LYRICA Hard capsule Ref.[7050] Active ingredients: Pregabalin

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

Lyrica 25 mg hard capsules.
Lyrica 50 mg hard capsules.
Lyrica 75 mg hard capsules.
Lyrica 100 mg hard capsules.
Lyrica 150 mg hard capsules.
Lyrica 200 mg hard capsules.
Lyrica 225 mg hard capsules.
Lyrica 300 mg hard capsules.

Pharmaceutical Form
Hard capsules. Lyrica 25 mg hard capsules: White marked “Pfizer” on the cap and “PGN 25” on the body with black ink. Lyrica 50 mg hard capsules: White marked “Pfizer” on the cap and “PGN 50” on the body with black ink. The body is also marked with a black band. Lyrica 75 mg hard capsules: White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink. Lyrica 100 mg hard capsules: Orange marked “Pfizer” on the cap and “PGN 100” on the body with black ink. Lyrica 150 mg hard capsules: White marked “Pfizer” on the cap and “PGN 150” on the body with black ink. Lyrica 200 mg hard capsules: Light orange, marked “Pfizer” on the cap and “PGN 200” on the body with black ink. Lyrica 225 mg hard capsules: White and light orange marked “Pfizer” on the cap and “PGN 225” on the body with black ink. Lyrica 300 mg hard capsules: White and orange, marked “Pfizer” on the cap and “PGN 300” on the body with black ink.

Qualitative and quantitative composition

Lyrica 25 mg hard capsules: Each hard capsule contains 25 mg of pregabalin.
Lyrica 50 mg hard capsules: Each hard capsule contains 50 mg of pregabalin.
Lyrica 75 mg hard capsules: Each hard capsule contains 75 mg of pregabalin.
Lyrica 100 mg hard capsules: Each hard capsule contains 100 mg of pregabalin.
Lyrica 150 mg hard capsules: Each hard capsule contains 150 mg of pregabalin.
Lyrica 200 mg hard capsules: Each hard capsule contains 200 mg of pregabalin.
Lyrica 225 mg hard capsules: Each hard capsule contains 225 mg of pregabalin.
Lyrica 300 mg hard capsules: Each hard capsule contains 300 mg of pregabalin.

Excipients with known effect:

Lyrica 25 mg hard capsules: Each hard capsule also contains 35 mg lactose monohydrate.
Lyrica 50 mg hard capsules: Each hard capsule also contains 70 mg lactose monohydrate.
Lyrica 75 mg hard capsules: Each hard capsule also contains 8.25 mg lactose monohydrate.
Lyrica 100 mg hard capsules: Each hard capsule also contains 11 mg lactose monohydrate.
Lyrica 150 mg hard capsules: Each hard capsule also contains 16.50 mg lactose monohydrate.
Lyrica 200 mg hard capsules: Each hard capsule also contains 22 mg lactose monohydrate.
Lyrica 225 mg hard capsules: Each hard capsule also contains 24.75 mg lactose monohydrate.
Lyrica 300 mg hard capsules: Each hard capsule also contains 33 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

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

List of Excipients
Lyrica 25 mg, 50 mg, 150 mg hard capsules Capsules content: Lactose monohydrate Maize starch Talc Capsules shell: Gelatin Titanium dioxide (E171) Sodium laurilsulphate Silica, colloidal anhydrous Purified water Printing ink: Shellac Black iron oxide (E172) Propylene glycol Potassium hydroxide Lyrica 75 mg, 100 mg, 200 mg, 225 mg, 300 mg hard capsules Capsules content: Lactose monohydrate Maize starch Talc Capsules shell: Gelatin Titanium dioxide (E171) Sodium laurilsulphate Silica, colloidal anhydrous Purified water Red iron oxide (E172) Printing ink: Shellac Black iron oxide (E172) Propylene glycol Potassium hydroxide

Pack sizes and marketing

Lyrica 25 mg hard capsules: PVC/Aluminium blisters containing 14, 21, 56, 84, 100 or 112 (2 × 56) hard capsules. 100 × 1 hard capsules in PVC/Aluminium perforated unit dose blisters. HDPE bottle containing 200 hard capsules.