Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Tablet core
Microcrystalline cellulose, starch pregelatinised, crospovidone, silica colloidal anhydrous, magnesium stearate

Tablet coat
Polyvinyl alcohol, titanium dioxide, macrogol 3350 (polyethylene glycol), talc, yellow iron oxide, FD&C blue #2 (indigo carmine aluminium lake)


6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

Store below 25°C.

6.5   Nature and contents of containers
Blisters
PVC/ACLAR/PVC - aluminum blister packs containing 14, 28, 30, 84 tablets per carton.
PVC/ACLAR/PVdC/PVC - aluminum blister packs containing 14, 28, 30, 84 tablets per carton.

Bottles
High Density Polyethylene (HDPE) bottle with child resistant, polypropylene screw cap.
High Density Polyethylene (HDPE) bottle containing silica gel desiccant with child resistant, polypropylene screw cap.

Each bottle contains 30 tablets.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    LICENCE HOLDER AND MANUFACTURER
Teva Pharmaceutical Industries Ltd.
P.O.Box 3190, Petah-Tiqva