国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
aripiprazole
Accord Healthcare S.L.U.
N05AX12
aripiprazole
Psycholeptics
Schizophrenia; Bipolar Disorder
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord 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. Aripiprazole Accord 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.,
Revision: 15
Authorised
2015-11-15
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE ACCORD 5 MG TABLETS ARIPIPRAZOLE ACCORD 10 MG TABLETS ARIPIPRAZOLE ACCORD 15 MG TABLETS ARIPIPRAZOLE ACCORD 30 MG TABLETS 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 Aripiprazole Accord is and what it is used for 2. What you need to know before you take Aripiprazole Accord 3. How to take Aripiprazole Accord 4. Possible side effects 5 How to store Aripiprazole Accord 6. Contents of the pack and other information 1. WHAT ARIPIPRAZOLE ACCORD IS AND WHAT IT IS USED FOR Aripiprazole Accord 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. This medicine 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 this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE ACCO 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets Aripiprazole Accord 10 mg tablets Aripiprazole Accord 15 mg tablets Aripiprazole Accord 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Accord 5 mg tablets Each tablet contains 5 mg of aripiprazole. Excipient with known effect Each 5 mg tablet contains 63 mg lactose (as monohydrate). _ _ Aripiprazole Accord 10 mg tablets Each tablet contains 10 mg of aripiprazole. Excipient with known effect Each 10 mg tablet contains 59 mg lactose (as monohydrate). Aripiprazole Accord 15 mg tablets Each tablet contains 15 mg of aripiprazole. Excipient with known effect Each 15 mg tablet contains 88 mg lactose (as monohydrate). Aripiprazole Accord 30 mg tablets Each tablet contains 30 mg of aripiprazole. Excipient with known effect Each 30 mg tablet contains 177 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Aripiprazole Accord 5 mg tablets Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain. Aripiprazole Accord 10 mg tablets Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, 3 uncoated tablets, debossed with “A10” on one side and another side is plain. Aripiprazole Accord 15 mg tablets Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain. Aripiprazole Accord 30 mg tablets Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord is indicated for 完全なドキュメントを読む