Salofalk


Brand Other Names Presentation Strengths Enquire
Salofalk ® mesalazine, 5-ASA Enema 4 g/60 mL x 7
Enema 2 g/60 mL x 7
Tablets 500 mg x 100 tablets
Granules 500 mg x 100 sachets
Granules 1.5 g x 60 sachets
Granules 1 g x 100 sachets
Foam enema 1 g/application; sufficient for 14 applications
Suppositories 1 g x 30 suppositories

TGA indication

SALOFALK tablets are indicated in the treatment of acute episodes and maintenance of remission of:

i. Mild to moderate ulcerative colitis and;
ii. Crohn’s ileitis and colitis.

SALOFALK granules are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance of remission and/or the long term treatment of ulcerative colitis.

SALOFALK foam enemas are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis 

SALOFALK enemas are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.

SALOFALK suppositories are indicated in the treatment of ulcerative proctitis.
PBS listing

TABLETS (500mg) : Authority required (STREAMLINED)

  • 1708 Ulcerative colitis where hypersensitivity to sulfonamides exists;
  • 1709 Ulcerative colitis where intolerance to sulfasalazine exists;
  • 2268 Crohn's disease where hypersensitivity to sulfonamides exists;
  • 2269 Crohn's disease where intolerance to sulfasalazine exists.

GRANULES (500mg, 1g, 1.5g) : Authority required (STREAMLINED)

  • 1708 Ulcerative colitis where hypersensitivity to sulfonamides exists;
  • 1709 Ulcerative colitis where intolerance to sulfasalazine exists.

Note: Not for the treatment of Crohn's disease.

ENEMAS (2g in 60 ml, 4g in 60ml) and FOAM ENEMAS (14 applications/can) : Authority  required (STREAMLINED)

  • 1707 Acute episode of mild to moderate ulcerative colitis. Note: Not for the treatment of Crohn's disease.
Information for Patients
Consumer Medicine Information (oral)

Salofalk tablets CMI

Salofalk granules CMI 

Consumer Medicine Information (rectal)

Salofalk Enemas CMi

Salofalk Foam Enemas CMI

Saofalk Suppositories CMI

 


Information for Healthcare Professionals
Product Information (oral)

Salofalk tablets PI

Salofalk granules PI

Product Information (rectal)

Salofalk Enema PI

Salofalk Foam Enema PI

Salofalk Suppository PI.pdf