1. Name Of The Medicinal Product
Colifoam. 10% w/w Rectal Foam
2. Qualitative And Quantitative Composition
Hydrocortisone Acetate 10% w/w.
For a full list of excipients see Section 6.1
3. Pharmaceutical Form
Aerosol foam.
4. Clinical Particulars
4.1 Therapeutic Indications
Ulcerative colitis, proctosigmoiditis and granular proctitis.
4.2 Posology And Method Of Administration
All ages:
One applicatorful inserted into the rectum once or twice daily for two to three weeks and every second day thereafter.
4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
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 (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), 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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Systemic and topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established but at present steroids should not be used extensively in pregnancy, that is in large amounts or for prolonged periods.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
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.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The use of topically applied steroids in the treatment of ulcerative colitis, proctosigmoiditis and granular proctitis is well known.
5.2 Pharmacokinetic Properties
The topically applied steroid acts locally and so pharmacokinetics are not relevant to its activity.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Propylene Glycol
Emulsifying Wax
Polyoxyethylene (10) Stearyl Ether
Cetyl Alcohol
Methyl Hydroxybenzoate
Propyl Hydroxybenzoate
Triethanolamine
Water Purified
Propellant HP-70
6.2 Incompatibilities
None known.
6.3 Shelf Life
60 months.
6.4 Special Precautions For Storage
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.
6.5 Nature And Contents Of Container
Aerosol canister containing 20.8g of foam, plus a plastic applicator.
6.6 Special Precautions For Disposal And Other Handling
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.
7. Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
249 West George Street
Glasgow
G2 4RB
UK
Trading as:
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
UK
8. Marketing Authorisation Number(S)
PL 15142/0088
9. Date Of First Authorisation/Renewal Of The Authorisation
02 Jul 2007.
10. Date Of Revision Of The Text
19th July 2010
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