Posology : מינונים

4.2    Posology and method of administration

Treatment with Fampyra is restricted to prescription and supervision by physicians experienced in the management of MS.

Posology

The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening). Fampyra should not be administered more frequently or at higher doses than recommended (see section 4.4). The tablets should be taken without food (see section 5.2).

Starting and Evaluating Fampyra Treatment

•      Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra •      An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four weeks. If no improvement is observed, Fampyra should be discontinued •      Fampyra should be discontinued if benefit is not reported by patients.

Re-Evaluating Fampyra Treatment

If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of Fampyra (see above). The re-evaluation should include withdrawal of Fampyra and performing an assessment of walking ability. Fampyra should be discontinued if patients 1
no longer receive walking benefit.

Missed Dose
The usual dosing regimen should always be followed. A double dose should not be taken if a dose is missed.

Elderly
Renal function should be checked in the elderly before starting treatment with Fampyra. Monitoring renal function to detect any renal impairment is recommended in the elderly (see section 4.4).

Patients with renal impairment
Fampyra is contraindicated in patients with mild, moderate and severe renal impairment (creatinine clearances <80 ml/min) (see section 4.3).

Patients with hepatic impairment
No dose adjustment is required for patients with hepatic impairment.

Paediatric population
Fampyra is not indicated for children and adolescents under 18 years old The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established. No data are available.

Method of Administration

Fampyra is for oral use.
The tablet must be swallowed whole. It must not be divided, crushed, dissolved, sucked or chewed.