Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, United Kingdom
Hypersensitivity to any of the ingredients.
Discontinue at the first appearance of a skin rash or any other signs of local or general hypersensitivity. Should any signs of hypersensitivity occur (e.g. rashes, urticaria, generalised pruritus, breathing difficulties), the product should be shampooed off immediately, and if symptoms do not resolve, medical advice sought.
For external use only.
Avoid contact with the eyes but if accidentally introduced into the eyes, flush with water.
Hedrin 4% cutaneous solution is combustible when on the hair and in direct contact with an open flame or other source of ignition; therefore during treatment hair should be kept away from open flames or other sources of ignition.
The labels and leaflets will state:
“Warning: Keep hair away from sources of ignition, especially naked flames and burning cigarettes, whilst being treated with Hedrin. Treated hair can readily burn if ignited”.
Dimeticone is not known to interact with other drugs.
There is no data to suggest that Hedrin may not be used in pregnancy.
None known.
Dimeticone is usually well tolerated.
Minor adverse events include skin irritation, an itchy or flaky scalp and irritation around the eyes.
Single cases of hair loss have been reported.
Signs of hypersensitivity reactions including rash, urticaria, generalised pruritus, and breathing difficulties.
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.
None known.
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