GRISOL Cutaneous spray, solution Ref.[8524] Active ingredients: Griseofulvin

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 0.05 ml 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 0.05 ml spray, which may be increased to three* 0.05 ml sprays, if necessary, should be sprayed once daily to each affected area, preferably at the same time of day.

A dosage of 0.05 ml (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 0.15 ml (3 sprays) daily in such resistant cases.

Clinical improvement usually occurs 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

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.

Children

Not to be used in children under 16 years of age.

* 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.

If Grisol is accidentally ingested, overdosage from 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.

3 years.

Do not store above 25°C. Protect from direct light and heat. Highly flammable, keep away from naked flames.

Glass bottles of nominal volume 20 ml, each fitted with a spray pump assembly designed to deliver approximately 0.05 ml per actuation and fitted with a protective plastic cap.

Each bottle is packed in an outer cardboard carton, also containing a patient information leaflet.

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.