Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
Vortioxetine (as hydrobromide 25.420mg)
LUNDBECK SINGAPORE PTE. LTD.
N06AX26
20.00mg
TABLET, FILM COATED
Vortioxetine (as hydrobromide 25.420mg) 20.00mg
ORAL
Prescription Only
H.Lundbeck A/S
ACTIVE
2014-11-17
H. Lundbeck A/S Confidential _Product Information Tabular Template v. 1.0 _ NATIONAL PRODUCT INFORMATION ( English translation) NAME OF THE MEDICINAL PRODUCT Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine. For the full list of excipients, see section 6.1. 10 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine. For the full list of excipients, see section 6.1. 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 5 mg Film-coated Tablets Film-coated tablet. Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side. 10 mg Film-coated Tablets Film-coated tablet. Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side. 20 mg Film-coated Tablets Film-coated tablet. 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. H. Lundbeck A/S Confidential _Product Information Tabular Template v. 1.0 _ 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 r Les hele dokumentet
H. Lundbeck A/S Brintellix ® 5mg, 10mg, 20mg film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT Brintellix 5 mg film-coated tablets Brintellix 10 mg film-coated tablets Brintellix 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine. 10 MG FILM-COATED TABLETS Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine. 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) 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. 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. 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. H. Lundbeck A/S 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 symp- toms (see section 4.8). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Brintell Les hele dokumentet