Aripiprazole 5 mg tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-08-2019
Summary of Product characteristics
(SPC)
08-08-2019
Active ingredient:
Aripiprazole
Available from:
Bristol Laboratories Limited
ATC code:
N05AX; N05AX12
INN (International Name):
Aripiprazole
Dosage:
5 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other antipsychotics; aripiprazole
Authorization status:
Not marketed
Authorization date:
2017-10-06
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIPRAZOLE 5 MG TABLETS
ARIPIPRAZOLE 10 MG TABLETS
ARIPIPRAZOLE 15 MG TABLETS
ARIPIPRAZOLE 20 MG TABLETS
ARIPIPRAZOLE 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 is and what it is used for
2.
What you need to know before you take Aripiprazole
3.
How to take Aripiprazole
4.
Possible side effects
5.
How to store Aripiprazole
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE IS AND WHAT IT IS USED FOR
This medicine 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.
This medicine 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
DO NOT TAKE ARIPIPRAZOLE:
if you are allergic to the active substance or
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
07 August 2019
CRN008VNJ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripiprazole 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: Also contains 73.20 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Light blue to blue, modified rectangular bevel edged biconvex tablets
debossed with ‘BL’ on one side and ‘5’ on other side. The
tablet dimensions are 8.0 mm x 4.5 mm
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.
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 Disorde_r: 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 man
Read the complete document
