to know before you are given Abilify Maintena 3. How Abilify Maintena is given 4. Possible side effects 5. How to store Abilify Maintena 6. Contents of the pack and other information 1. WHAT ABILIFY MAINTENA IS AND WHAT IT IS USED FOR Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat schizophrenia - a disease with 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. Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ABILIFY MAINTENA DO NOT USE ABILIFY MAINTENA • if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Abilify Maintena. Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. Before treatment with Abilify Maintena, tell your doctor Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Each vial contains 300 mg aripiprazole. Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Each vial contains 400 mg aripiprazole. Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Each pre-filled syringe contains 300 mg aripiprazole. Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Each pre-filled syringe contains 400 mg aripiprazole. After reconstitution each mL of suspension contains 200 mg aripiprazole. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection Powder: white to off-white Solvent: clear solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with Abilify Maintena. 3 Titration of the dose for Abilify Maintena is not required. The starting dose can be administered by following one of two regimens: • One injection start: On the day of initiation, administer one injection of 400 mg Abilify Maintena and continue treatment with 10 mg to 20 mg oral Aqra d-dokument sħiħ