Pharmaceutical particulars : מידע רוקחי

 6.       PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Tecfidera 120mg                                         Tecfidera 240mg Microtablets:                                     Microtablets:
Core-                                             Core-
Microcrystalline cellulose                        Dimethyl fumarate
Dimethyl fumarate                                 Microcrystalline cellulose Talc                                              Silica, colloidal anhydrous Croscarmellose sodium                             Croscarmellose sodium 
Magnesium stearate                                Magnesium stearate
Silica, colloidal anhydrous
Seal coating-                                     Seal coating-
Methacrylic acid– methyl methacrylate             Methacrylic acid methyl methacrylate copolymer 1:1                                     copolymer 1:1
Triethyl citrate                                  Triethyl citrate
Sodium laurel sulfate                             Sodium laurel sulfate 
Enteric coating-                                  Enteric coating-
Methacrylic acid–ethyl acrylate copolymer (1:1)   Methacrylic acid–ethyl acrylate copolymer dispersion 30%                                    (1:1) dispersion 30% Talc, micronized                                  Talc, micronized
Triethyl citrate                                  Triethyl citrate
Polysorbate 80                                    Polysorbate 80
Sodium laurilsulfate                              Sodium laurilsulfate 

Simeticone                                        Simeticone
Gelatin capsule:                                  Gelatin capsule:
Body-                                             Body-
Gelatin                                           Gelatin
Titanium dioxide                                  Titanium dioxide
Black ink                                         Yellow iron oxide
Cap-                                              Brilliant blue FCF – FD&C blue 1 Gelatin                                           Black ink
Titanium dioxide                                  Cap-
Yellow iron oxide                                 Gelatin
Brilliant blue FCF – FD&C                         Titanium dioxide blue 1                                            Yellow iron oxide
Black ink                                         Brilliant blue FCF – FD&C blue 1 Black ink

6.2      Incompatibilities

Not applicable.
6.3   Shelf life
The expiry date of the product is indicated on the packaging material.

6.4   Special precautions for storage

Do not store above 30ºC.
Keep the blisters in the outer carton in order to protect from light.
6.5   Nature and contents of container

120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
240 mg capsules: 56 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal

No special requirements.