DERBAC M Cutaneous emulsion Ref.[49891] Active ingredients: Malathion

• The eyes should be well protected during the application and washing of hair.
• Persons applying this product should wear rubber gloves so that their continued direct contact is avoided.
• All members of the household of the patients should be treated, preferably simultaneously.
• The source of infestation should be sought and treated.
• This product is poisonous if ingested. If accidentally swallowed, contact your local doctor or hospital immediately.
• Prolonged continued application should be avoided. It should not be used more than once a week and for not more than

three consecutive weeks.

• Keep out of reach of children.
• Children under the age of 6 months should only be treated under medical supervision.
• The lotion should not be applied to damaged skin except after medical consultation.
• This product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

None stated.

No know effects in pregnancy and lactation. However, as with all medicines, use with caution.

None stated.

Skin irritation and hypersensitivity reactions have been reported with malathion products. Chemical burns have also been reported.

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/; E-mail:medsafety@hpra.ie.

30 months.