STARLIX Film-coated tablet Ref.[8151] Active ingredients: Nateglinide

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

STARLIX 60 mg film-coated tablets.

STARLIX 120 mg film-coated tablets.

STARLIX 180 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

STARLIX 60 mg film-coated tablets: 60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other.

STARLIX 120 mg film-coated tablets: 120 mg yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.

STARLIX 180 mg film-coated tablets: 180 mg red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other.

Qualitative and quantitative composition

STARLIX 60 mg film-coated tablets: Each film-coated tablet contains 60 mg nateglinide.

Excipient with known effect: Lactose monohydrate: 141.5 mg per tablet.

STARLIX 120 mg film-coated tablets: Each film-coated tablet contains 120 mg nateglinide.

Excipient with known effect: Lactose monohydrate: 283 mg per tablet.

STARLIX 180 mg film-coated tablets: Each film-coated tablet contains 180 mg nateglinide.

Excipient with known effect: Lactose monohydrate: 214 mg per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nateglinide

Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from other antidiabetic agents. Nateglinide is a rapid, short-acting oral insulin secretagogue. Its effect is dependent on functioning beta cells in the pancreas islets.

List of Excipients

STARLIX 60 mg film-coated tablets:

Lactose monohydrate
Cellulose, microcrystalline
Povidone
Croscarmellose sodium
Magnesium stearate
Red iron oxide (E172)
Hypromellose
Titanium dioxide (E171)
Talc
Macrogol
Silica, colloidal anhydrous

STARLIX 120 mg film-coated tablets:

Lactose monohydrate
Cellulose, microcrystalline
Povidone
Croscarmellose sodium
Magnesium stearate
Yellow iron oxide (E172)
Hypromellose
Titanium dioxide (E171)
Talc
Macrogol
Silica, colloidal anhydrous

STARLIX 180 mg film-coated tablets:

Lactose monohydrate
Cellulose, microcrystalline
Povidone
Croscarmellose sodium
Magnesium stearate
Red iron oxide (E172)
Hypromellose
Titanium dioxide (E171)
Talc
Macrogol
Silica, colloidal anhydrous

Pack sizes and marketing

Blisters: PVC/PE/PVDC blisters, backed with a heat-sealable lacquered aluminium foil.

Packs contain 12, 24, 30, 60, 84, 120 and 360 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

STARLIX 60 mg film-coated tablets: EU/1/01/174/001-007
STARLIX 120 mg film-coated tablets: EU/1/01/174/008-014
STARLIX 180 mg film-coated tablets: EU/1/01/174/015-021

Date of first authorisation: 03 April 2001
Date of latest renewal: 24 April 2006

Drugs

Drug Countries
STARLIX Austria, Cyprus, Estonia, Ireland, Lithuania, Poland, Romania, Singapore, United States, South Africa

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