Add sub heading “Adults (including the elderly)”
Remove “Eurax Cream can be used in children”
Add subheading “Paediatric population” Information for use in children expanded
Under Scabies heading Add “There are no special dosage recommendations in the elderly”.
Add subheading “Paediatric population” Information for use in children expanded.
Clarification of hypersensitivity contra-indications.
Delete “Eurax Cream should not be used in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation.
Rewording on guidance for use in children. Warnings around contact with mouth and eyes expanded. Clarification given for use on skin conditions. Rewording of last paragraph to include pregnancy.
Add “Eurax cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and methyl hydroxybenzoate which may cause allergic reactions (possibly delayed).”
Replaced “None” with Add “No interaction studies have been performed.”
Heading Add “Fertility”
Add subheading “Pregnancy”
Rewording of pregnancy recommendations.
Add subheading “Breastfeeding”
Include “ Therefore mothers should not use Eurax Cream whilst breastfeeding unless directed by a physician” in addition to previous information.
Replaced “None” with “Eurax Cream has no influence on the ability to drive and use machines.
Clarification of specific side effects and frequencies added as per convention “
Delete “Eurax Cream is for application to the skin only “
Add “acute intoxication symptoms may be observed such as” Delete “have been reported. If accidental ingestion of large quantities occurs, there is no specific antidote”
Replace information about risk of methaemoglobinaemia “Moreover although very rare, in case of accidental ingestion as well as in case of excessive cutaneous absorption. The symptoms usually disappear following the discontinuation of the drug, but in severe cases treatment with methylene blue may be considered.”
Add “Pharmacotherapeutic group: other antipruritics (ATC code D04AX).”
“ As an acaricide agent, crotamiton is effective on the motor system of the mites by inducing irreversible cessation of spontaneous movements.
Eurax Cream will provide relief from irritation for 6 to 10 hours after each application.”
Add “Preclinical data do not show teratogenic nor genotoxic risk for crotamiton”. Add “topically” Replace “250mg” with “200 mg”
Delete “Crotamiton does not induce mutations in bacteria nor chromosomal damage in mammalian cells. Studies to detect a possible effect on fertility and reproductive behaviour also gave negative results.”