Consumer medicine information

1. Why am I using SALOFALK tablets?

SALOFALK tablets contain the active ingredient mesalazine (5-aminosalicylic acid). SALOFALK tablets are used to treat, and prevent relapses of mild to moderate attacks of ulcerative colitis (inflammation of the large bowel) and Crohn's ileitis and colitis (inflammation of the large bowel and last section of the small bowel).
For more information, see Section 1. Why am I using SALOFALK tablets? In the full CMI.

2. What should I know before I use SALOFALK tablets?

Do not use if you have ever had an allergic reaction to SALOFALK tablets or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use SALOFALK tablets? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SALOFALK tablets and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SALOFALK tablets?

Adults and elderly:

• For acute attacks of ulcerative colitis, take 1.5 g to 3 g SALOFALK tablets once a day or in 2-3 divided doses.

• For acute attacks of Crohn's ileitis and colitis take 3 g to 4.5 g SALOFALK tablets once a day or in 2-3 divided doses.

• For long term treatment of ulcerative colitis take 1.5 g SALOFALK tablets once a day or in 2-3 divided doses.

• For long term treatment of Crohn's ileitis and colitis take 1.5 g to 3 g SALOFALK tablets once a day or in 2-3 divided doses.

• The dose of SALOFALK tablets depends on disease severity and body weight. Your doctor will tell you how much SALOFALK tablets your child should take.

5. What should I know while using SALOFALK tablets?

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually mild and temporary. The most common side effects using SALOFALK tablets are: headache, mild stomach pains, excessive gas in the stomach or bowel, increased number of bowel motions, diarrhoea, nausea and vomiting, rash or itchy skin. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Salofalk mesalazine enteric coated tablets. Mesalazine.

2 Qualitative and Quantitative Composition

Salofalk Tablets contain either 500 mg or 1 g mesalazine, as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.
Excipients with known effect in Salofalk 500 mg tablets. Each tablet contains 49 mg of elemental sodium.
See Section 4.4 Special Warnings and Precautions for Use.

3 Pharmaceutical Form

Salofalk Tablets have a functional coating, which ensures gastro-resistance to allow a reliable distribution and pH-dependent release of the active ingredient, mesalazine, at the intended site of action starting in the ileocaecal region.
Salofalk 500 mg enteric coated tablets are presented as butter-yellow to ochre, oblong tablets.
Salofalk 1 g enteric coated tablets are presented as yellow to ochre, oblong tablets.

4 Clinical Particulars

4.9 Overdose

There are rare data on overdosage (e.g. intended suicide with high oral doses of mesalazine), which do not indicate renal or hepatic toxicity.
Possible symptoms may include nausea, vomiting, diarrhoea and symptoms similar to salicylate overdose.
There is no specific antidote. General supportive and symptomatic measures are recommended.
For advice on the management of overdosage, please contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There was no evidence of genotoxic potential with mesalazine in bacterial gene mutation assays, of chromosomal damage in mouse haematopoietic cells following a single oral dose, or of increases in sister chromatid exchange frequencies in Chinese hamster bone marrow following a single intraperitoneal dose.
Carcinogenicity. There was no evidence of carcinogenicity in rats treated with mesalazine in the diet for 127 weeks at doses up to 320 mg/kg/day, associated with plasma concentrations of mesalazine and N-acetyl-5-ASA of 1 and 6-fold the respective clinical plasma concentrations associated with a 1500 mg dose of the granules and 4 g/60 mL enema.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Mesalazine is a white to greyish, voluminous powder, slightly pink in colour. It is practically insoluble in ethanol (90%), methanol (70%), water, ether, and chloroform; soluble in HCl (warmed 10% solution), soluble in NaOH (10% solution, with salt formation).
Proper name: 5-Aminosalicylic Acid, chemical name: 2-hydroxy-5-aminobenzoic acid, also referred to as 5-amino salicylic acid or 5-ASA. C₇H₇NO₃ = 153.1.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMESALA.gif CAS number. 89-57-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SALTABST.gif