MIRENA LEVONORGESTREL INTRAUTERINE SYSTEM 20 mcg24 hr

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LEVONORGESTREL

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

G03AC02

Dosage:

52 mg

Pharmaceutical form:

INTRAUTERINE DEVICE

Composition:

LEVONORGESTREL 52 mg

Administration route:

INTRAUTERINE

Prescription type:

Prescription Only

Manufactured by:

BAYER OY

Authorization status:

ACTIVE

Authorization date:

1994-11-15

Patient Information leaflet

1
Mirena IUS PIL_SG_CCPI 27_28 Feb 2023
2
Mirena IUS PIL_SG_CCPI 27_28 Feb 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mirena 20 micrograms/24 hours intrauterine delivery system
Levonorgestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT MIRENA IS AND WHAT IS IT USED FOR ......................... 3
2.
BEFORE YOU USE MIRENA
............................................................ 3
3.
HOW TO USE
MIRENA....................................................................
11
4.
POSSIBLE SIDE EFFECTS
............................................................... 17
5.
HOW TO STORE MIRENA
.............................................................. 20
6.
FURTHER INFORMATION
............................................................. 20
1.
WHAT MIRENA IS AND WHAT IS IT USED FOR
Mirena is a T-shaped intrauterine delivery system (IUS) which after
insertion releases the
hormone levonorgestrel into the womb. The purpose of the T-body is to
adjust the system to
the shape of the womb. The vertical arm of the white T-body carries a
drug reservoir
containing levonorgestrel. Two brown colored removal threads are tied
to the loop at the
lower end of the vertical arm.
Mirena is used for
•
Contraception (prevention of pregnancy),
3
Mirena IUS PIL_SG_CCPI 27_28 Feb 2023
•
Idiopathic menorrhagia (excessive menstrual bleeding)
•
Protection from endometrial hyperplasia (excessive growth of the
lining of the
womb) during estrogen replacement therapy.
2.
BEFORE YOU USE MIRENA
GENERAL NOTES
Before you can begin using Mirena, your doctor will ask you some
questions ab

Summary of Product characteristics

Mirena IUS PI_SG_CCDS 27.1_31 Oct 2023
1.
NAME OF MEDICINAL PRODUCT
Mirena 20 micrograms/24 hours intrauterine delivery system
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levonorgestrel 52mg. The average in vivo release rate is 20
micrograms/day during the first year.
For a full list of excipients, see section 6.1, ‘List of
excipients’.
3.
PHARMACEUTICAL FORM
Intrauterine delivery system (IUS).
The levonorgestrel (LNG) IUS consists of a white or almost white drug
core covered with an
opaque membrane, which is mounted on the vertical stem of a T-body.
The white T-body has
a
loop at one end of the vertical stem and two horizontal arms at the
other end. Brown removal threads
are attached to the loop. The T-frame of Mirena contains barium
sulphate, which
makes it
visible in X-ray examination. The vertical stem of the IUS is loaded
in the insertion tube at the tip
of the inserter. The IUS and inserter are essentially free of visible
impurities.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
Contraception.
Idiopathic menorrhagia. Mirena may be particularly useful in women
with idiopathic
menorrhagia requiring (reversible) contraception.
Protection from endometrial hyperplasia during oestrogen replacement
therapy.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF ADMINISTRATION
Mirena is inserted into the uterine cavity. It is effective for 8
years for
contraception and for 5
years in the indication idiopathic menorrhagia
In the indication for the protection from endometrial hyperplasia
during oestrogen replacement
therapy, clinical data beyond 4 years of use are limited. Mirena
should therefore be removed after
4 years.
For timing regarding removal/replacement see section
‘Removal/Replacement’.
The in vivo levonorgestrel release rate 24 days after insertion is
approximately 21 μg/day,
decreasing continuously to approximately 19 μg/day after 1 year, to
11 μg/day after 5 years and to
7 μg/day after 8 years of use.
The average daily levonorgestrel release rates are approximately 20
μg/day during the first year