NURIKA Hard capsule Ref.[50571] Active ingredients: Pregabalin

The recommended starting dose for NURIKA is 75 mg twice daily (150 mg/day), with or without food. 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.

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

Patients with renal impairment

NURIKA is eliminated unchanged from the systemic circulation primarily by renal excretion. As NURIKA clearance is directly proportional to creatinine clearance (see section 5.2 – Pharmacokinetics in Special Patient Groups – Renal impairment), 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

NURIKA is removed effectively from plasma by haemodialysis (50% of pregabalin in 4 hours). For patients receiving haemodialysis, the daily dose of NURIKA 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 (refer to Table 1).

TABLE 1. NURIKA DOSAGE ADJUSTMENT BASED ON RENAL FUNCTION:

BD = Two divided doses
OD = Once daily
^* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose
⁺ Supplementary dose is a single additional dose

Use in patients with hepatic impairment

No dosage adjustments are required for patients with hepatic impairment (see section 5.2 – Pharmacokinetics in Special Patient Groups – Hepatic Impairment).

Use in children

The safety and effectiveness of NURIKA in patients below the age of 18 years with neuropathic pain has not been established.

Use in the elderly (over 65 years of age)

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

Method of administration

NURIKA is given orally with or without food.

Post-marketing reports of pregabalin overdose included affective disorder, somnolence, confusional state, depression, agitation, restlessness, seizures and coma.

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

2 years.

Store at or below 25°C in the original container.

Keep blisters in the outer carton until required for use. Keep bottles well closed.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

NURIKA 25, 50, 75 & 150 are packed in PVC/aluminium blisters. The blister consists of a silver/grey aluminum foil with a transparent, colourless PVC foil. Blisters are contained in an outer carton.

Pack size 14: Each carton contains 1 blister strip with 14 capsules per blister.

Pack size 56: Each carton contains 4 blister strips with 14 capsules per blister.

Pack size 60: Each carton contains 6 blister strips with 10 capsules per blister.

Pack size 100: Each carton contains 10 blister strips with 10 capsules per blister.

NURIKA 75 is packed in a white, high density polyethylene (HDPE) 150 ml bottle, with a white polypropylene closure with an inner seal. Pack size: 200 capsules.

NURIKA 150 is packed in a white, high density polyethylene (HDPE) 300 ml bottle, with a white polypropylene closure with an inner seal. Pack size: 200 capsules.

Not all pack sizes are marketed.

Any unused medicine or waste material should be disposed of in accordance with local requirements.