Aripiprazole Wockhardt 5mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aripiprazole

Available from:

Wockhardt UK Limited

ATC code:

N05AX; N05AX12

INN (International Name):

Aripiprazole

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Administration route:

oral use

Units in package:

14, 28, 49, 56, 98 and 100 tablets.

Prescription type:

Product subject to prescription which may not be renewed (A)

Manufactured by:

Pharmadox Healthcare Ltd.

Therapeutic group:

other antipsychotics

Therapeutic area:

Other antipsychotics; aripiprazole

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

Authorization status:

Marketed

Authorization date:

2015-10-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
ARIPIPRAZOLE WOCKHARDT 5 MG TABLETS
ARIPIPRAZOLE WOCKHARDT 10 MG TABLETS
ARIPIPRAZOLE WOCKHARDT 15 MG TABLETS
ARIPIPRAZOLE WOCKHARDT 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 Wockhardt Tablets
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE IS AND WHAT IT IS USED FOR
Aripiprazole Wockhardt Tablets contains the active substance
aripiprazole, and belong to a group of
medicines called antipsychotics.
Aripiprazole 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 Wockhardt Tablets 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 Wockhardt Tablets.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2020
CRN009TVG
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripiprazole Wockhardt 5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 73.200 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Aripiprazole 5 mg tablets are light blue to blue, modified
rectangular, bevel edged, biconvex; debossed with ‘I’ on one side
and
‘95’ on other side.
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 Disorder_: 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 manic episodes