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GERMOLOIDS HC SPRAY

Active substance(s): HYDROCORTISONE / LIDOCAINE HYDROCHLORIDE / HYDROCORTISONE / LIDOCAINE HYDROCHLORIDE / HYDROCORTISONE / LIDOCAINE HYDROCHLORIDE

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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.

5.3.

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 ozonefriendly. It is not an aerosol and does not contain any potentially irritant
propellants.

6.6.

Instruction for use and handling
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
Bayer plc
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom
Trading as Bayer plc, Consumer Care Division.

8.

MARKETING AUTHORISATION NUMBER
PL 00010/0274

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/02/2009

10

DATE OF REVISION OF THE TEXT
09/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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