Gliclazide DK/H/2302 â addition of pack size 2014/10
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
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