CORTIMENT MMX PROLONGED RELEASE TABLETS 9 MG

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, FILM COATED, EXTENDED RELEASE

**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.