Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 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
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 17. UNIQUE IDENTIFIER 2D BARCODE
- 18. UNIQUE IDENTIFIER HUMAN READABLE DATA
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON – WITH BLUE BOX
1.NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/850 mg
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
14
28
56
60
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
AstraZeneca AB
Sweden
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/13/900/001
EU/1/13/900/002
EU/1/13/900/003
EU/1/13/900/004
EU/1/13/900/005
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
xigduo 5 mg/850 mg
17.UNIQUE IDENTIFIER 2D BARCODE
2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON – PART OF MULTIPACK - WITH BLUE BOX
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/850 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Multipack: 196 (2 packs of 98)
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
AstraZeneca AB
Sweden
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/900/006
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
xigduo 5 mg/850 mg
17. UNIQUE IDENTIFIER 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INNER CARTON – PART OF MULTIPACK – WITHOUT BLUE BOX
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/850 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
98
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
AstraZeneca AB
Sweden
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/900/006
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
xigduo 5 mg/850 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON – WITH BLUE BOX
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/1,000 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
14
28
56
60
60x1
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
- Ebymect - A10BD15
Prescription drugs listed. ATC Code: "A10BD15"
AstraZeneca AB
Sweden
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/900/007
EU/1/13/900/008
EU/1/13/900/009
EU/1/13/900/010
EU/1/13/900/011
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
xigduo 5 mg/1,000 mg
17. UNIQUE IDENTIFIER 2D BARCODE
2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON – PART OF MULTIPACK – WITH BLUE BOX
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/1,000 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Multipack: 196 (2 packs of 98)
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
AstraZeneca AB
Sweden
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/900/012
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
xigduo 5 mg/1,000 mg
17. UNIQUE IDENTIFIER 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER HUMAN READABLE DATA
PC:
SN:
NN:

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INNER CARTON – PART OF MULTIPACK – WITHOUT BLUE BOX
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/1,000 mg
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
98
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
AstraZeneca AB
Sweden
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/900/012
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
xigduo 5 mg/1,000 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS (PERFORATED)
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
2.NAME OF THE MARKETING AUTHORISATION HOLDER
AstraZeneca AB
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
2. NAME OF THE MARKETING AUTHORISATION HOLDER
AstraZeneca AB
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
10 tablets blister: {Sun/Moon symbol}
14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS (PERFORATED)
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
2. NAME OF THE MARKETING AUTHORISATION HOLDER
AstraZeneca AB
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS
1. NAME OF THE MEDICINAL PRODUCT
Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
2. NAME OF THE MARKETING AUTHORISATION HOLDER
AstraZeneca AB
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
- Brinavess
- Enviage
- Capecitabine sun
- Zutectra
- Flebogamma dif (flebogammadif)
- Riprazo
Prescription drugs listed:
10 tablets blister: {Sun/Moon symbol}
14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}
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