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Drug information

POM
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Last updated: 17 Sep 2021

Summary of product characteristics


1. Name of the medicinal product

PREDFOAM

Prednisolone 20 mg/dose Rectal Foam


2. Qualitative and quantitative composition

Each metered dose contains 31.4 mg of the active ingredient prednisolone sodium metasulphobenzoate, equivalent to prednisolone 20.0 mg.

Excipients with known effect: Cetostearyl Alcohol 4.4 mg and Sorbic Acid 1.74 mg per dose.

For the full list of excipients, see section 6.1.


3. Pharmaceutical form

Rectal Foam

A white to pale cream coloured, metered-dose rectal foam.


4.1. Therapeutic indications

Treatment of proctitis and ulcerative colitis.


4.2. Posology and method of administration

Posology

Adults and elderly patients:

One metered dose rectally once or twice daily for 2 weeks, extending treatment for a further 2 weeks when a good response is obtained. Use should be discontinued at the discretion of the physician once the disease is stable and under control.

Paediatric population:

Not recommended.

Method of administration:

For rectal use only.


4.3. Contraindications

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

Corticosteroids are contraindicated in local conditions where infection might be masked or healing impaired, e.g. peritonitis, fistulae, intestinal obstruction, perforation of the bowel.


4.4. Special warnings and precautions for use

This product should be used with extreme caution in the presence of severe ulcerative colitis. The possibility of masking local or systemic infection should be borne in mind when using this product.

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.

Excipients

This medicinal product contains cetostearyl alcohol and sorbic acid which may cause local skin reactions, (e.g. contact dermatitis).


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. Fertility, pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.


4.7. Effects on ability to drive and use machines

Not relevant.


4.8. Undesirable effects

The consequences of systemic absorption should be considered if prednisolone rectal foam is used extensively over prolonged periods. As with all rectal corticosteroids, prolonged continuous use is undesirable.

Frequency 'not known': 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.


4.9. Overdose

Overdosage by this route is unlikely.


5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids for local use

ATC code: A07E A

Prednisolone sodium metasulphobenzoate is a synthetic glucocorticoid with anti-inflammatory action. The product is given rectally to enable local treatment and to reduce side effects associated with systemic administration of steroids.


5.2. Pharmacokinetic properties

None stated


5.3. Preclinical safety data

There is no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


6.1. List of excipients

Non-ionic Emulsifying Wax

Cetostearyl Alcohol

Oleyl Alcohol

Light liquid Paraffin

Phenoxyethanol

Sorbic Acid

Polysorbate 20

Disodium Edetate

Sodium Hydroxide

Purified Water

Butane 48


6.2. Incompatibilities

Not applicable.


6.3. Shelf life

6 years


6.4. Special precautions for storage

Pressurised container containing a flammable propellant. Do not store above 25 °C. Protect from sunlight and do not expose to temperatures exceeding 50 °C. Do not pierce or burn even after use. Do not spray on naked flame or any incandescent material.

Do not refrigerate.


6.5. Nature and contents of container

Each pack contains an aluminium aerosol can fitted with a metering valve containing sufficient for 14 doses plus 14 disposable applicators.


6.6. Special precautions for disposal and other handling

Shake canister before use. When using for the first time remove and discard the small plastic safety tag from under the button. An applicator nozzle is then pushed on to the side arm of the canister. The semi-circular cut-out on the cap is lined up with the nozzle.

The easiest way to administer prednisolone rectal foam is to stand with one foot raised on a chair and gently insert the nozzle tip into the rectum. Smearing the nozzle with lubricating jelly may help insertion. Holding the canister with the dose button pointing down, press the button on the canister firmly and release. Only press the button once so as not to exceed the recommended dose.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7. Marketing authorisation holder

Chemidex Pharma Limited

trading as Essential Generics

7 Egham Business Village

Crabtree Road

Egham

Surrey TW20 8RB

United Kingdom


8. Marketing authorisation number(s)

PL 17736/0130


9. Date of first authorisation/renewal of the authorisation

9 September 1986/ 7 October 1998


10. Date of revision of the text

15/04/2021

4.1 Therapeutic indications

Treatment of proctitis and ulcerative colitis.

4.2 Posology and method of administration

Posology

Adults and elderly patients:

One metered dose rectally once or twice daily for 2 weeks, extending treatment for a further 2 weeks when a good response is obtained. Use should be discontinued at the discretion of the physician once the disease is stable and under control.

Paediatric population:

Not recommended.

Method of administration:

For rectal use only.

4.3 Contraindications

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

Corticosteroids are contraindicated in local conditions where infection might be masked or healing impaired, e.g. peritonitis, fistulae, intestinal obstruction, perforation of the bowel.

4.4 Special warnings and precautions for use

This product should be used with extreme caution in the presence of severe ulcerative colitis. The possibility of masking local or systemic infection should be borne in mind when using this product.

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.

Excipients

This medicinal product contains cetostearyl alcohol and sorbic acid which may cause local skin reactions, (e.g. contact dermatitis).

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 Fertility, pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

The consequences of systemic absorption should be considered if prednisolone rectal foam is used extensively over prolonged periods. As with all rectal corticosteroids, prolonged continuous use is undesirable.

Frequency 'not known': 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).