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PENTASA PROLONGED RELEASE TABLETS 1G [SIN14479P]
Active ingredients: PENTASA PROLONGED RELEASE TABLETS 1G
Product Info
PENTASA PROLONGED RELEASE TABLETS 1G
[SIN14479P]
Product information
Active Ingredient and Strength | MESALAZINE - 1,000 MG |
Dosage Form | TABLET |
Manufacturer and Country | FERRING INTERNATIONAL CENTER SA - SWITZERLAND |
Registration Number | SIN14479P |
Licence Holder | FERRING PHARMACEUTICALS PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A07EC02 |
THERAPEUTIC INDICATIONS
Treatment of ulcerative colitis and Crohn’s disease.
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.
CONTRAINDICATIONS
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver or renal impairment.
