VORELLIX Film-coated tablet Ref.[50480] Active ingredients: Vortioxetine

Posology

The starting and recommended dose of VORELLIX is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily or reduced to a minimum of 5 mg daily. If a dose increase is required, this should be in periods of not less than one week of the treatment. A dose decrease may be considered for patients who do not tolerate higher doses. VORELLIX can be taken without regard to meals. After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the anti-depressive response.

Treatment discontinuation

Patients being treated with VORELLIX can abruptly stop taking VORELLIX without the need for a gradual reduction in dose.

Special populations

Elderly patients

The safety and efficacy of VORELLIX have been established in elderly patients. However, caution should be exercised when treating the elderly. Treatment should be initiated with 5 mg daily and, depending on the individual patient response, the dose may be increased to 10 mg daily. Limited data are available with doses exceeding 10 mg daily.

Renal Impairment

No dose adjustment is needed for patients with renal impairment or for patients with end-stage renal disease. However, caution should be exercised when treating patients with severe renal insufficiency.

Hepatic Impairment

No dose adjustment is needed for patients with mild or moderate hepatic impairment. VORELLIX has not been studied in patients with severe hepatic impairment and caution should be exercised when prescribing to these patients.

Cytochrome P450 Inhibitors

Depending on individual patient response, a lower dose of VORELLIX may be considered if strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine) are added to VORELLIX treatment.

Cytochrome P450 Inducers

Depending on individual patient response, a dose adjustment of VORELLIX may be considered if a broad cytochrome P450 inducer (e.g. rifampicin, carbamazepine, phenytoin) is added to VORELLIX treatment

Paediatric population

The safety and efficacy of VORELLIX in children and adolescents aged less than 18 years have not been established. No data are available.

Method of administration

VORELLIX is for oral use.

The film-coated tablets can be taken with or without food.

There is limited experience with VORELLIX overdose. Ingestion of 40 to 75 mg VORELLIX may cause an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing. Management of overdose should consist of treating clinical symptoms and relevant monitoring. Medical follow-up in a specialised environment is recommended.

2 years.

Store at or below 25°C.

KEEP OT OF THE REACH OF CHILDREN

VORELLIX 5, 10, 15 and 20: 50 cc HDPE container with 33 mm child resistant closure (blue) and silica gel bag 2,0 g containing 30 or 90 tablets per carton. or 200 cc HDPE container with 38 mm white screw cap and silica gel bag 5,0 g containing 500 tablets per carton.

Not all pack sizes may be marketed.

Any unused medicine or waste material should be disposed of in accordance with local requirements.