BRIEKA Capsule, hard Ref.[115948] Active ingredients: Pregabalin

Posology

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Neuropathic pain

Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.

Epilepsy

Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week.

Generalised Anxiety Disorder

The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.

Discontinuation of pregabalin

In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8).

Renal impairment

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

CL_cr(ml/min) = [1.23 × [140 –age (years)] x weight (kg) / serum creatinine (μmol/l) ]

(x 0.85 for female patients)

Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the pregabalin 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. Pregabalin dose adjustment based on renal function:

TID = Three divided doses
BID = Two divided doses
^* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose
<[For member states where 25 mg strength is not registered:]>
^** There is no marketing authorisation for Brieka 25 mg capsules, this presentation may be available from other pregabalin products.>
⁺ Supplementary dose is a single additional dose

Hepatic impairment

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

Paediatric population

The safety and efficacy of Brieka in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

Elderly

Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see section 5.2).

Method of administration

Brieka may be taken with or without food.

Brieka is for oral use only.

In the post-marketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. Seizures were also reported.

In rare occasions, cases of coma have been reported.

Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).

2 years.

Do not store above 30°C.

25 mg:

Aluminium/PVC blisters containing 14, 21, 30, 56, 60, 84, 90 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

50 mg:

Aluminium/PVC blisters containing 14, 21, 30, 56, 60, 84, 90 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

75 mg:

Aluminium/PVC blisters containing 14, 21, 30, 56, 60, 84, 90 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

100 mg:

Aluminium/PVC blisters containing 14, 21, 30, 56, 60, 84, 90 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

150 mg:

Aluminium/PVC blisters containing 14, 30, 56, 60 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

200 mg:

Aluminium/PVC blisters containing 14, 21, 30, 56, 60, 84, 90 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

225 mg:

Aluminium/PVC blisters containing 14, 21, 30, 56, 60, 84, 90 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

300 mg:

Aluminium/PVC blisters containing 14, 56, 60 or 100 capsules, hard.

HDPE bottle with LDPE lid or PP screw cap containing 100 capsules, hard.

Not all pack sizes may be marketed.

No special requirements for disposal.