Mirtazapine orodispergeerbare tablet 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:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N06AX11

INN (Algemene Internationale Benaming):

MIRTAZAPINE 0-WATER 45 mg/stuk

farmaceutische vorm:

Orodispergeerbare tablet

Samenstelling:

ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CALCIUMSTEARAAT (E 470A) ; CROSPOVIDON (E 1202) ; DEXTRINE ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours ; PEPERMUNTSMAAKSTOF PERMASEAL 76175-51 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF 55.301 AP 0551 ; SULFIET (SO3)2- ; TOCOFEROL, DL-ALFA (E 307), ASPARTAAM (E 951) ; CALCIUMSTEARAAT (E 470A) ; CROSPOVIDON (E 1202) ; DEXTRINE ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN ; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours ; PEPERMUNTSMAAKSTOF PERMASEAL 76175-51 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF 55.301 AP 0551 ; SULFIET (SO3)2- ; TOCOFEROL, DL-ALFA (E 307),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Mirtazapine

Product samenvatting:

Hulpstoffen: ASPARTAAM (E 951); CALCIUMSTEARAAT (E 470A); CROSPOVIDON (E 1202); DEXTRINE; MALTODEXTRINE; MANNITOL (D-) (E 421); NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN; PEPERMUNTSMAAKSTOF AF 1971 Alexander Flavours; PEPERMUNTSMAAKSTOF PERMASEAL 76175-51; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); SINAASAPPELSMAAKSTOF 55.301 AP 0551; SULFIET (SO3)2-; TOCOFEROL, DL-ALFA (E 307);

Autorisatie datum:

2007-07-23

Bijsluiter

Sandoz B.V.
Pagina 1 van 12
Mirtazapine orodispergeerbare tablet 15/30/45 mg,
RVG 33366-7-8
1313-V18
1.3.1.3 Bijsluiter
Oktober 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRTAZAPINE ORODISPERGEERBARE TABLET 15 MG, ORODISPERGEERBARE
TABLETTEN
MIRTAZAPINE ORODISPERGEERBARE TABLET 30 MG, ORODISPERGEERBARE
TABLETTEN
MIRTAZAPINE ORODISPERGEERBARE TABLET 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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is one of a group of medicines called
ANTIDEPRESSANTS
.
[nationally completed name] is used to treat depressive illness in
adults.
nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE OR TELL YOUR DOCTOR BEFORE TAKING [NATIONALLY COMPLETED NAME]:
•
if you are
ALLERGIC
to mirtazapine or any of the other ingredients of this medicine
(listed in s

Productkenmerken

Sandoz B.V.
Page 1/14
Mirtazapine orodispergeerbare tablet 15/30/45 mg,
RVG 33366-7-8
1311-V18
1.3.1.1 Samenvatting van de productkenmerken
Oktober 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mirtazapine orodispergeerbare tablet 15 mg, orodispergeerbare
tabletten
Mirtazapine orodispergeerbare tablet 30 mg, orodispergeerbare
tabletten
Mirtazapine orodispergeerbare tablet 45 mg, orodispergeerbare
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[nationally completed name 15 mg]:
Each orodispersible tablet contains 15 mg of mirtazapine.
Excipients with known effects
Each orodispersible tablet contains 3 mg of aspartame (E 951), 15
nanograms of sulphites and 0.047
mg of benzyl alcohol.
[nationally completed name 30 mg]:
Each orodispersible tablet contains 30 mg of mirtazapine.
Excipients with known effects
Each orodispersible tablet contains 6 mg of aspartame (E 951), 30
nanograms of sulphites and 0.093
mg of benzyl alcohol.
[nationally completed name 45 mg]:
Each orodispersible tablet contains 45 mg of mirtazapine.
Excipients with known effects
Each orodispersible tablet contains 9 mg of aspartame (E 951), 45
nanograms of sulphites and 0.14 mg
of benzyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
White to off-white, round, flat tablets with bevelled edges and plain
on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sandoz B.V.
Page 2/14
Mirtazapine orodispergeerbare tablet 15/30/45 mg,
RVG 33366-7-8
1311-V18
1.3.1.1 Samenvatting van de productkenmerken
Oktober 2020
[nationally completed name] is indicated in adults for the treatment
of episodes of major depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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,