Pharmaceutical particulars : מידע רוקחי

  6.    PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dimethyl fumarate Teva 120mg                               Dimethyl fumarate Teva240mg Dimethyl fumarate                                      Dimethyl fumarate Silicified Microcrystalline cellulose                      Silicified Microcrystalline cellulose Methacrylic acid and ethyl acrylate copolymer     Methacrylic acid and ethyl acrylate copolymer dispersion                                         dispersion persion
Croscarmellose sodium                                  Croscarmellose sodium Methacrylic acid copolymer, Type A                     Methacrylic acid copolymer, Type A Talc                                                   Talc

Triethyl citrate                                       Triethyl citrate Colloidal Silicon Dioxide                              Colloidal Silicon Dioxide Magnesium stearate                                     Magnesium stearate 
Gelatin capsule:                                       Gelatin capsule: Body-                                                  Body-
Gelatin                                                Gelatin
Titanium dioxide                                       Titanium dioxide FD&C blue 1
FD&C red 3
FD&C red 40
Cap-                                                   Cap-
Gelatin                                                Gelatin
Titanium dioxide                                       Titanium dioxide FD&C blue 1                                            FD&C blue 1
FD&C red 3                                             FD&C red 3
FD&C red 40                                            FD&C red 40

Black ink (Shellac, black iron oxide, propylene glycol, strong ammonium solution, potassium Hydroxide)

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 25°C.
This medicine can be used for up to 90 days after first opening the bottle, but no later than the expiry date that appears on the package.


     6.5   Nature and contents of container

120 mg capsules: 14 capsules in HDPE bottle packs.
240 mg capsules: 60 capsules in HDPE bottle packs.
Not all product strengths 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.         MA HOLDER

Teva Israel Ltd.,
124 Devora Ha’Nevi’a St.,
Tel Aviv 6944020.