ENTOCORT CR Capsule (2019)

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Περιεχόμενα

1. Name of the medicinal product

Entocort CR 3 mg Capsules.

2. Qualitative and quantitative composition

Each capsule contains budesonide 3 mg. Excipient(s) with known effect: Sucrose. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard gelatin capsules for oral administration with an opaque, light grey body and opaque, pink cap marked CIR 3mg in black radial print. Each capsule contains budesonide 3 mg as gastro-resistant, prolonged-release ...

4.1. Therapeutic indications

Crohns disease Induction of remission in patients with mild to moderate active Crohns disease affecting the ileum and/or the ascending colon. Microscopic colitis Induction of remission in patients with ...

4.2. Posology and method of administration

Posology Adults Active Crohns disease 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. ...

4.3. Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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. ...

4.5. Interaction with other medicinal products and other forms of interaction

Although not studied, concomitant administration of colestyramine may reduce Entocort uptake, in common with other drugs. Raised plasma concentrations of and enhanced effects of corticosteroids have been ...

4.6. Pregnancy and lactation

Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, in mice, budesonide and/or its metabolites have been shown to cross the placenta. In pregnant animals, ...

4.7. Effects on ability to drive and use machines

Entocort CR Capsules have no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Tabulated list of adverse events 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 ...

4.9. Overdose

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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids acting locally ATC code: A07EA06 Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. The exact mechanism of budesonide ...

5.2. Pharmacokinetic properties

Absorption After oral dosing of plain micronised compound, absorption is rapid and seems to be complete. A large proportion of the drug is absorbed from the ileum and ascending colon. Systemic availability ...

5.3. Preclinical safety data

Results from acute, subacute and chronic toxicity studies show that the systemic effects of budesonide are less severe or similar to those observed after administration of other glucocorticosteroids, e.g. ...

6.1. List of excipients

Ethylcellulose Tributyl acetylcitrate Methacrylic acid copolymer Triethylcitrate, Antifoam M Polysorbate 80 Talc Sucrose Maize starch Gelatine Titanium dioxide (E171) Iron oxide (E172)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

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.

6.5. Nature and contents of container

White polyethylene bottles of 50 or 100 capsules, having either a tamper-evident or child-resistant polypropylene screw cap, with an integral desiccant.

6.6. Special precautions for disposal and other handling

No special requirements. See section 4.2. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

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

8. Marketing authorization number(s)

PL 36633/0006

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 31st January 1996 Date of latest renewal: 4th June 2002

10. Date of revision of the text

17 October 2019

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