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Zalasta (olanzapine) – Labelling - N05AH03

Updated on site: 11-Oct-2017

Medication nameZalasta
ATC CodeN05AH03
Substanceolanzapine
ManufacturerKrka

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 2.5 mg TABLETS

1.NAME OF THE MEDICINAL PRODUCT

Zalasta 2.5 mg tablets

Olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg olanzapine.

3.LIST OF EXCIPIENTS

Contains lactose monohydrate. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

tablet

14 tablets

28 tablets

35 tablets

56 tablets

70 tablets

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/001 (14 tablets)

EU/1/07/415/002 (28 tablets)

EU/1/07/415/003 (35 tablets)

EU/1/07/415/004 (56 tablets)

EU/1/07/415/005 (70 tablets)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zalasta 2.5 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 2.5 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 2.5 mg tablets

Olanzapine

2.NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 5 mgTABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 5 mg tablets

Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg olanzapine.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

tablet

14 tablets

28 tablets

35 tablets

56 tablets

70 tablets

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/006 (14 tablets)

EU/1/07/415/007 (28 tablets)

EU/1/07/415/008 (35 tablets)

EU/1/07/415/009 (56 tablets)

EU/1/07/415/010 (70 tablets)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zalasta 5 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 5 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 5 mg tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 7.5 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 7.5 mg tablets

Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 7.5 mg olanzapine.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

tablet

14 tablets

28 tablets

35 tablets

56 tablets

70 tablets

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/011 (14 tablets)

EU/1/07/415/012 (28 tablets)

EU/1/07/415/013 (35 tablets)

EU/1/07/415/014 (56 tablets)

EU/1/07/415/015 (70 tablets)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zalasta 7.5 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 7.5 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 7.5 mg tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 10 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 10 mg tablets

Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg olanzapine.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

tablet

7 tablets

14 tablets

28 tablets

35 tablets

56 tablets

70 tablets

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/016 (7 tablets)

EU/1/07/415/017 (14 tablets)

EU/1/07/415/018 (28 tablets)

EU/1/07/415/019 (35 tablets)

EU/1/07/415/020 (56 tablets)

EU/1/07/415/021 (70 tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zalasta 10 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 10 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 10 mg tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 15 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 15 mg tablets

Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg olanzapine.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

tablet

14 tablets

28 tablets

35 tablets

56 tablets

70 tablets

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/022 (14 tablets)

EU/1/07/415/023 (28 tablets)

EU/1/07/415/024 (35 tablets)

EU/1/07/415/025 (56 tablets)

EU/1/07/415/026 (70 tablets)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zalasta 15 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 15 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 15 mg tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 20 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 20 mg tablets

Olanzapine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg olanzapine.

3. LIST OF EXCIPIENTS

Contains lactose monohydrate. See package leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

tablet

14 tablets

28 tablets

35 tablets

56 tablets

70 tablets

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/027 (14 tablets)

EU/1/07/415/028 (28 tablets)

EU/1/07/415/029 (35 tablets)

EU/1/07/415/030 (56 tablets)

EU/1/07/415/031 (70 tablets)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Zalasta 20 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 20 mg TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 20 mg tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 5 mg ORODISPERSIBLE TABLETS

I 1. NAME OF THE MEDICINAL PRODUCT

I

Zalasta 5 mg orodispersible tablets

Olanzapine

I 2. STATEMENT OF ACTIVE SUBSTANCE(S)

I

Each orodispersible tablet contains 5 mg olanzapine.

I 3. LIST OF EXCIPIENTS

I

Contains aspartame. See package leaflet for further information.

I 4. PHARMACEUTICAL FORM AND CONTENTS

I

orodispersible tablet

14 orodispersible tablets

28 orodispersible tablets

35 orodispersible tablets

56 orodispersible tablets

70 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Do not handle the tablets with wet hands as the tablets may break up.

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2. Pull up the edge of the foil and peel foil off completely. 3. Tip the tablet out onto your hand.

4. Put the tablet on the tongue as soon as it is removed from the packaging.

us3.

Swallow the tablet with or without water.

You can also place the tablet in a full glass or cup of water and drink it straight away.

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/032 (14 orodispersible tablets)

EU/1/07/415/033 (28 orodispersible tablets)

EU/1/07/415/034 (35 orodispersible tablets)

EU/1/07/415/035 (56 orodispersible tablets)

EU/1/07/415/036 (70 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zalasta 5 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 5 mg ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 5 mg orodispersible tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1.Tear.

2.Peel.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 7.5 mg ORODISPERSIBLE TABLETS

I 1. NAME OF THE MEDICINAL PRODUCT

I

Zalasta 7.5 mg orodispersible tablets

Olanzapine

I 2. STATEMENT OF ACTIVE SUBSTANCE(S)

I

Each orodispersible tablet contains 7.5 mg olanzapine.

I 3. LIST OF EXCIPIENTS

I

Contains aspartame. See package leaflet for further information.

I 4. PHARMACEUTICAL FORM AND CONTENTS

I

orodispersible tablet

14 orodispersible tablets

28 orodispersible tablets

35 orodispersible tablets

56 orodispersible tablets

70 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Do not handle the tablets with wet hands as the tablets may break up.

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

Swallow the tablet with or without water.

You can also place the tablet in a full glass or cup of water and drink it straight away.

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/037 (14 orodispersible tablets)

EU/1/07/415/038 (28 orodispersible tablets)

EU/1/07/415/039 (35 orodispersible tablets)

EU/1/07/415/040 (56 orodispersible tablets)

EU/1/07/415/041 (70 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zalasta 7.5 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 7.5 mg ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 7.5 mg orodispersible tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1.Tear.

2.Peel.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS

I 1. NAME OF THE MEDICINAL PRODUCT

I

Zalasta 10 mg orodispersible tablets

Olanzapine

I 2. STATEMENT OF ACTIVE SUBSTANCE(S)

I

Each orodispersible tablet contains 10 mg olanzapine.

I 3. LIST OF EXCIPIENTS

I

Contains aspartame. See package leaflet for further information.

I 4. PHARMACEUTICAL FORM AND CONTENTS

I

orodispersible tablet

14 orodispersible tablets

28 orodispersible tablets

35 orodispersible tablets

56 orodispersible tablets

70 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Do not handle the tablets with wet hands as the tablets may break up.

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

Swallow the tablet with or without water.

You can also place the tablet in a full glass or cup of water and drink it straight away.

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/042 (14 orodispersible tablets)

EU/1/07/415/043 (28 orodispersible tablets)

EU/1/07/415/044 (35 orodispersible tablets)

EU/1/07/415/045 (56 orodispersible tablets)

EU/1/07/415/046 (70 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zalasta 10 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 10 mg orodispersible tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1.Tear.

2.Peel.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS

I 1. NAME OF THE MEDICINAL PRODUCT

I

Zalasta 15 mg orodispersible tablets

Olanzapine

I 2. STATEMENT OF ACTIVE SUBSTANCE(S)

I

Each orodispersible tablet contains 15 mg olanzapine.

I 3. LIST OF EXCIPIENTS

I

Contains aspartame. See package leaflet for further information.

I 4. PHARMACEUTICAL FORM AND CONTENTS

I

orodispersible tablet

14 orodispersible tablets

28 orodispersible tablets

35 orodispersible tablets

56 orodispersible tablets

70 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Do not handle the tablets with wet hands as the tablets may break up.

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

Swallow the tablet with or without water.

You can also place the tablet in a full glass or cup of water and drink it straight away.

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/047 (14 orodispersible tablets)

EU/1/07/415/048 (28 orodispersible tablets)

EU/1/07/415/049 (35 orodispersible tablets)

EU/1/07/415/050 (56 orodispersible tablets)

EU/1/07/415/051 (70 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zalasta 15 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

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Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 15 mg orodispersible tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1.Tear.

2.Peel.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS

I 1. NAME OF THE MEDICINAL PRODUCT

I

Zalasta 20 mg orodispersible tablets

Olanzapine

I 2. STATEMENT OF ACTIVE SUBSTANCE(S)

I

Each orodispersible tablet contains 20 mg olanzapine.

I 3. LIST OF EXCIPIENTS

I

Contains aspartame. See package leaflet for further information.

I 4. PHARMACEUTICAL FORM AND CONTENTS

I

orodispersible tablet

14 orodispersible tablets

28 orodispersible tablets

35 orodispersible tablets

56 orodispersible tablets

70 orodispersible tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

Do not handle the tablets with wet hands as the tablets may break up.

1.Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.

2.Pull up the edge of the foil and peel foil off completely.

3.Tip the tablet out onto your hand.

4.Put the tablet on the tongue as soon as it is removed from the packaging.

Swallow the tablet with or without water.

You can also place the tablet in a full glass or cup of water and drink it straight away.

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

Store in the original package in order to protect from light and moisture.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/415/052 (14 orodispersible tablets)

EU/1/07/415/053 (28 orodispersible tablets)

EU/1/07/415/054 (35 orodispersible tablets)

EU/1/07/415/055 (56 orodispersible tablets)

EU/1/07/415/056 (70 orodispersible tablets)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Zalasta 20 mg orodispersible tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS

1. NAME OF THE MEDICINAL PRODUCT

Zalasta 20 mg orodispersible tablets

Olanzapine

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

1.Tear.

2.Peel.

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