XYLOPROCT

Route of administration:

Topical. To be applied several times daily according to the severity of the condition. For intrarectal use, apply the ointment with the special applicator. Cleanse the applicator thoroughly after use. A daily dose of 6 g ointment is well within safety limits.

The duration of treatment may vary between ten days and three weeks. If the treatment is prolonged, a free interval can be recommended, especially if it is suspected that irritation due to lidocaine or hydrocortisone has occurred. g.

by a patch test. Older people Debilitated or elderly patients should be given doses commensurate with their age, weight and physical condition. Paediatric population Children should be given doses commensurate with their age, weight and physical condition.

Contact sensitivity to lidocaine has been reported after perianal use. Contact sensitivity may also occur after the use of topical hydrocortisone. In extremely rare cases amide-type local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock).

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.

Xyloproct is intended for use for limited periods. Excessive dosage of lidocaine or short intervals between doses, may result in high plasma levels of lidocaine and serious adverse effects. Patients should be instructed to strictly adhere to recommended dosage.

g. 5). Appropriate antibacterial, antiviral or antifungal therapy should be given with Xyloproct if infection is present at the site of application. The possibility of malignancy should be excluded before use. If irritation or rectal bleeding develops treatment should be discontinued.

When using the special applicator, care should be taken to avoid instillation of excessive amounts of Xyloproct Ointment into the rectum. This is of particular importance in infants and children. Systemic absorption of lidocaine may occur from the rectum, and large doses may result in CNS side-effects.

On rare occasions convulsions have occurred in children. Prolonged and excessive use of hydrocortisone use may produce systemic corticosteroid effects or local effects such as skin atrophy. With the recommended dosage systemic effects of hydrocortisone are unlikely.

Xyloproct ointment is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken for vulnerable patients. g. contact dermatitis).

1 or to local anaesthetics of the amide type. Use on atrophic skin. Xyloproct Ointment should not be used in patients with untreated infections of bacterial, viral, pathogenic fungal or parasitic origin. 5).