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Pregabalin Zentiva (pregabalin) – Labelling - N03AX16

Updated on site: 09-Oct-2017

Medication namePregabalin Zentiva
ATC CodeN03AX16
Substancepregabalin
ManufacturerZentiva, k.s.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1.NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 25 mg hard capsules

Pregabalin

2.STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 25 mg of pregabalin.

3.LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

21 hard capsules

56 hard capsules

84 hard capsules

100 hard capsules

5.METHOD AND ROUTE 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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/001

EU/1/15/1021/002

EU/1/15/1021/003

EU/1/15/1021/004

EU/1/15/1021/005

13.BATCH NUMBER

Batch:

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Pregabalin Zentiva 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 25 mg hard capsules

Pregabalin

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Batch:

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 50 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 50 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

21 hard capsules

56 hard capsules

84 hard capsules

100 hard capsules

5. METHOD AND ROUTE 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 30°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

Zentiva, k.s..

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/006

EU/1/15/1021/007

EU/1/15/1021/008

EU/1/15/1021/009

EU/1/15/1021/010

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 50 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 50 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 75 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 75 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

56 hard capsules

100 hard capsules

5. METHOD AND ROUTE 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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/011

EU/1/15/1021/012

EU/1/15/1021/013

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 75 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 75 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 100 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 100 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

21 hard capsules

84 hard capsules

100 hard capsules

5. METHOD AND ROUTE 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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/014

EU/1/15/1021/015

EU/1/15/1021/016

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 100 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 100 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 150 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 150 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

56 hard capsules

100 hard capsules

5. METHOD AND ROUTE 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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/017

EU/1/15/1021/018

EU/1/15/1021/019

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 150 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 150 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 200 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 200 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

21 hard capsules

84 hard capsules

100 hard capsules

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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/020

EU/1/15/1021/021

EU/1/15/1021/022

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 200 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 200 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 225 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 225 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

56 hard capsules

100 hard capsules

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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/023

EU/1/15/1021/024

EU/1/15/1021/025

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 225 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 225 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PAPER FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 300 mg hard capsules

Pregabalin

2. STATEMENT OF ACTIVE SUBSTANCE

Each hard capsule contains 300 mg of pregabalin.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

56 hard capsules

100 hard capsules

5. METHOD AND ROUTE 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 30°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

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1021/026

EU/1/15/1021/027

EU/1/15/1021/028

13. BATCH NUMBER

Batch:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pregabalin Zentiva 300 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

1. NAME OF THE MEDICINAL PRODUCT

Pregabalin Zentiva 300 mg hard capsules

Pregabalin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Zentiva logo

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Batch:

5. OTHER

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