MIRENA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEVONORGESTREL

Available from:

BAYER ISRAEL LTD

ATC code:

G03AA07

Pharmaceutical form:

INTRAUTERINE DEVICE

Composition:

LEVONORGESTREL 52 MG

Administration route:

INTRAUTERINE

Prescription type:

Required

Manufactured by:

BAYER OY, FINLAND

Therapeutic group:

LEVONORGESTREL AND ESTROGEN

Therapeutic area:

LEVONORGESTREL AND ESTROGEN

Therapeutic indications:

Contraception and idiopathic menorrhagia. Protection from endometrial hyperplasia during estrogen replacement therapy.

Authorization date:

2022-07-31

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: J601,J605
material-no.: 89322154
PZ: 7621A-V0
code-no.:
name: LF-BRO MIRENA 52MG IUS BLI 1X1 PAT IL
country: IL/ARA-ENG-HEB
colors: BLACK
version: 14.09.2022/01
Restricted Document
dimension: 72 X 145 MM
page: 1 /
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
MIRENA
®
Intrauterine Delivery System
The active ingredient is levonorgestrel 52 mg
(20 micrograms/24 hours)
Inactive ingredients and allergens in the preparation – see
section 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that
their medical condition is similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
WHAT IS MIRENA?
Mirena is an intrauterine delivery system which releases at
a steady rate the hormone levonorgestrel inside the womb
after its installation.
The system is intended for treatment of the following
conditions:
for
contraception,
for
treatment
of
heavy
menstrual bleeding of unknown cause, and for protecting
the endometrium as part of estrogen-containing hormone
replacement
therapy
(HRT).
For contraception and for treatment of heavy menstrual
bleeding, Mirena can be used for up to 5 years.
If you are using Mirena for protection of the endometrium
during hormone replacement therapy, the Mirena system
should be removed after 4 years. It is not known if Mirena
is effective in protecting the endometrium as part of HRT
beyond 4 years.
THERAPEUTIC GROUP: progestogens.
How does Mirena work?
WHEN USED AS A CONTRACEPTIVE, the hormone in Mirena
prevents pregnancy by:
a) controlling the growth of the endometrium so that it is
not thick enough to enable pregnancy,
b) thickening the mucus in the cervix, thus c

Summary of Product characteristics

RESTRICTED
1. NAME OF THE MEDICINAL PRODUCT
Mirena
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Levonorgestrel 52mg.
The initial release of levonorgestrel is approximately 20 micrograms
per day.
For details of release rates, see section 5.2.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Levonorgestrel-releasing intrauterine system (IUS).
The product consists of an inserter and levonorgestrel intrauterine
system, which is
loaded at the tip of the inserter. Inserter components are an
insertion tube, plunger,
flange, body and slider. The system consists of a white or almost
white hormone-
elastomer core, mounted on a T-body and covered in opaque tubing,
which regulates
the
release of levonorgestrel. The white T-body has a loop at one end and
two 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.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
Idiopathic menorrhagia.
Protection from endometrial hyperplasia during oestrogen replacement
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_STARTING TREATMENT_
• Contraception and idiopathic menorrhagia
In women of fertile age, Mirena is inserted into the uterine cavity
within seven days of the onset of
menstruation. It can be replaced by a new system at any time of the
cycle.
Post-partum insertion: To reduce the risk of perforation, postpartum
insertions should be postponed
until the uterus is fully involuted. Do not insert earlier than six
weeks after delivery. If the patient is
experiencing significant post-partum bleeding and/or pain then
infection or other causes should be
excluded before insertion. Mirena can also be inserted immediately
after the first trimester abortion.
Mirena is effective for 5 years in the indications for contraception
and idiopathic menorrhagia so
should be removed after 5 years use. If the user wishes to continue
using the same method, a new
system can be inserted at the same time, in whi