ENTOCORT Dispersible tablet and solution for rectal suspension Ref.[27517] Active ingredients: Budesonide

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.

Reports of acute toxicity and/or death following overdosage of glucocorticosteroids are rare. Thus, acute overdosage with Entocort Enema, even in excessive doses, is not expected to be a clinical problem. In the event of acute overdosage, no specific antidote is available. If, by mistake, high doses of Entocort dispersible tablet have been taken orally, treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.

24 months.

Do not store above 30°C.

Entocort Enema 0.02 mg/ml consists of 2 components: A dispersible tablet and a vehicle.

The primary package for the tablets is an aluminium blister package consisting of polyamide 25 μm/Al ≥41 μm/polyvinylchloride 60 μm/A1 20 μm.

The primary package for the vehicle is a low density polyethylene (LDPE) bottle equipped with a high density polyethylene (HDPE) cap. Individually packaged nozzles (enema applicators) with non-return valves, both made of thermoplastic rubber.

Pack Size: each carton contains 7 tablets, 7 vehicle solutions, 7 nozzles (enema applicators), and 7 plastic bags to be used when giving the enema.

See section 4.2.