SALCROZINE GASTRO-RESISTANT TABLETS

100 tablets
SUMMARY REPORT ON DRUG PROPERTIES

ACTIVE SUBSTANCE

Mesalazine (500 mg per tablet)

WHAT SALCROZINE 500 mg GASTRO-RESISTANT TABLETS IS AND WHAT IT IS USED FOR?

Salcrozine contains mesalazine (also known as 5-aminosalicylic acid), which belongs to a class of medicines called intestinal anti-inflammatory agents. Salcrozine is indicated in the treatment of inflammation caused by inflammatory bowel disease (ulcerative colitis and Crohn’s disease).

HOW TO TAKE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long you need to take this medicine. Do not stop your treatment, even though you may feel better, as your symptoms may appear again if you stop your treatment too early.

Follow your doctor’s instructions carefully regarding how to use this medicine, during both acute inflammatory stages and maintenance treatment.

The recommended dose for adults is:

  • To treat an acute episode of colitis, your doctor will normally prescribe a dose of between 1.5 grams (3 gastro-resistant tablets) and 4 grams (8 gastro-resistant tablets) of mesalazine a day, which can be administered in one or more doses.
  • To help prevent further episodes of colitis, your doctor may prescribe a dose of between 1.5 grams (3 gastro-resistant tablets) and 3 grams (6 gastro-resistant tablets) of mesalazine a day, which may be administered in one or more doses.
  • For Crohn’s disease (acute phase and maintenance of remission): 1.5 g of mesalazine (3 tablets) a day, divided into three doses.

Salcrozine 500 mg gastro-resistant tablets must be administered orally.

The gastro-resistant tablets should be taken before meals and swallowed whole with the aid of some liquid.

Use in children and adolescents

The administration of Salcrozine to children and adolescents under 18 years of age is not recommended due to the lack of safety and efficacy data.

Do not administer in children under the age of 5 years.

Use in elderly patients

Salcrozine should be used with caution in elderly patients and its use should always be limited to patients with normal renal function.

PACKAGING

Alu//Alu blisters in packs containing 100 tablets, oblong (capsule-shaped) salmon-coloured gastro-resistant tablets.

MANNER OF PRESCRIPTION

Prescription only medicine