FORXIGA Film-coated tablet

Active ingredients: Dapagliflozin

Product name and form

Forxiga 5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side.

Qualitative and quantitative composition

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.

Excipient with known effect: Each 5 mg tablet contains 25 mg of lactose anhydrous.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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.

List of Excipients

Tablet core:

Microcrystalline cellulose (E460i)
Lactose
Crospovidone (E1202)
Silicon dioxide (E551)
Magnesium stearate (E470b)

Film-coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)
Iron oxide yellow (E172)

Pack sizes and marketing

Alu/Alu blister.

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

Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/12/795/001 14 film-coated tablets
EU/1/12/795/002 28 film-coated tablets
EU/1/12/795/003 98 film-coated tablets
EU/1/12/795/004 30 × 1 (unit dose) film-coated tablets
EU/1/12/795/005 90 × 1 (unit dose) film-coated tablets

Date of first authorisation: 12 November 2012
Date of latest renewal: 28 August 2017

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, Singapore, United Kingdom