SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Germoloids® HC Spray

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

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

For excipients, see 6.1.

3.    PHARMACEUTICAL FORM

Cutaneous spray solution.

Colourless to pale yellow.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

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

4.2.    Posology and method of administration

The product is for cutaneous use.

Prime pump before initial use by depressing its top once or twice.

Adults

The product is applied by parting the buttocks if necessary, spraying once over the affected area, up to three times daily depending on the severity of the condition. The spray will operate in any orientation.

Wash hands and replace cap after use.

Elderly

The same dose applies to the elderly.

Children

The spray should not be used in children under 16 years.

4.3. Contra-Indications

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 special precautions for use

Germoloids HC Spray is intended for use for limited periods and should not be used continuously for longer than 7 days. 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, abdominal pain, if the stomach is distended or if they are losing weight. Prompt medical treatment may be very important under such circumstances. Germoloids HC Spray should be kept away from the eyes, nose and mouth.

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

The product should not be used during pregnancy or breast-feeding. 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.

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.

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.

4.9. Overdose

Under exceptional circumstances, if Germoloids HC 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

ATC Code: C05AA Antihaemorrhoidals for topical use - products containing corticosteroids.

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.

Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Macrogol cetostearyl ether 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

High density polyethylene/aluminium/EEA copolymer collapsible laminate tube with metering spray pump.

Pack size: 25ml, 30ml.

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.