- lidocaine hydrochloride
GSL: General Sales Licence
This information is intended for use by health professionals
Germoloids® HC Spray
Hydrocortisone 0.2% w/w
Lidocaine Hydrochloride 1.0% w/w
For excipients, see 6.1.
Cutaneous spray solution
Colourless to pale yellow
For the symptomatic relief of anal and perianal itch, irritation and pain, associated with external haemorrhoids.
The product is for cutaneous use.
Prime pump before initial use by depressing its top once or twice.
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.
The same dose applies to the elderly.
The spray should not be used in children under 16 years.
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.
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.
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
No known interactions. Medical supervision is required if used in conjunction with other medicines containing steroids, owing to possible additive effects.
This 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.
A temporary tingling sensation may be experienced locally after initial application. Hypersensitivity to lidocaine has rarely been reported.
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.
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.
ATC Code: C05A A Antihaemorrhoidals for topical use – products containing corticosteroids
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.
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.
There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.
Macrogol cetostearyl ether
Citric Acid Monohydrate
Do not store above 25°C.
High density polyethylene/aluminium/EAA 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.
Trading as Bayer plc, Consumer Care Division.