AUROZAPINE 30 (Mirtazapine Tablets 30 mg)

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

MIRTAZAPINE

Saadav alates:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Rahvusvaheline Nimetus):

MIRTAZAPINE

Ühikuid pakis:

2 x 14tablet Tablets

Valmistatud:

Aurobindo Pharma Limited (Unit III),

Infovoldik

_Consumer Medication Information Leaflet (RiMUP) _
AUROZAPINE 15
AUROZAPINE 30
Mirtazapine Tablet (15mg & 30mg)
1
WHAT IS IN THIS LEAFLET
1.
What AUROZAPINE is used for
2.
How AUROZAPINE works
3.
Before you use AUROZAPINE
4.
How to use AUROZAPINE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
AUROZAPINE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS AUROZAPINE USED FOR
AUROZAPINE is indicated for use
in patients with major depression.
HOW AUROZAPINE WORKS
Mirtazapine
which
is
the
active
ingredient of AUROZAPINE works
by enhancing neurotransmission in
the brain and therefore contributing
to antidepressant activity.
BEFORE YOU USE AUROZAPINE
-When you must not use it
Do not use AUROZAPINE if you are
allergic to the active substance or any
of its excipients listed in this leaflet.
Do not use this product if you are
taking other medications called
monoamine
oxidase
(MAO)
inhibitors.
AUROZAPINE is not recommended
for use in patients below the age of
18 years.
-Before you start to use it
Tell your doctor if:
•
You are allergic to any of
the ingredients used in this
product.
•
You are pregnant, planning
to
start
a
family
or
breastfeeding.
If you have any of the following
medical conditions, please inform
your
doctor
before
taking
this
medication:
•
Thoughts of suicide or self-
harm.
•
Epilepsy (fits or
convulsions).
•
Liver disease such as
jaundice.
•
Kidney disease.
•
Heart disease.
•
Low blood pressure.
•
Any other mental illness
(e.g. schizophrenia, manic
depression).
•
Diabetes.
•
Glaucoma (increased
pressure in eye).
•
Problems urinating due to
enlarged prostate.
•
Unexplained high fever,
sore throat and mouth
ulcers.
•
Lactose intolerance.
•
Phenylketonuria.
-Taking other medications
Inform your doctor or pharmacist if
you are taking any other medications
including those purchased without a
prescription from the pharmacy or
from
a
health-food
shop
before
starting this medication.
AUROZAPINE is

Toote omadused

Date & Time
Component
Item Code
Reason Of Issue
Version No.
Customer / Country
Reviewed / Approved
by
Sign / Date
Product Name
Aurozapine Tablets
Leaflet
P1533880
Malaysia U3
NEW
01
07.04.2023 & 10.45 am
Dimensions
Pharmacode
Team Leader
Initiator
Additional Information : Supersede Code: P1514420
Artist: SCD
No. of Colours : 01
165 x 430 mm
Kiran
Shirisha
33880
Packaging Development
A/s: 165 x 430 mm
Black
NAME OF DRUG PRODUCT:
Mirtazapine Tablets 15 mg
Mirtazapine Tablets 30 mg (TRADE) NAME OF THE PRODUCT:
AUROZAPINE 15
AUROZAPINE 30
STRENGTH:
15 mg and 30 mg
PHARMACEUTICAL DOSAGE FORM:
Tablet.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Mirtazapine Tablets 15 mg:
Each film-coated tablet contains Mirtazapine Ph.Eur. 15 mg.
Mirtazapine Tablets 30 mg:
Each film-coated tablet contains Mirtazapine Ph.Eur. 30 mg.
PHARMACEUTICAL FORM:
Mirtazapine Tablets 15 mg: Yellow, biconvex capsule shaped film coated
tablets with a scoreline in between 0 and 8 on one side and ‘A’
debossed on the
otherside.
Mirtazapine Tablets 30 mg: Reddish brown, biconvex capsule shaped film
coated tablets with a scoreline in between 0 and 9 on one side and
‘A’ debossed
on the otherside.
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS
Episode of major depression.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: Treatment should begin with 15mg daily. The dosage generally
needs to be increased to obtain an optimal clinical response. The
effective daily
dose is usually between 15mg and 45mg (the dose should be taken at
night). Mirtazapine begins to exert its effect in general after 1 to 2
weeks of treatment.
Treatment with an adequate dose should result in a positive response
within 2 to 4 weeks. With an insufficient response, the dose can be
increased up to
the maximum dose. If there is no response within a further 2 to 4
weeks, then treatment should be stopped.
ELDERLY: The recommended dose is the same as that for adults. In
elderly patients an increase in dosing should be done under close
supervision to elicit
a satisfactory and safe response.