Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
QUETIAPINE FUMARATE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
QUETIAPINE FUMARATE
10tablet Tablets; 30tablet Tablets; 100tablet Tablets
TORRENT PHARMACEUTICALS LTD.
TORQUITE TABLETS _ _ Quetiapine Fumarate (25 mg, 300 mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Torquite used for 2. How Torquite works 3. Before you use Torquite 4. How to use Torquite 5. While you are using it 6. Side effects 7. Storage and Disposal of Torquite 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT TORQUITE IS USED FOR Torquite 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 do not there, believe in things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed. Your doctor may continue to prescribe Torquite even when you are feeling better. HOW TORQUITE WORKS Torquite contains a medicine called quetiapine. This belongs to a group of medicines called antipsychotics. Torquite helps to correct chemical imbalances in the brain. BEFORE YOU USE TORQUITE - _When you must not use it _ • If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Torquite (see Section 8: Further information). • If you are taking any of the following medicines: - Some medicines for HIV. - Azole medicines (for fungal infections). - Erythromycin or clarithromycin (for infections). - Nefazodone (for depression). Do not take Torquite if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Torquite. _Pregnancy and lactation _ _ _ _ _ Do not take Torquite if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Torquite, stop taking it immediately and contact your doctor. Do not take Torquite until you Διαβάστε το πλήρες έγγραφο
xxxxxxxx-5253 For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only. BRAND OR PRODUCT NAME TORQUITE TABLETS 25 MG TORQUITE TABLETS 300 MG NAME AND STRENGTH OF ACTIVE INGREDIENT TORQUITE TABLETS 25 MG Each film coated tablet contains: Quetiapine Fumarate Ph.Eur. equivalent to Quetiapine 25 mg Colours: Yellow oxide of Iron, Red Oxide of Iron and Titanium Dioxide TORQUITE TABLETS 300 MG Each film coated tablet contains: Quetiapine Fumarate Ph.Eur. equivalent to Quetiapine 300 mg Colour: Titanium Dioxide PRODUCT DESCRIPTION TORQUITE TABLETS 25 MG Brownish red coloured, round, biconvex, film coated tablets plain on both sides. TORQUITE TABLETS 300 MG White to off white, capsule shaped, biconvex, film coated tablets with break line on both sides. DOSAGE FORM Film coated tablet PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antipsychotics 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 (5HT2,) and dopamine D1, and D2- receptors. It is this combination of receptor antagonism with a higher selectivity for 5HT2, relative to D2- receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effect (EPS). Quetiapine has no affinity for the norepinephrine transporter (NET) and low affinity for the serotonin 5HT1A receptor, whereas norquetiapine has high affinity for both. Inhibition of NET and partial agonist action at 5HT1A sites by norquetiapine may contribute to quetiapine’s therapeutic efficacy as an antidepressant. Quetiapine and norquetiapine have high affinity at histaminergic and adrenergic alpha 1 receptors and moderate affinity at adrenergic alpha2 receptors. Quetiapine also has low or no affinity for muscarinic receptors, while norquetiapine has moderate to high affinity for several muscarinic receptor subtypes. PHARMACODYN Διαβάστε το πλήρες έγγραφο