Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Tablet core
Lactose monohydrate
Microcrystalline cellulose
Sodium starch glycolate
Colloidal silicone dioxide
Magnesium stearate

Tablet coating
Talc
Polyethylene glycol
Polyvinyl alcohol
Titanium dioxide


6.2   Incompatibilities

Not applicable.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.
Shelf life after first opening: use within 60 days.

6.4   Special precautions for storage

Store in the original container in order to protect from light at a temperature below 25 °C.
The bottle contains one sealed canister containing molecular sieve desiccant. Keep the canister in the bottle.

6.5   Nature and contents of container

Iclusig 15 mg film-coated tablets
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.

Iclusig 30 mg film-coated tablets
High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.

Iclusig 45 mg film-coated tablets
High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Disposal

No special requirements for disposal.