国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
aripiprazole
Mylan Pharmaceuticals Limited
N05AX12
aripiprazole
Psycholeptics
Schizophrenia; Bipolar Disorder
Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma 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 Mylan Pharma 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: 16
Authorised
2015-06-30
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE MYLAN PHARMA 5 MG TABLETS ARIPIPRAZOLE MYLAN PHARMA 10 MG TABLETS ARIPIPRAZOLE MYLAN PHARMA 15 MG TABLETS ARIPIPRAZOLE MYLAN PHARMA 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 Mylan Pharma is and what it is used for 2. What you need to know before you take Aripiprazole Mylan Pharma 3. How to take Aripiprazole Mylan Pharma 4. Possible side effects 5. How to store Aripiprazole Mylan Pharma 6. Contents of the pack and other information 1. WHAT ARIPIPRAZOLE MYLAN PHARMA IS AND WHAT IT IS USED FOR ARIPIPRAZOLE MYLAN PHARMA 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. Aripiprazole Mylan Pharma 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 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Mylan Pharma 5 mg tablets Aripiprazole Mylan Pharma 10 mg tablets Aripiprazole Mylan Pharma 15 mg tablets Aripiprazole Mylan Pharma 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Mylan Pharma 5 mg tablets Each tablet contains 5 mg of aripiprazole. Excipient with known effect 28 mg of maltose per tablet Aripiprazole Mylan Pharma 10 mg tablets _ _ Each tablet contains 10 mg of aripiprazole. Excipient with known effect 56 mg of maltose per tablet Aripiprazole Mylan Pharma 15 mg tablets _ _ Each tablet contains 15 mg of aripiprazole. Excipient with known effect 84 mg of maltose per tablet Aripiprazole Mylan Pharma 30 mg tablets _ _ Each tablet contains 30 mg of aripiprazole. Excipient with known effect 168 mg of maltose per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Aripiprazole Mylan Pharma 5 mg tablets Light blue to blue, mottled round and biconvex tablets of 6.1 mm in diameter, engraved with “5” on one side Aripiprazole Mylan Pharma 10 mg tablets Pink, round and biconvex tablets of 8.1 mm in diameter, engraved with “10” on one side _ _ 3 Aripiprazole Mylan Pharma 15 mg tablets Yellow, round and biconvex tablets of 10.1 mm in diameter, engraved with “15” on one side _ _ Aripiprazole Mylan Pharma 30 mg tablets Pink, oval and biconvex tablets of 17.1 mm in length, 8.1 mm in width, engraved with “30” on one side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma 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). Aripiprazole Mylan Pharma is indicated for the treatment up to 12 阅读完整的文件