After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed.

When withdrawing Trobalt, the dose must be gradually reduced (see section 4.4).

Renal impairment

Retigabine and its metabolites are eliminated principally by renal excretion.

No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).

A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min; see section 5.2). The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.

The effect of haemodialysis on retigabine clearance has not been adequately eva luated.

Hepatic impairment

No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).

A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child-Pugh score 7; see section 5.2). The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.

Paediatric population

The safety and efficacy of retigabine in children below 18 years of age have not been established yet. No data are available.

Elderly (65 years of age and above)

There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above. A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients. The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability. Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).

Method of administration

Trobalt must be taken orally in three divided doses each day. It may be taken with or without food (see section 5.2). The tablets should be swallowed whole, and not chewed, crushed or divided.
4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use

 Urinary retention
Urinary retention, dysuria and urinary hesitation were reported in controlled clinical studies with retigabine, generally within the first 8 weeks of treatment (see section 4.8). Trobalt must be used with caution in patients at risk of urinary retention, and it is recommended that patients are advised about the risk of these possible effects.
QT interval

A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT-prolonging effect. A mean increase in Individual Corrected QT Interval (QTcI) of up to 6.7 ms (upper bound of 95% one-sided CI 12.6 ms) was observed within 3 hours of dosing. Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treat