Regulatory Information
FERRING PHARMACEUTICALS PRIVATE LIMITED
FERRING PHARMACEUTICALS PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
GRANULE, DELAYED RELEASE
**POSOLOGY AND METHOD OF ADMINISTRATION** **Posology:** **Ulcerative colitis** Treatment of active disease: Adults: Individual dosage, up to 4 g given once daily or in divided doses. Paediatric population: There is only limited documentation for an effect in children (age 6–18 years). **Method of administration:** PENTASA® granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately.
ORAL
Medical Information
**THERAPEUTIC INDICATIONS** Treatment of mild to moderate ulcerative colitis.
**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
Active Ingredients
Documents
Package Inserts
Pentasa PR Granules 2g PI.pdf
Approved: May 24, 2023