The new enteric coated tablet Salofalk, mainly composed of mesalazine (the main active ingredient), has good therapeutic effects on mild to moderate ulcerative colitis and Crohn's disease (ileitis, colitis).

1、 Drug name

1. Product Name: SALOFALK

2. Common name: Mesalazine enteric coated tablets

3. English name: Mesalazineentericcoatedables

2、 Indications

1. Acute exacerbation and maintenance remission treatment of mild to moderate ulcerative colitis.

2. Treatment of Crohn's disease with ileitis and colitis.

3、 Specifications and characteristics

SALOFALK500mg: Butter to ochre colored, long oval enteric coated tablets.

4、 Main components

Active ingredient: Mesalazine.

5、 Usage and dosage

1. Adults and seniors:

Acute phase of ulcerative colitis: Take 1.5-3g daily, divided into 1-3 doses.

Acute stage of Crohn's disease: Take 3-4.5g daily, divided into 1-3 doses.

Maintenance treatment: Ulcerative colitis 1.5g per day; Crohn's disease 1.5-3g per day.

2. Children (over 6 years old, ulcerative colitis):

Acute phase: 30-50mg/kg body weight per day.

Maintenance period: 15-30mg/kg body weight per day.

For individuals weighing ≤ 40kg, adult half dose can be used, while for those weighing>40kg, adult full dose can be used. The total daily dose should not exceed the maximum adult dose.

6、 Dose adjustment

There are no special dosage adjustment instructions, but adjustments should be made based on the severity of the disease and individual response.

7、 Medication precautions

1. Medication time: The whole tablet should be swallowed at least 1 hour before meals, and should not be chewed or crushed.

2. Omission of medication: No clear instructions, it is recommended to take medication regularly to maintain the therapeutic effect.

3. Vomiting/Diarrhea: If severe gastrointestinal reactions or suspected intolerance (such as abdominal pain, fever, rash) occur, medication should be stopped immediately and medical attention sought.

4. Other: Blood routine and liver and kidney function should be regularly monitored during treatment.

8、 Medication for special populations

1. Children: Prohibited for children under 6 years old (ulcerative colitis); Prohibited for children under 12 years old (Crohn's disease).

2. Elderly: available, but clinical data is limited.

3. Pregnant women: Use only when the benefits outweigh the risks.

4. Breastfeeding period: Not recommended unless the therapeutic benefits outweigh the potential risks. If a baby experiences diarrhea, medication should be suspended and a doctor consulted.

5. Individuals with liver and kidney dysfunction: It is contraindicated for those with severe liver and kidney dysfunction; Mild to moderate patients should use caution and closely monitor.

9、 Adverse reactions

1. Common symptoms (≥ 1% -<10%) include headache, abdominal pain, diarrhea, nausea, vomiting, indigestion, bloating, worsening of ulcerative colitis, rash, etc.

2. Rare but serious adverse reactions include: abnormal blood system, liver and kidney function damage, pancreatitis, myocarditis/pericarditis, severe skin reactions (such as DRESS, SJS, TEN), idiopathic intracranial hypertension, etc.

10、 Contraindications

1. People who are allergic to salicylic acid or its derivatives (such as mesalazine).

2. Individuals with severe liver dysfunction.

3. Individuals with severe renal insufficiency.

11、 Drug interactions

1. Possible interactions with other drugs, including anticoagulants (such as warfarin), glucocorticoids, sulfonylureas, methotrexate, probenecid/sulfonylurea, spironolactone/furosemide, rifampicin, etc.

2. When used together, caution should be exercised and relevant indicators should be monitored.

12、 Storage method

Store below 25 ° C in a dry and dark place.

13、 Manufacturer

DrFalkPharma Australia PtyLtd, Australia.

Salofalkinformation