ENTOCORT ENEMA

Posology Adults:

One Entocort Enema nightly for 4 weeks. Full effect is usually achieved within 2–4 weeks. If the patient is not in remission after 4 weeks, the treatment period may be prolonged to 8 weeks.

Paediatric population Children:

Not recommended. Elderly Dosage as for adults. No dosage reduction is necessary in patients with reduced liver function. Method of administration The route of administration is rectal. Instructions for correct use of Entocort enema. Entocort enema consists of a dispersible tablet, a vehicle in a bottle and an individually packed nozzle for the application of the enema.

Note: it is important to instruct the patient • To carefully read the instructions for use in the patient information leaflet which are packed together with each product. • To reconstitute the enema immediately before use, put one dispersible tablet into the vehicle bottle, then shake the bottle vigorously for at least 15 seconds or until the tablet is completely dissolved.

• To administer in the evening before going to bed.

The following definitions apply to the incidence of undesirable effects:

Very Common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000). , flatulence, nausea, diarrhoea Uncommon Duodenal or gastric ulcer Gastrointestinal disorders Rare Pancreatitis Common Skin reactions (urticaria, exanthema)Skin and subcutaneous tissue disorders Rare Ecchymosis Musculoskeletal and connective tissue disorders Rare Osteonecrosis Most of the adverse events mentioned in this SmPC can also be expected for other treatments with glucocorticoids.

Description of selected adverse events 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.

Very rarely a wide range of psychiatric/ behavioural effects may occur, when systemic steroids are prescribed at high doses and for prolonged periods. 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk or search for MHRA Yellow Card in the Google Play or Apple App.

Side effects typical of systemic corticosteroids may occur. Potential systemic effects include glaucoma. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

When patients are transferred from systemic glucocorticosteroid treatment with higher systemic effect to Entocort enema, they may have adrenocortical suppression. Therefore, monitoring of adrenocortical function may be considered in these patients and their dose of systemic steroid should be reduced cautiously.

g. rhinitis and eczema, which were previously controlled by the systemic drug. Reduced liver function affects the elimination of glucocorticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects.

The pharmacokinetics after oral ingestion of budesonide was affected by compromised liver function as evidenced by increased systemic availability in patients with moderately severe hepatic cirrhosis. Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or their first degree relatives.

8). Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods. 8). Co-treatment with CYP3A inhibitors, including ketoconazole and cobicistat- containing products, is expected to increase the risk of systemic side-effects.

The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. 5). Entocort enema contains the excipients lactose and methyl-, propyl- parahydroxybenzoate, therefore caution should be taken in patients with hypersensitivity to these excipients.

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