Summary of Product Characteristics (SmPC) - 4Head 90% w/w cutaneous Stick
1 NAME OF THE MEDICINAL PRODUCT
4head 90 % w/w cutaneous stick
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Levomenthol 90.0 % w/w
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cutaneous Stick
4. CLINICAL PARTICULARS
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 any 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 Special 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. Interactions with other Medicinal Products and other forms of Interaction
None.
4.6. 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
None.
4.8 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. PHARMACOLOGICAL PROPERTIES
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. Pre-clinical Safety Data
None.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol 20000
Peppermint oil
6.2. Incompatibilities
None known.
6.3 Shelf life
3 years
6.4 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. Instruction for Use, Handling and Disposal
To be applied as directed. For single patients use only.
7. MARKETING AUTHORISATION HOLDER
Diomed Developments Ltd
Trading as Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Herts SG4 7QR
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00173/0193.
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
12 June 2002
10 DATE OF REVISION OF THE TEXT
10/05/2018