Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
QUETIAPINE FUMARATE
RANBAXY (MALAYSIA) SDN. BHD.
QUETIAPINE FUMARATE
03x10 Tablets
Sun Pharmaceutical Industries Limited
SIZONORM (Quetiapine Tablets USP 25, 100, 200mg) Page 1 SIZONORM_ _ _ _ _ _ ( Quetiapine Tablets USP 25, 100, 200mg) _ Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What SIZONORM is used for 2. How SIZONORM works 3. Before you use SIZONORM 4. How to use SIZONORM 5. While you are using SIZONORM 6. Side Effects 7. Storage and Disposal of SIZONORM 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision This leaflet answers some common questions about SIZONORM. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SIZONORM against the benefits it is expected to have for you. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT SIZONORM IS USED FOR SIZONORM contains a substance called quetiapine which is used to treat conditions such as: 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. Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive. Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep. HOW SIZONORM WORKS Quetiapine belongs to a group of medicines called anti- psychotics. It helps to correct chemical imbalances in the brain. BEFORE YOU USE SIZONORM _WHEN YOU MUST NOT USE IT _ DO NOT TAKE SIZONORM: if you are allergic to quetiapine or any of the other ingredients of this medicine if you are taking any of the following medicines: - Some medicines for HIV (protease inhibitors) - Azole medicines (for fungal infections) - Erythromycin or clarithromycin (for infections) - Nefazodone (for depression). Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. _BEFORE YOU START TO USE IT _ TELL YOUR DOCTOR IF YO Belgenin tamamını okuyun
1 _For the use of a Registered Medical Practitioner_ _Only _ PRESCRIBING INFORMATION SIZONORM (QUETIAPINE TABLETS USP 25MG, 100MG, 200MG) COMPOSITION SIZONORM 25 QUETIAPINE TABLET USP 25MG EACH FILM COATED TABLET CONTAINS: Quetiapine fumarate 28.78 mg Equivalent to quetiapine .......…25 mg USP SIZONORM 100 QUETIAPINE TABLET USP 100MG EACH FILM COATED TABLET CONTAINS: Quetiapine fumarate 115.12mg Equivalent to quetiapine .......…100 mg USP SIZONORM 200 QUETIAPINE TABLET USP 200MG EACH FILM COATED TABLET CONTAINS: Quetiapine fumarate 230.24mg Equivalent to quetiapine .......…200 mg USP _EXCIPIENTS:_ Silicified microcrystalline cellulose, Crospovidone, Colloidal anhydrous silica, Anhydrous citric acid, Polysorbate 80, Silicon dioxide, Magnesium stearate, Opadry II 33F58617 white, Opadry II 33F84535 Pink, Opadry II 33F82557 yellow, Purified water._ _ DESCRIPTION SIZONORM 25 Peach, round, biconvex, film coated tablets plain on both sides. SIZONORM 100 Yellow, round, biconvex, film coated tablets plain on one side and Break-line on other side. THE SCORED LINE IS JUST FOR IDENTIFICATION PURPOSE AND NOT MEANT TO BE HALVED. SIZONORM 200 2 White, round, biconvex, film coated tablets plain on one side and Break-line on other side. THE SCORED LINE IS JUST FOR IDENTIFICATION PURPOSE AND NOT MEANT TO BE HALVED. PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES _PHARMACODYNAMIC PROPERTIES _ Pharmacotherapeutic group: Antipsychotics, ATC code: N05A H04 _Mechanism of Action _ Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors. Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT 2 ) and dopamine D 1 - and D 2 -receptors. It is this combination of receptor antagonism with a higher selectivity for 5HT 2 relative to D 2 -receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effect (EPS) liability of quetiapine. Quetiapine has no affinity Belgenin tamamını okuyun