Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Tablet and film-coated tablet content
Microcrystalline cellulose
Lactose monohydrate
Sodium starch glycolate
Magnesium stearate
Colloidal Silicon Dioxide

Film-coating

25 mg and 100 mg film-coated tablets
Polyvinyl alcohol-part. hydrolyzed
Macrogol
Titanium dioxide (E171)
Talc
Iron oxide red (E172)
Iron oxide yellow (E172)
Indigo carmine aluminum lake (E132)
50 mg film-coated tablets
Polyvinyl alcohol-part. hydrolyzed
Titanium dioxide (E171)
Macrogol
Talc
Iron oxide yellow (E172)

150 mg and 200 mg film-coated tablets
Polyvinyl alcohol-part. hydrolyzed
Titanium dioxide (E171)
Macrogol
Talc
Iron oxide yellow (E172)
Iron oxide red (E172)

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

This medicinal product does not require any special storage conditions. It is recommended to store at room temperature.

6.5   Nature and contents of container

Blister
Xcopri 12.5 mg tablets and 25 mg film-coated tablets
Packs of 7 and 14 tablets
Titration pack (treatment initiation pack): Pack of 14 tablets of 12.5 mg and 14 film- coated tablets of 25 mg

Xcopri 50 mg film-coated tablets
Packs of 7, 14 and 30 film-coated tablets
Titration pack: Pack of 14 film-coated tablets of 50 mg and 14 film-coated tablets of 100 mg Maintenance pack (250 mg daily dose): Pack of 28 film-coated tablets of 50 mg and 28 film-coated tablets of 200 mg

Xcopri 100 mg film-coated tablets
Packs of 14 and 30 film-coated tablets
Titration pack: Pack of 14 film-coated tablets of 50 mg and 14 film-coated tablets of 100 mg 
Xcopri 150 mg film-coated tablets
Packs of 14 and 30 film-coated tablets
Titration pack: Pack of 14 film-coated tablets of 150 mg and 14 film-coated tablets of 200 mg Maintenance pack (350 mg daily dose): Pack of 28 film-coated tablets of 150 mg and 28 film-coated tablets of 200 mg

Xcopri 200 mg film-coated tablets
Packs of 14 and 30 film-coated tablets
Titration pack: Pack of 14 film-coated tablets of 150 mg and 14 film-coated tablets of 200 mg Maintenance pack (250 mg daily dose): Pack of 28 film-coated tablets of 50 mg and 28 film-coated tablets of 200 mg
Maintenance pack (350 mg daily dose): Pack of 28 film-coated tablets of 150 mg and 28 film-coated tablets of 200 mg


Bottle
Xcopri 50, 100, 150, 200 mg film-coated tablets
Pack of 30 film-coated tablets
Not all pack sizes may be marketed.

6.6   Special precautions for disposal

Cenobamate is very persistent (vP) in aquatic systems. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.