Consultation: miconazole and fluconazole: proposed advisory statements for medicines

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on the wording of additional and amended advisory statements for labels of non-prescription medicines containing miconazole for topical oral or vaginal use, as well as for fluconazole for oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document. In particular, the additional RASML advisory statement ‘Ask your doctor or pharmacist before use if you are taking warfarin, a medicine used to thin the blood, because bleeding or bruising may occur’ is proposed in order to ensure that health professionals and patients are warned about the risks of drug interaction with warfarin.

Proposedamended RASML entries for medicinescontaining miconazole for vaginal use ortopical-oral use (the proposed newadditional text is indicated by bold/redtext)

Column 1 Substance(s)

Column 2 Conditions

Column 3Requiredstatement(s)

Miconazole(Entry 1 of 2)

Inpreparations forvaginal use

Seek medical advice beforefirst course oftreatment

See a doctorbeforeuse ifyou are pregnant ordiabetic

Askyour doctoror pharmacist before use if you are taking warfarin, a medicineused to thinthe blood, because bleeding or bruising mayoccur.

Seea doctor if no betterafter [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][Insertnumber ofdays as per approved ProductInformation]days.

See a doctor ifproblemreturns.

Miconazole(Entry 2 of2)

Inpreparations fortopical oral use

Ask your doctoror pharmacist before use if you aretaking warfarin, a medicine used to thinthe blood, because bleeding orbruising mayoccur.

Proposedamended RASML entries for medicines containing fluconazole for oraladministration

Column 1 Substance(s)

Column 2 Conditions

Column 3 Requiredstatement(s)

Fluconazole

In oral medicines fortreatment of vaginal candidiasis

Seek medical advice beforefirst course of treatment

Do not use if pregnant or likely to become pregnant

See a doctor before use ifyou are diabetic

Ask your doctoror pharmacist before use if you are taking warfarin, a medicine used to thinthe blood, because bleeding or bruising may occur.

See a doctor if no betterafter [Insertnumber of days as per approved Product Information]days.

See a doctor if problemreturns.

Interested parties should respond by close of business 21 June 2018. Feedback will be released following consideration of submissions. The recent TGA Medicines Safety Update of 20 March 2018 recommended an additional advisory statement for labels of OTC medicines containing miconazole for topical oral or vaginal use. As the Australian Regulatory Guidelines for OTC Medicines (ARGOM) indicate that this statement is also relevant to fluconazole, the TGA proposes to update the RASML entries for both miconazole and fluconazole. With this consultation, the TGA is seeking comments on the proposed wording of the new and amended RASML advisory statements. Through the consultation process, the TGA is requesting comments that will help ensure that the wording of the proposed advisory statements is appropriate and supports the quality use of the medicines; and that the label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.

TGA, 24 May 2018 ; http://www.tga.gov.au/[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]