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ENTOCORT Enema (2020)

Active ingredients: Budesonide

Product name and form

Entocort Enema.

Pharmaceutical Form

Dispersible tablet and solution for rectal suspension.

Each Entocort enema consists of 2 components:

  • A 2.3 mg faintly yellow, circular biconvex tablet.
  • A 115 ml clear colourless solution.

Qualitative and quantitative composition

0.02 mg/ml budesonide (2 mg budesonide/100 ml).

Excipient(s) with known effect:

  • Lactose anhydrous
  • Lactose monohydrate
  • Methyl-parahydroxybenzoate
  • Propyl-parahydroxybenzoate

For the full list of excipients, see section 6.1.

Active Ingredient
Description
Budesonide

Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At doses clinically equivalent to systemically acting glucocorticosteroids, budesonide gives significantly less HPA axis suppression and has a lower impact on inflammatory markers.

List of Excipients

Tablet:

Lactose anhydrous
Riboflavine sodium phosphate (E101)
Lactose monohydrate
Polyvidone
Colloidal anhydrous silica
Magnesium stearate

Vehicle:

Sodium chloride
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Water purified

Pack sizes and marketing

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.

Marketing Authorization Holder
Authorization Dates

Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom

4th June 2002

Marketing authorization number:

PL 36633/0007

Drugs

Drug
Countries
ENTOCORT
Austria, Canada, France, Netherlands, United Kingdom