REMERON SOLTAB 30 mg

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

COATED MIRTAZAPINE 125 mg EQV MIRTAZAPINE

Dostupné z:

ORGANON SINGAPORE PTE. LTD.

ATC kód:

N06AX11

Dávkovanie:

Mirtazapine 30 mg eqv coated mirtazapine 125.00mg

Forma lieku:

TABLET

Zloženie:

COATED MIRTAZAPINE 125 mg EQV MIRTAZAPINE 30 mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

Anesta LLC

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2004-03-25

Príbalový leták

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

Súhrn charakteristických

S-CCDS-MK8246-ALL-072020
REMERON SolTab®
15 and 30 mg
Orodispersible Tablet
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).
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. 2
Fig. 3
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 dose should result in a positive response
within 2-4
weeks. With an insufficient response, the dose can be increased up to
the
maximum
dose.