QTERN Film-coated tablet Ref.[7953] Active ingredients: Dapagliflozin Saxagliptin Saxagliptin and Dapagliflozin

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden

Product name and form

Qtern 5 mg/10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Light brown to brown, biconvex, 0.8 cm round, film-coated tablet, with “5/10” printed on one side, and “1122” printed on the other side, in blue ink.

Qualitative and quantitative composition

Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.

Excipient with known effect: Each tablet contains 40 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dapagliflozin

Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion.

Saxagliptin

Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor. Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.

Saxagliptin and Dapagliflozin

Combination of saxagliptin and dapagliflozin with complementary mechanisms of action to improve glycaemic control. Saxagliptin, through the selective inhibition of dipeptidyl peptidase-4 (DPP-4), enhances glucose-mediated insulin secretion (incretin effect). Dapagliflozin, a selective inhibitor of sodium-glucose co-transporter 2 (SGLT2), inhibits renal glucose reabsorption independently of insulin. Actions of both medicinal products are regulated by the plasma glucose level.

List of Excipients

Tablet core:

Microcrystalline cellulose (E460i)
Croscarmellose sodium (E468)
Lactose
Magnesium stearate (E470b)
Dental type silica (E551)

Film-coating:

Poly(vinyl alcohol) (E1203)
Macrogol (3350)
Titanium dioxide (E171)
Talc (E553b)
Iron oxide yellow (E172)
Iron oxide red (E172)

Printing ink:

Shellac
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

PA/Alu/PVC-Alu blister.

Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters.

Pack size of 30 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85, Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/16/1108/001 14 film-coated tablets
EU/1/16/1108/002 28 film-coated tablets
EU/1/16/1108/003 98 film-coated tablets
EU/1/16/1108/004 30 film-coated tablets

Date of first authorisation: 15 July 2016
Date of latest renewal: 19 May 2021

Drugs

Drug Countries
QTERN Austria, Australia, Brazil, Estonia, Finland, Ireland, Lithuania, Poland, Romania, Turkey, United Kingdom, United States

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