Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom
Crohn’s disease – Induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon.
Microscopic colitis – Induction of remission in patients with active microscopic colitis
Maintenance of remission in patients with microscopic colitis.
The recommended daily dose for induction of remission is 9 mg once daily in the morning, for up to eight weeks. The full effect is usually achieved within 2–4 weeks.
When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy.
The recommended dose is 9 mg once daily in the morning (corresponding to 3 capsules).
The recommended dose is 6 mg once daily in the morning (corresponding to 2 capsules), or the lowest effective dose.
There are limited data on the use of Entocort CR Capsules in children (see Sections 5.1 and 5.2). The available data are insufficient to support safety and efficacy in the paediatric population, therefore such use cannot be recommended until further data become available.
No special dose adjustment is recommended. However, experience with Entocort CR Capsules in older people is limited.
The capsules should be swallowed whole with water. The capsules must not be chewed.
Reports of acute toxicity or death following overdosage of glucocorticosteroids are rare. Thus, acute overdosage with Entocort CR Capsules even in excessive doses, is not expected to lead to an acute clinical crisis. In the event of acute overdosage, no specific antidote is available. Treatment consists of supportive and symptomatic therapy.
Chronic overdosage may lead to systemic corticosteroid effects, such as Cushingoid features. If such changes occur, the dose of Entocort CR Capsules should be gradually reduced until treatment is discontinued, in accordance with normal procedures for the discontinuation of prolonged oral glucocorticosteroid therapy.
3 years.
Do not store above 30°C.
Store in the original container in order to protect from light/moisture. Replace cap firmly after use. Keep this medicine out of the sight and reach of children.
White polyethylene bottles of 50 or 100 capsules, having either a tamper-evident or child-resistant polypropylene screw cap, with an integral desiccant.
No special requirements. See section 4.2.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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