UNIROID-HC

Posology Adults Treatment with Uniroid-HC Suppositories should be limited to seven days. Patients should be advised to return to their doctor if the condition persists beyond this time.

Directions for use and dosage schedule:

Peel away the foil and insert a suppository as far as possible into the anus. One suppository to be inserted twice a day (morning and evening) and after each bowel movement, or as prescribed by the doctor. The suppositories may be used separately or concurrently with the ointment.

Elderly patients Dosage modifications are not required in the elderly. Paediatric population Uniroid-HC Suppositories are not recommended for use in children under 12 years of age unless directed by a doctor. Method of administration For rectal use only

The frequencies of adverse events are ranked according to the following convention: 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).

4). 4).

Gastrointestinal disorders Not known:

Anorectal discomfort. 4). 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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Recurrent or prolonged application may increase the risk of contact sensitisation particularly to cinchocaine. 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 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).

1. This product is contraindicated in tuberculosis, anal thrush and most viral lesions of the skin including herpes simplex, vaccinia and varicella.