Predfoam

1. Name Of The Medicinal Product

PREDFOAM

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Aerosol foam for rectal administration

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of proctitis and ulcerative colitis.

4.2 Posology And Method Of Administration

For 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.

For children:

Not recommended.

4.3 Contraindications

Corticosteroids are contra-indicated 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.

For rectal use only

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 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

None stated

4.8 Undesirable Effects

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

4.9 Overdose

Overdosage by this route is unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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 are no preclinical 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

Non-ionic Emulsifying Wax

Cetostearyl Alcohol

Oleyl Alcohol

Technical White Oils

Phenoxyethanol

Sorbic Acid

Polysorbate 20

Disodium Edetate

Sodium Hydroxide

Purified Water

Butane 48

6.2 Incompatibilities

None stated

6.3 Shelf Life

4 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 Predfoam 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.

7. Marketing Authorisation Holder

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL

8. Marketing Authorisation Number(S)

PL 0108/0101

9. Date Of First Authorisation/Renewal Of The Authorisation

9 September 1986 / 7 October 1998

10. Date Of Revision Of The Text

March 2010

11. Legal Category

POM