This information is intended for use by health professionals

1. Name of the medicinal product

Perinal Cutaneous Spray

2. Qualitative and quantitative composition

Hydrocortisone 0.2% w/w

Lidocaine hydrochloride monohydrate 1.0% w/w

For the full list of excipients, see section 6.1.

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 skin owing to the possibly increased risk of systemic side effects (see section 4.9). Not to be used on infected skin including bacterial, viral, tuberculous or fungal lesions of the 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 not be ingested or applied into the mouth, inside the nose or in the eyes.

Avoid prolonged, excessive use as this may produce local atrophy of the skin, striae or systemic corticosteroid effects such as suppression of adrenocortical function.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

4.5 Interaction with other medicinal products and other forms of interaction

Due to possible lidocaine additive effects, Perinal cutaneous Spray should be used with caution in patients taking Class III antiarrhythmic drugs (such as amiodarone), or other local anaesthetics at the same time.

Medicinal products that reduce the clearance of lidocaine (eg cimetidine or betablockers) may increase the risk of overdose (see section 4.9), although the risk is considered very low for Perinal Cutaneous Spray owing to the low doses applied.

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

4.6 Fertility, 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. Perinal Cutaneous Spray should only be used during pregnancy if the patient's physician considers that the potential benefits outweigh the potential risks to the foetus.

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.

Eye disorders

Not known (frequency cannot be estimated from the available data): Vision, blurred (see also section 4.4).

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Overdose may cause systemic side effects such as nervous system excitation and, in severe cases, central nervous and cardiovascular depression.

In case of suspected overdose, discontinue use of this product and seek urgent medical attention.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihemorrhoidals for topical use (products containing corticosteroids), ATC code: C05AA.

The preparation combines the well-known local anti-inflammatory and antipruritic 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

Macrogol cetostearyl ether (cetomacrogol)

Citric acid monohydrate

Sodium citrate

Propyl gallate

Phenoxyethanol

Purified water

6.2 Incompatibilities

Not applicable

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 high density polyethylene/aluminium/EAA copolymer collapsible laminate tube with spray pump (precitube) and cap.

The spray operates when held in any direction. The container is ozone-friendly. 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

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Hertfordshire, SG4 7QR

8. Marketing authorisation number(s)

PL 00173/0049

9. Date of first authorisation/renewal of the authorisation

5 June 2002/18 August 2010 (unlimited validity)

10. Date of revision of the text

9 December 2019