ARIPLY 30

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

ARIPIPRAZOLE

Saadav alates:

UNIPHARM LTD, ISRAEL

ATC kood:

N05AX12

Ravimvorm:

TABLETS

Koostis:

ARIPIPRAZOLE 30 MG

Manustamisviis:

PER OS

Retsepti tüüp:

Required

Valmistatud:

UNIPHARM LTD, ISRAEL

Terapeutiline ala:

ARIPIPRAZOLE

Näidustused:

Ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment

Loa andmise kuupäev:

2019-03-03

Infovoldik

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only.
ARIPLY 5, 10, 15, 30
TABLETS
COMPOSITION:
ARIPLY 5: Each tablet contains: Aripiprazole 5 mg
ARIPLY 10: Each tablet contains: Aripiprazole 10 mg
ARIPLY 15: Each tablet contains: Aripiprazole 15 mg
ARIPLY 30: Each tablet contains: Aripiprazole 30 mg
Inactive and allergenic ingredients in the preparation –
see in section 2 “Important information about some of
the ingredients of the medicine” and section 6 “Further
information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment of
your ailment. Do not pass it on to others. It may harm
them even if it seems to you that their medical condition
is similar.
Elderly patients with dementia-related psychosis
treated with antipsychotics are at high risk of death.
ARIPLY is not intended for the treatment of dementia-
related psychosis.
Antidepressants increase the risk of suicidal thoughts
in children, adolescents and young adults up to the
age of 25.
When starting treatment with the medicine, patients of
all ages and their relatives must monitor for behavioral
changes, such as: worsening of depression, suicidal
thoughts, aggressiveness and the like (see in section
2 “Special warnings regarding use of the medicine”).
1. WHAT IS THE MEDICINE INTENDED FOR?
ARIPLY 5, 10, 15, 30 are intended:
For treatment of schizophrenia.
For treatment of moderate to severe manic states
in bipolar disorder type 1 and for the prevention of
new manic episodes in patients who experience
predominantly manic episodes and who had previous
manic episodes that responded to aripiprazole treatment.
In addition, ARIPLY 5, 10, 15 are intended:
For combined treatment of clinical depression (major
depressive disorder [MDD]) for patients who

Toote omadused

ARIPLY 5;10;15;30
1.
NAME OF THE MEDICINAL PRODUCT:
ARIPLY 5; ARIPLY 10; ARIPLY 15 and ARIPLY 30
1.1
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
ARIPLY 5- Aripiprazole 5 mg, Tablet
•
ARIPLY 10 - Aripiprazole 10 mg, Tablet
•
ARIPLY 15- Aripiprazole 15 mg, Tablet
•
ARIPLY 30- Aripiprazole 30 mg, Tablet
2.
THERAPEUTIC INDICATIONS
:
Ariply 5;10;15 and 30 Oral Tablets are indicated for the treatment of:
•
For the treatment of schizophrenia.
•
Acute Treatment of Manic and Mixed Episodes associated with Bipolar
I [see Clinical Studies (15.2)]
Ariply 5;10 and 15 Oral Tablets are indicated for the treatment of:
•
use as an adjunctive therapy to antidepressants for the treatment of
major depressive disorder (MDD). Efficacy was established in two 6-
week trials in adults with MDD who had an inadequate response to
antidepressant therapy during the current episode.
•
Irritability Associated with Autistic Disorder in Pediatric Patients
(6
to 17 years) [see Clinical Studies (14.4)]
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL THOUGHTS AND
BEHAVIORS WITH ANTIDEPRESSANT DRUGS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are
at an increased risk of death. Aripiprazole is not approved for the
treatment of patients
with dementia-related psychosis [see Warnings and Precautions (6.1)].
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show an
increase in the risk of suicidal thoughts and behavior with
antidepressant use in
patients over age 24 years; there was a reduction in risk with
antidepressant use in
patients aged 65 years and older [see Warnings and Precautions (6.3)].
In patients of all ages who are started on antidepressant therapy,
monitor closely for
worsening, and for emergence of suicidal thoughts and behaviors.
Advise families and
caregivers of the need for close observation and communication with
the prescriber
[see