Drug Product: Gliclazide Zentiva 30 and 60 mg tbl ret DCP
Name of Document: 1.3.1 SPC and Labelling and Package Leaflet
Gliclazide DK/H/2302 – addition of pack size 2014/10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
NAME OF THE MEDICINAL PRODUCT
[Product Name] 30 mg modified-release tablets
[Product Name] 60 mg modified-release tablets
Gliclazide
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each modified-release tablet contains 30 mg gliclazide
Each modified-release tablet contains 60 mg gliclazide
3.
LIST OF EXCIPIENTS
Contains lactose, see leaflet for further information.
4.
PHARMACEUTICAL FORM AND CONTENTS
Modified-release tablet
[Product Name] 30 mg
20 modified-release tablets
60 modified-release tablets
[Product Name] 60 mg
30 modified-release tablets
90 modified-release tablets tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
Swallow the whole tablet.
Swallow your half tablet or whole tablet(s) in one piece.* Do not chew or crush.
* for 60 mg tablet only.
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.
CONFIDENTIAL
Module 1 Page 12
Drug Product: Gliclazide Zentiva 30 and 60 mg tbl ret DCP
Name of Document: 1.3.1 SPC and Labelling and Package Leaflet
Gliclazide DK/H/2302 – addition of pack size 2014/10
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP: MM-YYYY
9.
SPECIAL STORAGE CONDITIONS
This medicinal product does not require any 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
[To be completed nationally]
12.
MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
13.
BATCH NUMBER
Batch
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
[Product Name] 30 mg
[Product Name] 60 mg
CONFIDENTIAL
Module 1 Page 13
Drug Product: Gliclazide Zentiva 30 and 60 mg tbl ret DCP
Name of Document: 1.3.1 SPC and Labelling and Package Leaflet
Gliclazide DK/H/2302 – addition of pack size 2014/10
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER
1.
NAME OF THE MEDICINAL PRODUCT
[Product Name] 30 mg modified-release tablets
[Product Name] 60 mg modified-release tablets
Gliclazide
2.
NAME OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
3.
EXPIRY DATE
EXP:
4.
BATCH NUMBER
Lot:
5.
OTHER
CONFIDENTIAL
Module 1 Page 14