Aripiprazole Teva 15 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aripiprazole

Available from:

Teva B.V.

ATC code:

N05AX; N05AX12

INN (International Name):

Aripiprazole

Dosage:

15 milligram(s)

Pharmaceutical form:

Tablet

Administration route:

Oral use

Units in package:

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

Prescription type:

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

Manufactured by:

Merckle GmbH, Teva Pharma B.V, PLIVA Hrvatska d.o.o. , Teva Operations Poland Sp. z.o.o

Therapeutic group:

Nervous system; psycholeptics; antipsychotics; other antipsychotics

Therapeutic area:

Other antipsychotics; aripiprazole

Therapeutic indications:

It is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older

Authorization status:

Marketed

Authorization date:

2015-06-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIPRAZOLE TEVA 5 MG TABLETS
ARIPIPRAZOLE TEVA 10 MG TABLETS
ARIPIPRAZOLE TEVA 15 MG TABLETS
ARIPIPRAZOLE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Aripiprazole Teva
3.
How to take Aripiprazole Teva
4.
Possible side effects
5.
How to store Aripiprazole Teva
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE TEVA IS AND WHAT IT IS USED FOR
Aripiprazole Teva 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 Teva 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 Teva.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE TEVA
DO NOT TAKE ARIPIPRAZOLE TEVA
•
if

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2022
CRN00D6Z7
Page 1 of 16
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
15 MG
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.
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.
Aripiprazole Teva 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 Teva 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 mg/day 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 mg/day 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 high