Страна: Мальта
мова: англійська
Джерело: Medicines Authority
ARIPIPRAZOLE
Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland
N05AX12
ARIPIPRAZOLE 1 mg/ml
ORAL SOLUTION
ARIPIPRAZOLE 1 mg/ml
POM
PSYCHOLEPTICS
Authorised
2016-11-15
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER Aripiprazole 1mg/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 onto others. It may harm them, even if their symptoms 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 Oral Solution is and what it is used for 2. What you need to know before you take Aripiprazole Oral Solution 3. How to take Aripiprazole Oral Solution 4. Possible side effects 5. How to store Aripiprazole Oral Solution 6. Contents of the pack and other information. 1. WHAT ARIPIPRAZOLE ORAL SOLUTION IS AND WHAT IT IS USED FOR Aripiprazole Oral Solution contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. Aripiprazole Oral Solution 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. • 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 Oral Solution. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE ORAL SOLUTION: DO NOT TAKE ARIPIPRAZOLE ORAL SOLUTION: • if you a Прочитайте повний документ
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aripiprazole 1mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg of Aripiprazole. Excipients with known effect (ml): 200 mg fructose 400 mg sucrose 1.8 mg of methyl parahydroxybenzoate (E218) 0.2 mg of propyl parahydroxybenzoate (E216) 1.0 mg of orange flavour For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, colourless to light yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole 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 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 Aripiprazole Oral Solution is 10 or 15 ml solution/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. A calibrated 30ml measuring cup (graduated at every 2.5ml equivalent to 2.5mg) and a 2 ml graduated oral syringe (graduated at every 0.5 ml equivalent to 0.5mg) and an adaptor for the syringe are included in the carton. Page 2 of 22 Aripiprazole Oral Solution 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 fo Прочитайте повний документ