Predfoam®
Prescription Products
Prednisolone Metasulphobenzoate Sodium
Patient Information Leaflet
Please read this leaflet carefully before you start to use your medicine. If there is anything you do not understand, please ask your doctor or pharmacist (chemist) to explain it to you.
1. What is in Predfoam?
Predfoam is a foam enema for application into the rectum. Each canister contains enough product for 14 doses and comes supplied with disposable applicators and disposal bags. Each metered dose contains 31.4mg of the active ingredient prednisolone metasulphobenzoate sodium (equivalent to 20.0mg of prednisolone).
Predfoam belongs to a group of medicines called corticosteroids which are used to reduce inflammation.
As well as the active ingredient, your medicine also contains: Non-ionic emulsifying wax, cetostearyl alcohol, oleyl alcohol, technical white oil, phenoxyethanol, sorbic acid, polysorbate 20, disodium edetate, sodium hydroxide and purified water. The propellant in Predfoam is Butane 48.
The Marketing Authorisation holder and Manufacturer is:
Forest Laboratories UK Limited, Bourne Road, Bexley, DA5 1NX, UK
2. What is Predfoam used for?
Predfoam is used to treat ulcerative colitis (inflammation of the bowels) and may be used to treat proctitis (inflammation of the rectum).
3. Before using Predfoam
Predfoam is only suitable for adults.
Your doctor will not normally prescribe Predfoam if you suffer from peritonitis (inflammation of the peritoneum) or from bowel problems such as obstruction, perforation or where there may be infection. Predfoam may not be suitable in severe ulcerative colitis.
You must inform your doctor if you are pregnant or breast-feeding before you use Predfoam.
Your doctor will advise you on how best to use your medicine.
One metered-dose of Predfoam should be inserted rectally, using one of the applicator nozzles provided, once or twice daily for 2 weeks. Your doctor may decide to extend the treatment for a further 2 weeks.
Follow the instructions shown below:
Instructions to patient: Predfoam has been designed for your maximum comfort and ease of use. Read these instructions carefully before using Predfoam for the first time.
- Shake before use.
- When using for the first time remove and discard the small plastic safety tag from under the button.
- Carefully push the applicator nozzle onto the side arm of the canister. Line up semi-circular cut out on cap with nozzle.
- The easiest way to use Predfoam is to stand with one foot raised on a chair and gently insert the nozzle tip into the rectum. It may help if you smear the nozzle with lubricating jelly before insertion.
- Important: 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.
Note: the canister will only work when held with the dose button pointing down.
Foam is expelled when the button is released.
Dispose of the used nozzle in the plastic bag provided.
The nozzle will not flush down toilets.
IF YOU FIND IT DIFFICULT TO USE PREDFOAM IN A STANDING POSITION AN ALTERNATIVE IS TO ADMINISTER WHILE LYING ON YOUR SIDE WITH BOTH LEGS BENT UP.
5. What if I miss a dose?
Do not worry if you miss your dose of Predfoam. Administer Predfoam as soon as you remember and then use your next dose at the usual time. Do not use more than 2 doses in one day.
6. After using your medicine
Normally, there should be no problems associated with the use of Predfoam. However, if you think that Predfoam is causing you any unusual discomfort or problems, please contact your doctor or pharmacist (chemist).
7. Storing your medicine
Predfoam is supplied in a pressurised container containing a flammable propellant. Do not store above 25°C. Protect from sunlight and do not expose to temperatures above 50°C. Do not pierce or burn even after use. Do not spray on naked flame or any incandescent material. Discard after 14 doses have been used. Do not use after the expiry date printed on the carton. Keep out of the reach and sight of children.