Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
QUETIAPINEFUMARAAT 345,38 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 300 mg/stuk
AstraZeneca B.V Prinses Beatrixlaan 582 2595 BM DEN HAAG
N05AH04
QUETIAPINEFUMARAAT 345,38 mg/stuk SAMENSTELLING overeenkomend met ; QUETIAPINE 300 mg/stuk
Tablet met verlengde afgifte
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),
Oraal gebruik
Quetiapine
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);
2010-11-03
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument