Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vortioxetine hydrobromide
Lundbeck Ltd
N06AX26
Vortioxetine hydrobromide
10mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5702157142187
BRINTELLIX 5 MG FILM-COATED TABLETS BRINTELLIX 10 MG FILM-COATED TABLETS BRINTELLIX 15 MG FILM-COATED TABLETS BRINTELLIX 20 MG FILM-COATED TABLETS Vortioxetine ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 and you have been given this medicine to treat your depression. 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. Brintellix is used to treat major depressive episodes in adults. 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 monoamin Прочитайте повний документ
OBJECT 1 BRINTELLIX TABLETS 5, 10 AND 20MG Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 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 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. 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 dos Прочитайте повний документ