Mirena 52mg Intrauterine Delivery System

REC30572+REC31963_BP23039

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3 Pharmaceutical form

The product levonorgestrel intrauterine delivery system consists of a white or almost white drug core covered with an semi-opaque membrane, which is mounted on the vertical stem of a T-body.

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4.2 Posology and method of administration

Removal/Replacement

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Mirena is removed by gently pulling on the threads with forceps. The use of excessive force/sharp instruments during removal may cause breakage of the system device. After removal of Mirena, the system device should therefore be examined to ensure that it is intact and has been completely removed entirely. […..]

If the threads are not visible, determine the location of the system via ultrasound or other method. and If the system is in the uterine cavity, it may be removed using a narrow forceps tenaculum. […..]

4.4 Special warnings and precautions for use

Precautions at time of removal

The use of excessive force/sharp instruments during removal may cause breakage of the system device (see section 4.2). After removal of Mirena, the system device should therefore be examined to ensure that it is intact and has been completely removed entirely.

10 Date of revision of the text

April 2023July 2024

REC30572+REC31963_BP23039

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4 Possible side effects

Very common side effects: may affect more than 1 in 10 people

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Common side effects: may affect up to 1 in 10 people

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Uncommon side effects: may affect up to 1 in 100 people

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6 Contents of the pack and other information

This leaflet was last revised in June 2023July 2024.

The following information is intended for healthcare professionals only:

Removal/ replacement

For removal/replacement, please consult the Summary of Product Characteristics for Mirena prescribing information.

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After removal of Mirena, the system device should be examined to ensure that it is intact and has been completely removed entirely. See Summary of Product Characteristics for further information.

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DATE OF REVISION OF THE TEXT: March 2023July 2024

BP23021, REC31616

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Text in red with strikethrough = deleted text

Text in black = unchanged text.

3. How to use Mirena

How quickly does Mirena work?

Contraception:

You are protected from pregnancy as soon as Mirena is fitted. Mirena will work right away and will prevent you from getting pregnant when:

-         it is inserted within 7 days from the start of your menstrual period. If this is not possible, or if your menstrual period comes at unpredictable times, see section 3 “Starting to use Mirena”.

-         it is inserted immediately after an abortion or miscarriage if the pregnancy was less than 3 months along, provided that there are no genital infections.

-         it is replacing a previously fitted Mirena at any time in your menstrual cycle.

For more information see section 3 “When should Mirena be inserted?”.

6. Contents of the pack and other information

This leaflet was last revised in March June 2023.