- Approval Id
- 1f5133300fd3d43c
- Drug Approval Emc Name
- 4head 90% w/w Cutaneous Stick
- Drug Name
- 4head 90% w/w Cutaneous Stick
- Company Name
- Diomed Developments Limited
- Company Address
- Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
- Company Website
- //www.diomedgroup.co.uk
- Company Telephone
- +44 (0)1462 458 866
- Legal Category
- General Sales List
- Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Hertfordshire SG4 7QR
UK
- Authorisation Number
- PL 00173/0193
- Authorisation Date
- 12 June 2002/12 January 2009 (unlimited validity)
- Instruction Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Hertfordshire SG4 7QR
UK
- Instruction Authorisation Number
- PL 00173/0193
- Instruction Authorisation Date
- 12 June 2002/12 January 2009 (unlimited validity)
- Instruction Composition
- Levomenthol 90.0% w/w
For full list of excipients, see section 6.1.
- Instruction Dosage Form
- Cutaneous Stick
- Instruction 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 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.
- Instruction Pharmacology
- 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
- Instruction Pharmaceutical Particulars
- 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.
- Instruction Content
- ## Composition
Levomenthol 90.0% w/w
For full list of excipients, see section 6.1.
## Pharmaceutical Form
Cutaneous Stick
## 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 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.
## 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 Preclinical safety data
None
## Pharmaceutical Particulars
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.
