Land: Niederlande
Sprache: Niederländisch
Quelle: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
QUETIAPINEFUMARAAT SAMENSTELLING overeenkomend met ; QUETIAPINE
Adamed Sp. z o.o.
N05AH04
QUETIAPINEFUMARAAT COMPOSITION corresponding to ; QUETIAPINE
Filmomhulde tablet
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),
Oraal gebruik
Quetiapine
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);
2009-01-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KWETAPLEX, FILMOMHULDE TABLETTEN VAN 25 MG KWETAPLEX, FILMOMHULDE TABLETTEN VAN 100 MG KWETAPLEX, FILMOMHULDE TABLETTEN VAN 150 MG KWETAPLEX, FILMOMHULDE TABLETTEN VAN 200 MG KWETAPLEX, FILMOMHULDE TABLETTEN VAN 300 MG KWETAPLEX, 4 DAY STARTERPACK, FILMOMHULDE TABLETTEN 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 sign of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kwetaplex is and what it is used for 2. What you need to know before you take Kwetaplex 3. How to take Kwetaplex 4 Possible side effects 5. How to store Kwetaplex 6. Contents of the pack and other information 1. WHAT KWETAPLEX IS AND WHAT IT IS USED FOR Kwetaplex contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. Kwetaplex 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 Kwetaplex even when you are feeling better 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE < PRODUCT NAME > DO NOT TAKE KWETAPLEX : if you are allergic to quetiapine or any of the other ingredients of this m Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS KWETAPLEX 1. NAME OF THE MEDICINAL PRODUCT Kwetaplex filmomhulde tabletten van 25 mg Kwetaplex filmomhulde tabletten van 100 mg Kwetaplex filmomhulde tabletten van 150 mg Kwetaplex filmomhulde tabletten van 200 mg Kwetaplex filmomhulde tabletten van 300 mg Kwetaplex 4-Daagse Startverpakking, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mg film-coated tablet contains 25 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) 4-Day StarterPack contains 6 tablets of quetiapine (as quetiapine fumarate) of 25 mg, 3 tablets of100 mg and 1 tablet of 200 mg Excipient(s): Lactose monohydrate and Sunset yellow (E110) Each 25 mg film-coated tablet contains 7.00mg of lactose monohydrate and 0.003 mg of Sunset yellow (E110) 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 Kwetaplex 25 mg: Peach, round, biconvex film coated tablets with a diameter of approximately 5.7mm. Kwetaplex 100 mg: Yellow, round, biconvex film coated tablets with a score line on one side and a diameter of approximately 9.1mm. Kwetaplex 150 mg: Pale yellow, round, biconvex film coated tablets with a diameter of approximately 10.45 mm. Kwetaplex 200 mg: White, round, biconvex film coated tablets with a score line on one side and a diameter of approximately 12.1mm. Kwetaplex 300 mg: White, oblong, biconvex film coated tablets with a score line on one side. The 100 Lesen Sie das vollständige Dokument