Aripiprazole Universal Farma 5 mg tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Aripiprazole

Fáanlegur frá:

Universal Farma S.L.

ATC númer:

N05AX; N05AX12

INN (Alþjóðlegt nafn):

Aripiprazole

Skammtar:

5 milligram(s)

Lyfjaform:

Tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Other antipsychotics; aripiprazole

Leyfisstaða:

Not marketed

Leyfisdagur:

2015-08-28

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE UNIVERSAL FARMA 5 MG TABLETS
ARIPIPRAZOLE UNIVERSAL FARMA 10 MG TABLETS
ARIPIPRAZOLE UNIVERSAL FARMA 15 MG TABLETS
ARIPIPRAZOLE UNIVERSAL FARMA30 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 Universal Farma is and what it is used for
2.
What you need to know before you take Aripiprazole Universal Farma
3.
How to take Aripiprazole Universal Farma
4.
Possible side effects
5
How to store Aripiprazole Universal Farma
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE UNIVERSAL FARMA IS AND WHAT IT IS USED FOR
Aripiprazole Universal 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE UNIVERSAL FARMA
DO NOT TAKE ARIPIPRAZOLE UNIVERSAL FARMA

if you are allergic to aripiprazole or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Aripiprazole Universal if you suffer
from

High blood sugar (characterised by symptoms such as excessive thirst,
passing of large

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripiprazole Universal Farma 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 53 mg lactose per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round plane pale pink tablet (diameter 5.3 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.
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.
_Paediatric population_
_Schizophrenia in adolescents aged 15 years and older_: the
recommended dose for ARIPIPRAZOLE is 10 mg/day
administered on a once-a-day schedule without regard to meals.
Treatment should be initiated at 2 mg (using
Aripiprazole oral solution 1 mg/ml available from other licence
holders) for 2 days, titrated to 5 mg for 2 additional
days to reach the recommended daily dose of 10 mg. When appropriate,
subsequent dose increases should be
administered in 5 mg increments without exceeding the maximum daily
dose of 30 mg (see section 5.1).
Aripiprazole is effective in a dose range of 10 to 30 mg/day. Enhanced
efficacy at doses higher than a daily dose of 10
mg has not been demonstrated although individual patients may benefit
from a higher dose.
Aripiprazole is not recommended for use in patients with schizophrenia
below 15 years of age due to insufficient data
on safety and efficacy (see sections 4.8 and 5.1).
_Patients with hepatic impairment_:
No dosage adjustment is re