Colifoam

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

19^th July 2010