ARPENIA 10 mg tablet

Country: Սաուդյան Արաբիա

language: անգլերեն

source: SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

active_ingredient:

ARIPIPRAZOLE

MAH:

Tabuk Pharmaceutical Manufacturing Company, Saudi Arabia

ATC_code:

N05AX12

INN:

ARIPIPRAZOLE

dosage:

10 mg

pharmaceutical_form:

Tablet

administration_route:

Oral use

units_in_package:

30 Bottle

class:

Generic

prescription_type:

Prescription

manufactured_by:

TABUK PHARMACEUTICAL MANUFACTURING CO., Saudi Arabia

leaflet_short:

Agent: Tabuk Pharmaceutical Manufacturing Company; Price: 200; Storage conditions: store below 30°c; Shelf life: 24; Description code: 7000000091-10-100000073664; Distribution area: Pharmacy

authorization_status:

Marketed; Valid

authorization_date:

2016-01-01

PIL

IN THIS LEAFLET:
1. Serious side effects
2. What ARPENIA is and what it is used for
3. Before you take ARPENIA
4. How to take ARPENIA
5. Possible side effects
6. How to store ARPENIA
7. Further information
1. SERIOUS SIDE EFFECTS
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDALITY AND ANTIDEPRESSANT DRUGS
-
Elderly
patients
with
dementia-related
psychosis
treated
with
antipsychotic drugs are at an increased risk of death. ARPENIA is not
approved
for
the
treatment
of
patients
with
dementia-related
psychosis.
- Children, adolescents, and young adults taking antidepressants for
major depressive disorder (MDD) and other psychiatric disorders
are at increased risk of suicidal thinking and behavior.
2. WHAT ARPENIA IS AND WHAT IT IS USED FOR
ARPENIA is one of 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.
ARPENIA
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 ARPENIA.
3. BEFORE YOU TAKE ARPENIA
DO NOT TAKE ARPENIA
- If you are allergic to aripiprazole or any of the other ingredients
of this
medicine.
TAKE SPECIAL CARE WITH ARPENIA
Talk to your doctor before taking ARPENIA if you suffer from:
- High blood sugar (characterised by symptoms such as excessive
thirst,
passing of large amounts of urine, increase in appetite, and feeling
weak) or family history of diabetes.
- Seizure.
- Involuntary, irregular muscle m