Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Tablet core
Lactose monohydrate
Cellulose, microcrystalline
Croscarmellose sodium
Hydroxypropyl cellulose
Magnesium stearate

Film-coating
Opadry White, YS-1-18177-A contains: Hypromellose, titanium dioxide and polyethylene glycol 400 
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 25OC , in a dry place.
Do not refrigerate or freeze.
The medicine can be used within 12 months after first opening the bottle, but no later than the expiry date that appears on the package.
Keep the bottle tightly closed.
Do not use if inner seal of bottle is broken or missing.

6.5   Nature and contents of container

HDPE bottle with child resistant closure of polypropylene.
SPRYCEL 20mg, 50mg, 70mg; Cartons containing one bottle with 60 film-coated tablets.
SPRYCEL 100mg; Cartons containing one bottle with 30 film-coated tablets.
6.6   Special precautions for disposal and other handling

The film-coated tablets consist of a core tablet, surrounded by a film coating to prevent exposure of health care professionals to the active substance. The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended to minimise the risk of dermal exposure.

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