CORTIMENT Prolonged release tablet Ref.[116526] Active ingredients: Budesonide

Posology

Adults

Ulcerative colitis and microscopic colitis

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 4.4).

Paediatric population

The safety and efficacy of 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 Cortiment in the elderly is limited.

Hepatic and renal impairment population

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.

Method of administration

One tablet of 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.

Due to the low systemic availability of Cortiment tablets, acute overdosage even at very high doses is not expected to lead to an acute clinical crisis. In the event of acute overdosage, no specific antidote is available. Treatment consists of supportive and symptomatic therapy.

3 years.

Store below 30°C.

The tablets are packaged in polyamide/ aluminium/PVC foil blister packs with aluminium push through foil, contained in a cardboard carton.

Packs contain 10, 20, 30, 50, 60 or 80 tablets. Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.