4head 90% w/w Cutaneous Stick

Cutaneous Stick

4.1 Therapeutic indications For the relief of headaches.4.2 Posology and method of administration 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.4.3 Contraindications Not recommended in patients where there is a known hypersensitivity to menthol.4.4 Special warnings and precautions for use 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.4.5 Interaction with other medicinal products and other forms of interaction None4.6 Fertility, pregnancy and lactation There is no information on safety when used during pregnancies and breast feeding, but there should be no hazard when applied as advised.4.7 Effects on ability to drive and use machines None4.8 Undesirable effects 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.4.9 Overdose 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.

5.1 Pharmacodynamic properties Applied to the skin, menthol dilates local blood vessels, causing a sensation of coldness, followed by an analgesic effect.5.2 Pharmacokinetic properties After absorption, menthol is excreted in the urine and bile as the glucuronide.5.3 Preclinical safety data None

6.1 List of excipients Macrogol 20000 Peppermint oil6.2 Incompatibilities None known6.3 Shelf life 3 years6.4 Special precautions for storage Do not store above 25°C. To be kept away from heat. (Melts at about 49 - 56°C).6.5 Nature and contents of container Plastic base holding 3.6 g of product in a cone, with screw-on plastic cover.6.6 Special precautions for disposal and other handling To be applied as directed. For single patient use only.