Mirena, IUD 20 micrograms/24 hours

Country: Malta

Language: English

Source: Medicines Authority

Available from:

JV Healthcare Limited Navi Buidlings, Pantar Road, Lija, LJA 2021, Malta

ATC code:

G02BA03

INN (International Name):

LEVONORGESTREL 52 mg

Pharmaceutical form:

INTRAUTERINE DELIVERY SYSTEM

Composition:

LEVONORGESTREL 52 mg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Product summary:

Licence number in the source country: Netherlands - RVG 16681

Authorization status:

Authorised

Authorization date:

2024-02-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRENA, IUD 20 MICROGRAMS/24 HOURS
levonorgestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mirena is and what it is used for
2. What you need to know before you use Mirena
3. How to use Mirena
4. Possible side effects
5. How to store Mirena
6. Contents of the pack and other information
1.
WHAT MIRENA IS AND WHAT IT IS USED FOR
Mirena is an 'intra-uterine device' (IUD), also called an 'IUD', that,
after insertion, releases a small
amount of the hormone levonorgestrel into the uterus every day.
Because Mirena is T-shaped, the
IUD stays in place in the uterus. . In the vertical part of the white
T-shape there is a rod that
contains levonorgestrel. At the bottom of the T-shape there is an eye
to which two brown-colored
removal wires are attached.
Mirena is an intrauterine delivery system (IUS) placed inside the womb
(uterus) where it
slowly releases the hormone levonorgestrel. It can be used in the
following three ways:
1. As an effective long-term and reversible method of
CONTRACEPTION
.
It is used for prevention of pregnancy (contraception) for a maximum
of 8 years.
2. For
REDUCING MENSTRUAL BLOOD FLOW
, so it can be used if you suffer from heavy
periods (heavy menstrual bleeding). This is called menorrhagia.
It is used for heavy menstrual bleeding (idiopathic menorrhagia) for
up to 5 years. If symptoms
have not returned after 5 years of use, continued use may be
considered. Your Mirena should be
removed or replaced after a maximum of 8 years.
3. If you are going through the
MENOPAUSE
, a gradual process which usually takes place

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Mirena, IUD 20 micrograms/24 hours
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
substance
:
levonorgestrel
52
mg
.
The average in vivo release rate during the first year is 20 µg
levonorgestrel per 24 hours.
For
the
full
list
of
excipients
,
see
section
6
.
1
.
For
details
on
release
rates
,
see
section
5
.
2
.
3. PHARMACEUTICAL FORM
Intrauterine
delivery
system
.
The
levonorgestrel
intrauterine
delivery
system
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
intrauterine
delivery
system
is
loaded
in
the
insertion
tube
at
the
tip
of
the
inserter
.
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
Method
of
administration
Mirena
is
inserted
into
the
uterine
cavity
.
It
is
effective
for
8
years
in
the
indication
contraception
and
5
years
in
the
indications
idiopathic
menorrhagia
and
protection
from
endometrial
hyperplasia
during
oestrogen
replacement
therapy
.
For
timing
regarding
removal/replacement
,
see
section
“Removal/Replacement”
.
_Insertion _
It
is
strongly
recommended
that
Mirena
should
only
be
inserted
by
healthcare
professionals
who
are
experienced
in
Mirena
insertions
and/or
have
undergone
sufficient
training
for
Mirena
insertion
.
Mirena
must
be
inserted
using
aseptic
technique
.
Before
insertion
,
the
patient
should
have
been
carefully
examined
in
order
to
detect
any
contraindication
to
IUS
insertion
.
Exclude
pregnancy
before
insertion
.
Consider
the
possibility
of
ovulation
and
conception
before
using
this
produc