Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
kvetiapinfumarat
Orion Corporation
N05AH04
quetiapine fumarate
25 mg
Filmdragerad tablett
kvetiapinfumarat 28,78 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Blister, 30 tabletter; Blister, 10 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter
Godkänd
2019-01-28
PACKAGE LEAFLET: INFORMATION FOR THE USER QUETIAPIN ORION 25 MG FILM-COATED TABLETS QUETIAPIN ORION 100 MG FILM-COATED TABLETS QUETIAPIN ORION 200 MG FILM-COATED TABLETS QUETIAPIN ORION 300 MG FILM-COATED 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 Quetiapin Orion is and what it is used for 2. What you need to know before you take Quetiapin Orion 3. How to take Quetiapin Orion 4. Possible side effects 5. How to store Quetiapin Orion 6. Contents of the pack and other information 1. WHAT QUETIAPIN ORION IS AND WHAT IT IS USED FOR Quetiapin Orion contains a substance called quetiapine . This belongs to a group of medicines called antipsychotics. Quetiapin Orion 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 are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed. Your doctor may continue to prescribe Quetiapin Orion even when you are feeling better. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPIN ORION DO NOT TAKE QUETIAPIN ORION - if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6) - if you are taking any Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Quetiapin Orion 25 mg film-coated tablets Quetiapin Orion 100 mg film-coated tablets Quetiapin Orion 200 mg film-coated tablets Quetiapin Orion 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 25 mg tablet: Each film-coated tablet contains quetiapine fumarate equivalent to 25 mg quetiapine. 100 mg tablet: Each film-coated tablet contains quetiapine fumarate equivalent to 100 mg quetiapine. 200 mg tablet: Each film-coated tablet contains quetiapine fumarate equivalent to 200 mg quetiapine. 300 mg tablet: Each film-coated tablet contains quetiapine fumarate equivalent to 300 mg quetiapine. Excipient with known effect: 25 mg tablet: Each tablet contains 4.9 mg lactose (as monohydrate). 100 mg tablet: Each tablet contains 19.7 mg lactose (as monohydrate). 200 mg tablet: Each tablet contains 39.3 mg lactose (as monohydrate). 300 mg tablet: Each tablet contains 59 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 25 mg: Peach, round film-coated tablets with diameter 6 mm, debossed ‘F71’ on one side and plain on the other side. 100 mg: Yellow, round film-coated tablets with diameter 9 mm, debossed ‘F73’ on one side and plain on the other side. 200 mg: White, round film-coated tablets with diameter 11 mm, debossed ‘F75’ on one side and plain on the other side. 300 mg: White, capsule-shaped film-coated tablets with length 19 mm, debossed ‘F76’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Quetiapin Orion is indicated for: • treatment of schizophrenia • treatment of bipolar disorder o for the treatment of moderate to severe manic episodes in bipolar disorder o for the treatment of major depressive episodes in bipolar disorder o for the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment. 4.2 POSOLOGY AND METHOD O Läs hela dokumentet