Country: United Kingdom
Language: English
Source: myHealthbox
Aripiprazole
TEVA UK Limited
N05AX12
Aripiprazole
15mg
Tablets
Oral use
Pack sizes of 7, 7 x 1, 14, 14 x 1, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1 and 100 tablets.
POM - Prescription Only Medicine
Nervous system; psycholeptics; antipsychotics; other antipsychotics
Is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Authorised
2015-05-06
DE/H/5039/001-005/DC 1 PACKAGE LEAFLET: INFORMATION FOR THE USER5 MG TABLETS Read the complete document10 MG TABLETS 15 MG TABLETS 20 MG TABLETS 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 _ _is and what it is used for 2. What you need to know before you take _ _ 3. How to take _ _ 4. Possible side effects 5. How to store _ _ 6. Contents of the pack and other information 1. WHAT _ _IS AND WHAT IT IS USED FOR _ _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. _ _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 _ _. 2. WHAT YOU NEED TO KN
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aripiprazole Teva 15 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg of aripiprazole. Excipient with known effect: 88.5 mg lactose per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Light yellow coloured, round, flat-faced bevelled edged tablets with debossed “15” on one side and breakline on the other side. The diameter is 7.1 mm. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole Teva_ _is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. 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. 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. Paediatric population _Schizophrenia in adolescents aged 15 years and older_ The recommended dose for aripiprazole is 10 mg/day administered on a once- a-day schedule without regard to meals. Treatment should be initiated at 2 mg (e.g. using an oral solution) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 5.1). Aripiprazole is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses higher than a daily dose of 10 mg ha Read the complete document