Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Seizure risk
Treatment with fampridine increases seizure risk (see section 4.8).

Fampyra should be administered with caution in the presence of any factors which may lower seizure threshold.

Fampyra should be discontinued in patients who experience a seizure while on treatment.

Renal impairment
Fampyra is primarily excreted unchanged by the kidneys. Patients with renal impairment have higher plasma concentrations which are associated with increased adverse reactions, in particular neurological effects. Determining renal function before treatment and its regular monitoring during 2
treatment is recommended in all patients (particularly in the elderly in whom renal function might be reduced). Creatinine clearance can be estimated using the Cockroft-Gault formula.
Fampyra should not be administered to patients with renal impairment (creatinine clearance <80 ml/min) (see section 4.3).

Caution is required when Fampyra is prescribed concurrently with medicinal products that are substrates of OCT2 for example, carvedilol, propranololand metformin.

Hypersensitivity Reactions

In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) have been reported, the majority of these cases occurred within the first week of treatment. Particular attention should be given to patients with a previous history of allergic reactions. If an anaphylactic or other serious allergic reaction occurs, Fampyra should be discontinued and not restarted.

Other warnings and precautions

Fampyra should be administered with caution to patients with cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in overdose).
There is limited safety information in these patients.

The increased incidence of dizziness and balance disorder seen with Fampyra may result in an increased risk of falls. Therefore, patients should use walking aids as needed.

In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo. Infections were seen in the clinical studies (see section 4.8) and increased infection rate and impairment of the immune response cannot be excluded.

Effects on Driving

4.7    Effects on ability to drive and use machines

Fampyra has a moderate influence on the ability to drive and use machines because Fampyra can cause dizziness.