Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
QUETIAPINE FUMARATE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
QUETIAPINE FUMARATE
10tablet Tablets; 60tablet Tablets
TORRENT PHARMACEUTICALS LTD
TORQUITE SR TABLETS _ _ Quetiapine Fumarate 200mg _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Torquite SR used for 2. How Torquite SR works 3. Before you use Torquite SR 4. How to use Torquite SR 5. While you are using it 6. Side effects 7. Storage and Disposal of Torquite SR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TORQUITE SR IS USED FOR Torquite SR contains a medicine called quetiapine. Torquite SR can be 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 may feel sad all the time or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep. When Torquite SR is is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness. Your doctor may continue to prescribe Torquite SR even when you are feeling better. HOW TORQUITE SR WORKS Torquite SR contains a medicine called quetiapine. This belongs to a group of medicines called antipsychotics. Torquite SR helps to correct chemical imbalances in the brain. BEFORE YOU USE TORQUITE SR - _When you must not use it _ • If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Torquite SR. • If you are taking any of the following medicines: - Protease inhibitors, such as nelfinavir (for HIV infection). - Azole medicines (for fungal infections). - Medicines for an infection (like erythromycin or clarithromycin). - Nefazodone (for depression). Do not take Torquite SR if the above applies to you. If you are not sure, talk to your doctor or pharmacist before Olvassa el a teljes dokumentumot
Proposed Prescribing Information For the use of a Registered Medical Practitioner or a Hospital or a Laboratory TORQUITE SR 200 MG TABLETS QUETIAPINE FUMARATE SUSTAINED RELEASE TABLETS 200MG BRAND OR PRODUCT NAME TORQUITE SR 200 MG TABLETS NAME AND STRENGTH OF ACTIVE S UBSTANCE(S) TORQUITE SR 200 MG TABLETS Each film coated sustained release tablet contains: Quetiapine Fumarate equivalent to Quetiapine ………200mg Colors: Titanium Dioxide and Yellow oxide of Iron PRODUCT DESCRIPTION TORQUITE SR 200 MG TABLETS Yellow coloured, capsule shaped biconvex film coated tablets, printed with '243'. DOSAGE FORM Film coated sustained release tablet PHARMACODYNAMICS 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 compared to typical antipsychotics. Additionally, norquetiapine has high affinity at serotonin 5HT 1 receptors. Quetiapine and norquetiapine also have high affinity at histaminergic and adrenergic α 1 -receptors, with a lower affinity at adrenergic α 2 - receptors. Quetiapine has no appreciable affinity at muscarinic or benzodiazepine receptors. Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance. It also blocks the action of dopamine agonists, measured either behaviourally or electrophysiologically, and elevates dopamine metabolite concentrations, a neurochemical index of D 2 -receptor blockade. The extent to which the norquetiapine metabolite contributes to the pharmacological activity of quetiapine in humans is not k Olvassa el a teljes dokumentumot