INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo COLIFOAM® Aerosol Foam

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

COLIFOAM® Aerosol Foam

COMPOSITION:
Contains
Hydrocortisone Acetate 10% (m/m).
Preserved with Methylparaben 0,1% (m/m) and Propylparaben 0,01% (m/m).

PHARMACOLOGICAL CLASSIFICATION:
A 11 Medicines acting on the gastro-intestinal tract.

PHARMACOLOGICAL ACTION:
Hydrocortisone is an anti-inflammatory corticosteroid.

INDICATIONS:
The topical treatment of non-specific ulcerative colitis localised to the rectal area and procto-sigmoiditis.

CONTRA-INDICATIONS:
Sensitivity to corticosteroids. Local contra-indications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulae, tuberculous, fungal or viral infections. Also contra-indicated in coincidental herpes simplex, vaccinia and varicella infections and bacterial infection.
Pregnancy: Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore COLIFOAM should not be used during pregnancy.

WARNINGS:
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.

DOSAGE AND DIRECTIONS FOR USE:
One applicatorful inserted into the rectum once or twice daily for two to three weeks and every second day thereafter, or as directed by the doctor. (See illustrated instructions). Dosage for children should be specified by the doctor. In infants, long term continuos topical therapy should be avoided Adrenal suppression can occur even without occlusion. Satisfactory response usually occurs within five to seven days, marked by a decrease in clinical symptoms. Symptomatic improvements in ulcerative colitis should not be used as the sole criterion of efficacy nor the duration of treatment.
Sigmoidoscopy and/or radiological examination arc more reliable means of assessing response to treatment. For rectal and external use only.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
General precautions common to all corticosteroid therapy should be observed during treatment with COLIFOAM
®. Possible adverse systemic effects include depression of the hypothalamic pituitary-adrenal axis with consequent suppression of the adrenal gland, growth retardation in children, Cushingoid state and rarely benign intracranial hypertension.
Symptoms typical of hyperactivity of the adrenal cortex include moon-face, sometimes with hirsutism, buffalo hump, flushing, increased bruising, striae and acne, sometimes leading to a fully developed Cushing s syndrome. If administration of the hormone is discontinued on the appearance of these symptoms they are usually reversed. Systemic absorption of topically applied corticosteroids may occur, particularly if used in large amounts or for prolonged periods or to damaged skin. If a secondary microbial skin infection is present, suitable concomitant antimicrobial therapy should be instituted.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No specific symptoms of an overdose may be apparent but the progress of treatment must be followed very carefully in view of the wide spectrum of activity of corticosteroids.

IDENTIFICATION:
A white, odourless aerosol foam.

PRESENTATION:
Aerosol canister containing 20,8 g (approximately 14 applications) with a special applicator.

STORAGE INSTRUCTIONS:
Pressurised canister containing flammable propellant. Protect from sunlight and do not expose to temperatures above 50°C. Do not spray onto a naked flame or any incandescent material. Keep away from sources of ignition - no smoking.
Do not pierce or burn even after use. Store in a cool place below 25°C.
Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
L/11/22.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd., 14 Mandy Road, Reuven, Johannesburg.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 December 1978.

MANUFACTURED BY: Stafford-Miller Ltd., Welwyn Garden City.
Herts AL7 3SP, U.K.
COLIFOAM
® is the registered trademark of Stafford-Miller Ltd.
040/6365/62/0

How to use COLIFOAM
® [Illustated]
Follow these three simple steps:
ONE Shake the foam container vigorously (minimum 1 min) before each use to evenly disperse contents. Draw out the plunger of the plastic applicator into as far as the stop ridge. Insert the tip of the container into the opening in the tip of the applicator.

TWO To fill hold container and applicator upright. Ensure plunger is held in place during the entire filling process. BRIEFLY press down on the collar of the cap using thumb and forefinger thus releasing the foam in a controlled fashion. Then repeat, filling to the "fill line" with a further release. Filling should take 2-3 seconds.
Caution: The foam container should never be inserted directly into the back passage.

THREE Remove applicator from container. Some foam should remain on the applicator tip to provide lubrication. Standing with one foot raised on a chair (see illustration), hold applicator by barrel and gently insert up into the back passage . With applicator in place push plunger in order to expel foam, then withdraw applicator.
For external use: Fill the applicator and expel the foam onto a tissue or pad. Use the tissue or pad to apply foam to the affected area. Remember: Always take the applicator apart and wash it thoroughly after use. Store in a cool place (below 25°C).

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