TIMIRIL Capsule Ref.[51193] Active ingredients: Pregabalin

Posology

The recommended starting dose is 75 mg twice daily (150 mg/day). Based on individual patient response and tolerability, the dose may be increased to 150 mg twice daily after an interval of 3 to 7 days.

Discontinuation of Pregabalin

In accordance with current clinical practice, if TIMIRIL must be discontinued, it is recommended this should be done gradually over a minimum of 1 week.

Special populations

Patients with renal impairment

TIMIRIL is eliminated unchanged from the systemic circulation primarily by renal excretion. As TIMIRIL clearance is directly proportional to creatinine clearance (see section 5.2), dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CL_Cr), as indicated in Table 1 determined using the following formula:

CL_Cr (ml/min) = (140 – age) x Weight (kg) / 0,82 x Serum creatinine (μmol/l)

^* For females multiply the CL_Cr, by 0,85

TIMIRIL is removed effectively from plasma by haemodialysis (50 % of pregabalin in 4 hours). For patients receiving haemodialysis, the TIMIRIL daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see Table 1).

Table 1. TIMIRIL dose adjustment based on renal function:

Use in patients with hepatic impairment

No dosage adjustment is required for patients with hepatic impairment (see section 5.2).

Use in the elderly (over 65 years of age)

No dosage adjustment is necessary for elderly patients unless their renal function is compromised, see Table 1.

Paediatric population

The safety and effectiveness of TIMIRIL in patients below the age of 18 years has not been established.

Method of administration

TIMIRIL is given orally with or without food.

There were no unexpected adverse reactions reported in overdoses up to 15 g.

In post-marketing experiences, the following adverse events were commonly reported when TIMIRIL was taken in overdose: affective disorder, somnolence, confused state, agitation and restlessness.

Treatment of TIMIRIL overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2).

2 years. Store at or below 25°C.

HDPE Bottles: Keep the bottle tightly closed until use. Blisters: Do not remove blisters from carton until required for use.

TIMIRIL 25: White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 50: Clear PVC/Aluminium blisters containing 100 capsules. Blisters are enclosed in a cardboard carton. White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 75: Clear PVC/Aluminium blisters containing 100 capsules. Blisters are enclosed in a cardboard carton. White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 100: Clear PVC/Aluminium blisters containing 100 capsules. Blisters are enclosed in a cardboard carton. White HDPE bottle sealed with a white child resistant cap containing 90 capsules.

TIMIRIL 150: Clear PVC/Aluminium blisters containing 100 capsules. White HDPE bottle sealed with a white child resistant cap containing 90 capsules. Blisters are enclosed in a cardboard carton. Not all pack sizes may be marketed.

Not all pack sizes may be marketed.

No special requirements.