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Ebixa (memantine hydrochloride) – Labelling - N06DX01

Updated on site: 06-Oct-2017

Medication nameEbixa
ATC CodeN06DX01
Substancememantine hydrochloride
ManufacturerH. Lundbeck A/S

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Ebixa 10 mg film-coated tablets

Memantine hydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets

49 x 1 film-coated tablets

50 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablets

70 film-coated tablets

84 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablets

100 film-coated tablets

100 x 1 film-coated tablets

112 film-coated tablets

5.METHOD AND ROUTE 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 {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/016 14 film-coated tablets

EU/1/02/219/007 28 film-coated tablets

EU/1/02/219/001 30 film-coated tablets

EU/1/02/219/017 42 film-coated tablets

EU/1/02/219/010 49 x 1 film-coated tablets

EU/1/02/219/002 50 film-coated tablets

EU/1/02/219/008 56 film-coated tablets

EU/1/02/219/014 56 x 1 film-coated tablets

EU/1/02/219/018 70 film-coated tablets

EU/1/02/219/019 84 film-coated tablets

EU/1/02/219/020 98 film-coated tablets

EU/1/02/219/015 98 x 1 film-coated tablets

EU/1/02/219/003 100 film-coated tablets

EU/1/02/219/011 100 x 1 film-coated tablets

EU/1/02/219/009 112 film-coated tablets

13.BATCH NUMBER

Lot {number}

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Ebixa 10 mg tablets

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

CARTON AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 10 mg film-coated tablets

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets 50 film-coated tablets 98 film-coated tablets

Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE 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 {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/021 980 (10 packs of 98) film-coated tablets

EU/1/02/219/012 1000 (20 packs of 50) film-coated tablets

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 10 mg tablets

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 WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 10 mg film-coated tablets

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

Multipack: 980 ( 10 packs of 98) film-coated tablets.

Multipack: 1000 ( 20 packs of 50) film-coated tablets

5. METHOD AND ROUTE 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 {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/021 980 (10 packs of 98) film-coated tablets

EU/1/02/219/012 1000 (20 packs of 50) film-coated tablets

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 10 mg tablets

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 BLISTER

BLISTER FOR TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 10 mg film-coated tablets

Memantine hydrochloride

2.NAME OF THE MARKETING AUTHORISATION HOLDER

H. Lundbeck A/S

3.EXPIRY DATE

EXP {MM.YYYY}

See embossed stamp.

4.BATCH NUMBER

Lot {number}

See embossed stamp.

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE

PACKAGING

CARTON AND LABEL FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 5 mg/pump actuation oral solution

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.

3. LIST OF EXCIPIENTS

The solution also contains potassium sorbate and sorbitol E420.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Oral solution 50 ml

100 ml

5. METHOD AND ROUTE OF ADMINISTRATION

Once daily

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 {MM.YYYY}

9. SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

When opened, use within 3 months.

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/005 50 ml

EU/1/02/219/006 100 ml

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 5 mg/pump actuation oral solution

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 AND THE IMMEDIATE

PACKAGING

CARTON AND LABEL FOR BOTTLE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 5 mg/pump actuation oral solution memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.

3. LIST OF EXCIPIENTS

The solution also contains potassium sorbate and sorbitol E420.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Oral solution 50 ml

Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE OF ADMINISTRATION

Once daily

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 {MM.YYYY}

9. SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

When opened, use within 3 months.

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/ 013500 ml (10 bottles of 50 ml)

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 5 mg/pump actuation oral solution

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 WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 5 mg/pump actuation oral solution memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.

3. LIST OF EXCIPIENTS

The solution also contains potassium sorbate and sorbitol E420.

See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Oral solution

Multipack: 500 ml (10 bottles of 50 ml) oral solution.

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily

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 {MM.YYYY}

9. SPECIAL STORAGE CONDITIONS

Do not store above 30ºC.

When opened, use within 3 months.

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/ 013500 ml (10 bottles of 50 ml)

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 5 mg/pump actuation oral solution

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

CARTON FOR 28 TABLETS – TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 5 mg film-coated tablets.

Ebixa 10 mg film-coated tablets.

Ebixa 15 mg film-coated tablets.

Ebixa 20 mg film-coated tablets.

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Treatment initiation pack

Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 film-coated tablets of Ebixa 5 mg

7 film-coated tablets of Ebixa 10 mg

7 film-coated tablets of Ebixa 15 mg

7 film-coated tablets of Ebixa 20 mg

5. METHOD AND ROUTE OF ADMINISTRATION

Once daily

Read the package leaflet before use

Oral use

Take only one tablet per day

Ebixa 5 mg

Memantine hydrochloride Week 1, Day 1 2 3 4 5 6 7

7 Film-coated tablets Ebixa 5 mg

Ebixa 10 mg

Memantine hydrochloride Week 2, Day 8 9 10 11 12 13 14

7 Film-coated tablets Ebixa 10 mg

Ebixa 15 mg

Memantine hydrochloride

Week 3, Day 15 16 17 18 19 20 21 7 Film-coated tablets Ebixa 15 mg

Ebixa 20 mg

Memantine hydrochloride

Week 4, Day 22 23 24 25 26 27 28 7 Film-coated tablets Ebixa 20 mg

For continuation of your treatment please consult your doctor

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 {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets EU/1/02/219/036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 5 mg, 10 mg, 15 mg, 20 mg tablets

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

CARTON FOR BLISTER PACK

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 20 mg film-coated tablets

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets

49 x 1 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablets

70 film-coated tablets

84 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablets

100 x 1 film-coated tablets

112 film-coated tablets

5. METHOD AND ROUTE OF ADMINISTRATION

Once daily

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 {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/023 14 film-coated tablets

EU/1/02/219/024 28 film-coated tablets

EU/1/02/219/025 42 film-coated tablets

EU/1/02/219/026 49 x 1 film-coated tablets

EU/1/02/219/027 56 film-coated tablets

EU/1/02/219/028 56 x 1 film-coated tablets

EU/1/02/219/029 70 film-coated tablets

EU/1/02/219/030 84 film-coated tablets

EU/1/02/219/031 98 film-coated tablets

EU/1/02/219/032 98 x 1 film-coated tablets

EU/1/02/219/033 100 x 1 film-coated tablets

EU/1/02/219/034 112 film-coated tablets

EU/1/02/219/037 14 film-coated tablets

EU/1/02/219/038 28 film-coated tablets

EU/1/02/219/039 42 film-coated tablets

EU/1/02/219/040 49 x 1 film-coated tablets

EU/1/02/219/041 56 film-coated tablets

EU/1/02/219/042 56 x 1 film-coated tablets

EU/1/02/219/043 70 film-coated tablets

EU/1/02/219/044 84 film-coated tablets

EU/1/02/219/045 98 film-coated tablets

EU/1/02/219/046 98 x 1 film-coated tablets

EU/1/02/219/047 100 x 1 film-coated tablets

EU/1/02/219/048 112 film-coated tablets

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 20 mg tablets

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

CARTON FOR INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 20 mg film-coated tablets

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets 42 film-coated tablets

Component of a multipack, can’t be sold separately

5. METHOD AND ROUTE OF ADMINISTRATION

Once daily

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 {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/035 840 (20 packs of 42) film-coated tablets

EU/1/02/219/049 840 (20 packs of 42) film-coated tablets

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 20 mg tablets

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 WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 20 mg film-coated tablets

Memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets

Multipack: 840 (20 packs of 42) film-coated tablets.

5. METHOD AND ROUTE OF ADMINISTRATION

Once daily

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 reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP {MM.YYYY}

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

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/219/035 840 (20 packs of 42) film-coated tablets

EU/1/02/219/049 840 (20 packs of 42) film-coated tablets

13. BATCH NUMBER

Lot {number}

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ebixa 20 mg tablets

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

BLISTER FOR TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Ebixa 20 mg film-coated tablets

Memantine hydrochloride

2. NAME OF THE MARKETING AUTHORISATION HOLDER

H. Lundbeck A/S

3. EXPIRY DATE

EXP {MM.YYYY}

See embossed stamp.

4. BATCH NUMBER

Lot {number}

See embossed stamp.

5. OTHER

Mon → Tue → Wed → Thu → Fri → Sat → Sun

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