Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Tablet core
Microcrystalline cellulose (E460)
Calcium hydrogen phosphate (anhydrous)
Sodium stearyl fumarate (E487)
Croscarmellose sodium
Magnesium stearate (E470b)
Tablet coat
Hypromellose (E464)
Hydroxypropyl cellulose (E463)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Iron oxide black (E172)
Carnauba wax (E903)

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

The expiry date is indicated on the packaging materials.

6.4   Special precautions for storage
Store below 300C in the original package in order to protect from moisture.

6.5   Nature and contents of container

Alu/PVC/PA/Alu blisters
Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Packs of 30x1 film-coated tablets in perforated unit dose blisters.
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.    MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme (Israel-1996) Company Ltd.,         34 Ha’charash St., Hod-Hasharon, Israel.