Quetiapine Neuraxpharm 200 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

QUETIAPINEFUMARAAT 230,27 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 200 mg/stuk

Beschikbaar vanaf:

Neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Strasse 23 D-40764 LANGENFELD (DUITSLAND)

ATC-code:

N05AH04

INN (Algemene Internationale Benaming):

QUETIAPINEFUMARAAT 230,27 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 200 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; 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); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

1900-01-01

Bijsluiter

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUETIAPINE NEURAXPHARM 25 MG FILMOMHULDE TABLETTEN
QUETIAPINE NEURAXPHARM 50 MG FILMOMHULDE TABLETTEN
QUETIAPINE NEURAXPHARM 100 MG FILMOMHULDE TABLETTEN
QUETIAPINE NEURAXPHARM 150 MG FILMOMHULDE TABLETTEN
QUETIAPINE NEURAXPHARM 200 MG FILMOMHULDE TABLETTEN
QUETIAPINE NEURAXPHARM 300 MG FILMOMHULDE TABLETTEN
Quetiapine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
1.
What Quetiapine Neuraxpharm is and what it is used for
2.
What you need to know before you take Quetiapine Neuraxpharm
3.
How to take Quetiapine Neuraxpharm
4.
Possible side effects
5.
How to store Quetiapine Neuraxpharm
6.
Contents of the pack and other information
1.
WHAT QUETIAPINE NEURAXPHARM IS AND WHAT IT IS USED FOR
Quetiapine Neuraxpharm contains a substance called quetiapine. This
belongs to a group of
medicines called antipsychotics. Quetiapine Neuraxpharm 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 Quetiapine Neuraxpharm even when
you are feeling
better.
2.
What you need to know before you take Quetiapine Neuraxpharm
DO NOT TAKE

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
QUETIAPINE NEURAXPHARM
1.
NAME OF THE MEDICINAL PRODUCT
Quetiapine Neuraxpharm 25 mg filmomhulde
tabletten
Quetiapine Neuraxpharm 50 mg filmomhulde
tabletten
Quetiapine Neuraxpharm 100 mg filmomhulde
tabletten
Quetiapine Neuraxpharm 150 mg filmomhulde
tabletten
Quetiapine Neuraxpharm 200 mg filmomhulde
tabletten
Quetiapine Neuraxpharm 300 mg filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg quetiapine (as quetiapine
fumarate)
Each 50 mg film-coated tablet contains 50 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)
Excipient(s) with known effect:
Each 25 mg film-coated tablet contains 7.00mg of lactose monohydrate
and 0.003 mg of
Sunset yellow (E 110).
Each 50 mg film-coated tablet contains 14.00mg of lactose monohydrate
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
Quetiapine Neuraxpharm 25 mg: Peach, round, biconvex film coated
tablets.
Quetiapine Neuraxpharm 50 mg: White, round, biconvex film coated
tablets with a score line
on one side.
Quetiapine Neuraxpharm 100 mg: Yellow, round, biconvex film coated
tablets with a score
line on one side.
Quetiapine Neuraxpharm 150 mg: Pale yellow, round, biconvex film
coated tablets
Quetiapine Neuraxpharm 200 mg: White, round, biconvex film coated
tablets with a score
line on one side.
Quetiapine Neuraxpharm 300 mg: White, oblong, biconv