ENTOCORT Dispersible tablet and solution for rectal suspension (2020)
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Περιεχόμενα
1. Name of the medicinal product
Entocort Enema.
2. Qualitative and quantitative composition
0.02 mg/ml budesonide (2 mg budesonide/100 ml). <u>Excipient(s) with known effect:</u> Lactose anhydrous Lactose monohydrate Methyl-parahydroxybenzoate Propyl-parahydroxybenzoate For the full list of ...
3. 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.
4.1. Therapeutic indications
Ulcerative colitis involving rectal and recto-sigmoid disease.
4.2. Posology and method of administration
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. ...
4.3. Contraindications
Hypersensitivity to the active substance 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
Raised plasma concentrations of and enhanced effects of corticosteroids have been reported in women also treated with oestrogens and contraceptive steroids. However, a low-dose combination oral contraceptive ...
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 Enema has no influence on the ability to drive and operate machinery.
4.8. Undesirable effects
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). ...
4.9. Overdose
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. ...
5.1. Pharmacodynamic properties
<b>ATC Code:</b> A07EAO6 Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. Paediatric population A 4-week single-blind, randomized, reference-controlled, parallel-group study ...
5.2. Pharmacokinetic properties
The mean maximal plasma concentration after rectal administration of 2 mg budesonide is 3 nmol/L (range 1–9 nmol/L), reached within 1.5 hours. Budesonide undergoes an extensive degree (~90%) of biotransformation ...
5.3. Preclinical safety data
Results from acute, subacute and chronic toxicity studies show that the systemic effects of budesonide, e.g. decreased body-weight gain and atrophy of lymphoid tissues and adrenal cortex, are less severe ...
6.1. List of excipients
<u>Tablet:</u> Lactose anhydrous Riboflavine sodium phosphate (E101) Lactose monohydrate Polyvidone Colloidal anhydrous silica Magnesium stearate <u>Vehicle:</u> Sodium chloride Methyl parahydroxybenzoate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
See section 4.2.
7. Marketing authorization holder
Tillotts Pharma UK Limited., Wellingore Hall, Wellingore, Lincolnshire, LN5 0HX, United Kingdom
8. Marketing authorization number(s)
PL 36633/0007
9. Date of first authorization / renewal of the authorization
4<sup>th</sup> June 2002
10. Date of revision of the text
November 2020
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