Dermal Laboratories Limited

PERINAL™ CUTANEOUS SPRAY

Hydrocortisone 0.2% w/w; Lidocaine Hydrochloride 1.0% w/w.

For a full list of excipients, see section 6.1.

Colourless to pale yellow aqueous cutaneous spray solution.

For the symptomatic relief of anal and perianal pruritus, pain and inflammation such as associated with haemorrhoids, anal fissures or loose stools.

The same dosage schedule applies to all age groups, although the spray is not normally recommended for children under 14 years unless instructed by their doctor.

Spray once over the affected area up to three times daily, depending on the severity of the condition, or as recommended by the physician.

Not to be used if sensitive to lidocaine or any other of the ingredients. Not to be used on broken or infected skin. Do not use on children under the age of 14 years without medical supervision.

Perinal Cutaneous Spray is intended for use for limited periods and so should not be used continuously for longer than 7 days without medical advice. Patients should be instructed to seek medical advice if they experience persistent pain or bleeding from the anus, especially where associated with a change in bowel habit, if the stomach is distended or if they are losing weight. Prompt medical treatment may be very important under such circumstances.

Not to be used internally (inside the anus), or anywhere other than the anal area.

Medical supervision is required if used in conjunction with other medicines containing steroids, owing to possible additive effects.

Perinal Cutaneous Spray should be kept away from the eyes, nose and mouth.

No known interactions.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. The risk/benefit needs to be carefully assessed, therefore, before prescribing this medicine.

None known.

A temporary tingling sensation may be experienced locally after initial application. Hypersensitivity to lidocaine has rarely been reported.

Under exceptional circumstances, if Perinal Cutaneous Spray is used excessively, particularly in young children, it is theoretically possible that adrenal suppression and skin thinning may occur. The symptoms are normally reversible on cessation of treatment.

Pharmacotherapeutic group: Antihemorrhoidals for topical use (products containing corticosteroids), ATC code: C05A A.

The preparation combines the well-known local anti-inflammatory and anti-pruritic properties of hydrocortisone and the analgesic effect of lidocaine in an aqueous spray formulation.

The active ingredients of the formulation are readily available for intimate contact with the skin and mucous membranes, as the preparation is sprayed in small droplets which dry after application to leave the active ingredients in close contact with the affected area.

No special information.

Macrogol Cetostearyl Ether (cetomacrogol); Citric Acid Monohydrate; Sodium Citrate; Propyl Gallate; Phenoxyethanol; Purified Water.

Not applicable.

30 months.

Do not store above 25°C.

30 ml collapsible laminate tube with metering-dose pump spray and cap.

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

PA 278/17/1.

5 June 2007.

January 2012.