ENTOCORT ENEMA

1 Dosing Considerations Not Applicable. 3 Pediatrics). 3 Reconstitution ENTOCORT ENEMA (budesonide dispersible tablets) is reconstituted by adding one dispersible tablet into the enema bottle, whereafter the bottle is vigorously shaken for at least 15 seconds or until the tablet is completely dissolved.

The tablet will disintegrate rapidly and the suspension will turn slightly yellowish. 4 Administration One ENTOCORT ENEMA retention enema is given nightly to the patient for 4 weeks. If the patient is not in remission after 4 weeks, the treatment period may be prolonged to 8 weeks.

5 Missed Dose If a dose of ENCOCORT ENEMA is missed, patients should be instructed not to take the missed dose but to resume dosing with the next scheduled dose. ENTOCORT® ENEMA (Budesonide dispersible tablets) Page 5 of 26

1 Adverse Reaction Overview Known corticosteroid-related systemic adverse effects include, but are not limited to, hypercorticism, adrenal suppression, immunosuppression, decreased bone mineral density, cataract, glaucoma, growth retardation, and rarely psychiatric/behavioral effects.

These side effects often depend on the dosage, and duration of treatment (see 7 WARNINGS AND PRECAUTIONS). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. No major side effects attributable to the use of ENTOCORT ENEMA (budesonide) have been reported.

During clinical trials, the frequency of subjectively reported side effects in a total of 247 patients and healthy volunteers given 2 mg budesonide, once daily in the morning, was low. , flatulence, nausea, diarrhoea. These symptoms were reported in 23 of the 247 patients (9%) receiving 2 mg of budesonide.

Psychiatric symptoms (insomnia, agitation, anxiety, depression, dysphoria, emotional ENTOCORT® ENEMA (Budesonide dispersible tablets) Page 9 of 26 lability, somnolence) were reported in 7 patients (3%) receiving 2 mg budesonide. Skin reactions (rash, urticaria) occurred in 5 patients (2%).

Systemic effects of budesonide on the HPA-axis function were found to be dose-dependent. In rare cases, signs or symptoms of systemic glucocorticosteroid effects, including hypofunction of the adrenal gland, may occur with rectally administered glucocorticosteroids, probably depending on dose, treatment time, concomitant and previous glucocorticosteroid intake, and individual sensitivity.

, Hypersensitivity 03/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 4 DOSAGE AND ADMINISTRATION ................................................................................. 4 5 OVERDOSAGE..............................................................................................................

5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 8 8 ADVERSE REACTIONS ..................................................................................................

9 9 DRUG INTERACTIONS .................................................................................................. 10 10 CLINICAL PHARMACOLOGY .......................................................................................

10 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 12 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 12 PART II: SCIENTIFIC INFORMATION .......................................................................................

Budesonide dispersible tablets are contraindicated for the following: • Imminent bowel perforation as well as the probability of obstruction, abscess or other pyogenic infection, fresh intestinal anastomoses, extensive fistulas and sinus tracts.

• Systemic or local bacterial, fungal or viral infections (see 7 WARNINGS AND PRECAUTIONS, Immune). • In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Active tuberculosis.