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MIRENA

Active substance: LEVONORGESTREL

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JT Job No.: 250724
Item No.: 81636834
Drawn up/OS: Taija Oksanen
Date: 10.6.2013
Client: Bayer Oy
Folding:
Dimensions (mm): 560 x 280
Folded (W x L mm): 70 x 280

Font / Font size / Spacing:
BayerSans / 10 pt / 11 pt
8 pt / 7,9 pt

Colors: 2/2
Pms 321, black

Pharmacode: 1732

81636834

Mirena®
20 micrograms/24 hours
intrauterine delivery system
(levonorgestrel)

Insertion

1.

Insertion Instructions

R

Insert a speculum, visualise the
cervix, and then thoroughly cleanse
the cervix and vagina with a
suitable antiseptic solution.

R

Use an assistant as necessary.

R

Grasp the anterior lip of the cervix
with a tenaculum or other forceps
to stabilise the uterus. If the uterus
is retroverted, it may be more
appropriate to grasp the posterior
lip of the cervix. Gentle traction
on the forceps can be applied to
straighten the cervical canal. The
forceps should remain in position
and gentle counter traction on
the cervix should be maintained
throughout the insertion procedure.

R

Advance a uterine sound through
the cervical canal to the fundus
to measure the depth and confirm
the direction of the uterine cavity
and to exclude any evidence of
intrauterine abnormalities (e.g.
septum, submucous fibroids) or
a previously inserted intrauterine
contraceptive which has not
been removed. If difficulty is
encountered, consider dilatation of
the canal. If cervical dilatation is
required, consider using analgesics
and/or a paracervical block.

250724 81636834 Mirena EVO as.ohje GB.indd 1

9

7

6

4

8

Insertion tube
with plunger
and scale

Flange

Mark

Slider

Handle with
threads inside

2.

9

8

7

6

Push the
slider forward in
the direction of
the arrow to the
furthest position
to load Mirena into
the insertion tube
(Figure 2).

Figure 2

4

Examine the patient to establish
the size and position of the uterus,
in order to detect any signs of
acute genital infections or other
contraindications for the insertion
of Mirena and to exclude pregnancy.

Mirena

5

R

Figure 4

While holding the slider
in the furthest position,
advance the inserter through
the cervix until the flange is
approx. 1.5-2.0 cm from the
uterine cervix (Figure 4).

1.5 - 2.0 cm

Mirena is supplied within an inserter
in a sterile package which should not
be opened until needed for insertion.
Do not resterilise. As supplied, Mirena
is for single use only. Do not use if the
inner package is damaged or open. Do
not insert after the expiry month and
year shown on the label.

Preparation for insertion

5

Figure 1

Only to be inserted by a trained
healthcare professional using aseptic
technique.

For timing of insertion, please consult
the Mirena prescribing information.

4.

First, open the sterile package completely (Figure 1). Then use sterile
technique and sterile gloves.

Holding the inserter
in place, release Mirena
by pulling the slider all
the way down (Figure 7).
While holding the slider
all the way down, gently
remove the inserter by
pulling it out. Cut the
threads to leave about
2-3 cm visible outside of
the cervix.

Figure 7

4
5

7
8
9

IMPORTANT! Do not force the
inserter. Dilate the cervical canal,
if necessary.

5.

While holding the
inserter steady, pull the
slider to the mark to
open the horizontal arms
of Mirena (Figure 5). Wait
5 -10 seconds for the
horizontal arms to open
completely.

Figure 5

IMPORTANT! Should you suspect that the system is not in the correct position, check
placement (e.g. with ultrasound). Remove the system if it is not positioned properly
within the uterine cavity. A removed system must not be re-inserted.

4
5

7

8

Removal / replacement

9

For removal/replacement, please consult the Mirena prescribing information.
Mirena is removed by
pulling on the threads with
a forceps (Figure 8).

IMPORTANT!
Do not pull the
slider downwards as
this may prematurely
release Mirena. Once released,
Mirena cannot be re-loaded.

Figure 8

You may insert a new
Mirena immediately
following removal.

3.

Holding the
slider in the furthest
position, set the upper
edge of the flange to
correspond to the sound
measurement of the
uterine depth (Figure 3).

7.

Figure 3
sound
measure

4
5

4
7

5

8
9

7

6.

Figure 6

Advance the inserter
gently towards the fundus
of the uterus until the
flange touches the
cervix. Mirena is now
in the fundal position
(Figure 6).
Manufactured by:
Bayer Oy
Pansiontie 47
20210 Turku
Finland

10.6.2013 12.57

Mirena®

20 micrograms/24 hours
intrauterine delivery system
(levonorgestrel)

THERAPEUTIC 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.
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 postpartum 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
which case no additional protection is required.
If pregnancy is not desired, the removal should
be carried out during the first few days after the
onset of the woman’s menstruation. Otherwise
contraception has to be ensured with other
methods (e.g. condoms) starting at least 7 days
before the removal.
♦ Protection from endometrial hyperplasia
during oestrogen replacement therapy.
When used for endometrial protection during
oestrogen replacement therapy, Mirena can be
inserted at any time in an amenorrhoeic woman,
or during the last days of menstruation or
withdrawal bleeding.
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 after 4 years.
Mirena provides the progestogen component
of hormone therapy (HRT). Therefore in
women receiving HRT, Mirena can be used in
combination with oral or transdermal oestrogen
preparations without additional exogenous
progestogens. The product information of the
oestrogen component of the HRT should be
consulted prior to the use of Mirena as the
important risk factors associated with HRT
use should be considered, such as the risk of
endometrial cancer, breast cancer and venous
thromboembolisms.
Instructions for use and handling
Mirena is supplied in a sterile pack which should
not be opened until required for insertion. The
exposed product should be handled with aseptic
precautions. If the seal of the sterile package
is broken, the product should be discarded (see
‘Special precautions for disposal’).
R How to Insert Mirena
It is strongly recommended that Mirena should
only be inserted by physicians/healthcare
professionals who are experienced in Mirena
insertions and/or have undergone sufficient
training for Mirena insertion.
In case of difficult insertion and/or exceptional
pain or bleeding during or after insertion, please
refer to ‘Special warnings and precautions for
use: Insertion/removal warnings and precautions.’
Please see the ‘Insertion instructions’ section of
this leaflet.

250724 81636834 Mirena EVO as.ohje GB.indd 2

R How to Remove Mirena
Please see the ‘Insertion instructions’ section of
this leaflet.
R Paediatric population
There are no relevant indications for use of
Mirena before menarche.
R Geriatric patients
Mirena has not been studied in women over the
age of 65 years.
R Patients with hepatic impairment
Mirena is contraindicated in women with
acute liver disease or liver tumour (see
'Contraindications').
R Patients with renal impairment
Mirena has not been studied in women with
renal impairment.

CONTRAINDICATIONS
Known or suspected pregnancy; confirmed
or suspected hormone dependent tumours
including breast cancer; current or recurrent
pelvic inflammatory disease; cervicitis; current
genital infection; postpartum endometritis,
infected abortion during the past three
months; conditions associated with increased
susceptibility to infections; cervical dysplasia;
uterine or cervical malignancy; undiagnosed
abnormal genital bleeding; congenital or
acquired abnormality of the uterus including
fibroids if they distort the uterine cavity; liver
tumour or other acute or severe liver disease;
acute malignancies affecting the blood or
leukaemias except when in remission; recent
trophoblastic disease while hCG levels remain
elevated; hypersensitivity to the active substance
or to any of the excipients.
Active or previous severe arterial disease,
such as stroke or myocardial infarction is
a contraindication when Mirena is used in
conjunction with an oestrogen for HRT use.
SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
Medical Examination
Before insertion, a complete personal and
family medical history should be taken. Physical
examination should be guided by this and by
the contraindications and warnings for use.
Pulse and blood pressure should be measured
and a bimanual pelvic examination performed
to establish the orientation of the uterus. The
patient should be re-examined six weeks after
insertion and further examinations should be
performed where clinically indicated and adapted
to the individual woman rather than as routine
procedure. Prior to insertion pregnancy should
be excluded and genital infection should be
successfully treated. Women should be advised
that Mirena does not protect against HIV (AIDs)
and other sexually transmitted disease (please
refer to the section below on pelvic infections).
Women should be encouraged to attend cervical
and breast screening as appropriate for their age.
For the treatment of postmenopausal symptoms,
HRT should only be initiated for symptoms
that adversely affect quality of life. In all cases,
a careful appraisal of the risks and benefits
should be undertaken at least annually and HRT
should only be continued as long as the benefit
outweighs the risk. The contraindications and
warnings for the oestrogen component should
also be considered prior to commencing the HRT
regimen.
Conditions under which Mirena can be used
with caution
Should any of the following conditions exist or
arise for the first time during treatment, removal
of the system should be considered:
R Migraine with aura
R Unusually severe or unusually frequent
headache
R Jaundice
R Marked increase of blood pressure
R Malignancies affecting the blood or
leukaemias in remission
R Use of chronic corticosteroid therapy
R Past history of symptomatic functional
ovarian cysts

R Active

or previous severe arterial disease,
such as stroke or myocardial infarction (see
‘Contraindications’ when Mirena is used in
conjunction with an oestrogen for HRT use).
R Severe or multiple risk factors for arterial
disease
R Thrombotic arterial or any current embolic
disease
R Acute venous thromboembolism
In general, women using hormonal contraception
should be encouraged to give up smoking.
Mirena should be used with caution in
postmenopausal women with advanced uterine
atrophy.
Insertion/removal warnings and precautions
R General Information:
As the insertion technique is different from
other intrauterine devices, special emphasis
should be given to training in the correct
insertion technique. Instructions for insertion
are in the package. Insertion and removal may
be associated with some pain and bleeding. In
case of difficult insertion and/or exceptional
pain or bleeding during or after insertion,
physical examination and ultrasound should be
performed immediately to exclude perforation
of the uterine corpus or cervix (see also
‘Perforation’). The procedure may precipitate
fainting as a vasovagal reaction, or a seizure in
an epileptic patient. In the event of early signs
of a vasovagal attack, insertion may need to be
abandoned or the system removed. The woman
should be kept supine, the head lowered and the
legs elevated to the vertical position if necessary
in order to restore cerebral blood flow. A clear
airway must be maintained; an airway should
always be at hand. Persistent bradycardia may be
controlled with intravenous atropine. If oxygen is
available it may be administered.
R Perforation:
Perforation of the uterine corpus or cervix may
occur, most commonly during insertion. This may
be associated with severe pain and continued
bleeding. If perforation is suspected the system
should be removed as soon as possible. The
risk of perforation is increased in breastfeeding
women and may be increased in post-partum
insertions (see ‘Posology and method of
administration, Starting treatment’), and in
women with a fixed retroverted uterus.
R Pelvic infection:
The insertion tube helps to prevent Mirena from
contamination with micro-organisms during
the insertion and the Mirena inserter has been
designed to minimise the risk of infections. In
users of copper intrauterine devices (IUDs), the
highest rate of pelvic infections occurs during
the first month after insertion and decreases
later. Known risk factors for pelvic inflammatory
disease are multiple sexual partners, frequent
intercourse and young age. Pelvic infection
may have serious consequences as it may
impair fertility and increase the risk of ectopic
pregnancy. As with other gynaecological or
surgical procedures, severe infection or sepsis
(including group A streptococcal sepsis) can
occur following IUS insertion, although this
is extremely rare. For women using Mirena
with symptoms and signs suggestive of pelvic
infection, bacteriological examinations are
indicated and monitoring is recommended,
even with discrete symptoms, and appropriate
antibiotics should be started. There is no need
to remove Mirena unless the symptoms fail to
resolve within the following 72 hours or unless
the woman wishes Mirena to be removed. Mirena
must be removed if the woman experiences
recurrent endometritis or pelvic infection, or if an
acute infection is severe.
Complications leading to failure
R Expulsion:
Symptoms of the partial or complete expulsion
of any IUS may include bleeding or pain.
However, a system can be expelled from the
uterine cavity without the woman noticing it.
Partial expulsion may decrease the effectiveness
of Mirena. As the system decreases menstrual
flow, increase of menstrual flow may be
indicative of an expulsion. A displaced Mirena
should be removed and a new system inserted.

The woman should be advised how to check the
threads of Mirena.
R Lost threads:
If the retrieval threads are not visible at the
cervix on follow-up examination - first exclude
pregnancy. The threads may have been drawn
up into the uterus or cervical canal and may
reappear during the next menstrual period. If
they cannot be found, they may have broken off,
the system may have been expelled, or rarely
the device may be extrauterine after having
perforated the uterus. An ultrasound should be
arranged to locate the device and alternative
contraception should be advised in the mean
time. If an ultrasound cannot locate the device
and there is no evidence of expulsion, a plain
abdominal X-ray should be performed to exclude
an extrauterine device.
Bleeding irregularities
R Irregular bleeding:
Mirena usually achieves a significant reduction
in menstrual blood loss in 3 to 6 months
of treatment. Increased menstrual flow or
unexpected bleeding may be indicative of
expulsion. If menorrhagia persists then the
woman should be re-examined. An assessment
of the uterine cavity should be performed using
ultrasound scan. An endometrial biopsy should
also be considered.
Risk in pre-menopausal women
Because irregular bleeding/spotting may occur
during the first months of therapy in premenopausal women, it is recommended to
exclude endometrial pathology before insertion
of Mirena.
Risk in post-menopausal women
If the woman continues the use of Mirena
inserted earlier for contraception, endometrial
pathology has to be excluded if bleeding
disturbances appear after commencing oestrogen
replacement therapy. If bleeding irregularities
develop during a prolonged treatment,
appropriate diagnostic measures should also be
taken as irregular bleeding may mask symptoms
and signs of endometrial polyps or cancer.
R When to check for pregnancy in women of child
bearing potential:
The possibility of pregnancy should be
considered if menstruation does not occur within
six weeks of the onset of previous menstruation
and expulsion should be excluded. A repeated
pregnancy test is not necessary in amenorrhoeic
subjects unless indicated by other symptoms.
In a study in women who used Mirena for
contraception (n=130), oligomenorrhoea and
amenorrhoea were reported in 57% and 16% of
women respectively at the end of the first year
of use.
R Treatment review advice for Menorrhagia:
Mirena usually achieves a significant reduction
in menstrual blood loss in 3 to 6 months of
treatment. If significant reduction in blood loss
is not achieved in these time-frames, alternative
treatments should be considered.
Other risks during use
R Ectopic pregnancy
The absolute risk of ectopic pregnancy in Mirena
users is low. However, when a woman becomes
pregnant with Mirena in situ, the relative
likelihood of ectopic pregnancy is increased.
The possibility of ectopic pregnancy should
be considered in the case of lower abdominal
pain - especially in connection with missed
periods or if an amenorrhoeic woman starts
bleeding. The absolute rate of ectopic pregnancy
in users of Mirena is approximately 0.1% per
year. This rate is lower than the rate of 0.3-0.5 %
per year estimated for women not using any
contraception. Women with a previous history of
ectopic pregnancy carry a higher risk of a further
ectopic pregnancy.
R Ovarian Cysts
Since the contraceptive effect of Mirena
is mainly due to its local effect, ovulatory
cycles with follicular rupture usually occur
in women of fertile age. Sometimes atresia
of the follicle is delayed and folliculogenesis
may continue. These enlarged follicles cannot
be distinguished clinically from ovarian cysts.

Data from clinical trials suggest that ovarian
cysts have been reported as an adverse drug
reaction in approximately 7% of women using
Mirena, however some published studies have
reported a higher incidence of ovarian cysts
(which could have been influenced by factors
including frequency and criteria of ultrasound
scanning, and patient population). Most of these
follicles are asymptomatic, although some may
be accompanied by pelvic pain or dyspareunia.
In most cases, the ovarian cysts disappear
spontaneously during two to three months’
observation. Should this not happen, continued
ultrasound monitoring and other diagnostic/
therapeutic measures are recommended. Rarely,
surgical intervention may be required.
R Breast cancer
Risk in pre-menopausal women
A meta-analysis from 54 epidemiological
studies reported that there is a slightly increased
relative risk (RR = 1.24) of having breast cancer
diagnosed in women who are currently using
combined oral contraceptives (COCs), mainly
using oestrogen-progestogen preparations.
The excess risk gradually disappears during the
course of the 10 years after cessation of COC use.
Because breast cancer is rare in women under
40 years of age, the excess number of breast
cancer diagnoses in current and recent COC users
is small in relation to the overall risk of breast
cancer.
The risk of having breast cancer diagnosed
in users of progestogen-only methods (POPs,
implants and injectables), including Mirena, is
possibly of similar magnitude to that associated
with COC. However, for progestogen-only
contraceptive preparations, the evidence is based
on much smaller populations of users and so is
less conclusive than that for COCs.
Risk in post-menopausal women
The risk of breast cancer is increased in postmenopausal women using systemic (i.e. oral
or transdermal) hormone replacement therapy
(HRT). This risk is higher with combined oestrogen­
progestogen HRT than with oestrogen-only
HRT. The risk of breast cancer when Mirena
is prescribed to provide the progestogen
component of HRT is not yet known. The product
information of the oestrogen component of
the treatment should also be consulted for
additional information.
General Information
R Glucose tolerance
Low-dose levonorgestrel may affect glucose
tolerance, and the blood glucose concentration
should be monitored in diabetic users of Mirena.
R Post-coital contraception
Limited experience suggests that Mirena is not
suitable for use as a post-coital contraceptive.
INTERACTION WITH OTHER MEDICINAL
PRODUCTS AND OTHER FORMS OF
INTERACTION
The metabolism of progestogens may be
increased by concomitant use of substances
known to induce drug-metabolising enzymes,
specifically cytochrome P450 enzymes, such as
anticonvulsants (e.g. phenobarbital, primidone,
phenytoin, carbamazepine) and anti-infectives
(e.g., griseofulvin, rifampicin, rifabutin,
nevirapine, efavirenz). The influence of these
drugs on the contraceptive efficacy of Mirena
has not been studied but is not believed to be of
major importance due to the local mechanism
of action.
FERTILITY, PREGNANCY AND LACTATION
R Pregnancy

The use of Mirena during an existing or
suspected pregnancy is contraindicated. In
case of an accidental pregnancy with Mirena in
situ, ectopic pregnancy should be excluded (see
‘Special warnings and precautions for use’) and
the system must be removed and termination of
the pregnancy should be considered. Removal
of Mirena or probing of the uterus may result in
spontaneous abortion. Should these procedures
not be possible, the woman should be informed
about increased risk of spontaneous abortion
or premature labour observed during the use of
copper and plastic IUDs. Accordingly, such

pregnancies should be closely monitored. The
woman should be instructed to report all symp­
toms that suggest complications of the preg­
nancy, like cramping abdominal pain with fever.
Because of the intrauterine administration and
the local exposure to the hormone, teratogenicity
(especially virilisation) cannot be completely
excluded. It can be expected that the systemic
hormone exposure of the foetus through the
maternal circulation is lower than with any
other hormonal contraceptive method. Clinical
experience of the outcomes of pregnancies with
Mirena in situ is limited. However, the woman
should be informed that, to date, there is no
evidence of birth defects caused by Mirena use
in cases where pregnancy continues to term with
Mirena in place.
R Lactation
Levonorgestrel has been identified in the breast
milk. About 0.1% of the levonorgestrel dose
is transferred during breast-feeding, but it is
not likely that there will be a risk for the child
with the dose released from Mirena, when it is
inserted in the uterine cavity.
There appears to be no deleterious effects on
infant growth or development when using
any progestogen-only method after six weeks
postpartum. Progestogen-only methods do not
appear to affect the quantity or quality of breast
milk. Uterine bleeding has rarely been reported
in women using Mirena during lactation.
R Fertility
Studies have suggested that in women who
discontinue Mirena for planned pregnancy the
pregnancy rate at one year is similar to those
who do not use contraception.
UNDESIRABLE EFFECTS
Undesirable effects are more common during
the first months after the insertion, and subside
during prolonged use.
Very common undesirable effects (occurring in
more than 10% of users) include uterine/vaginal
bleeding including spotting, oligomenorrhoea,
amenorrhoea (see ‘Pharmacodynamic
properties’).
The frequency of benign ovarian cysts depends
on the diagnostic method used (see ‘Special
warnings and precautions for use’) but has been
estimated from clinical trial data to occur in 7%
of users.
Cases of sepsis (including group A streptococcal
sepsis) have been reported following IUD
insertion (see ‘Special warnings and precautions
for use’).
When a woman becomes pregnant with Mirena
in situ, the relative risk of ectopic pregnancy is
increased.
Cases of breast cancer have been reported in
Mirena users.
Clinical trials with Mirena excluded breastfeeding
women. A large post authorisation safety
study shows an increased risk of perforation in
breastfeeding women (see ‘Special warnings and
precautions for use’).
The following adverse reactions have been
reported in connection with the insertion or
removal procedure of Mirena: pain, bleeding
and insertion-related vasovagal reaction with
dizziness or syncope. The procedure may also
precipitate a seizure in patients with epilepsy.
The removal threads may be felt by the partner
during intercourse.
OVERDOSE
Not applicable.
PHARMACODYNAMIC PROPERTIES
ATC Code: G02BA03
Pharmacotherapeutic group: Plastic IUD with
progestogen
Levonorgestrel is a progestogen used in gynae­
cology in various ways: as the progestogen
component in oral contraceptives, in hormonal
replacement therapy or alone for contraception
in minipills and subdermal implants.
Levonorgestrel can also be administered directly
into the uterine cavity as an intrauterine system.
This allows a very low daily dosage, as the hor­
mone is released directly into the target organ.

The contraceptive mechanism of action of
Mirena is based on mainly hormonal effects
producing the following changes:
R Prevention of proliferation of the
endometrium
R Thickening of the cervical mucus thus
inhibiting the passage of sperm
R Suppression of ovulation in some women.
The physical presence of the system in the
uterus would also be expected to make a minor
contribution to its contraceptive effect.
When inserted according to the insertion
instructions, Mirena has a contraceptive failure
rate of approximately 0.2% (95% CI: 0.1-0.3)
per year and a cumulative failure rate of
approximately 0.7% at 5 years. The failure rate
may increase in case of Mirena expulsion or
perforation.
Mirena may be particularly useful for contra­
ception in patients with excessive menstrual
bleeding, and can be successfully used in the
treatment of idiopathic menorrhagia. Results
from three comparative studies indicate that
in menorrhagic women, menstrual blood loss
decreased by 62-94% at the end of three months
and by 71-95% at the end of six months of
use. Mirena appears to have similar effects to
endometrial ablation/resection in reducing
the menstrual blood loss up to two years.
Menorrhagia caused by submucosal fibroids
may respond less favourably. Reduced bleeding
promotes the increase of blood haemoglobin in
patients with menorrhagia.
In idiopathic menorrhagia, prevention of
prolifera­ ion of the endometrium is the probable
t
mechanism of action of Mirena in reducing blood
loss.
The efficacy of Mirena in preventing endometrial
hyperplasia during continuous oestrogen
treat­ ent is the same when oestrogen is
m
administered orally or transdermally. The observed
hyperplasia rate under oestrogen therapy alone
is as high as 20%. In clinical studies with a total
of 634 perimenopausal and postmenopausal
users of Mirena, no cases of endometrial
hyperplasia were reported up to four years.
System Organ
Class

Common
≥ 1/100 to
< 1/10

Bleeding Patterns:
Different kinds of bleeding changes (frequent,
prolonged or heavy bleeding, spotting, oligomen­
orrhoea, amenorrhoea) are experienced by all
users of Mirena. In fertile women the average
number of spotting days/month decreases
gradually from nine to four days during the first
six months of use. The percentage of women
with prolonged bleeding (more than eight days)
decreases from 20% to 3% during the first three
months of use. In clinical studies during the
first year of use, 17% of women experienced
amenorrhoea of at least three months duration.
When used in combination with oestrogen
replacement therapy, perimenopausal users of
Mirena may experience spotting and irregular
bleeding during the first months of the
treatment. The amount of bleeding becomes
minimal during the first year, and 30-60% of
users are totally free of bleedings.
SPECIAL PRECAUTIONS FOR DISPOSAL
Mirena is supplied in a sterile pack which should
not be opened until required for insertion.
Each system should be handled with aseptic
precautions. If the seal of the sterile envelope
is broken, the system inside should be disposed
of in accordance with the local guidelines for
the handling of biohazardous waste. Likewise, a
removed Mirena and inserter should be disposed
of in this manner. The outer carton package
and the inner blister package can be handled as
household waste.
MARKETING AUTHORISATION NUMBER:
PL 00010/0547
MARKETING AUTHORISATION HOLDER:
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire RG14 1JA
DATE OF PREPARATION:
April 2013

Uncommon
≥ 1/1000 to
< 1/100

Rare
≥ 1/10,000 to
< 1/1000

Unknown

Hypersensitivity
including rash,
urticaria and
angioedema

Immune system
disorders

Nervous system
disorders

Depressed mood/
Depression
Nervousness
Decreased libido
Headache
Migraine

Gastrointestinal
disorders

Abdominal pain
Nausea

Abdominal distension

Skin and
subcutaneous
tissue disorders

Acne
Hirsutism

Alopecia
Pruritus
Eczema
Chloasma/Skin
Hyperpigmentation

Rash

Musculoskeletal,
connective tissue
and bone
disorders

Back pain

Reproductive
system and
breast disorders

Ovarian cysts
Pelvic pain
Dysmenorrhoea
Vaginal
discharge
Vulvovaginitis
Breast
tenderness
Breast pain
Intrauterine
contraceptive
device expelled

Pelvic inflammatory
disease
Endometritis
Cervicitis/
Papanicolaou smear
normal, class II

Uterine
perforation

Psychiatric
disorders

General
disorders and
administration
site conditions
Investigations

Weight increase

Oedema

Blood pressure
increased
IV-2013

10.6.2013 12.57

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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