Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aripiprazole
Otsuka Pharmaceuticals (U.K.
N05AX12
Aripiprazole
1mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5012712003663
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ABILIFY 1 MG/ML ORAL SOLUTION 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 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. 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 AND PRECAUTIONS Talk to your doctor before taking ABILIFY. Suicidal thoughts and Прочитать полный документ
OBJECT 1 ABILIFY ORAL SOLUTION 1 MG ML Summary of Product Characteristics Updated 24-Apr-2018 | Otsuka Pharmaceuticals (UK) Ltd 1. Name of the medicinal product ABILIFY 1 mg/ml oral solution 2. Qualitative and quantitative composition Each ml oral solution contains 1 mg of aripiprazole. Excipients with known effect (per ml) 200 mg fructose, 400 mg sucrose, 1.8 mg methyl parahydroxybenzoate (E218), 0.2 mg propyl parahydroxybenzoate (E 216) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral solution Clear, colourless to light yellow liquid solution. 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 _ _Schizophrenia:_ the recommended starting dose for ABILIFY is 10 or 15 mg/day (i.e. 10 or 15 ml solution/day) with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY is effective in a dose range of 10 to 30 mg/day (i.e. 10 to 30 ml solution/day). Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. _Manic episodes in Bipolar I Disorder:_ the recommended starting dose for ABILIFY is 15 mg (i.e. 15 ml solution/day) administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1). Some patients may benefit from a higher dose. The maximum daily Прочитать полный документ