Entocort® (budesonide) CR 3 mg Gastro-Resistant Hard Capsules

Ireland

Hard gelatin capsules with an opaque, light grey body and opaque, pink cap, marked CIR 3 mg each containing budesonide 3 mg.

INDICATIONS: Crohn’s disease: Induction of remission in mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon.
Active microscopic colitis: Induction of remission in active microscopic colitis, and maintenance treatment of severe, recurrent microscopic colitis.

DOSAGE AND ADMINISTRATION: Oral use. Swallow whole with water, do not chew. Use lowest effective dose. When discontinuing, reduce dose for last 2 to 4 weeks.

Adults: Active Crohn’s disease: 9 mg once daily in the morning, for up to eight weeks. Effect is usually achieved within 2 to 4 weeks. Entocort can be used for up to 3 months: 6 mg, once daily in the morning. Long-term use is not recommended. To replace prednisolone in steroid-dependent patients, 6 mg once daily in the morning. Prednisolone dose should be tapered. To prevent recurrence after surgery in patients with high disease activity: 6 mg once daily in the morning. No benefit shown in post surgical patients with obstructive fibrostenotic Crohn’s disease.

Active microscopic colitis: Induction of remission: 9 mg once daily in the morning for up to 8 weeks. Maintenance of remission of MC in patients who have already had a recurrence after discontinuation of induction therapy: 6 mg once daily in the morning or the lowest effective dose.

Elderly: As for adults. Experience is limited.  Children: Not recommended.

CONTRAINDICATIONS: Hypersensitivity to active or excipients.

PRECAUTIONS AND WARNINGS:

Systemic corticosteroid effects may occur, including glaucoma. Monitor for visual disturbance caused by e.g. cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).

Monitor for infections.

Caution in: patients with reduced liver function; patients with infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or family history of diabetes or glaucoma or any condition where glucocorticosteroids may have unwanted effects; patients with severe affective disorders (or family history), including depressive or manic-depressive illness and previous steroid psychosis; patients not immune to chicken pox and measles. If exposed, consider immunoglobulin therapy, or antiviral agents. Contains sucrose. Caution when transferring from another glucocorticosteroid to Entocort CR Capsules, monitor adrenocortical function and unmasked allergies. During surgery or other stress situations, supplementary glucocorticoid treatment is recommended. On discontinuation, reduce dose over 2 to 4 weeks, monitor for withdrawal effects, adjust dose if necessary. Coadministration of CYP3A inhibitors is expected to increase side effects: avoid/monitor (see interactions). With chronic high doses, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may occur, and very rarely psychiatric/behavioural effects. Contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. This product is essentially ‘sodium-free’. Children: not recommended. If used monitor child’s growth, evaluate risk-benefit. Long-term studies have not been performed.

INTERACTIONS: CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, HIV protease inhibitors and grapefruit juice) can increase systemic budesonide, The combination should be avoided, but if not possible, the period between treatments should be as long as possible and a reduction of the budesonide dose could also be considered. CYP3A4 inducers (e.g. carbamazepine) may reduce budesonide levels, which may require a dose increase. Colestyramine may reduce Entocort uptake. Raised levels/effects of corticosteroids reported with oestrogens and contraceptive steroids. At recommended doses, omeprazole does not affect the pharmacokinetics of oral budesonide whereas cimetidine has a slight but clinically insignificant effect. Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).

USE DURING PREGNANCY AND LACTATION: Pregnancy: Associated with foetal abnormalities in animals; consider risk-benefit. Breast-feeding: Budesonide is excreted in breast milk; at therapeutic doses, exposure to breast-fed infants anticipated to be low.

UNDESIRABLE EFFECTS: Common (≥1/100 to < 1/10): Cushingoid features, hypokalemia, behavioural changes such as nervousness, insomnia, mood swings, and depression, palpitations, dyspepsia, skin reactions (urticaria, exanthema), muscle cramps, menstrual disorders; Uncommon (≥ 1/1,000 to < 1/100):  Anxiety, tremor, psychomotor hyperactivity. Rare (≥1/10,000 to <1/1,000): Aggression, blurred vision, glaucoma, cataract, ecchymosis. Very rare (< 1/10,000): Anaphylactic reaction, growth retardation. Frequency unknown: Hypersensitivity reactions such as angioedema.

Systemic corticosteroid effects may occur depending on dose, duration, concomitant and previous corticosteroid intake and individual sensitivity. Refer to Summary of Product Characteristics.

LEGAL CATEGORY: POM. MA No: PA2018/003/001.

MA HOLDER: TILLOTTS PHARMA GmbH, Warmbacher Strasse 80, 79618 Rheinfelden, Germany DATE OF PREPARATION: September 2025. ADDITIONAL INFORMATION IS AVAILABLE ON REQUEST FROM THE MARKETING AUTHORISATION HOLDER OR FROM TILLOTTS PHARMA LIMITED, SPACES, 1ST FLOOR BUILDING 2, THE GREEN, DUBLIN AIRPORT CENTRAL, DUBLIN AIRPORT, SWORDS, COUNTY DUBLIN, K67 E2H3. Tel:(00 353 1) 294 2015. Entocort® is a trademark.