Perinal Cutaneous Spray

1. Name Of The Medicinal Product

PERINAL™ CUTANEOUS SPRAY

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Colourless to pale yellow aqueous cutaneous spray solution.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of anal and perianal itch, irritation and pain, such as associated with haemorrhoids.

4.2 Posology And Method Of Administration

The same dosage schedule applies to all age groups, although the spray is not normally recommended for children under 14 years unless on medical advice:-

Spray once over the affected area up to three times daily, depending on the severity of the condition.

4.3 Contraindications

Not to be used if sensitive to lidocaine or any of the other ingredients. Not to be used on broken or infected skin. Not to be used internally (inside the anus), or anywhere other than the anal area.

4.4 Special Warnings And Precautions For Use

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

The label will state:-

Perinal Spray should not be used during pregnancy, while breast feeding or by children under the age of 14 without medical advice. Keep spray away from the eyes, nose and mouth, and do not apply to broken or infected skin, or to any part of the body except the anal area. Prime pump before initial use by depressing its top once or twice. Wash hands, and replace cap after use. Consult your doctor if the condition does not improve, or if rectal bleeding occurs. Do not use continuously for more than 7 days, unless recommended by your doctor. Do not use if sensitive to any of the ingredients. Keep out of the reach of children. For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No known interactions. Medical supervision is required if used in conjunction with other medicines containing steroids, owing to possible additive effects.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

4.9 Overdose

Under exceptional circumstances, if Perinal 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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. On application, finger contact with the affected area can be avoided which makes for improved hygiene, and lessens the risk of infection.

5.2 Pharmacokinetic Properties

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.

Because the preparation is a clear solution, it is entirely homogeneous, and the availability of the active ingredient is optimal.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetomacrogol 1000; Citric Acid Monohydrate; Sodium Citrate; Propyl Gallate; Phenoxyethanol; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

30 ml collapsible laminate tube with metering-dose spray pump and cap, which is ozone-friendly.

The spray operates when held in any direction. It is not an aerosol and does not contain any potentially irritant propellants.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0049.

9. Date Of First Authorisation/Renewal Of The Authorisation

18 August 2010.

10. Date Of Revision Of The Text

August 2010.