Faykompa tablets 8mg, No. 28

as part of additional therapy for the treatment of partial seizures in patients with epilepsy aged 12 years and older with or without secondary generalized seizures;

as part of additional therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.

Inside, at bedtime, regardless of the meal.

Adults and adolescents. Perampanel is taken once a day. The tablet must be swallowed whole with 1 glass of water, it must not be chewed, crumbled or broken, because the tablet cannot be neatly divided, because there are no risks on it.

Partial seizures. It has been shown that FaycompaЃ in daily doses of 4 to 12 mg is effective in the treatment of partial epileptic seizures. Taking FaycompaЃ should be started with a dose of 2 mg / day. The dose can be increased depending on the clinical response and tolerability, in 2 mg increments no more than once a week, up to 4Ц8 mg / day. Depending on the individual clinical response and the tolerability of the drug at a dose of 8 mg / day, it is possible to further increase the dose of FaycompaЃ to 12 mg / day, in increments of 2 mg, no more than once a week. In patients receiving concomitant AEDs that do not reduce the T1 / 2 of perampanel, the dose of perampanel should be adjusted at 2-week intervals. In patients receiving concomitant AEDs that reduce the T1 / 2 of perampanel, the dose of perampanel should be increased once a week (see Interaction).

Primary generalized tonic-clonic seizures. It has been shown that FaycompaЃ in daily doses up to 8 mg is effective in the treatment of primary generalized tonic-clonic seizures. In some patients, higher doses may be indicated (up to 12 mg / day). The drug should be taken at a dose of 2 mg / day. The dose can be increased depending on the clinical response and tolerability in 2 mg increments (once a week or once every 2 weeks, taking into account T1 / 2 of the drug) up to 8 mg / day.

Depending on the individual clinical response and the tolerability of the drug at a dose of 8 mg / day, a further increase in the dose to 12 mg / day is possible. In patients receiving concomitant AEDs that do not reduce the T1 / 2 of perampanel, the dose of perampanel should be titrated at 2-week intervals. In patients receiving concomitant AEDs that reduce T1 / 2 of perampanel, the dose of perampanel should be titrated (increased) once a week (see Interaction).

Despite the fact that perampanel has a long T1 / 2, it is recommended, as with other AEDs, to withdraw it gradually to minimize the likelihood of an increase in the frequency of attacks.

One-time pass of taking the drug. Due to the fact that perampanel has a sufficiently long T1 / 2, the patient must wait and take the next scheduled dose in accordance with the agreed dosage regimen.

If more than 1 dose is missed, (the total duration without the drug is less than 5 T1 / 2: 3 weeks - for patients not receiving AED, altering the metabolism of perampanel, and 1 week - for patients receiving AED, altering the metabolism of perampanel), you should consider resuming the drug at the last dose taken.

If the patient has interrupted the drug intake for more than 5 half-lives, the recommendations should be followed as when initiating treatment.

Use in children under 12 years of age. The safety and efficacy of perampanel in children under 12 years of age has not been established (see 'Contraindications').

Use in elderly patients (over 65 years old). An insufficient number of patients with epilepsy over 65 years of age participated in clinical studies of FycompaЃ to assess the differences with younger patients. Analysis of safety information in patients taking perampanel did not reveal differences in the safety profile depending on age. These data confirm that dose adjustment of perampanel depending on age is not required. In elderly patients, perampanel should be used with caution (see 'Interaction', 'Special instructions').

Use in patients with renal impairment. In case of mild renal failure, dose adjustment of perampanel is not required. The use of FaycompaЃ in patients with moderate to severe renal failure or in patients on hemodialysis is not recommended (see 'Contraindications').

Use in patients with hepatic impairment. The dose increase in patients with mild to moderate hepatic impairment, as in other patients, is performed depending on the clinical response and tolerability. Since in mild to moderate hepatic insufficiency, T1 / 2 of perampanel is lengthened, the minimum time interval before each dose increase should be 2 weeks, and the maximum dose should not exceed 8 mg / day. Application for severe hepatic impairment is not recommended (see 'Contraindications').

hypersensitivity to perampanel or any of the excipients of the drug;

galactose intolerance, lactase deficiency or glucose-galactose malabsorption;

severe renal or hepatic impairment;

patients on hemodialysis;

pregnancy;

lactation period;

children under 12 years of age (data on efficacy and safety are not available).