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 FOR BLISTER PACK
1.NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg
memantine hydrochloride
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
3.LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4.PHARMACEUTICAL FORM AND CONTENTS
42
98
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.

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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/001 42
EU/1/13/824/002 98
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Nemdatine 5 mg
17.UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg tablets
memantine hydrochloride
2.NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR BLISTER PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
28
30
42
50
56
60
98
112
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/003 28
EU/1/13/824/004 30
EU/1/13/824/005 42
EU/1/13/824/006 50
EU/1/13/824/007 56
EU/1/13/824/008 60
EU/1/13/824/009 98
EU/1/13/824/010 112
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 10 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR BOTTLE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
100
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.
Use within 100 days after opening.

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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/019
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 10 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
LABEL FOR BOTTLE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose.
4. PHARMACEUTICAL FORM AND CONTENTS
100 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.
Use within 100 days after opening.

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
[Actavis Group PTC ehf. Logo]
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/019
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR BLISTER PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 15 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
7
42
98
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.

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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/011 7
EU/1/13/824/012 42
EU/1/13/824/013 98
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 15 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 15 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON AND WALLET FOR 28 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE – Frontside
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Treatment initiation pack.
28
Treatment initiation pack with 28
7
7
7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/018
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 5 mg, 10 mg, 15 mg, 20 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON AND WALLET FOR 28 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE – Inside
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
memantine hydrochloride
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Each pack with 28
Week 2: 7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
One tablet daily.
For continuation of your treatment please consult your doctor.
Nemdatine 5 mg
Week 1
Day 1, 2, 3, 4, 5, 6, 7
Nemdatine 10 mg
Week 2
Day 8, 9, 10, 11, 12, 13, 14
Nemdatine 15 mg
Week 3
Day 15, 16, 17, 18, 19, 20, 21

Nemdatine 20 mg
Week 4
Day 22, 23, 24, 25, 26, 27, 28
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
[Actavis Group PTC ehf. Logo]
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/018
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

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 15 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING.
CARTON FOR BLISTER PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
28
42
56
98
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.

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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/014 28
EU/1/13/824/015 42
EU/1/13/824/016 56
EU/1/13/824/017 98
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 20 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Mon.
Tue.
Wed.
Thu.
Fri.
Sat.
Sun.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING.
CARTON FOR BOTTLE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
100
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.
Use within 100 days after opening.

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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/020
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 20 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING. LABEL FOR BOTTLE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose.
4. PHARMACEUTICAL FORM AND CONTENTS
100 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before 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
Do not store above 25°C.
Use within 100 days after opening.

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
[Actavis Group PTC ehf. Logo]
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/020
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D BARCODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR 28 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE – OUTER CARTON (WITH BLUE BOX)
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
- Memantine accord - N06DX01
- Memantine mylan - N06DX01
- Memantine ratiopharm - N06DX01
- Axura - N06DX01
- Memantine merz - N06DX01
- Ebixa - N06DX01
Prescription drugs listed. ATC Code: "N06DX01"
Treatment initiation pack.
Treatment initiation pack with 28 (4x7)
7
7
7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
For continuation of your treatment please consult your doctor.
Week 1: Take one tablet daily of Nemdatine 5 mg.
Week 2: Take one tablet daily of Nemdatine 10 mg.
Week 3: Take one tablet daily of Nemdatine 15 mg.
Week 4: Take one tablet daily of Nemdatine 20 mg.

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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/021
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 5 mg, 10 mg, 15 mg, 20 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: {number}
SN: {number}
NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
One tablet daily.
For continuation of your treatment please consult your doctor.
Week 1
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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/021
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 5 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 5 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Week 1
Mon.
Tue.
Wed.
Thu.
Fri.
Sat.
Sun.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
One tablet daily.
For continuation of your treatment please consult your doctor.
Week 2
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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/021
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 10 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FORTREATMENT INITIATION PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 10 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Week 2
Mon.
Tue.
Wed.
Thu.
Fri.
Sat.
Sun.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 15 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
One tablet daily.
For continuation of your treatment please consult your doctor.
Week 3
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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/021
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 15 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 15 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Week 3
Mon.
Tue.
Wed.
Thu.
Fri.
Sat.
Sun.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING.
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT SCHEDULE
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg
memantine hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
3. LIST OF EXCIPIENTS
Contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
7
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
One tablet daily.
For continuation of your treatment please consult your doctor.
Week 4
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
Do not store above 25°C.
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
Actavis Group PTC ehf. 220 Hafnarfjörður Iceland
12. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/824/021
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Nemdatine 20 mg
17. UNIQUE IDENTIFIER – 2D BARCODE
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
1. NAME OF THE MEDICINAL PRODUCT
Nemdatine 20 mg tablets
memantine hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[Actavis Group PTC ehf. Logo]
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
Week 4
Mon.
Tue.
Wed.
Thu.
Fri.
Sat.
Sun.
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