MIRENA INTRA-UTERINE SYSTEM

Active substance: LEVONORGESTREL

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Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Marina intra-uterine system

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0579G

DATE OF PROOF:

08/02/13

DATE:

PROOF HISTORY:
v.2 - waymade - 08/02/13

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2012

By mcdermottc at 10:16 am, Feb 25, 13 Assessed against
Each pack contains 1 Mirena intra-uterine system.
POM

MOCK UP

Pg
the UK4 PIL dated
May 2012

PL No: 6464/0579

This product is manufactured by Schering Oy, 20121 Turku, Finland and is procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 7.2.2013

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About this leaflet
Please read this leaflet carefully before you decide to have Mirena fitted.

Patient Name: …………………………...................
Date of Fitting: …………………………
Doctor’s Name: ………………………..

In this leaflet:
1. What Mirena is and what it is used for
2. Before you have Mirena fitted
3. How and when Mirena is used
4. Possible side effects
5. How to store Mirena
6. Further information

1. What Mirena is and what it is used for
Mirena is an intrauterine 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.
2. For reducing menstrual blood flow, if you suffer from heavy periods (heavy menstrual bleeding).
It can be used for contraception and heavy menstrual bleeding until it is removed or up to a maximum of 5
years.
3. If you are going through the menopause Mirena can be used in conjunction with an oestrogen as part of a
hormone replacement therapy (HRT) regimen to protect the lining of your womb.
Not so much is known about how well Mirena protects the lining of the womb beyond 4 years of use in women
who are taking oestrogen to treat menopausal symptoms. Therefore, if you are using it in this way, your
doctor or nurse will remove your Mirena after 4 years. Your doctor will be able to advise you further.
How does Mirena work?
As a contraceptive:
The hormone in Mirena prevents pregnancy by:

controlling the monthly development of the womb lining so that it is not thick enough for you to
become pregnant

making the mucus in the opening to the womb (the cervical canal) thicker, so that the sperm
cannot get through to fertilise the egg

preventing the release of eggs (ovulation) in some women.
There are also some effects on the lining of the womb caused by the presence of the T-shaped frame of the
Mirena device.
In the treatment of heavy menstrual bleeding:
The hormone in Mirena reduces menstrual bleeding by controlling the monthly development of the womb
lining, making it thinner, so that there is less bleeding every month.

Patient Information

Telephone No: ………………

First check-up visit: .……………………….
Next visits:
1.
2.
3.
4.
5.

This product is known by the above name but will usually be referred to as Mirena throughout this leaflet.

It provides you with some useful information about Mirena. The information in this leaflet applies only to
Mirena. If you have any questions or are not sure about anything, please ask your doctor or nurse.

MIRENA is a registered trademark of SCHERING OY

Date of insertion = X

Pg 1

MIRENA® INTRA-UTERINE SYSTEM
(levonorgestrel)
Patient Information Leaflet

As part of an HRT regimen:
The menopause is a gradual process which usually takes place between the ages of about 45 and 55.
Although the menopause is natural, it often causes distressing symptoms such as hot flushes and night
sweats. These symptoms are due to the gradual loss of the female sex hormones (oestrogen and
progestogen) produced by the ovaries.
Oestrogens can be used to relieve the menopausal symptoms. However, taking oestrogens alone increases
the risk of abnormal growth or cancer of the lining of the womb. Taking a progestogen, such as the hormone
in Mirena (levonorgestrel), as part of an HRT regimen lowers this risk by protecting the lining of the womb.

2. Before you have Mirena fitted
Your doctor or nurse will carry out some tests before you have Mirena fitted to make sure that it is suitable for
you to use. This will include a pelvic examination so that pregnancy and sexually transmitted diseases can be
excluded and may also include other examinations such as a breast examination, if your doctor or nurse feels
this is appropriate.
Genital infections will need to be successfully treated before you can have Mirena fitted.
If Mirena is to be fitted for HRT use your doctor will firstly carry out an assessment of your symptoms to
ensure that treatment is only initiated for symptoms that adversely affect your quality of life. Such an
assessment should be repeated by your doctor at least annually. You should also consult the Patient
Information Leaflet of the oestrogen product that is to be used in conjunction with Mirena before starting your
HRT regimen as there are some important risk factors associated with HRT that you should consider, such as
the risk of endometrial cancer, breast cancer and blood clots. You may feel pain or have some bleeding during
insertion.
If you have epilepsy, tell the doctor or nurse fitting the Mirena because, although rare, a fit can occur during
insertion. Some women might feel faint after the procedure. This is normal and your doctor or nurse will tell
you to rest for a while.
Do not use Mirena and please tell your doctor or nurse if you:

are pregnant or suspect that you may be pregnant

have undiagnosed vaginal bleeding

have an abnormal womb or abnormal growths in the womb (fibroids) which distort the uterine
cavity

have an unusual or unpleasant vaginal discharge, or vaginal itching as this may indicate an
infection

currently have or have had recurrent pelvic inflammatory disease

have or have had inflammation of the lining of your womb following delivery of your baby

have or have had an infection of the womb after delivery or after abortion during the past 3 months

have or have had inflammation of the neck of the womb (cervix)

have or have had an abnormal smear test (changes in the cervix)

have or have had liver problems

have any condition which makes you susceptible to infections. A doctor will have told you if you
have this

have or have had any type of cancer or suspected cancer including blood cancer (leukaemia)
unless in remission, uterine, cervical and breast cancer

have or have had trophoblastic disease. A doctor will have told you if you have this

are sensitive to the hormone levonorgestrel or to any of the ingredients in Mirena (see Section 5
‘What Mirena contains’).
Mirena must not be used as part of an HRT regimen if you have had a stroke, heart attack or any heart
problems.
Mirena may not be suitable for all women.
Consult your doctor or nurse if you:

have or develop migraine with visual disturbances, unusually bad headaches or if you have
headaches more often than before

have yellowing of the skin or whites of the eyes (jaundice)

have high blood pressure

have had a cancer affecting your blood (including leukaemia) which is now in remission

are on long-term steroid therapy

have ever had a previous ectopic pregnancy

have a history of fluid filled sacks in the ovary (ovarian cysts)

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Marina intra-uterine system

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/0579G

DATE OF PROOF:

08/02/13

DATE:

PROOF HISTORY:
v.2 - waymade - 08/02/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2012

Pg 2






are having Mirena fitted for contraception or heavy menstrual bleeding and have had a stroke or
heart attack, or if you have any heart problems
have disease of your arteries (arterial disease)
have a history of blood clots (thrombosis)
are diabetic, as Mirena may affect glucose tolerance.

You may still be able to use Mirena if you have or have had some of these conditions.
Your doctor or nurse will advise you.
You must also tell your doctor or nurse if any of these conditions occur for the first time while you have Mirena
in place.

Pg 3

If you have had Mirena fitted for heavy menstrual bleeding:
You should have lighter periods after 3 to 6 months. If you do not have lighter periods after 3 to 6 months,
alternative treatments should be considered.
If you have had Mirena fitted for HRT use:
If you have had Mirena fitted for quite a long time and then start to have bleeding problems, it is important
that you contact your doctor so that tests can be carried out to exclude changes to your womb.
There is a calendar on the back page of this patient information leaflet. Your doctor or nurse may ask you to fill
this in to check your pattern of bleeding. If you are asked to do so, mark the date of insertion with an “X” in the
appropriate date square. Mark days of spotting with “o” and bleeding with “•”.

4. Possible side effects

You must see a doctor or nurse as soon as possible if you develop painful swelling in your leg,
sudden chest pain or difficulty breathing as these may be a sign of a blood clot.
It is important that any blood clots are treated promptly.

Taking any medicine carries some risk of side effects. With Mirena these are most common during the first
months after it is fitted and decrease as time goes on.

It is advisable to give up smoking when using hormone containing products such as Mirena.
Can I change my mind?
Your doctor or nurse can remove Mirena at any time. The removal is very easy. Unless you wish to get
pregnant the removal should be carried out during the first few days of your period. Otherwise it is important
to use another form of contraception (e.g. condoms) in the 7 days leading up to the removal as intercourse
during this week could lead to pregnancy after Mirena is removed.

If you experience any of the following serious side effects please contact your doctor or nurse
immediately:

Severe pain and continued bleeding as this might be a sign of damage or tear in the wall of the
womb (perforation). This occurs most often during the fitting of the Mirena, although the
perforation may not be detected until sometime later. If this happens the Mirena will be removed.

Taking other medicines
The effect of hormonal contraceptives such as Mirena may be reduced by medicines that increase the
amounts of enzymes made by the liver. Please tell your doctor or nurse if you are taking:

barbiturates (to treat anxiety)

primidone, phenytoin or carbamazepine (to treat epilepsy)

griseofulvin (an antifungal)

rifampicin (an antibiotic).



Lower abdominal pain especially if you also have a fever or have missed a period or have
unexpected bleeding, as this might be a sign of ectopic pregnancy. The absolute risk of ectopic
pregnancy in Mirena users is low. However, when a woman becomes pregnant with Mirena in
place, the relative likelihood of ectopic pregnancy is increased.



If you do wish Mirena to be removed so that you can get pregnant your usual level of fertility is expected to
return after it is removed. Studies have suggested that in women who discontinue Mirena (in order to become
pregnant) the pregnancy rate at one year is similar to those who do not use contraception.

Lower abdominal pain or experience painful or difficult sex as this might be a sign of ovarian
cysts or pelvic inflammatory disease. This is important as pelvic infections can reduce your
chances of having a baby and can increase the risk of ectopic pregnancy.

Very Common (more than 1 in 10 women)

vaginal bleeding including spotting

absent, light or infrequent menstrual periods

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including
medicines obtained without prescription.
Pregnancy and breastfeeding
Mirena should not be used during pregnancy or if you think you are pregnant.
It is very rare for women to become pregnant with Mirena in place.
Missing a period may not mean that you are pregnant as some women may not have periods at all while
using Mirena. However, in order to exclude the possibility of pregnancy, you should consider a pregnancy test
if you have not had a period for 6 weeks. If this test is negative there is no need to carry out another test,
unless you have other signs of pregnancy, e.g. sickness, tiredness or breast tenderness.
If you do become pregnant with Mirena in place, please contact your doctor as soon as possible so that
ectopic pregnancy can be excluded and Mirena removed to reduce the risk of spontaneous abortion.
Very small amounts of the hormone in Mirena are found in breast milk but the levels are lower than with any
other hormonal contraceptive method. Please ask your doctor or nurse for advice before breastfeeding.

3. How and when Mirena is used
Only a doctor or specially trained nurse can fit Mirena. They will explain the fitting procedure and any risks
associated with its usage. You will then be examined by your doctor or nurse before Mirena is fitted. If you
have any concerns over its usage you should discuss it with them.
When Mirena is fitted for contraception or heavy menstrual bleeding:
Mirena should be inserted either during your period or within seven days from the beginning of your period. If
you already have Mirena and it is time to replace it with a new one, you do not need to wait until your period.
If you have just had a baby, you should wait at least 6 weeks before having Mirena fitted. Mirena can
sometimes be fitted immediately after you have had an abortion, provided that you have no genital infections.
When Mirena is fitted for HRT use:
If you no longer have periods then Mirena can be inserted at any time. If you still have periods, Mirena should
be inserted during the last days of bleeding.
How quickly does Mirena work?
Contraception:
You are protected from pregnancy as soon as Mirena is fitted. The possibility of becoming pregnant is
approximately 2 in 1,000 per year.
The failure rate may increase in case of the Mirena coming out by itself (see section below "How can I tell
whether Mirena is in place?") or perforation (see Section 4 ‘Possible Side Effects’).

Common (less than 1 in 10 women)

ovarian cysts

painful periods

weight gain

depression, nervousness

headache

migraine

abdominal, pelvic or back pain

nausea

increased growth of hair on the face and body

acne

reduced sex drive

increased vaginal discharge

inflammation of the vulva and vagina

tender, painful breasts

Mirena coming out by itself
Uncommon (less than 1 in 100 women)

genital infections that may cause: vaginal itching; pain on passing urine; or lower abdominal pain
from inflammation of the womb, ovaries or Fallopian tubes

infection or inflammation of the lining of the womb, which may cause a foul smelling vaginal
discharge (endometritis)

inflammation of the neck of the womb (cervicitis)

swelling of your abdomen, legs or ankles

hair loss

itchy skin including eczema

mood changes
Rare (less than 1 in 1000 women)

rashes
Unknown frequency

allergic reaction (symptoms may include rash, itching or rapid swelling of the face, mouth, tongue
and/or throat)

increased blood pressure
Your partner may feel the removal threads during intercourse.
Every woman is at risk of breast cancer, but it is rare in women under the age of 40. Breast cancer has been
reported in Mirena users, although the risk and frequency are unknown.

Heavy menstrual bleeding:
Mirena usually results in lighter periods after 3 to 6 months of treatment.

In pre-menopausal women, the frequency of developing breast cancer whilst using Mirena is possibly similar to
that associated with using Combined Oral Contraceptives, but the evidence for this is less conclusive.

HRT use:
The hormone in Mirena will begin to protect the lining of your womb as soon as it is fitted.

In post-menopausal women, using hormone replacement therapy (HRT) slightly increases the risk of breast
cancer. Although the risk of developing breast cancer is higher with combined oestrogen/progestogen HRT,
than with oestrogen-only HRT, the risk of breast cancer developing when Mirena is prescribed to provide the
progestogen component of HRT is not yet known. The patient information leaflet of the oestrogen component
of the treatment should also be consulted for additional information.

How often should I have Mirena checked?
You should have it checked 6 weeks after it is fitted, again at 12 months and then once a year until it is
removed.
How can I tell whether Mirena is in place?
After each menstrual period, you can feel for the two thin threads attached to the lower end of Mirena. Your
doctor or nurse will show you how to do this.
Do not pull the threads because you may accidentally pull it out. If you cannot feel the threads, contact your
doctor or nurse. The threads may have simply drawn up into the womb or cervical canal. If the threads still
cannot be found by your doctor or nurse, they may have broken off, or Mirena may have come out by itself, or
in rare cases it may have perforated the wall of your womb (uterine perforation, see section 4). It may be
necessary for you to have an ultrasound scan or x-ray to locate Mirena.
Contact your doctor or nurse if you can feel the lower end of Mirena itself or you or your partner feel pain or
discomfort during sexual intercourse.
What happens if Mirena comes out by itself?
If it comes out either completely or partially you may not be protected against pregnancy.
It is rare but possible for this to happen without you noticing during your menstrual period. An unusual
increase in the amount of bleeding during your period might be a sign that this has happened. Tell your doctor
or nurse if there are any unexpected changes in your bleeding pattern.
How will Mirena affect my periods?
Mirena will affect your menstrual cycle.
For all uses of Mirena:
You may have lighter periods or painful periods or some spotting (light bleeding in between periods) and
irregular bleeding during the first few months after Mirena is fitted.
You may have prolonged or heavy bleeding or an increase in the frequency of bleeding, usually in the first 2
to 3 months, before a reduction in blood loss is achieved.
Overall you are likely to have fewer days bleeding in each month and you might eventually have no periods at
all. This is due to the effect of the hormone (levonorgestrel) on the lining of the womb.
Pg 3

It is important to regularly check your breasts and you should contact your doctor if you feel any lump in your
breasts. You should also tell your doctor if a close relative has or ever had breast cancer.
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 nurse.

5. How to store Mirena
Do not use after the expiry date printed on the carton label or packaging. This date refers to the last day of that
month.
Mirena intra-uterine system should be stored in the manufacturer's original packaging, away from direct
sunlight.
Protect from moisture.
Do not store above 30°C.
Do not open the pack. Only your doctor or clinic should do this.
Keep all medicines out of the sight and reach of children.

6. Further information
Your medicine is called Mirena intra-uterine system.
What Mirena contains
Each intra- uterine system consists of a small T-shaped frame made from a plastic called polyethylene. This
carries 52 milligrams of levonorgestrel, a hormone used in many contraceptive pills. The hormone is contained
within a substance called polydimethylsiloxane. This is surrounded by a membrane (skin) also made of
polydimethylsiloxane.
The T-shaped frame also contains barium sulphate so that it can be seen on X-rays.
This structure provides a system for releasing the hormone gradually into the uterus (womb).
There are two fine threads, made of iron oxide (E172) and polyethylene, attached to the bottom of the frame.
These allow easy removal and allow you or your doctor or nurse to check that the system is in place.
Pg 4

Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Mirena medical information leaflet

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/0579G

DATE OF PROOF:

08/02/13

DATE:

PROOF HISTORY:
v.2 - waymade - 08/02/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2012

Pg 1

Pg 4

MIRENA®

The contraceptive mechanism of action of Mirena is based on mainly hormonal effects producing the following
changes:
• Prevention of proliferation of the endometrium
• Thickening of the cervical mucus thus inhibiting the passage of sperm
• 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 contraception 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 proliferation of the endometrium is the probable mechanism of action of
Mirena in reducing blood loss.
The efficacy of Mirena in preventing endometrial hyperplasia during continuous oestrogen treatment is the same
when oestrogen is 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.
Bleeding Patterns
Different kinds of bleeding changes (frequent, prolonged or heavy bleeding, spotting, oligomenorrhoea,
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.
System Organ Class

Common
≥1/100 to <1/10

Uncommon
≥1/1000 to <1/100

Rare
≥1/10000 to <1/1000

Immune system
disorders

Psychiatric disorder

Unknown
Hypersensitivity
including rash,
urticaria and
angioedema

Depressed mood
Nervousness
Decreased libido

Altered mood

Headache
Migraine

Gastrointestinal
disorders

Abdominal pain
Nausea

Abdominal
distension

Skin and
subcutaneous tissue
disorders

Acne
Hirsutism

Alopecia
Pruritus
Eczema

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

Investigations

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.

How to Insert Mirena

It is recommended that Mirena should only be inserted by physicians/health care professionals who are
experienced in Mirena insertions and/or have undergone sufficient training for Mirena insertion.

Rash

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.


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

Uterine
perforation



Do not store above 30°C. Protect from moisture and direct sunlight.
POM

PACKAGE QUANTITIES:
Carton containing one sterile system.
MANUFACTURER AND PL HOLDER:
Mirena intra-uterine system is manufactured by Schering Oy, 20121 Turku, Finland and is procured from within
the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR

Geriatric patients
Mirena has not been studied in women over the age of 65 years.



Blood pressure
increased

Paediatric population
There are no relevant indication for use of Mirena before menarche.



Oedema

Weight increase

How to Remove Mirena

Please see the ‘Insertion instructions’ section of this leaflet.

PHARMACEUTICAL PRECAUTIONS

PL: 6464/0579
Ref.: 7.2.2013

This product is known by the above name but will usually be referred to as Mirena in this Medical Information
leaflet.



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.

LEGAL CATEGORY:

Medical Information Leaflet

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’).

Nervous system
disorders

General disorders and Intrauterine
administration site
contraceptive
conditions
device expelled

INTRA-UTERINE SYSTEM
(levonorgestrel)

Patients with hepatic impairment
Mirena is contraindicated in women with acute liver disease or liver tumour (see Contraindications).



Patients with renal impairment
Mirena has not been studied in women with renal impairment.

CONTRAINDICATIONS
Known or suspected pregnancy; undiagnosed abnormal genital bleeding; congenital or acquired abnormality
of the uterus including fibroids if they distort the uterine cavity; current genital infection; current or recurrent
pelvic inflammatory disease; postpartum endometritis, infected abortion during the past three months;
cervicitis; cervical dysplasia; uterine or cervical malignancy; liver tumour or other acute or severe liver disease;
conditions associated with increased susceptibility to infections; acute malignancies affecting the blood or
leukaemias except when in remission; recent trophoblastic disease while hCG levels remain elevated;
hypersensitivity to the constituents of the preparation, confirmed or suspected hormone dependent tumours
including breast cancer.
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 overleaf 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.

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Mirena medical information leaflet

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/0579G

DATE OF PROOF:

08/02/13

DATE:

PROOF HISTORY:
v.2 - waymade - 08/02/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MAY 2012

Pg 2

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:












Migraine with aura
Unusually severe or unusually frequent headache
Jaundice
Marked increase of blood pressure
Malignancies affecting the blood or leukaemias in remission
Use of chronic corticosteroid therapy
Past history of symptomatic functional ovarian cysts
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)
Severe or multiple risk factors for arterial disease
Thrombotic arterial or any current embolic disease
Acute venous thromboembolism

General Information:

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.
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 may be increased in postpartum insertions (see ‘Posology and
method of Administration, Starting treatment’), in lactating women and in women with a fixed retroverted
uterus.


Pelvic infection:

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.
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


Irregular bleeding:

Risk in pre-menopausal women
Because irregular bleeding/spotting may occur during the first months of therapy in pre-menopausal 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 cancer.

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




Glucose tolerance

Low-dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be
monitored in diabetic users of Mirena.
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 effect of hormonal contraceptives may be impaired by drugs which induce liver enzymes, including
barbiturates, primidone, phenytoin, carbamazepine, griseofulvin and rifampicin. The influence of these drugs
on the contraceptive efficacy of Mirena has not been studied.

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 symptoms that suggest complications of the
pregnancy, 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.


Lactation

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.
• 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 section ‘Special warning
and precautions for use’) but has been estimated from clinical trial data to occur in 7% of users.

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.


General Information

Levonorgestrel has been identified in the breast milk, 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.

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 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.

FERTILITY, PREGNANCY AND LACTATION
• Pregnancy

Complications leading to failure



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.



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. For women using Mirena with symptoms and signs suggestive of pelvic infection
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.



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.

Insertion/removal warnings and precautions



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.


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.



Pg 3



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.
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

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 rate of ectopic pregnancy in users of Mirena is 0.06
per 100 woman-years. This rate is lower than the rate of 0.3-0.5 per 100 woman years estimated for women
not using any contraception. The corresponding figure for the copper IUD is 0.12 per 100 woman-years.
Women with a previous history of ectopic pregnancy carry a higher risk of a further ectopic pregnancy.

Pg 3

Pharmacotherapeutic group: Plastic IUD with progestogen
Levonorgestrel is a progestogen used in gynaecology 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 hormone is released directly into the target organ.

Pg 4

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

Use an assistant as necessary.

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.

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.









Preparation for insertion

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.

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

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.

To be inserted by a health care professional using aseptic technique.

4

5

7

8

9

Slider

7

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).

6.

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.

5.

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

9

8

7

5

4

Figure 6

Figure 5

5

7
8
9

Q.A.
APPROVED:
CUSTOMER
APPROVED:

CODE:
6464/0579H
DATE OF PROOF:
08/02/13
DATE:
DATE:

PROOF HISTORY:
v.2 - waymade - 08/02/13

PL 6464/0579
REF 7.2.2013

Figure 8

DT

MANUFACTURED BY:
Schering OY,
20121 Turku, Finland.

You may insert a new
Mirena immediately
following removal.

Mirena is removed by
pulling on the threads with
a forceps (Figure 8).

For removal/replacement, please consult the Mirena prescribing information.

Removal / replacement

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

ARTWORKER:

5

4

sound
measure

Figure 3

Figure 2

Handle with
threads inside

1.5 - 2.0 cm

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.

7.
Figure 7

02-1808

Marena insertion instructions

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).

Insertion tube
with plunger
and scale

Mark

Figure 1

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).

Figure 4

PRE-PRESS NO.:

PRODUCT:

3.

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

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

2.

Flange

Mirena

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

1.

5

6

Insertion Instructions

6

7

This product is known by the above name but will usually be referred to as Mirena in this
Insertion Instruction leaflet.

Insertion

9

MIRENA® INTRA-UTERINE SYSTEM
INSERTION INSTRUCTIONS

4

7

8

4

5

8

9

CUSTOMER: Waymade
Leaflet Flat Size = 296 x 600

Expand view ⇕

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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