Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Vortioxetine
H. Lundbeck A/S
N06AX26
vortioxetine
Psychoanaleptics,
Depressive Disorder, Major
Treatment of major depressive episodes in adults.
Revision: 23
Authorised
2013-12-18
72 B. PACKAGE LEAFLET v. 77.0 REG_00028683 73 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRINTELLIX 5 MG FILM-COATED TABLETS vortioxetine 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 Brintellix is and what it is used for 2. What you need to know before you take Brintellix 3. How to take Brintellix 4. Possible side effects 5. How to store Brintellix 6. Contents of the pack and other information 1. WHAT BRINTELLIX IS AND WHAT IT IS USED FOR Brintellix contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants. Brintellix is used to treat major depressive episodes in adults. Brintellix has been shown to reduce the broad range of depressive symptoms, including sadness, inner tension (feeling anxious), sleep disturbances (reduced sleep), reduced appetite, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, feeling of being slowed down. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRINTELLIX DO NOT TAKE BRINTELLIX: - if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6). - if you are taking other medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. Ask your doctor if you are uncertain. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Brintellix if you: - are taking medicines with a so-called serotonergic effect, such as: - tramadol and similar medicines (strong painkillers). - sumatr Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS v. 77.0 REG_00028683 2 1. NAME OF THE MEDICINAL PRODUCT Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 15 mg film-coated tablets Brintellix 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Brintellix 5 mg film-coated tablets Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine. Brintellix 10 mg film-coated tablets Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine. Brintellix 15 mg film-coated tablets Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine. Brintellix 20 mg film-coated tablets Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Brintellix 5 mg film-coated tablets Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side. Brintellix 10 mg film-coated tablets Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side. Brintellix 15 mg film-coated tablets Orange, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side. Brintellix 20 mg film-coated tablets Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side. v. 77.0 REG_00028683 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brintellix is indicated for the treatment of major depressive episodes in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily. After the dep Прочетете целия документ