Mirena® was approved in the UK for extended duration of use in contraception for up to 8 years.
Contraception: Mirena is effective for 8 years for contraception and should be removed no later than 8 years after insertion.
Idiopathic menorrhagia: Mirena is effective for 5 years in the indication idiopathic menorrhagia. Clinical data (from clinical trials conducted in women of 18 years and over) beyond 5 years of use are limited, return of symptoms may indicate reduced efficacy. The system should be removed or replaced in case symptoms return. If symptoms have not returned after 5 years of use, continued use of the system may be considered. Remove or replace no later than 8 years after insertion.
Protection from endometrial hyperplasia during oestrogenreplacement therapy: In the indication for protection from endometrial hyperplasia during oestrogen replacement therapy, clinical data (from clinical trials conducted in women of 18 years and over) beyond 4 years of use are limited. Mirena should therefore be removed no later than 4 years after insertion.
PP-PF-WHC-GB-1363 January 2024
Reporting adverse events and quality complaints
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bayer plc.
If you want to report an adverse event or quality complaint, reports can be directed to: Tel: 01182063500 or email: email@example.com
Further information is available on the “contact” tab at www.bayer.co.uk.