RAYVOW Film-coated tablet Ref.[112844] Active ingredients: Lasmiditan

Posology

In general, recommended initial dose in adults is 100 mg lasmiditan for acute treatment of migraine attacks. If necessary, the dose can be increased to 200 mg for greater efficacy or can be decreased to 50 mg for greater tolerability.

If the migraine headache recurs within 24 hours of an initial response after taking 50 mg or 100 mg lasmiditan, a second dose of the same strength may be taken. The second dose should not be taken within 2 hours of the initial dose.

No more than 200 mg should be taken in 24 hours.

If a patient does not respond to the first dose, it is unlikely that a second dose will be of benefit in the same attack.

Lasmiditan may be taken with or without food.

Elderly (>65 years)

No dose adjustment is required for elderly patients (see section 5.2).

Renal impairment

No dose adjustment is necessary in patients with mild, moderate, or severe renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is necessary in patients with mild or moderate hepatic impairment. The use of lasmiditan has not been studied in subjects with severe hepatic impairment and therefore is not recommended for this population (see section 5.2).

Paediatric population

The safety and efficacy of lasmiditan in children and adolescents aged 6 to <18 years have not yet been established. No data are available.

There is no relevant use of lasmiditan in children below the age of 6 years for the treatment of migraine.

Method of administration

Oral use.

There is limited clinical trial experience with lasmiditan overdose. In cases reported as overdose, adverse events were similar to those seen at lower doses, including dizziness, somnolence, fatigue, paraesthesia, and hypoaesthesia but have not been associated with increase in severity or frequency. However, because adverse reactions are possible in case of an overdose, patients should be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment initiated. There is no known antidote to lasmiditan overdose.

3 years.

This medicinal product does not require any special storage conditions.

Polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) perforated unit dose blisters sealed with an aluminium foil lid in packs of 2 × 1, 4 × 1, 6 × 1, 12 × 1 and 16 × 1 film-coated tablets.

Polyvinyl chloride (PVC) perforated unit dose blisters sealed with an aluminium foil lid in packs of 2 × 1, 4 × 1, 6 × 1, 12 × 1 and 16 × 1 film-coated tablets.

Not all pack sizes may be marketed.

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