Quetiapine Fair-Med 200 mg, filmomhulde tabletten

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

QUETIAPINEFUMARAAT 230,3 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 200 mg/stuk

Verfügbar ab:

Fair-Med Healthcare GmbH Planckstraße 13 22765 HAMBURG (DUITSLAND)

ATC-Code:

N05AH04

INN (Internationale Bezeichnung):

QUETIAPINEFUMARAAT 230,3 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 200 mg/stuk

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

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),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Quetiapine

Produktbesonderheiten:

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);

Berechtigungsdatum:

2012-09-06

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUETIAPINE FAIR-MED 25 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 100 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 150 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 200 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 300 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 4-DAAGSE STARTVERPAKKING, FILMOMHULDE TABLETTEN
6X25 MG, 3X100 MG
EN 1X200 MG
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 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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR

contains a substance called quetiapine. This belongs to a group of
medicines
called anti-psychotics. 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 even when you are
feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE

Lesen Sie das vollständige Dokument

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
QUETIAPINE FAIR-MED 25 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 100 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 150 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 200 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 300 MG, FILMOMHULDE TABLETTEN
QUETIAPINE FAIR-MED 4-DAAGSE STARTVERPAKKING, FILMOMHULDE TABLETTEN
6X25 MG, 3X100 MG
EN 1X200 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg contains 25 mg quetiapine (as quetiapine
fumarate).
Excipients with known effect: 7.00 mg lactose (monohydrate) and 0.003
mg sunset yellow
(E110).
100 mg contains 100 mg quetiapine (as quetiapine
fumarate).
Excipient with known effect: 28.00 mg lactose (monohydrate).
150 mg contains 150 mg quetiapine (as quetiapine
fumarate).
Excipient with known effect: 42.00 mg lactose (monohydrate).
200 mg contains 200 mg quetiapine (as quetiapine
fumarate).
Excipient with known effect: 56.00 mg lactose (monohydrate).
300 mg contains 300 mg quetiapine (as quetiapine
fumarate).
Excipient with known effect: 84.00 mg lactose (monohydrate).
StarterPack contains 6 tablets of 25 mg, 3 tablets of
100 mg and 1 tablet of 200
mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
25 mg tablets are peach, round, biconvex with a
diameter of approximately 5.7
mm.
100 mg tablets are yellow, round, biconvex, scored on
one side, with a diameter
of approximately 9.1 mm.
150 mg tablets are pale yellow, round, biconvex, with a
diameter of
approximately 10.45 mm.
200 mg tablets are white, round, biconvex, scored on
one side, with a diameter
of approximately 12.1 mm.
300 mg tablets are white, oblong, biconvex, scored on
one side. The tablet is
approximately 7 mm thick, 19 mm long & 9 mm wide.
The 100, 200 and 300 mg tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1_ _
THER