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GRISOL AF 1% SPRAY SOLUTION

Active substance(s): GRISEOFULVIN / GRISEOFULVIN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
GRISOL AF 1% Spray Solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Griseofulvin 1% w/w
Each spray delivers 400 micrograms of griseofulvin (0.05ml per dose)
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Cutaneous spray, solution.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
The treatment of tinea pedis (athletes foot).

4.2.

Posology and Method of Administration
Method of Administration:
Cutaneous use; to be applied topically to the feet.
When applied to the feet it may be necessary to hold the toes apart to reveal
the full area to be treated. The affected areas should be washed, dried
thoroughly and flaking skin removed before spraying with Grisol.
Posology:
Adults:

The area covered by one 0.05ml dose (as delivered by one depression of the
spray button), when sprayed from a distance of 2 inches, is approximately 2
square inches.
A dose of one 0.05ml spray, which may be increased to three* 0.05ml sprays,
if necessary, should be sprayed once daily to each affected area, preferably at
the same time of day.
A dosage of 0.05ml (one spray) daily is recommended for mild athlete’s foot.
If it is more severe or extensive affecting sides or soles of feet the dose should
be increased to 0.15ml (3 sprays) daily in resistant cases.
Clinical improvement usually occurs promptly, between two and four weeks.
It is important to use the Grisol Spray regularly as premature stoppage of
treatment can cause the infection to re-occur. To prevent relapse, treatment
should be continued for ten days after all the lesions have disappeared.
Treatment period should not exceed four weeks. If there is no improvement
within four weeks, a physician should be consulted.
Children:
For the treatment of infection in children, the dosage instructions are the same
as those given for adults.
Elderly:
For the treatment of infection in the elderly the dosage instructions are the
same as those given for adults. There are no additional specific instructions.
* If more than one dose is necessary the first dose should be allowed to dry for
a few seconds before the second application which similarly should be allowed
to dry prior to a third application.

4.3.

Contra-indications
Hypersensitivity to griseofulvin or organic solvents.

4.4.

Special Warnings and Precautions for Use
Grisol is for external use only and should only be applied to the feet. Do not
spray onto any other parts of the body. Avoid spraying Grisol into the eyes.
The solution should not be allowed to come into contact with mucuos
membranes.
Caution should be exercised when using Grisol on broken skin as the solution
may cause stinging.

The adverse reactions associated with oral griseofulvin therapy, have not been
reported in association with topical administration.

4.5.

Interactions with other Medicaments and other forms of Interaction
None known.

4.6.

Pregnancy and Lactation
Systemic treatment with griseofulvin should be avoided in pregnancy, and
although human studies have not shown any significant absorption into the
systemic circulation following topical administration of Grisol, safety in
human pregnancy or lactation has not been established, and therefore it should
not be used unless the practitioner considers that the benefit of treatment
outweighs the risk.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8.

Undesirable Effects
Grisol may cause skin irritation, i.e. slight stinging or burning on application,
although this is unlikely to necessitate discontinuation of treatment.

4.9.

Overdose
If Grisol is accidentally ingested, overdosage from the griseofulvin active
ingredient is unlikely to require treatment, however the component solvents
could give rise to symptoms of alcoholic intoxication and poisoning so that
gastric lavage and emesis may be required. Any additional treatment should be
symptomatic and supportive.
Grisol contains an alcohol base which will cause burning and irritation to the
eyes. In the event that Grisol is accidentally sprayed into the eyes, the area
should be bathed with large amounts of cool tap water.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
The active ingredient of Grisol, griseofulvin, is an antifungal agent which,
when applied topically in this formulation, penetrates the skin in the tissues of
which it remains active against dermatophyte infections even after subsequent
evaporation of the solvent system.
Grisol is active against dermatophytes including microsporum canis,
trichophyton rubrum and tricophyton verrucosum.

5.2.

Pharmacokinetic Properties
Studies in humans have demonstrated that there is no significant absorption.
When taken orally, griseofulvin is metabolised by the liver mainly to 6desmethyl-griseofulvin which is excreted in the urine. A large amount of an
oral dose of griseofulvin is excreted unchanged in faeces and a small amount
in urine; some is excreted in sweat.

5.3.

Preclinical Safety Data
Animal studies undertaken with respect to Grisol relate appropriately to local
toxicity and absorption.
Twenty-eight day studies of the effects of griseofulvin, benzyl alcohol,
acetone and isopropyl alcohol on the skin of rabbits showed few signs of
dermal irritation.
Systemic absorption after topical administration of Grisol to shaved rats is
poor, being approximately 20% in 24 hours. The data suggest a reduced
systemic absorption in man by the topical route and a much more favourable
distribution between the dermis and the skin.
In human volunteer studies, serum concentrations after topical administration
of high doses are too small to be measured.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients

Acetone
Benzyl alcohol
Isopropyl alcohol

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
The shelf life of Grisol is two years.

6.4.

Special Precautions for Storage
Do not store above 25ºC. Protect from direct light and heat. Highly flammable,
keep away from naked flames.

6.5.

Nature and Contents of Container
Glass bottles of nominal volume 20ml each fitted with a spray pump assembly
designed to deliver approximately 0.05ml per actuation, and fitted with a
protective plastic cap.
Each bottle is packed in an outer cardboard carton, also containing a patient
information leaflet.

6.6.

Instruction for Use/Handling
Highly flammable, keep away from naked flames. Store the container in an
upright position.
Before using the spray, one dose should be directed at a piece of waste paper
or tissue to make sure the spray nozzle is working properly.
The bottle should be held about two inches away from the skin, pointing the
nozzle in the correct direction.
Grisol should not be sprayed into eyes, nose, mouth or other sensitive areas.
Grisol should be used on feet only.

7.

MARKETING AUTHORISATION HOLDER
Transdermal Limited
35 Grimwade Avenue
Croydon
Surrey CRO 5DJ
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 14308/0007

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/12/2010

10

DATE OF REVISION OF THE TEXT
February 2005

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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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