4.1. Therapeutic indications

Local treatment of ulcerative colitis.

4.2. Posology and method of administration

Adults (including the elderly):

One dose (20 mg) each night for 2-4 weeks, the course may be extended when a good response is obtained.

Children (under 12):

Not recommended.

For rectal administration only.

4.3. Contraindications

In local conditions where use might mask infection or impair healing, such as peritonitis, sinus infection, fistulae, intestinal obstruction, perforation of the bowel. Hypersensitivity to any of the ingredients.

4.4. Special warnings and precautions for use

Symptoms of adrenal insufficiency have not been reported, but prolonged therapy should be carefully monitored. Prolonged continuous use is not recommended. Use with caution in patients with intestinal obstruction.

Scleroderma renal crisis

Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone. Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

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

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

4.6. Pregnancy and lactation

Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established.

However, physicians should be aware of the possibility of teratogenic effects, and also of potential suppression of the HPA axis, and should weigh up the risk/benefit ratio before using the medicinal product n pregnancy.

If treatment is instituted, the minimum dosage and frequency of administration required for clinical control should be employed, and prolonged usage should be avoided.

4.7. Effects on ability to drive and use machines

None stated.

4.8. Undesirable effects

Administration of prednisolone via this route, for this indication, is seldom associated with adverse effects. The consequence of systemic absorption (e.g. suppression of the HPA axis) should be considered if the medicinal product is used extensively over prolonged periods. As with all rectal corticosteroids, prolonged continuous use is undesirable. Possible adverse events include osteoporosis, peptic ulceration, ocular hypertension, subcapsular cataract, pancreatic disturbances and myopathy.

Frequency 'unknown': Scleroderma renal crisis*, bradycardia** , vision, blurred (see also section 4.4).

*see section c) **following high doses

c) Scleroderma renal crisis

Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Overdose is not likely with this route of administration.