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Nemdatine (memantine) – Labelling - N06DX01

Updated on site: 08-Oct-2017

Medication nameNemdatine
ATC CodeN06DX01
Substancememantine
ManufacturerActavis Group PTC ehf.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Nemdatine 5 mg film-coated tablets

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 film-coated tablets

98 film-coated 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.

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 film-coated tablets

EU/1/13/824/002 98 film-coated tablets

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 film-coated tablets

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 film-coated tablets

30 film-coated tablets

42 film-coated tablets

50 film-coated tablets

56 film-coated tablets

60 film-coated tablets

98 film-coated tablets

112 film-coated 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.

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 film-coated tablets

EU/1/13/824/004 30 film-coated tablets

EU/1/13/824/005 42 film-coated tablets

EU/1/13/824/006 50 film-coated tablets

EU/1/13/824/007 56 film-coated tablets

EU/1/13/824/008 60 film-coated tablets

EU/1/13/824/009 98 film-coated tablets

EU/1/13/824/010 112 film-coated tablets

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 film-coated tablets

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 film-coated 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. 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 film-coated tablets

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 film-coated tablets

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 film-coated tablets

42 film-coated tablets

98 film-coated 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.

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 film-coated tablets

EU/1/13/824/012 42 film-coated tablets

EU/1/13/824/013 98 film-coated tablets

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 film-coated tablets

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 film-coated tablets

Treatment initiation pack with 28 film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg

7 film-coated tablets of Nemdatine 10 mg

7 film-coated tablets of Nemdatine 15 mg

7 film-coated tablets of Nemdatine 20 mg

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 film-coated tablets

memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

memantine hydrochloride

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg

Week 2: 7 film-coated tablets of Nemdatine 10 mg Week 3: 7 film-coated tablets of Nemdatine 15 mg Week 4: 7 film-coated tablets of Nemdatine 20 mg

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 film-coated tablets

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 film-coated tablets

42 film-coated tablets

56 film-coated tablets

98 film-coated 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.

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 film-coated tablets

EU/1/13/824/015 42 film-coated tablets

EU/1/13/824/016 56 film-coated tablets

EU/1/13/824/017 98 film-coated tablets

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 film-coated tablets

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 film-coated 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. 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 film-coated tablets

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 film-coated tablets

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.

Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg

7 film-coated tablets of Nemdatine 10 mg

7 film-coated tablets of Nemdatine 15 mg

7 film-coated tablets of Nemdatine 20 mg

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 –IMMEDIATE CARTON (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Nemdatine 5 mg film-coated tablets

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 film-coated tablets

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 –IMMEDIATE CARTON (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Nemdatine 10 mg film-coated tablets

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 film-coated tablets

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 –IMMEDIATE CARTON (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Nemdatine 15 mg film-coated tablets

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 film-coated tablets

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 –IMMEDIATE CARTON (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Nemdatine 20 mg film-coated tablets

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 film-coated tablets

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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