REMERON SOLTAB 45 mg

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

MIRTAZAPINE

Dostupno od:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC koda:

N06AX11

Doziranje:

Mirtazapine 45 mg eqv coated mirtazapine 187.50mg

Farmaceutski oblik:

TABLET

Administracija rute:

ORAL

Tip recepta:

Prescription Only

Proizveden od:

Cephalon, Inc.

Datum autorizacije:

2004-03-25

Uputa o lijeku

S-CCDS-MK8246-ALL-122018
REMERON SolTab®
15, 30 and 45 mg
Orodispersible Tablet
1.
NAME OF THE MEDICINAL PRODUCT
Remeron SolTab 15 mg orodispersible tablets
Remeron SolTab 30 mg orodispersible tablets
Remeron SolTab 45 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.
Each
Remeron
SolTab
45 mg
orodispersible
tablet
contains
45 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.
Each
Remeron
SolTab
45 mg
orodispersible
tablet
contains
13.95 mg
aspartame and about 84 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.
45 mg orodispersible tablet:
Round, white, standard beveled-edge, coded with “TZ4” 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).
Each strip contains six tablet pockets, which are separated by
perforations. Tear
off one tablet pocket along the dotted lines (Figure 1).
Carefully peel off the lidding foil, starting in the corner indicated
by the arrow
(Figures 2 and 3).
Fig. A
Fig. 1
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.
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