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

Source: Medicines Authority (MT)  Revision Year: 2018  Publisher: Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Product name and form

Brieka 25 mg capsules, hard.

Brieka 50 mg capsules, hard.

Brieka 75 mg capsules, hard.

Brieka 100 mg capsules, hard.

Brieka 150 mg capsules, hard.

Brieka 200 mg capsules, hard.

Brieka 225 mg capsules, hard.

Brieka 300 mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

The 25 mg capsule is white, size 4 (14.5 mm), marked "PGB 25" on the body with black ink.

The 50 mg capsule is white, size 3 (16 mm), marked "PGB 50" on the body with black ink. The body is also marked with a black circular line.

The 75 mg capsule is white and orange, size 4 (14.5 mm), marked "PGB 75" on the body with black ink.

The 100 mg capsule is orange, size 3 (16 mm), marked "PGB 100" on the body with black ink.

The 150 mg capsule is white, size 2 (18 mm), marked "PGB 150" on the body with black ink.

The 200 mg capsule is light orange, size 1 (19.5 mm), marked "PGB 200" on the body with black ink.

The 225 mg capsule is white and light orange, size 1 (19.5 mm), marked "PGB 225" on the body with black ink.

The 300 mg capsule is white and orange, size 0 (21.5 mm), marked "PGB 300" on the body with black ink.

Qualitative and quantitative composition

Each capsule, hard contains 25 mg of pregabalin.

Each capsule, hard contains 50 mg of pregabalin.

Each capsule, hard contains 75 mg of pregabalin.

Each capsule, hard contains 100 mg of pregabalin.

Each capsule, hard contains 150 mg of pregabalin.

Each capsule, hard contains 200 mg of pregabalin.

Each capsule, hard contains 225 mg of pregabalin.

Each capsule, hard contains 300 mg of pregabalin.

For the full list of excipients, see section 6.1.

Active Ingredient

Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.

List of Excipients

Capsules content:

Mannitol
Co-processed starch (pregelatinised starch and maize starch)
Talc

Capsules shell:

Gelatin
Titanium dioxide (E171)

Only applicable for 75 mg, 100 mg, 200 mg, 225 mg and 300 mg

Red iron oxide (E172)

Printing Ink:

Shellac
Black iron oxide (E172)
Potassium hydroxide

Pack sizes and marketing

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.

Marketing authorization holder

Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Marketing authorization dates and numbers

Brieka, 25 mg, Capsule, hard MA628/13301
Brieka, 50 mg, Capsule, hard MA628/13302
Brieka, 75 mg, Capsule, hard MA628/13303
Brieka, 100 mg, Capsule, hard MA628/13304
Brieka, 150 mg, Capsule, hard MA628/13305
Brieka, 200 mg, Capsule, hard MA628/13306
Brieka, 225 mg, Capsule, hard MA628/13307
Brieka, 300 mg, Capsule, hard MA628/13308

22nd June 2015

Drugs

Drug Countries
BRIEKA Estonia, Ireland, Lithuania, Singapore

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