Not applicable.
60 months.
Local contra-indications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulae, and tuberculous, fungal or viral infections.
None known.
Propylene Glycol Emulsifying Wax Polyoxyethylene (10) Stearyl Ether Cetyl Alcohol Methyl Hydroxybenzoate Propyl Hydroxybenzoate Triethanolamine Water Purified Propellant HP-70
Aerosol foam.
Although uncommon at this dosage, irritation may occur.
Side effects are very unusual with Colifoam, but long term frequent use may cause problems in some people. This is particularly so if the medicine is not used as directed. Although uncommon at this dosage, the following side effects may occur; unexpected fattening of the face, neck and body, periods may stop unexpectedly and hair starts to grow on the face (in women), dusky complexion with purple markings, local irritation.
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
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
None stated.
Ulcerative colitis, proctosigmoiditis and granular proctitis.
The use of topically applied steroids in the treatment of ulcerative colitis, proctosigmoiditis and granular proctitis is well known.
The topically applied steroid acts locally and so pharmacokinetics are not relevant to its activity.
February 2017
Colifoam. 10% w/w Rectal Foam
Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK
Pressurised container containing flammable propellant. Protect from sunlight and do not expose to temperatures about 50°C. Store below 25°C. Do not refrigerate. Do not spray on naked flame or any incandescent material. Keep away from sources of ignition - no smoking. Do not pierce or burn even after use.
Aerosol canister containing 20.8g of foam, plus a plastic applicator.
PL 15142/0088
Hydrocortisone Acetate 10% w/w.
General precautions common to all corticosteroid therapy should be observed during treatment with Colifoam, especially in the case of young children. Treatment should be administered with caution in patients with severe ulcerative disease because of their predisposition to perforation of the bowel wall. Although uncommon at this dosage local irritation may occur.
Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids.), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.
None known.
All ages:
One applicatorful inserted into the rectum once or twice daily for two to three weeks and every second day thereafter.
SEE LEAFLET.
1 Shake the canister vigorously before each use.
2 Fill applicator so that the foam fills about ¼ of the applicator body. Only a short press is needed to do this.
3 Wait until foam has stopped expanding.
4 Repeat step 2 until the foam expands to just reach the “Fill†line. This normally takes 2-4 short press/waits.
5 Stand with one leg raised on a chair, or lie down on your left side. Insert gently into back passage and push plunger fully into the applicator.
02 Jul 2007
