Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aripiprazole
Otsuka Pharmaceuticals (U.K.
N05AX12
Aripiprazole
15mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5012712003618
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ABILIFY 10 MG ORODISPERSIBLE TABLETS ABILIFY 15 MG ORODISPERSIBLE TABLETS ABILIFY 30 MG ORODISPERSIBLE 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 ABILIFY is and what it is used for 2. What you need to know before you take ABILIFY 3. How to take ABILIFY 4. Possible side effects 5 How to store ABILIFY 6. Contents of the pack and other information 1. WHAT ABILIFY IS AND WHAT IT IS USED FOR ABILIFY contains the active substance aripiprazole and belong 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. ABILIFY 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 ABILIFY. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABILIFY DO NOT TAKE ABILIFY • if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6). WARNINGS Lugege kogu dokumenti
OBJECT 1 ABILIFY 10 MG ORODISPERSIBLE TABLETS Summary of Product Characteristics Updated 25-Jan-2018 | Otsuka Pharmaceuticals (UK) Ltd 1. Name of the medicinal product ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets 2. Qualitative and quantitative composition ABILIFY 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg of aripiprazole. Excipient with known effect 2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet ABILIFY 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg of aripiprazole. Excipient with known effect 3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet ABILIFY 30 mg orodispersible tablets Each orodispersible tablet contains 30 mg of aripiprazole. Excipient with known effect 6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet For the full list of excipients, see section 6.1. 3. Pharmaceutical form Orodispersible tablet ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other. ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other. ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other. 4. Clinical particulars 4.1 Therapeutic indications ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. ABILIFY 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). ABILIFY 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 (see section 5.1). 4.2 Posology and method of administration Posology _Adults _ _Schiz Lugege kogu dokumenti