REMERON SOLTAB 15MG

国家: 马来西亚

语言: 英文

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

有效成分:

MIRTAZAPINE

可用日期:

ORGANON MALAYSIA SDN. BHD.

INN（国际名称）:

MIRTAZAPINE

每包单位数:

6tablet Tablets; 18tablet Tablets; 30tablet Tablets

厂商:

Anesta LLC

资料单张

REMERON SOLTAB
®
Mirtazapine (15mg, 30mg)
_Consumer Medication Information Leaflet (RiMUP) _
1
Copyright 2021 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What REMERON SolTab is used for
2.
How REMERON SolTab works
3.
Before you take REMERON SolTab
4.
How to take REMERON SolTab
5.
While you are using REMERON
SolTab
6.
Side effects
7.
Storage and disposal of REMERON
SolTab
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT REMERON SOLTAB IS USED FOR
REMERON SolTab is one of a group of
medicines called
ANTIDEPRESSANTS
.
REMERON SolTab is used to treat
depressive illness.
HOW REMERON SOLTAB WORKS
REMERON SolTab belongs to the group
of medicines known as antidepressants
that alleviate depressed mood, a
characteristic of depression. Depression is
a disturbance in emotional life. During
depression changes in the brain take place.
Nerve cells in the brain communicate with
each other by means of chemical
substances. In cases of depression the
normal supply of these substances is
reduced. Antidepressants can restore these
deficiencies and re-establish the normal
function of the brain. In general it may
take two to four weeks of oral treatment
before you experience an improvement.
BEFORE YOU TAKE REMERON SOLTAB
-
_When you must not take it _
DO NOT TAKE REMERON SOLTAB:
•
if you are allergic (hypersensitive) to
mirtazapine or any of the other ingredients
of REMERON SolTab. If so, you must
talk to your doctor as soon as you can
before taking REMERON SolTab.
•
if you are taking or have recently taken
(within the last two weeks) medicines
called monoamine oxidase inhibitors
(MAO-Is).
-
_Before you start to take it _
USE IN CHILDREN AND ADOLESCENTS UNDER
18 YEARS OF AGE
REMERON SolTab should normally not
be used for children and adolescents under
18 years as efficacy was not demonstrated
in two short-term clinical trials and
because of safety concerns.
Also, you should know that patients under
18 have an increased risk of side-effects
such as suic

产品特点

Remeron Soltab (mirtazapine)
15 & 30mg
S-LPC-OG8246-ALL-072020
1
05MYPJ
1.
NAME OF THE MEDICINAL PRODUCT
Remeron SolTab 15 mg orodispersible tablets
Remeron SolTab 30 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Remeron SolTab 15 mg orodispersible tablet contains 15 mg of
mirtazapine.
Each Remeron SolTab 30 mg orodispersible tablet contains 30 mg of
mirtazapine.
Excipients:
Each Remeron SolTab 15 mg orodispersible tablet contains 4.65 mg
aspartame and
about 28 mg sucrose.
Each Remeron SolTab 30 mg orodispersible tablet contains 9.30 mg
aspartame and
about 56 mg sucrose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
15 mg orodispersible tablet:
Round, white, standard beveled-edge, coded with “TZ1” on one side.
30 mg orodispersible tablet:
Round, white, standard beveled-edge, coded with “TZ2” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Episode of major depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In order to prevent crushing the tablet, do not push against the
tablet pocket (Figure A).
Remeron Soltab (mirtazapine)
15 & 30mg
S-LPC-OG8246-ALL-072020
2
05MYPJ
Fig. 2
Fig. A
Each strip contains six tablet pockets, which are separated by
perforations. Tear
off one tablet pocket along the dotted lines (Figure 1).
Fig. 1
Carefully peel off the lidding foil, starting in the corner indicated
by the arrow
(Figures 2 and 3).
Fig. 3
Remeron Soltab (mirtazapine)
15 & 30mg
S-LPC-OG8246-ALL-072020
3
05MYPJ
The tablet should be taken out of the strip with dry hands and should
be placed
on
the
tongue
(Figure
4).
The
tablet
will
rapidly
disintegrate
and
can
be
swallowed without water.
Fig. 4
Adults
Treatment should begin with 15 mg daily. The dosage generally needs to
be increased
to obtain an optimal clinical response. The effective daily dose is
usually between 15 and
45 mg. (the dose should be taken at night).
Mirtazapine begins to exert its effect in general after 1-2 weeks of
treatment. Treatment
with an adequate d