XEPIN

Adults and children over 12 years A thin film of Xepin should be applied three to four times daily, to the affected area only. Clinical experience has shown that drowsiness is significantly more common in patients applying cream to more than 10% of the body surface area, therefore, the maximum coverage should be less than 10% of body surface area.

For an average sized patient, this would equate to 3g of Xepin per application and not more than 12g of Xepin per day. If excessive drowsiness does occur, it may be necessary to reduce the number of applications, the amount of cream applied and/or the percentage of body surface area treated.

Occlusive dressings or clothing may increase the absorption of any topically applied drug, including Xepin; therefore, caution must be exercised when utilising occlusive dressings. Children under 12 years There are insufficient data to enable dosage recommendations to be made for children.

Elderly There are no specific dosage recommendations for elderly patients.

Drowsiness has been reported in clinical trials, with an incidence of 12-19%. However, it is generally of mild to moderate severity and of short duration. Limiting the body surface treated to less than 10% is important in minimising the risk of drowsiness.

Local adverse reactions have been reported with the use of Xepin and may occur more frequently with the use of occlusive dressings. Local reactions, in decreasing order of frequency, include burning, stinging, irritation, and tingling and local rash.

Systemic effects which have been observed with orally administered doxepin hydrochloride are rarely observed with topical Xepin. These may include anticholinergic effects (dry mouth, changes in taste, dry eyes, blurred vision, urinary retention); central nervous system effects other than drowsiness (headaches, fever, dizziness); and gastrointestinal effects (nausea, indigestion, vomiting and diarrhoea or constipation).

Cases of suicidal ideation and suicidal behaviours have been reported during oral doxepin hydrochloride therapy or early after treatment discontinuation. 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).

Drowsiness may occur with the use of Xepin. Clinical trial data demonstrate that drowsiness is observed principally in patients receiving treatment to greater than 10% of body surface area and that drowsiness is transient, usually remitting after the first few days of treatment.

Patients should, therefore be warned of this possibility and cautioned against driving or operating machinery if they become drowsy while being treated with Xepin. Patients should also be warned that the effects of alcohol could be potentiated.

In view of the known adverse effects of orally administered doxepin hydrochloride, Xepin should be used with caution in patients with the following conditions: glaucoma, a tendency to urinary retention, severe liver disease, mania, or severe heart disease including those prone to cardiac arrythmias.

g. contact dermatitis).

Xepin is contra-indicated in individuals who have shown previous hypersensitivity to any of its components.