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EZETIMIBE/SIMVASTATIN 10MG/20MG TABLETS

Active substance(s): EZETIMIBE / SIMVASTATIN

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR BLISTER

1.

NAME OF THE MEDICINAL PRODUCT

Ezetimibe/Simvastatin 10 mg/40 mg Tablets

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.

3.

LIST OF EXCIPIENTS

Contains lactose monohydrate.
Please see the enclosed leaflet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

30 Tablets
100 Tablets

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use
Please 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.

Version 1.3 II008 RUP updates

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.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland
12.

MARKETING AUTHORISATION NUMBER(S)

PL 30306/0798
13.

BATCH NUMBER

Lot

14.

GENERAL CLASSIFICATION FOR SUPPLY

POM

15.

INSTRUCTIONS ON USE

Use as directed by the doctor.
16.

INFORMATION IN BRAILLE

Ezetimibe/Simvastatin 10 mg/40 mg Tablets
17.

UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

18.

UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:
SN:
NN:

Version 1.3 II008 RUP updates

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER

1.

NAME OF THE MEDICINAL PRODUCT

Ezetimibe/Simvastatin 10 mg/40 mg Tablets

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf.
3.

EXPIRY DATE

EXP

4.

BATCH NUMBER

Lot

5.

OTHER

Version 1.0

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING
CARTON FOR TABLET CONTAINER

1.

NAME OF THE MEDICINAL PRODUCT

Ezetimibe/Simvastatin 10 mg/40 mg Tablets

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.

3.

LIST OF EXCIPIENTS

Contains lactose monohydrate.
Please see the enclosed leaflet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

100 Tablets
180 Tablets

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use
Please 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.

Version 1.0

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.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland

12.

MARKETING AUTHORISATION NUMBER(S)

PL 30306/0798

13.

BATCH NUMBER

Lot
14.

GENERAL CLASSIFICATION FOR SUPPLY

POM

15.

INSTRUCTIONS ON USE

Use as directed by the doctor.
16.

INFORMATION IN BRAILLE

Ezetimibe/Simvastatin 10 mg/40 mg Tablets

Version 1.0

PARTICULARS TO APPEAR ON THE OUTER AND IMMEDIATE PACKAGING
LABEL FOR TABLET CONTAINER

1.

NAME OF THE MEDICINAL PRODUCT

Ezetimibe/Simvastatin 10 mg/40 mg Tablets

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.

3.

LIST OF EXCIPIENTS

Contains lactose monohydrate.
Please see the enclosed leaflet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

100 Tablets
180 Tablets

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use.
Please 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

Version 1.3 II008 RUP updates

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjördur
Iceland

12.

MARKETING AUTHORISATION NUMBER(S)

PL 30306/0798
13.

BATCH NUMBER

Lot
14.

GENERAL CLASSIFICATION FOR SUPPLY

POM

15.

INSTRUCTIONS ON USE

Use as directed by the doctor.
16.

INFORMATION IN BRAILLE

Ezetimibe/Simvastatin 10 mg/40 mg Tablets

17.

UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>


18.

UNIQUE IDENTIFIER – HUMAN READABLE DATA

< PC: {number} [product code]
SN: {number} [serial number]
NN: {number} [national reimbursement number or other national number identifying the medicinal
product]>


Version 1.3 II008 RUP updates

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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