Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
VORTIOXETINE AS HYDROBROMIDE
LUNDBECK ISRAEL LTD.
N06AX26
FILM COATED TABLETS
VORTIOXETINE AS HYDROBROMIDE 20 MG
PER OS
Required
H.LUNDBECK A/S, DENMARK
VORTIOXETINE
Brintellix is indicated for the treatment of major depressive episodes in adults.
2020-03-31
PHARMACIST’S REGULATIONS (PREPARATIONS) PATIENT LEAFLET IN ACCORDANCE WITH 1986 The medicine is marketed according to doctor’s prescription only. BRINTELLIX, COATED TABLETS 5 MG, 10 MG, 15 MG, 20 MG COMPOSITION: the active ingredient and its quantity: _ Brintellix 5 mg: Each coated tablet contains 5 mg _Vortioxetine (as hydrobromide) _Brintellix 10 mg: Each coated tablet contains 10 mg _Vortioxetine (as hydrobromide) _Brintellix 15 mg: Each coated tablet contains 15 mg _Vortioxetine (as hydrobromide) _Brintellix 20 mg: Each coated tablet contains 20 mg _Vortioxetine (as hydrobromide) INACTIVE INGREDIENTS: See section 6 - READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further question, consult your doctor or pharmacist. - This medicine was prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar to your own. 1. WHAT IS THE MEDICINE BEING USED FOR? Brintellix belongs to a group of medicines called antidepressants and you have been given this medicine to treat your depression. 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 appetite, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, feeling of being slowed down. 2. BEFORE USING THIS MEDICINE DO NOT TAKE THIS MEDICINE IF: _-_You are sensitive (allergic) to the active ingredient 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 BEFORE USING BRINTELLIX, TELL YOUR DOCTOR IF YOU: - are taking medicines with a so-called serotonergic effect, such as: - trama Прочитайте повний документ
1 1. NAME OF THE MEDICINAL PRODUCT Brintellix 5, 10, 15 and 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5, 10, 15 and 20 mg vortioxetine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Brintellix 5 mg: 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: 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: 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: 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 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 depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response. Treatment discontinuation A gradual reduction in dosage may be considered to avoid the occurrence of discontinuation symptoms (see section 4.8). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Brintellix. Special populations _ _ _Elderly patients _ 2 The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vorti Прочитайте повний документ