Kwetaplex 100 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

QUETIAPINEFUMARAAT SAMENSTELLING overeenkomend met ; QUETIAPINE

Beschikbaar vanaf:

Adamed Sp. z o.o.

ATC-code:

N05AH04

INN (Algemene Internationale Benaming):

QUETIAPINEFUMARAAT COMPOSITION corresponding to ; QUETIAPINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Quetiapine

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2009-01-27

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KWETAPLEX, FILMOMHULDE TABLETTEN VAN 25 MG
KWETAPLEX, FILMOMHULDE TABLETTEN VAN 100 MG
KWETAPLEX, FILMOMHULDE TABLETTEN VAN 150 MG
KWETAPLEX, FILMOMHULDE TABLETTEN VAN 200 MG
KWETAPLEX, FILMOMHULDE TABLETTEN VAN 300 MG
KWETAPLEX, 4 DAY STARTERPACK, FILMOMHULDE TABLETTEN
Quetiapine
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 sign of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kwetaplex is and what it is used for
2.
What you need to know before you take Kwetaplex
3.
How to take Kwetaplex
4
Possible side effects
5.
How to store Kwetaplex
6.
Contents of the pack and other information
1.
WHAT KWETAPLEX IS AND WHAT IT IS USED FOR
Kwetaplex contains a substance called quetiapine. This belongs to a
group of medicines called
anti-psychotics. Kwetaplex can be used to treat several illnesses,
such as:

Bipolar depression: where you feel sad. You may find that you feel
depressed, feel guilty,
lack energy, lose your appetite or can’t sleep.

Mania: where you may feel very excited, elated, agitated, enthusiastic
or hyperactive or
have poor judgment including being aggressive or disruptive.

Schizophrenia: where you may hear or feel things that are not there,
believe things that are
not true or feel unusually suspicious, anxious, confused, guilty,
tense or depressed.
Your doctor may continue to prescribe Kwetaplex even when you are
feeling better
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE < PRODUCT NAME >
DO NOT TAKE KWETAPLEX :

if you are allergic to quetiapine or any of the other ingredients of
this m

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
KWETAPLEX
1.
NAME OF THE MEDICINAL PRODUCT
Kwetaplex filmomhulde tabletten van 25 mg
Kwetaplex filmomhulde tabletten van 100 mg
Kwetaplex filmomhulde tabletten van 150 mg
Kwetaplex filmomhulde tabletten van 200 mg
Kwetaplex filmomhulde tabletten van 300 mg
Kwetaplex 4-Daagse Startverpakking, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg quetiapine (as quetiapine
fumarate)
Each 100 mg film-coated tablet contains 100 mg quetiapine (as
quetiapine fumarate)
Each 150 mg film-coated tablet contains 150 mg quetiapine (as
quetiapine fumarate)
Each 200 mg film-coated tablet contains 200 mg quetiapine (as
quetiapine fumarate)
Each 300 mg film-coated tablet contains 300 mg quetiapine (as
quetiapine fumarate)
4-Day StarterPack contains 6 tablets of quetiapine (as quetiapine
fumarate) of 25 mg, 3 tablets
of100 mg and 1 tablet of 200 mg
Excipient(s): Lactose monohydrate and Sunset yellow (E110)
Each 25 mg film-coated tablet contains 7.00mg of lactose monohydrate
and 0.003 mg of Sunset
yellow (E110)
Each 100 mg film-coated tablet contains 28.00mg of lactose monohydrate
Each 150 mg film-coated tablet contains 42.00mg of lactose monohydrate
Each 200 mg film-coated tablet contains 56.00mg of lactose monohydrate
Each 300 mg film-coated tablet contains 84.00mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Kwetaplex 25 mg: Peach, round, biconvex film coated tablets with a
diameter of approximately
5.7mm.
Kwetaplex 100 mg: Yellow, round, biconvex film coated tablets with a
score line on one side and
a diameter of approximately 9.1mm.
Kwetaplex 150 mg: Pale yellow, round, biconvex film coated tablets
with a diameter of
approximately 10.45 mm.
Kwetaplex 200 mg: White, round, biconvex film coated tablets with a
score line on one side and a
diameter of approximately 12.1mm.
Kwetaplex 300 mg: White, oblong, biconvex film coated tablets with a
score line on one side.
The 100