PROCTOSEDYL

Apply the ointment in small quantities with the finger, on the painful or pruritic area, morning and evening and after each stool. For deep application attach cannula to tube, insert to full extent and squeeze tube gently from lower end whilst withdrawing.

The ointment may be used separately or concurrently with the suppositories.

The following CIOMS frequency rating is used:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data). 4) Endocrine disorders: Not known: Adrenal suppression.

When applied topically and to a large enough area, especially of damaged skin for long enough, or if under occlusive dressing, hydrocortisone may have this adverse effect.

Skin and subcutaneous disorders:

Not known: Urticaria, Rash. 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.

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Apply only to the region of the rectum and anus and surrounding skin. Hydrocortisone can cause thinning and damage to the skin especially of the face. As with all preparations containing topical steroids, the possibility of systemic absorption should be considered.

In particular, long-term continuous therapy should be avoided in infants. Adrenal suppression can occur even without occlusion. Visual disturbance 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.

Known hypersensitivity to any of the ingredients. Not for use in the presence of infections.