PREDNISOLONE 20 MG / 100ML RECTAL SOLUTION, PREDENEMA - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

PREDENEMA

Prednisolone 20 mg/100 ml Rectal Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 100ml enema contains 35mg prednisolone metasulphobenzoate sodium equivalent to prednisolone 20mg.

3 PHARMACEUTICAL FORM

Rectal Solution

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Local treatment of ulcerative colitis.

4.2 Posology and method of administration

Adults                     ­One dose (20 mg) each night for 2–4 weeks, the

(including the elderly):      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.

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 in 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

*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 Y ellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Overdose is not likely with this route of administration.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Prednisolone 21-sodium metasulphobenzoate has the general properties of prednisolone as a potent anti-inflammatory agent with immuno-suppressant glucocorticoid properties. Esterification of prednisolone at the 21 position increases the topical activity of the drug.

5.2 Pharmacokinetic properties

Following rectal administration of prednisolone 21-sodium metasulphobenzoate in the form of an enema, the action of the drug is predominantly local. The peak plasma levels obtained following this treatment are significantly lower than those obtained following treatment with prednisolone 21-phosphate.

Following absorption, the drug is hydrolysed to m-sulphobenzic acid (and salts) and free prednisolone.

At the low plasma levels obtained, following rectal administration of prednisolone 21-sodium metasulphobenzoate the precautions generally applied to the use of prednisolone are considered to be unnecessary.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium Edetate Ph.Eur., Nipastat and Purified Water Ph. Eur.

6.2 Incompatibilities

None stated.

6.3 Shelf life

12 months.

6.4 Special precautions for storage

Store below 25°C, protected from light.

6.5 Nature and contents of container

Presentation: a ready to use, single dose, disposable plastic bag or EVA bottle, with prelubricated PVC nozzle, containing 100ml of solution. A version with an extension tube is available for those patients who may find it helpful.

6.6 Special precautions for disposal

Before use the patient should lie in bed on their side with knees drawn up.

The product may be administered at room temperature, or warmed in warm water before use.

Bag: Hold the bag with tube upwards, squeeze base of tube where it joins the bag. Remove cap and lubricate tube before inserting into rectum. Squeeze gently until fluid is dispelled, and discard bag hygienically.

Bottle: Keeping bottle upright, remove blue protective cap. Insert nozzle into rectum and squeeze bottle gently until fluid is dispelled. Discard bottle hygienically. For the long-tube version first carefully remove the bottle cap, screw on the applicator and then administer as above.

After administration the patient should lie face down for a few minutes to retain the fluid before going to sleep in their usual position.

7 MARKETING AUTHORISATION HOLDER

Chemidex Pharma Ltd.

T/A Essential Generics

7 Egham Business Village

Crabtree Road.

Egham

Surrey TW20 8RB

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 17736/0102

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

20 January 1986 / 31 January 1996