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Samsca (tolvaptan) – Labelling - C03XA01

Updated on site: 10-Oct-2017

Medication nameSamsca
ATC CodeC03XA01
Substancetolvaptan
ManufacturerOtsuka Pharmaceutical Europe Ltd.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Samsca 15 mg tablets tolvaptan

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg tolvaptan.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

10 tablets

30 tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs

Framewood Road

Wexham, SL3 6PJ

UK

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/539/001 10 tablets

EU/1/09/539/002 30 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Samsca 15 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Samsca 15 mg tablets tolvaptan

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Samsca 30 mg tablets tolvaptan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 30 mg tolvaptan.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

10 tablets

30 tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

For 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

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs

Framewood Road

Wexham, SL3 6PJ

UK

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/539/003 10 tablets

EU/1/09/539/004 30 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Samsca 30 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Samsca 30 mg tablets tolvaptan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Otsuka

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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