Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
aripiprazole
Zentiva, k.s.
N05AX12
aripiprazole
Psycholeptics
Schizophrenia; Bipolar Disorder
Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva 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 Zentiva 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
2015-06-25
75 B. PACKAGE LEAFLET 76 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE ZENTIVA 5 MG TABLETS ARIPIPRAZOLE ZENTIVA 10 MG TABLETS ARIPIPRAZOLE ZENTIVA 15 MG TABLETS ARIPIPRAZOLE ZENTIVA 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 Zentiva is and what it is used for 2. What you need to know before you take Aripiprazole Zentiva 3. How to take Aripiprazole Zentiva 4. Possible side effects 5. How to store Aripiprazole Zentiva 6. Contents of the pack and other information 1. WHAT ARIPIPRAZOLE ZENTIVA IS AND WHAT IT IS USED FOR Aripiprazole Zentiva 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 Zentiva 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 Aripiprazole Zentiva. 2. WHAT YOU NEED TO KNOW BEFORE YOU T Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Zentiva 5 mg tablets Each tablet contains 5 mg of aripiprazole. Excipient with known effect Each tablet contains 33 mg of lactose (as monohydrate). Aripiprazole Zentiva 10 mg tablets Each tablet contains 10 mg of aripiprazole. Excipient with known effect Each tablet contains 66 mg of lactose (as monohydrate). Aripiprazole Zentiva 15 mg tablets Each tablet contains 15 mg of aripiprazole. Excipient with known effect Each tablet contains 99 mg of lactose (as monohydrate). Aripiprazole Zentiva 30 mg tablets Each tablet contains 30 mg of aripiprazole. Excipient with known effect Each tablet contains 198 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Aripiprazole Zentiva 5 mg tablets White to off-white round flat bevel edged uncoated tablets with ‘5’ debossed on one side and plain on the other side with diameter approx. 6 mm. 3 Aripiprazole Zentiva 10 mg tablets White to off-white round uncoated tablets with ‘10’ debossed on one side and snap tab breakline on the other side with diameter approx. 8 mm. The score line is not intended for breaking the tablet. Aripiprazole Zentiva 15 mg tablets White to off-white round flat bevel edged uncoated tablets with ‘15’ debossed on one side and plain on the other side with diameter approx. 8.8 mm. Aripiprazole Zentiva 30 mg tablets White to off-white capsule shaped uncoated tablets with ‘30’ debossed on one side and snap tab breakline on the other side with dimensions approx. 15.5 x 8 mm. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Ze Прочетете целия документ