Regulatory Information
FERRING PHARMACEUTICALS PRIVATE LIMITED
FERRING PHARMACEUTICALS PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET
**POSOLOGY AND METHOD OF ADMINISTRATION** Posology: **Ulcerative colitis** Treatment of active disease: Adults: Individual dosage, up to 4 g daily in divided doses. Children 6 years of age and older: Individual dosage, usually 20–30 mg/kg bodyweight daily in divided doses. Maintenance treatment: Adults: Individual dosage, usually 2 g daily in divided doses. Children 6 years of age and older: Individual dosage, usually 20–30 mg/kg bodyweight daily in divided doses. **Crohn’s disease** Treatment of active disease and maintenance treatment: Adults: Individual dosage, up to 4g daily in divided doses. Children 6 years of age and older: Individual dosage, usually 20–30 mg/kg bodyweight daily in divided doses. Paediatric population: There is only limited documentation for an effect in children (age 6–18 years). Method of administration: PENTASA® tablets must not be chewed. To facilitate swallowing, the tablets may be dispersed in 50 ml of cold water. Stir and drink immediately.
ORAL
Medical Information
**THERAPEUTIC INDICATIONS** Treatment of ulcerative colitis and Crohn’s disease.
**CONTRAINDICATIONS** Hypersensitivity to mesalazine, any of the excipients, or salicylates. Severe liver or renal impairment.
A07EC02
mesalazine
Manufacturer Information
FERRING PHARMACEUTICALS PRIVATE LIMITED
Ferring International Center SA
Pharbil Pharma GmbH
Active Ingredients
Documents
Package Inserts
Pentasa PR Tablets PI.pdf
Approved: May 24, 2023