Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
QUETIAPINE
Arrow Generics Limited
QUETIAPINE
200 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-06-17
UK/H/2218/01-05/DC/IA/012G PIL 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Quetiapine Arrow 25mg Film-coated Tablets Quetiapine Arrow 100mg Film-coated Tablets Quetipaine Arrow 150mg Film-coated Tablets Quetiapine Arrow 200mg Film-coated Tablets Quetipaine Arrow 300mg Film-coated Tablets _(Quetiapine) _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Quetiapine Arrow Tablets are and what they are used for 2. Before you take Quetiapine Arrow Tablets 3. How to take Quetiapine Arrow Tablets 4. Possible side effects 5. How to store Quetiapine Arrow Tablets 6. Further information. 1. WHAT QUETIAPINE ARROW TABLETS ARE AND WHAT THEY ARE USED FOR Quetiapine belongs to a group of medicines called antipsychotics. These medicines help with conditions that cause symptoms such as: Hallucinations (like hearing unexplained voices), strange and frightening thoughts, changes in how you act, and feeling alone and confused. This is also known as schizophrenia. Effects on your mood and feeling very “high” or excited. You may find that you need to sleep less than usual. You may aslo be more talkative and have racing thoughts or ideas. You may also fell more irritable than usual. This is also known as bipolar mania. Effects on your mood whereby you feel sad all the Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quetiapine Arrow 200mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of quetiapine (as quetiapine fumarate). Excipient: lactose (anhydrous) 39.33mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off white, round coated biconvex tablet with ‘QT’ over ‘200’ on one side and ‘ ’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of schizophrenia. • Treatment of moderate to severe manic episodes. • Treatment of major depressive episodes in bipolar disorder. Quetiapine has not been demonstrated to prevent recurrence of manic or depressive episodes (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Quetiapine Tablets can be administered with or without food. _Adults_ FOR THE TREATMENT OF SCHIZOPHRENIA: Quetiapine should be administered twice a day. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300 to 450 mg/day. Depending on the clinical response and tolerability of the individual patient, the dose may be adjusted within the range 150 to 750 mg/day. FOR THE TREATMENT OF MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER: Quetiapine should be administered twice a day. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800 mg per day by Day 6 should be in increments of no greater than 200 mg per day. The dose may be adjusted depending on clinical response and tolerability of the individual patient, with Прочитайте повний документ