Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
ARIPIPRAZOLE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
N05AX12
ARIPIPRAZOLE 5 mg
TABLET
ARIPIPRAZOLE 5 mg
POM
PSYCHOLEPTICS
Withdrawn
2015-06-11
Page 1 of 9 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE ACCORD HEALTHCARE 5 MG TABLETS ARIPIPRAZOLE ACCORD HEALTHCARE 10 MG TABLETS ARIPIPRAZOLE ACCORD HEALTHCARE 15 MG TABLETS ARIPIPRAZOLE ACCORD HEALTHCARE 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 Accord Healthcare is and what it is used for 2. What you need to know before you take Aripiprazole Accord Healthcare 3. How to take Aripiprazole Accord Healthcare 4. Possible side effects 5 How to store Aripiprazole Accord Healthcare 6. Contents of the pack and other information 1. WHAT ARIPIPRAZOLE ACCORD HEALTHCARE IS AND WHAT IT IS USED FOR Aripiprazole Accord Healthcare 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 Accord Healthcare 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 p Perskaitykite visą dokumentą
Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord Healthcare 5 mg tablets Aripiprazole Accord Healthcare 10 mg tablets Aripiprazole Accord Healthcare 15 mg tablets Aripiprazole Accord Healthcare 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of aripiprazole. Excipient with known effect: 27.9 mg lactose monohydrate per tablet Each tablet contains 10 mg of aripiprazole. Excipient with known effect: 55.8 mg lactose monohydrate per tablet Each tablet contains 15 mg of aripiprazole. Excipient with known effect: 83.7 mg lactose monohydrate per tablet Each tablet contains 30 mg of aripiprazole. Excipient with known effect: 167.4 mg lactose monohydrate per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 5 mg Round, biconvex and white, 5 mm, debossed "5" on one side and "ZL" on one side. Tablet 10 mg Capsule shaped, biconvex and white, 8 mm x 5 mm, debossed "10" on one side and "ZL" on one side. Tablet 15 mg Round, biconvex and white 7 mm, debossed "15" on one side and "ZL" on one side. Tablet 30 mg Round, biconvex and white 9 mm, debossed "30" on one side and "ZL" on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole Accord Healthcare is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord Healthcare 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 Page 2 of 21 predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). Aripiprazole Accord Healthcare 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 Accord Healthcar Perskaitykite visą dokumentą