देश: स्वीडन
भाषा: स्वीडिश
स्रोत: Läkemedelsverket (Medical Products Agency)
kvetiapinfumarat
Aristo Pharma GmbH
N05AH04
quetiapine fumarate
400 mg
Depottablett
kvetiapinfumarat 460,54 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Blister, 10 tabletter; Blister, 20 tabletter; Blister, 14 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Burk, 60 tabletter; Blister, 28 tabletter
Avregistrerad
2017-03-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KAGITZ 50 MG PROLONGED-RELEASE TABLETS KAGITZ 300 MG PROLONGED-RELEASE TABLETS KAGITZ 400 MG PROLONGED-RELEASE TABLETS 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kagitz is and what it is used for 2. What you need to know before you take Kagitz 3. How to take Kagitz 4. Possible side effects 5. How to store Kagitz 6. Contents of the pack and other information 1. WHAT KAGITZ IS AND WHAT IT IS USED FOR Kagitz contains a substance called quetiapine. This belongs to a group of medicines called anti- psychotics. Kagitz can be used to treat several illnesses, such as: Bipolar depression and major depressive episodes in major depressive disorder: 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. When Kagitz prolonged-release tablet is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine being used to treat this illness. Your doctor may continue to prescribe Kagitz even when you are feeling better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KAGITZ DO NOT TAKE KAGITZ: i पूरा दस्तावेज़ पढ़ें
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kagitz 50 mg prolonged-release tablets Kagitz 300 mg prolonged-release tablets Kagitz 400 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kagitz 50 mg contains 50 mg quetiapine (as quetiapine fumarate) Excipient: 119mg lactose monohydrate per tablet Kagitz 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient: 96 mg lactose monohydrate per tablet Kagitz 400 mg contains 400 mg quetiapine (as quetiapine fumarate) Excipient: 128 lactose monohydrate per tablet For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet Kagitz 50 mg tablets are peach, bi-convex, capsule shaped, coated tablets, of dimension about 16.5 mm x 6.6 mm, debossed “AI001” on one side and plain on other side. Kagitz 300 mg tablets are pale yellow, bi-convex, capsule shaped, coated tablets, of dimension about 19.1 mm x 8.1 mm, debossed “AI004” on one side and plain on other side. Kagitz 400 mg tablets are white to off white, bi-convex, capsule shaped, coated tablets, of dimension about 20.5 mm x 9.3 mm, debossed “AI005” on one side and plain on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kagitz prolonged-release tablet is indicated for: Treatment of schizophrenia Treatment of bipolar disorder - For the treatment of moderate to severe manic episodes in bipolar disorder - For the treatment of major depressive episodes in bipolar disorder - For the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment. Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy (see Section 5.1). Prior to initiating treatment, clinicians should consider the safety profile of Kagitz (see Section 4.4). 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Different dosing schedules exist for each indication. पूरा दस्तावेज़ पढ़ें