Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Vortioxetine hydrobromide
Lundbeck Malaysia Sdn. Bhd.
Vortioxetine hydrobromide
14tablet Tablets; 28tablet Tablets
H.LUNDBECK A/S
_Consumer Medication Information Leaflet (RiMUP) _ BRINTELLIX FILM-COATED TABLETS Vortioxetine (5mg, 10mg, 15mg and 20mg) 1 WHAT IS IN THIS LEAFLET 1. What Brintellix is used for 2. How Brintellix works 3. Before you use Brintellix 4. How to use Brintellix 5. While you are using it 6. Side effects 7. Storage and Disposal of Brintellix 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT BRINTELLIX IS USED FOR Brintellix is used to treat major depressive episodes in adults. HOW BRINTELLIX WORKS Brintellix contains the active substance vortioxetine. It belongs to a group of medicines called antidepressants. Brintelix 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. BEFORE YOU USE BRINTELLIX _When you must not use it _ - if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section Product Description). - 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. _Before you start use it _ 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). • sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). Taking these medicines together with Brintellix may cause serotonin syndrome. This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea. - have had fits (seizures). Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorders/epilepsy. Fits Прочетете целия документ
PHYSICIAN INFORMATION LEAFLET BRINTELLIX 5MG FILM-COATED TABLETS BRINTELLIX 10MG FILM-COATED TABLETS BRINTELLIX 15MG FILM-COATED TABLETS BRINTELLIX 20MG FILM-COATED TABLETS 1. NAME OF MEDICINAL PRODUCT Brintellix 5mg film-coated tablets Brintellix 10mg film-coated tablets Brintellix 15mg film-coated tablets Brintellix 20mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5mg vortioxetine. For the full list of excipients, see section 6.1 10MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10mg vortioxetine. For the full list of excipients, see section 6.1 15MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15mg vortioxetine. For the full list of excipients, see section 6.1 20MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20mg vortioxetine. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM 5mg Film-coated Tablets: Pink, almond-shaped (5 x 8.4mm) film-coated tablet engraved with “TL” on one side and “5” on the other side. 10mg Film-coated Tablets: Yellow, almond-shaped (5 x 8.4mm) film-coated tablet engraved with “TL” on one side and “10” on the other side. 15mg Film-coated Tablets: Orange, almond-shaped (5 x 8.4mm) film-coated tablet engraved with “TL” on one side and “15” on the other side. 20mg Film-coated Tablets: Red, almond-shaped (5 x 8.4mm) 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 dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg Прочетете целия документ