Prednisolone 20 mg/100 ml Rectal Solution

Prednisolone 20 mg/100 ml Rectal Solution

(prednisolone sodium metasulphobenzoate)

Please read this leaflet carefully. It gives you a summary of the information about your medicine. If there is anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.

Prednisolone Rectal Solution is a single dose retention enema for application into the rectum. Each single dose, disposable enema contains a rectal solution of 20mg prednisolone, as prednisolone sodium metasulphobenzoate, in 100ml.

Prednisolone belongs to a group of medicines called corticosteroids which are used to reduce inflammation.

As well as the active ingredient, your medicine also contains disodium edetate, parahydroxybenzoates (E214, E216, E218), and purified water.

Prednisolone Rectal Solution is supplied as a plastic bag containing the enema solution with an applicator nozzle and cap or alternatively with an extension tube attached to the nozzle (long-tube version) to enable easier self-administration.

The standard version is available in packs of 10 and the long tube version is available in packs of 7.

The Marketing Authorisation holder is

Chemidex Pharma Ltd., trading as

and the manufacturer is

It is used to treat ulcerative colitis (inflammation of the bowels).

If you are not sure why you have been given this medicine ask your doctor or pharmacist (chemist).

This medicine is suitable for adults and children over 12 years of age.

Do not administer to younger children. Do not use but tell your doctor if you are pregnant or breast feeding or suffering from peritonitis (inflammation of the walls of the abdominal cavity), anal sinus infection, fistulae (an unnatural connection between the bowel and other body organ or to outside the body), intestinal obstruction or perforation of the bowel.

Talk to your doctor before taking Prednisolone Rectal Solution, if you have scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. The doctor may advise that you have your blood pressure and urine regularly checked.

Contact your doctor if you experience blurred vision or other visual disturbances.

Parahydroxybenzoates may cause allergic type reactions in sensitive patients. If this applies to you contact your doctor before using this medicine.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Prednisolone 20 mg/100 ml Rectal Solution and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)

Side effects where the frequency is not known:

Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

Slow heart rate.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

This medicine is for rectal use only. The normal dose is one enema nightly for two to four weeks.

It may be administered at room temperature, or warmed in warm water before use. Holding the bag with the tube upwards, squeeze base of tube where it joins the bag. Remove cap and lubricate the nozzle. Lie in bed on your side with knees drawn up. Insert into rectum as far as the flange on the nozzle. Squeeze container gently until empty and discard bottle hygienically. Lie face downwards for a few minutes in order to retain thefluid before going to sleep in your usual position.

This medicine should be stored below 25°C and protected from light.

Do not use after the expiry date.