COLIFOAM

Posology:

One applicatorful inserted into the rectum once or twice daily for two to three weeks and every second day thereafter. Paediatric population Safety and efficacy have not been established in the paediatric population.

Method of administration:

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.

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) The following undesirable effects were observed with Colifoam: Infections and infestations Not known: Decreased resistance to infections Immune system disorders Not known: Hypersensitivity reactions including anaphylactic reaction, angioedema Gastrointestinal disorders Not known: Proctalgia, Anorectal discomfort Skin and subcutaneous tissue disorders Not known: Dermatitis allergic, urticaria, skin reactions (local, generalised) like blister, pruritus, rash General disorders and administration site conditions Not known: Application site reactions like erythema, irritation, burning, dryness Drugs of this class may cause systemic side effects (such as Cushing- Syndrome, decreased resistance to infections), especially in long-term use, and if the medicine is not used as directed.

The risk of systemic side effects when used at the correct dose by the local administration route is much lower than under systemic application. 4). 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.

Methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) may cause allergic reactions (possibly delayed). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

General precautions common to all corticosteroid therapy should be observed during treatment with Colifoam, especially in the case of young children, due to the risk of growth retardation. 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. When treating diabetic patients, it should be taken into consideration that they may need more insulin or oral anti-diabetics. Special care should be taken when treating patients with myasthenia gravis.

Corticosteroids can cause elevation of blood pressure, salt and water retention in the blood, and increased urinary excretion of potassium. Therefore, patients with severe cardiac and/or renal insufficiency as well as patients with hypertension, will require careful monitoring.

The medicinal product should not be used in patients with narrow- or wide- angle glaucoma. 8). Symptoms typically emerge within a few days or weeks of starting the treatment. 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. Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished while on hydrocortisone therapy.

Patients under prolonged treatment should be observed for systemic effects. Treatment should be discontinued gradually. Abrupt cessation of therapy should be avoided. g. contact dermatitis). Propylene glycol may cause skin irritation. Visual disturbance may be reported with systemic and topical corticosteroid use.

If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

1. • Obstruction • Abscess • Perforation • Peritonitis • Fresh intestinal anastomoses • Extensive fistulae • Fungal, viral, tuberculous and other bacterial infections