GSL: General Sales Licence
This information is intended for use by health professionals
4HEAD™ CUTANEOUS STICK
Levomenthol 90% w/w.
For full list of excipients, see section List of excipients.
For the relief of headaches.
4head is to be applied gently to the forehead. To be used as required, but excessive use avoided. If symptoms persist or worsen seek medical advice. For external topical application only.
Not recommended in patients where there is a known hypersensitivity to menthol.
Keep away from the eyes, levomenthol is irritant if allowed to come into contact with the eyes.
For single patient use only. For topical use - not to be taken.
There is no information on safety when used during pregnancies and breast feeding, but there should be no hazard when applied as advised.
Menthol may give rise to hypersensitivity reactions including contact dermatitis. Because levomenthol is volatile, in rare cases it may cause temporary, mild watering of the eyes.
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.
If accidentally ingested menthol is reported to cause severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness and coma. Treatment for accidental ingestion is by emptying the stomach by gastric lavage. A saline laxative and activated charcoal should be administered. Convulsions may be controlled by the slow intravenous administration of diazepam. Haemodialysis with a lipid dialysate has been employed.
Applied to the skin, menthol dilates local blood vessels, causing a sensation of coldness, followed by an analgesic effect.
After absorption, menthol is excreted in the urine and bile as the glucuronide.
No special information.
Macrogol 20000; Peppermint Oil.
Do not store above 25°C.
To be kept away from heat. (Melts at about 49-56°C).
Plastic twist-up dispenser containing 3.6 g menthol, with plastic cover.
To be applied as directed. For single patient use only.
Diomed Developments Limited
Tatmore Place, Gosmore
Hitchin, Herts SG4 7QR, UK
12 January 2009.
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
+44 (0)1462 420 565