Salofalk Tablets

Generic Name: Mesalazine
Product Name: Salofalk Tablets

Indication

Salofalk tablets contain an ingredient called mesalazine (5-aminosalicylic acid). This is used to treat inflammatory bowel disease (IBD). IBD can be generally divided into 2 types: ulcerative colitis and Crohn’s disease. Salofalk tablets can be used to treat acute episodes of:

• Mild to moderate ulcerative colitis
• Crohn’s disease

Salofalk tablets can be used as longer term treatment when the both the diseases are under control and inactive.

Action

Mesalazine has been identified as the active component in the treatment of inflammatory bowel disease, specifically ulcerative colitis. The exact method of which it acts is not known. However, mesalazine is thought to act in several ways against the inflammation that happens in the large bowels.

Dose advice

Mesalazine is a prescription-only drug, available in several forms including granules, tablets, suspension enemas and foam enemas. However, only the tablet form will be described here.

Salofalk tablets are used to control the symptoms of inflammatory bowel disease but it does not cure it. Hence, there is no fixed routine onto how long the tablets is to be used. This is all according to the doctor’s advice.

Oral administration

Each tablet contains 500mg of mesalazine.The recommended dose is dependent on the type and severity of the disease. The following are the recommendations:

• Acute ulcerative colitis: 500mg to 1 g 3 times a day.
• Crohn’s disease: 1 to 1.5g three times a day.
• Long term treatment of ulcerative colitis: 500mg 3 times a day.
• Long term treatment of Crohn’s disease: 500mg-1g 3 times a day.

Advice on taking Salofalk tablets

• Tablets should be swallowed whole and with sufficient fluid in the morning, midday and evening (hence, 3 times a day).
• The tablets should be taken at least 1 hour before meal.
• The tablets should be taken regularly and consistently to achieve the desired effect.

Schedule

S4 (prescription only)

Side effects

Common side effects

• Headache;
• Hair loss;
• Abdominal pain;
• Diarrhoea;
• Nausea and vomiting;
• Flatulence;
• Rash;
• Worsening of ulcerative colitis.

Uncommon side effects

The side effects shown below has been reported in surveillance of Salofalk preparations, including both enemas and tablets. However, it is worthwhile to remember that the direct relationship has not been established.

• Fever, feeling generally unwell and tired;
• Allergic reaction;
• Dizziness;
• Abnormal sensations in the body (e.g. numbness or weakness in the arms or legs);
• Inflammation of bodily organs (e.g. pancreas, colon, liver, muscle, heart);
• Impaired hearing;
• Blood problems including low platelets, low red blood cells and low white blood cells leading to infection, tiredness and easy bruising;
• Lung side effects such as spasm of the windpipes in the lungs;
• Skin problems including sensitivity to sunlight, allergic reaction;
• Joint inflammation leading to joint pain and swelling.

References

1. Mims online – Prescribing information for Salofalk Granules and Tablets [online]. 2003 [cited 2005 September 15th]. Available from: [URL Link]
2. Consumer Medicine Information on Salofalk Tablets [online]. 2005. [Cited 2005 September 15th]. Available from: [PDF File]
3. Product Information on Salofalk Tablets. 2005. [Cited 2005 September 15th].

For further information talk to your doctor.