Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
Brintellix is indicated for the treatment of major depressive episodes in adults.
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.
Patients treated with vortioxetine can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see section 5.1).
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 vortioxetine once daily for which data are limited (see section 4.4).
Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.5).
Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5).
The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established. No data are available (see section 4.4).
Brintellix is for oral use. The film-coated tablets can be taken with or without food.
Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg. In the majority of cases, no symptoms or mild symptoms were reported. The most frequently reported symptoms were nausea and vomiting.
There is limited experience with vortioxetine overdoses above 80 mg. Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Management of overdose should consist of treating clinical symptoms and relevant monitoring. Medical follow-up in a specialised environment is recommended.
Shelf life: 4 years.
This medicinal product does not require any special storage conditions.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 14, 28 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 126 (9 × 14) and 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 7, 14, 28, 56 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 126 (9 × 14) and 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 14, 28, 56 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 14, 28, 56 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 126 (9 × 14) and 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.
This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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