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HSA Approval

PENTASA PROLONGED RELEASE TABLETS 1G

SIN14479P

PENTASA PROLONGED RELEASE TABLETS 1G

PENTASA PROLONGED RELEASE TABLETS 1G

January 9, 2014

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

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

Mesalazine

1000 mg

Mesalazine

Documents

Package Inserts

Pentasa PR Tablets PI.pdf

Approved: May 24, 2023

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