Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
ARIPIPRAZOLE
J. Uriach y Compania, S.A. Av. Cami Reial, 51-57 08184 - Palau-solita I Plegamans, Barcelona, Spain
N05AX12
ARIPIPRAZOLE 15 mg
TABLET
ARIPIPRAZOLE 15 mg
POM
PSYCHOLEPTICS
Withdrawn
2015-05-05
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE URIACH 15 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 Uriach is and what it is used for 2. What you need to know before you take Aripiprazole Uriach 3. How to take Aripiprazole Uriach 4. Possible side effects 5. How to store Aripiprazole Uriach 6. Contents of the pack and other information 1. WHAT ARIPIPRAZOLE URIACH IS AND WHAT IT IS USED FOR Aripiprazol 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 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE URIACH DO NOT TAKE ARIPIPRAZOLE - if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in secti Perskaitykite visą dokumentą
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Uriach 15 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of aripiprazole. Excipient with known effect: 160.48 mg lactose per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 8mm, round biconvex pale pink tablet, scored in one side, weight of 225mg. The score line is not intended for breaking the tablet. 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 is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals. Page 2 of 21 Aripiprazole is effective in a dose range of 10 to 30 mg/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 Aripiprazole is 15 mg 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 dose should not exceed 30 mg. _ _ _Recurrence prevention of manic episodes in Bipolar I Disorder:_ for preventing recurrence of manic episode Perskaitykite visą dokumentą