Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ARIPIPRAZOLE
Milpharm Limited
N05AX12
ARIPIPRAZOLE
30 Milligram
Tablets
Oral use
Blister packs: 14, 28, 30, 49, 56 and 98 tablets, bottle packs: 30, 100, 250 and 500 tablets
Product subject to prescription which may not be renewed (A)
APL Swift Services (Malta) Limited
Other antipsychotic
Other antipsychotics
It is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Authorised
2015-06-26
PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE MILPHARM 5 MG TABLETS ARIPIPRAZOLE MILPHARM 10 MG TABLETS ARIPIPRAZOLE MILPHARM 15 MG TABLETS ARIPIPRAZOLE MILPHARM 30 MG TABLETS aripiprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Milpharm is and what it is used for 2. What you need to know before you take Aripiprazole Milpharm 3. How to take Aripiprazole Milpharm 4. Possible side effects 5. How to store Aripiprazole Milpharm 6. Contents of the pack and other information. 1. WHAT ARIPIPRAZOLE MILPHARM IS AND WHAT IT IS USED FOR Aripiprazole Milpharm 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE MILPHARM DO NOT TAKE ARIPIPRAZOLE MILPHARM If you are allergic to aripiprazole or any of the other ingredients of this me Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aripiprazole Milpharm 30mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of aripiprazole. Excipient with known effect: 199.500 mg lactose monohydrate per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White colored, round shaped (diameter 9 mm), uncoated tablets debossed with ‘66’ on one side and ‘H’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole Milpharm 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 Milpharm 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 Milpharm 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. Special populations _Paediatric population_ _Other pharmaceutical formulations containing aripiprazole are available and may be more suitable to perform any_ _initial titration in 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 (using aripiprazole oral solution 1 mg/ml) 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 e Read the complete document