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CORTIMENT PROLONGED RELEASE TABLETS 9 MG [SIN15311P]

Active ingredients: CORTIMENT PROLONGED RELEASE TABLETS 9 MG

Last updated 26 October 2025

Product Info

CORTIMENT PROLONGED RELEASE TABLETS 9 MG

[SIN15311P]

Product information

Active Ingredient and Strength

(TABLET CORE) BUDESONIDE MICRONIZED - 9 MG

Dosage Form

TABLET, FILM COATED, EXTENDED RELEASE

Manufacturer and Country

COSMO SPA - ITALY

Registration Number

SIN15311P

Licence Holder

FERRING PHARMACEUTICALS PRIVATE LIMITED

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A07EA06

THERAPEUTIC INDICATIONS
Budesonide (CORTIMENT) is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient.

POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks.

When treatment is discontinued, it may be useful to gradually reduce the dose (for more details on treatment discontinuation, see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of Budesonide (CORTIMENT) tablets in children aged 0–18 years have not yet been established. No data are available, therefore the use in paediatric population is not recommended until further data become available.

Elderly
No special dose adjustment is recommended. However, experience of the use of Budesonide (CORTIMENT) in the elderly is limited.

Hepatic and renal impairment population
Budesonide (CORTIMENT) 9 mg was not studied in patients with hepatic and renal impairment, therefore caution should be exercised in the administration and monitoring of the product in these patients (see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
One tablet of Budesonide (CORTIMENT) 9 mg is taken orally in the morning, with or without food. The tablet should be swallowed with a glass of water and must not be broken, crushed or chewed as the film coating is intended to ensure a prolonged release.

CONTRAINDICATIONS
Hypersensitivity to the active substance, lecithin (derived from soya oil, peanut oil) or any of the excipients listed in section LIST OF EXCIPIENTS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.