Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Core

Croscarmellose sodium
Lactose monohydrate
Betadex
Lactose anhydrous
Magnesium stearate
Coating

Briviact 10 mg film-coated tablets
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Briviact 25 mg film-coated tablets
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide yellow (E172)
Iron oxide black (E172)
Briviact 50 mg film-coated tablets
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide yellow (E172)
Iron oxide red (E172)

Briviact 75 mg film-coated tablets
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide yellow (E172)

Iron oxide red (E172)
Iron oxide black (E172)
Briviact 100 mg film-coated tablets
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide yellow (E172)
Iron oxide black (E172)

6.2   Incompatibilities

Not applicable
6.3   Shelf life

The expiery 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 the product at room temperature.

6.5   Nature and contents of container

Briviact 10 mg film-coated tablets
• Packs of 14,100, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film- coated tablets in PVC/PCTFE - Aluminium blisters

Briviact 25 mg film-coated tablets
• Packs of 14,100, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film- coated tablets in PVC/PCTFE - Aluminium blisters

Briviact 50 mg film-coated tablets
• Packs of 14,100, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film- coated tablets in PVC/PCTFE - Aluminium blisters

Briviact 75 mg film-coated tablets
• Packs of 14,100, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film- coated tablets in PVC/PCTFE - Aluminium blisters

Briviact 100 mg film-coated tablets
• Packs of 14,100, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) film- coated tablets in PVC/PCTFE - Aluminium blisters

Not all pack sizes may be marketed.

6.6   Special precautions for disposal
No special requirements.

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