Brintellix tablets are indicated for the treatment of major depressive disorder in adults.
Active substance: vortioxetine;
1 coated tablet contains 5 mg or 10 mg vortioxetine as vortioxetine hydrobromide;
Excipients: mannitol (E 421), microcrystalline cellulose, hydroxypropyl cellulose, sodium starch (type A), magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E 171) tablets 5 mg iron oxide red (E172) tablets 10 mg iron oxide yellow (E 172).
Hypersensitivity to the active substance or to any component of the preparation.
Concomitant use with non-selective MAO inhibitors (MAO) or selective MAO-A inhibitors.
Brintellix is administered orally, with or without food.
The starting and maintenance dose is 10 mg once daily for adults under the age of 65.
Depending on the individual sensitivity of the patient, the dose can be increased to a maximum of 20 mg vortioxetine once a day or reduced to at least 5 mg vortioxetine once a day.
After elimination of the symptoms of depression, it is recommended to continue treatment for at least 6 months to strengthen the antidepressant effect.
Pregnant
Brintellix should be used if the expected benefit to the mother outweighs the potential risk to the fetus.
Children
Application is not recommended.
Drivers
Carefully.
Reception of vortioxetine in clinical studies in the dose range from 40 mg to 75 mg caused an exacerbation of such side effects: nausea, postural dizziness, diarrhea, abdominal discomfort, generalized itching, drowsiness and facial flushing.
Post-registration experience mainly concerns overdose of vortioxetine up to 80 mg. In most cases, symptoms were not reported. The most common side effects are nausea and vomiting.
Experience with overdose with vortioxetine above 80 mg is limited. After taking doses several times higher than the therapeutic range, cases of trial and serotonin syndrome have been reported.
Treatment should be symptomatic and include appropriate monitoring. Medical supervision in a specialized setting is recommended.
The most common adverse reaction was nausea.
Concomitant use with non-selective MAO inhibitors (MAO) or selective MAO-A inhibitors is contraindicated.
No special storage conditions are required.
Keep out of the reach of children.
The shelf life is 48 months.
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