Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Tablet core:
Lactose monohydrate
Cellulose microcrystalline
Croscarmellose sodium
Magnesium stearate

Film coating:
Polyvinyl alcohol
Macrogol/3350
Titanium dioxide (E171)
Talc (E553b)
Iron oxide red (E172) 5 mg Tablets only
Iron oxide yellow (E172) 2.5 mg Tablets only
Printing ink:
Shellac
Indigo carmine aluminium lake (E132)


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 30°C
6.5 Nature and contents of container

Alu/Alu blister.
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 10 and 30x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal

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

7. Manufacturer: Bristol-Mayers Squibb Company, USA (for AstraZeneca)