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Jardiance (empagliflozin) – Labelling - A10BK03

Updated on site: 08-Oct-2017

Medication nameJardiance
ATC CodeA10BK03
Substanceempagliflozin
ManufacturerBoehringer Ingelheim International GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Jardiance 10 mg film-coated tablets

Empagliflozin

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg of empagliflozin.

3.LIST OF EXCIPIENTS

Contains lactose, see leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

7 x 1 film-coated tablets

10 x 1 film-coated tablets

14 x 1 film-coated tablets

28 x 1 film-coated tablets

30 x 1 film-coated tablets

60 x 1 film-coated tablets

70 x 1 film-coated tablets

90 x 1 film-coated tablets

100 x 1 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim International GmbH

D-55216 Ingelheim am Rhein

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/930/010 7 tablets

EU/1/14/930/011 10 tablets

EU/1/14/930/012 14 tablets

EU/1/14/930/013 28 tablets

EU/1/14/930/014 30 tablets

EU/1/14/930/015 60 tablets

EU/1/14/930/016 70 tablets

EU/1/14/930/017 90 tablets

EU/1/14/930/018 100 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Jardiance 10 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters (perforated)

1. NAME OF THE MEDICINAL PRODUCT

Jardiance 10 mg tablets

Empagliflozin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Jardiance 25 mg film-coated tablets

Empagliflozin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 25 mg of empagliflozin.

3. LIST OF EXCIPIENTS

Contains lactose, see leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

7 x 1 film-coated tablets

10 x 1 film-coated tablets

14 x 1 film-coated tablets

28 x 1 film-coated tablets

30 x 1 film-coated tablets

60 x 1 film-coated tablets

70 x 1 film-coated tablets

90 x 1 film-coated tablets

100 x 1 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim International GmbH

D-55216 Ingelheim am Rhein

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/930/001 7 tablets

EU/1/14/930/002 10 tablets

EU/1/14/930/003 14 tablets

EU/1/14/930/004 28 tablets

EU/1/14/930/005 30 tablets

EU/1/14/930/006 60 tablets

EU/1/14/930/007 70 tablets

EU/1/14/930/008 90 tablets

EU/1/14/930/009 100 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Jardiance 25 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blisters (perforated)

1. NAME OF THE MEDICINAL PRODUCT

Jardiance 25 mg tablets

Empagliflozin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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