XYLOPROCT Ointment Ref.[50625] Active ingredients: Hydrocortisone Lidocaine

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.

Hospitalised patients treated with anti-arrhythmic drugs class III (e.g. amiodarone or sotalol) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive (see sections 4.3 and 4.5).

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.

Xyloproct contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Lidocaine should be used with caution in patients receiving anti-arrhythmic drugs, local anaesthetics or agents structurally related to local anaesthetics, since the toxic effects of these compounds are additive (see sections 4.3 and 4.4).

Pregnancy

Xyloproct should not be used during pregnancy unless considered essential by the physician.

Breast-feeding

Lidocaine and hydrocortisone acetate are excreted into breast milk, but at therapeutic doses of Xyloproct, effects on the breastfed newborns/infants are unlikely.

Fertility

There is no fertility data available.

Xyloproct has minor influence on the ability to drive and use machines. Depending on the dose local anaesthetics may have a very mild effect on mental function and coordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness. With the recommended doses of Xyloproct adverse effects on the CNS are unlikely.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

Not applicable.