QUETRA Film-coated tablet Ref.[51167] Active ingredients: Levetiracetam

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Quetra 250 mg film-coated tablets.

Quetra 500 mg film-coated tablets.

Quetra 750 mg film-coated tablets.

Quetra 1000 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

250 mg: Blue, oval shaped film coated tablets scored on one side with dimensions 12.9 × 6.1 mm. The tablet can be divided into equal doses.

500 mg: Yellow, oval shaped film coated tablets scored on one side with dimensions 16.5 × 7.7 mm. The tablet can be divided into equal doses.

750 mg: Orange, oval shaped film coated tablets scored on one side with dimensions 18.8 × 8.9 mm. The tablet can be divided into equal doses.

1000 mg: White, oval shaped film coated tablets scored on one side with dimensions 19.2 × 10.2 mm. The tablet can be divided into equal doses.

Qualitative and quantitative composition

Quetra 250: each film-coated tablet contains 250 mg levetiracetam.

Quetra 500: each film-coated tablet contains 500 mg levetiracetam.

Quetra 750: each film-coated tablet contains 750 mg levetiracetam.

Quetra 1000: each film-coated tablet contains 1000 mg levetiracetam.

Excipients with known effect:

750mg: Quetra 750 film-coated tablets contain 0.36 mg Sunset Yellow Aluminium Lake (E110).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levetiracetam

Levetiracetam, is a pyrrolidone derivative, chemically unrelated to existing antiepileptic active substances. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive.

List of Excipients

Tablet core:

Crospovidone (Type B)
Povidone K30
Silica colloidal anhydrous
Magnesium stearate

Film-coating 250 mg:

Hypromellose
Macrogol/PEG 400
Titanium Dioxide (E171)
Purified Talc
Indigo Carmine Aluminium Lake (E132)

Film-coating 500 mg:

Hypromellose
Macrogol/PEG 400
Titanium Dioxide (E171)
Purified Talc
Iron Oxide Yellow (E172)

Film-coating 750 mg:

Hypromellose
Macrogol/PEG 400
Titanium Dioxide (E171)
Purified Talc
Sunset Yellow Aluminium Lake (E110)
Iron Oxide Red (E172)

Film-coating 1000 mg:

Hypromellose
Macrogol/PEG 400
Titanium Dioxide (E171)
Purified Talc

Pack sizes and marketing

Quetra 250 mg film-coated tablets are packaged in aluminium/PVC-PE-PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 80, 100, 120 and 200 filmcoated tablets.

Quetra 500 mg film-coated tablets are packaged in aluminium/PVC-PE-PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 80, 100, 120 and 200 filmcoated tablets.

Quetra 750 mg film-coated tablets are packaged in aluminium/PVC-PE-PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 80, 100, 120 and 200 filmcoated tablets.

Quetra 1 000 mg film-coated tablets are packaged in aluminium/PVC-PE-PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 80, 100, 120 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Quetra 1000 mg film-coated tablets: MA084/10806

Date of first authorization: 01 November 2019

Drugs

Drug Countries
QUETRA Albania, Cyprus, Malta

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