Summary of Product Characteristics Updated 17-Dec-2020 | Diomed Developments Limited
4head 90% w/w cutaneous stick
Levomenthol 90.0% w/w
For full list of excipients, see section 6.1.
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.
Do not store above 25°C.
To be kept away from heat. (Melts at about 49 - 56°C).
Plastic base holding 3.6 g of product in a cone, with screw-on plastic cover.
To be applied as directed. For single patient use only.
Diomed Developments Limited
T/A Dermal Laboratories
Hertfordshire SG4 7QR
12 June 2002/12 January 2009 (unlimited validity)
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866