Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
QUETIAPINEFUMARAAT 172,7 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 150 mg/stuk
Fair-Med Healthcare GmbH Planckstraße 13 22765 HAMBURG (DUITSLAND)
N05AH04
QUETIAPINEFUMARAAT 172,7 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 150 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; 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) ; HYPROLOSE (E 463) ; 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) ; HYPROLOSE (E 463) ; 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),
Oraal gebruik
Quetiapine
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); 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);
2012-09-06
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
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 COMPOSITION25 mg contains 25 mg quetiapine (as quetiapine fumarate). Excipients with known effect: 7.00 mg lactose (monohydrate) and 0.003 mg sunset yellow (E110). Lesen Sie das vollständige Dokument100 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