Aripiprazole Accord Healthcare 30 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aripiprazole

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N05AX; N05AX12

INN (International Name):

Aripiprazole

Dosage:

30 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Other antipsychotics; aripiprazole

Authorization status:

Not marketed

Authorization date:

2015-07-10

Patient Information 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 patients who have responded t

Summary of Product characteristics

Health Products Regulatory Authority
12 March 2020
CRN0098MC
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripiprazole Accord Healthcare 30 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 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
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
Healthcare 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 Accord Healthcare 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 Accord Healthcareis 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