Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
aripiprazole
Sandoz GmbH
N05AX12
aripiprazole
Psycholeptics
Schizophrenia; Bipolar Disorder
Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz 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 Sandoz 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: 9
Authorised
2015-08-20
54 B. PACKAGE LEAFLET 55 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE SANDOZ 5 MG TABLETS ARIPIPRAZOLE SANDOZ 10 MG TABLETS ARIPIPRAZOLE SANDOZ 15 MG TABLETS ARIPIPRAZOLE SANDOZ 20 MG TABLETS ARIPIPRAZOLE SANDOZ 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 Sandoz tablets are and what they are used for 2. What you need to know before you take Aripiprazole Sandoz tablets 3. How to take Aripiprazole Sandoz tablets 4. Possible side effects 5. How to store Aripiprazole Sandoz tablets 6. Contents of the pack and other information 1. WHAT ARIPIPRAZOLE SANDOZ IS AND WHAT IT IS USED FOR Aripiprazole Sandoz 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 Sandoz 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 w Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets Aripiprazole Sandoz 10 mg tablets Aripiprazole Sandoz 15 mg tablets Aripiprazole Sandoz 20 mg tablets Aripiprazole Sandoz 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Sandoz 5 mg tablets Each tablet contains 5 mg of aripiprazole. Excipient with known effect 67.47 mg lactose (as monohydrate) per tablet. Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg of aripiprazole. Excipient with known effect 62.67 mg lactose (as monohydrate) per tablet. Aripiprazole Sandoz 15 mg tablets _ _ Each tablet contains 15 mg of aripiprazole. Excipient with known effect 92.86 mg lactose (as monohydrate) per tablet. Aripiprazole Sandoz 20 mg tablets Each tablet contains 20 mg of aripiprazole. Excipient with known effect 125.72 mg lactose (as monohydrate) per tablet. Aripiprazole Sandoz 30 mg tablets Each tablet contains 30 mg of aripiprazole. Excipient with known effect 186.68 mg lactose (as monohydrate) per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Aripiprazole Sandoz 5 mg tablets 3 Blue coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side. Aripiprazole Sandoz 10 mg tablets Pink coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side. Aripiprazole Sandoz 15 mg tablets Yellow coloured, mottled, round shaped tablet, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side. Aripiprazole Sandoz 20 mg tablets White coloured, round shaped tablet, with an approximate diameter of 7.8 mm, debossed with “SZ” on one side and “448” on the other side. _ _ _ _ Aripiprazole Sandoz 30 mg tablets Pink coloured, mottled, round shaped tablet, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and Прочетете целия документ