Meda Health Sales

Colifoam 10% w/w Rectal Foam

Hydrocortisone Acetate 10% w/w.

Excipients: contains cetyl alcohol 0.18% w/w, methyl parahydroxybenzoate (E218) 0.10% w/w and propyl parahydroxybenzoate (E216) 0.01% w/w

For a full list of excipients, see section 6.1.

Rectal foam.

A white odourless rectal foam.

For the topical intra-rectal management of distal ulcerative colitis and allied conditions such as procto-sigmoiditis and granular proctitis.

For adults, children and the elderly:

One applicator full inserted into the rectum once or twice daily for two to three weeks and every second day thereafter.

Shake the canister vigorously before filling the applicator. Withdraw the plunger and hold the container upright when filling the applicator. Fill the applicator just to the fill line. Insert the contents into the rectum following the instructions and explanatory pictures on the leaflet.

Local contraindications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulae and tuberculous, fungal or viral infections.

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 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.

Colifoam contains cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Colifoam also contains methyl parahydroxybenzoate (E216) and propyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm. This product also contains propyleneglycol which may cause skin irritation.

None known.

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, this is in large amounts or for prolonged periods.

None known.

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.

Not applicable.

The use of topically applied steroids in the treatment of ulcerative colitis and procto-sigmoiditis is well known.

The systemic absorption of hydrocortisone has been shown not to make a significant contribution to the pharmacological activity of Colifoam in treating ulcerative colitis. For this reason the pharmacodynamic and pharmacokinetic aspects of hydrocortisone acetate are not relevant to the consideration of the efficacy of this preparation.

The active ingredient in Colifoam, hydrocortisone acetate, is widely used in pharmaceutical preparations. The mode of action of Colifoam is predominantly by surface contact with the affected area of the intestinal tract. The amount of systemic absorption is low and the plasma levels of hydrocortisone are regulated by a natural feedback mechanism, based on metabolic requirement. Hence, the toxicity of hydrocortisone is not an issue with Colifoam.

Propylene glycol

Emulsifying wax

Polyoxyl (10) stearyl ether

Cetyl alcohol

Methyl parahydroxybenzoate E 218

Propyl parahydroxybenzoate E 216

Trolamine (for pH adjustment)

Purified water

Hydrocarbon propellant HP-70 (consisting of isobutene and propane)

Not applicable.

5 years.

Do not store above 25°C. Do not refrigerate or freeze.

A pressurised aluminium monobloc can decorated and lacquered outside and epoxy resin coated inside. The can is closed with a continuous valve and is supplied with an actuator and two piece plastic syringe applicator.

Contains approximately 14 doses.

For internal use only

1. Shake the canister vigorously for 30 seconds before each use.

2. Withdraw the plunger slowly until it stops at the catch line.

3. Holding UPRIGHT, insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers.

4. Press down gently down on the canister top with your fingers, so that the foam fills about ¼ of the applicator body. Only a short press is needed to do this.

5. Wait for a few seconds until the foam starts expanding. Do not fill the applicator in one go. Always release the canister top after a short press.

6. Repeat steps 4 & 5 until the foam expands to just reach the "Fill" line.

This normally takes 2-4short press/waits.

7. Stand with one leg raised on a chair, or lie down on your side. Insert gently into the back passage and push the plunger fully into the applicator.

These instructions are provided on the leaflet with illustrations to assist understanding.

Any unused product or waste material should be disposed of in accordance with local requirements.

Pressurised container containing flammable propellant. Protect from sunlight and do not expose to temperatures above 50°C. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition- no smoking. Do not pierce or burn even after use.

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne

Co. Meath

Ireland

PA 1332/211

Date of first authorisation: 01 April1978

Date of last renewal: 01 April 2008

October 2011