PROCTOFOAM HC RECTAL

Posology One applicator full per rectum two or three times daily and after each bowel evacuation (up to a maximum of four times daily). For perianal administration, apply a small quantity on two fingers. Paediatric population Not recommended for use in children.

6 for handling instructions.

4) 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 sensation, dryness Drugs of this class may cause systemic side effects (such as Cushing’s syndrome, increased infection susceptibility), 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; secondary infection and skin atrophy may occur. Systemic absorption of topical corticosteroids has produced reversible suppression of the hypothalamic - pituitary – adrenal axis.

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.

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

Not for prolonged use. Contact sensitization to local anaesthetics is common following prolonged application. Seek medical advice if symptoms worsen, or do not improve within 7 days or if bleeding occurs. Shake vigorously before use, use at room temperature, keep out of the reach of children.

For external use only. Rectal examination must be performed to exclude serious pathology before initiating treatment with Proctofoam. Treatment should be administered with caution in patients with severe ulcerative disease because of their predisposition to perforation of the bowel wall.

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.

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.

1 • Bacterial, viral or fungal infections.