Mirtazapine ratiopharm dispergeerbaar 45 mg, orodispergeerbare tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

MIRTAZAPINE 0-WATER 45 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

N06AX11

INN (Algemene Internationale Benaming):

MIRTAZAPINE 0-WATER 45 mg/stuk

farmaceutische vorm:

Orodispergeerbare tablet

Samenstelling:

AARDBEIENSMAAKSTOF 52.312 AP 0551 Firmenich ; ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; NATRIUM (NA+) ; PEPERMUNTSMAAKSTOF ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; TRIETHYLCITRAAT (E 1505), AARDBEIENSMAAKSTOF 52.312 AP 0551 Firmenich ; ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUM (NA+) ; PEPERMUNTSMAAKSTOF ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; TRIETHYLCITRAAT (E 1505), AARDBEIENSMAAKSTOF 52.312 AP 0551 Firmenich ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; PEPERMUNTSMAAKSTOF ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; TRIETHYLCITRAAT (E 1505),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Mirtazapine

Product samenvatting:

Hulpstoffen: AARDBEIENSMAAKSTOF 52.312 AP 0551 Firmenich; ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); MALTODEXTRINE; MANNITOL (D-) (E 421); PEPERMUNTSMAAKSTOF; PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); TRIETHYLCITRAAT (E 1505);

Autorisatie datum:

1900-01-01

Bijsluiter

Mirtazapine, NL/H/1103+1104/001-003, 24.03.21
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRTAZAPINE RATIOPHARM DISPERGEERBAAR 15 MG, ORODISPERGEERBARE
TABLETTEN
MIRTAZAPINE RATIOPHARM DISPERGEERBAAR 30 MG, ORODISPERGEERBARE
TABLETTEN
MIRTAZAPINE RATIOPHARM DISPERGEERBAAR 45 MG, ORODISPERGEERBARE
TABLETTEN
(Mirtazapine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Mirtazapine is and what it is used for
2.
What you need to know before you take Mirtazapine
3.
How to take Mirtazapine
4.
Possible side effects
5.
How to store Mirtazapine
6.
Contents of the pack and other information
1.
WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine is one of a group of medicines called
ANTIDEPRESSANTS
.
Mirtazapine is used to treat depressive illness in adults.
Mirtazapine will take 1 to 2 weeks before it starts working. After 2
to 4 weeks you may start feeling
better. You must talk to your doctor if you do not feel better or if
you feel worse after 2 to 4 weeks.
More information is in section 3 heading "When can you expect to start
feeling better".
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE
DO NOT TAKE MIRTAZAPINE
-
if you are allergic to mirtazapine or any of the other ingredients of
this medicine (listed in
section 6). If so, you must talk to your doctor as soon as you can
before taking mirtazapine.
-
if you are taking or have recently taken (within the last two weeks)
medicines called monoamine
oxidase inhibitors (MAO-Is).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacis

Productkenmerken

Mirtazapine, NL/H/1103+1104/001-003, 24.03.21
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mirtazapine ratiopharm dispergeerbaar 15 mg, orodispergeerbare
tabletten
Mirtazapine ratiopharm dispergeerbaar 30 mg, orodispergeerbare
tabletten
Mirtazapine ratiopharm dispergeerbaar 45 mg, orodispergeerbare
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg mirtazapine.
Each orodispersible tablet contains 30 mg mirtazapine.
Each orodispersible tablet contains 45 mg mirtazapine.
Excipients with known effect:
Each Mirtazapine 15 mg orodispersible tablet contains 3 mg aspartame
and 0.24 µg benzyl alcohol.
Each Mirtazapine 30 mg orodispersible tablet contains 6 mg aspartame
and 0.48 µg benzyl alcohol.
Each Mirtazapine 45 mg orodispersible tablet contains 9 mg aspartame
and 0.72 µg benzyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Mirtazapine 15 mg orodispersible tablets:
White, round tablets debossed with “36”on one side and ‘A’ on
the other side with an embossed
circular edge.
Mirtazapine 30 mg orodispersible tablets:
White, round tablets debossed with “37” on one side and ‘A’ on
the other side with an embossed
circular edge.
Mirtazapine 45 mg orodispersible tablets:
White, round tablets debossed with “38” on one side and ‘A’ on
the other side with an embossed
circular edge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mirtazapine orodispersible tablets are indicated in adults for the
treatment of episodes of major
depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Mirtazapine, NL/H/1103+1104/001-003, 24.03.21
2
Posology
_Adults _
The effective daily dose is usually between 15 and 45 mg; the starting
dose is 15 or 30 mg.
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