Quetiapine XR Cheplapharm 300 mg, tabletten met verlengde afgifte

Valsts: Nīderlande

Valoda: holandiešu

Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktīvā sastāvdaļa:

QUETIAPINEFUMARAAT 345,38 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 300 mg/stuk

Pieejams no:

AstraZeneca B.V Prinses Beatrixlaan 582 2595 BM DEN HAAG

ATĶ kods:

N05AH04

SNN (starptautisko nepatentēto nosaukumu):

QUETIAPINEFUMARAAT 345,38 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 300 mg/stuk

Zāļu forma:

Tablet met verlengde afgifte

Kompozīcija:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331),

Ievadīšanas:

Oraal gebruik

Ārstniecības joma:

Quetiapine

Produktu pārskats:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); HYPROMELLOSE (Release controlling polymer)(E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171); TRINATRIUMCITRAAT 2-WATER (E 331);

Autorizācija datums:

2010-11-03

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUETIAPINE XR CHEPLAPHARM 50 MG, TABLETTEN MET VERLENGDE AFGIFTE
QUETIAPINE XR CHEPLAPHARM 150 MG, TABLETTEN MET VERLENGDE AFGIFTE
QUETIAPINE XR CHEPLAPHARM 200 MG, TABLETTEN MET VERLENGDE AFGIFTE
QUETIAPINE XR CHEPLAPHARM 300 MG, TABLETTEN MET VERLENGDE AFGIFTE
QUETIAPINE XR CHEPLAPHARM 400 MG, TABLETTEN MET VERLENGDE AFGIFTE
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 Quetiapine XR Cheplapharm is and what it is used for
2.
What you need to know before you take Quetiapine XR Cheplapharm
3.
How to take Quetiapine XR Cheplapharm
4.
Possible side effects
5.
How to store Quetiapine XR Cheplapharm
6.
Contents of the pack and other information
1.
WHAT QUETIAPINE XR CHEPLAPHARM IS AND WHAT IT IS USED FOR
Quetiapine XR Cheplapharm contains a substance called quetiapine. This
belongs to a group of
medicines called anti-psychotics. Quetiapine XR Cheplapharm can be
used to treat several illnesses,
such as:
•
Bipolar depression and major depressive episodes in major depressive
disorder: 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.
When Quetia

Produkta apraksts

1
1.
NAME OF THE MEDICINAL PRODUCT
Quetiapine XR Cheplapharm 50 mg, tabletten met verlengde afgifte
Quetiapine XR Cheplapharm 150 mg, tabletten met verlengde afgifte
Quetiapine XR Cheplapharm 200 mg, tabletten met verlengde afgifte
Quetiapine XR Cheplapharm 300 mg, tabletten met verlengde afgifte
Quetiapine XR Cheplapharm 400 mg, tabletten met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quetiapine XR Cheplapharm 50 mg contains 50 mg quetiapine (as
quetiapine fumarate)
Quetiapine XR Cheplapharm 150 mg contains 150 mg quetiapine (as
quetiapine fumarate)
Quetiapine XR Cheplapharm 200 mg contains 200 mg quetiapine (as
quetiapine fumarate)
Quetiapine XR Cheplapharm 300 mg contains 300 mg quetiapine (as
quetiapine fumarate)
Quetiapine XR Cheplapharm 400 mg contains 400 mg quetiapine (as
quetiapine fumarate)
Excipients with known effect:
Quetiapine XR Cheplapharm 50 mg contains 119 mg lactose (anhydrous)
per tablet
Quetiapine XR Cheplapharm 150 mg contains 71 mg lactose (anhydrous)
per tablet
Quetiapine XR Cheplapharm 200 mg contains 50 mg lactose (anhydrous)
per tablet
Quetiapine XR Cheplapharm 300 mg contains 47 mg lactose (anhydrous)
per tablet
Quetiapine XR Cheplapharm 300 mg contains 27 mg sodium per tablet
Quetiapine XR Cheplapharm 400 mg contains 15 mg lactose (anhydrous)
per tablet
Quetiapine XR Cheplapharm 400 mg contains 27 mg sodium per tablet
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Quetiapine XR Cheplapharm 50 mg tablets are peach-coloured and
engraved with “XR 50” on one
side
Quetiapine XR Cheplapharm 150 mg tablets are white and engraved with
“XR 150” on one side
Quetiapine XR Cheplapharm 200 mg tablets are yellow and engraved with
“XR 200” on one side
Quetiapine XR Cheplapharm 300 mg tablets are pale yellow and engraved
with “XR 300” on one side
Quetiapine XR Cheplapharm 400 mg tablets are white and engraved with
“XR 400” on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Quetiapine XR Cheplapharm is