Aripiprazole Uriach 30mg tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

ARIPIPRAZOLE

Beschikbaar vanaf:

J. Uriach y Compania, S.A. Av. Cami Reial, 51-57 08184 - Palau-solita I Plegamans, Barcelona, Spain

ATC-code:

N05AX12

INN (Algemene Internationale Benaming):

ARIPIPRAZOLE 30 mg

farmaceutische vorm:

TABLET

Samenstelling:

ARIPIPRAZOLE 30 mg

Prescription-type:

POM

Therapeutisch gebied:

PSYCHOLEPTICS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2015-05-05

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE URIACH 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 Uriach
is and what it is used for
2.
What you need to know before you take Aripiprazole Uriach
3.
How to take Aripiprazole Uriach
4.
Possible side effects
5.
How to store Aripiprazole Uriach
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE URIACH IS AND WHAT IT IS USED FOR
Aripiprazol 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 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 URIACH
DO NOT TAKE ARIPIPRAZOLE
-
if you are allergic to aripiprazole or any of the other ingredients of
this medicine (listed in
secti

Productkenmerken

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Uriach 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect: 320.96 mg lactose per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
9.5mm, round biconvex pale pink tablet, weight of 450mg.
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
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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 in Bipolar I Disorder:_
for preventing recurrence of manic
episodes in patients who have been receiving Aripiprazole as
monotherapy or combi