Mirena Intrauterine Delivery System 1'S

Introduction About MIRENA INTRAUTERINE DELIVERY SYSTEM

MIRENA INTRAUTERINE DELIVERY SYSTEM contains Levonorgestrel, which belongs to
the group of medicines called Progestins. It is an intrauterine delivery system
(IUS) that is placed inside the womb (uterus), where it slowly releases the
hormone levonorgestrel. It is used as a long-term, reversible and effective
method of contrace
bleeding (menorrhagia) and to protect the lining of your womb during menopause
as part of a hormone replacement therapy (HRT) regimen.

Heavy menstrual bleeding (menorrhagia) is heavy or lengthy menstrual bleeding
that affects women of reproductive age, either alone or in association with
other symptoms. Heavy menstrual bleeding (menorrhagia) is heavy or lengthy
menstrual bleeding that affects women of reproductive age, either alone or in
association with other symptoms. Menopause symptoms occur due to the loss of
female sex hormones, which are released by the ovaries.

Avoid smoking, as it increases the risk of developing a heart attack, stroke or
blood clot. MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for patients
who have liver problems or a liver tumour, endocarditis (infection of the inner
layer of the heart), pelvic inflammatory disease (infection or inflammation of
the female reproductive system), unexpected or painful vaginal discharge or
vaginal itching, womb lining inflammation after giving birth, uterus infection
following delivery or an abortion within the previous 3 months, cervix (neck of
your womb) inflammation, an abnormal.

Inform your doctor before the placement of MIRENA INTRAUTERINE DELIVERY SYSTEM
if you have or have ever had a migraine, feel dizzy, have impaired vision, have
very severe headaches or get headaches more frequently than normal; have had
jaundice (yellowing of the skin or eyes); have had high blood pressure; have had
a heart attack; have had congenital heart diseases or heart valve diseases or
have had any heart problems; have abnormal blood lipid levels; have diabetes
(high blood sugar levels).

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use during pregnancy
or if you suspect that you may be pregnant. A small amount of the active
ingredient MIRENA INTRAUTERINE DELIVERY SYSTEM is excreted into breast milk;
however, there is no potential risk to babies or newborns and breastfeeding can
be continued. MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in
children and adolescents before the first menstrual bleeding (menarche). MIRENA
INTRAUTERINE DELIVERY SYSTEM should not be used by postmenopausal women.

Specific serious side effects include depression and suicidal thoughts in some
patients. Consult your doctor immediately if you have such thoughts. The most
common side effects of using MIRENA INTRAUTERINE DELIVERY SYSTEM are irregular,
mild or missing menstrual periods, spotting as well as vaginal bleeding, vaginal
and external genital (vulva) infections caused by bacteria or fungi and acne.
Consult your physician if any of the side effects worsen.

Uses Of MIRENA INTRAUTERINE DELIVERY SYSTEM

• As contrace
• Hormone replacement management (HRT) regimen to protect the lining of your womb

How MIRENA INTRAUTERINE DELIVERY SYSTEM Works

MIRENA INTRAUTERINE DELIVERY SYSTEM acts as a contrace
lining of the uterus it manages pregnancy and manages sperm entry by thickening
the lining of the uterus, thus it inhibits fertilization and it also blocks the
release of eggs (ovulation). Reduces heavy menstrual bleeding by thinning the
lining of the uterus. In menopause, it replaces hormones such as progesterone
and manages cancer by protecting the lining of the womb.

How to use MIRENA INTRAUTERINE DELIVERY SYSTEM

Only a doctor or a nurse with specialised training may fit the system.

The device needs to be placed either during your period or within seven days
after the start of your cycle. You don't have to wait until your period to
replace the device if you currently have the device and it's time to get a new
one.

You should wait at least 6 weeks after giving birth before getting MIRENA
INTRAUTERINE DELIVERY SYSTEM fitted. If you have no vaginal infections, you may
be able to get MIRENA INTRAUTERINE DELIVERY SYSTEM installed right away after
having an abortion.

Side Effects Of MIRENA INTRAUTERINE DELIVERY SYSTEM

Common

• irregular, mild or missing menstrual periods
• spotting as well as vaginal bleeding
• vaginal and external genitalia (vulva) infections caused by bacteria or fungi
• acne
• anxiousness, depression or other mood swings
• less sexual drive
• headache, migraine, dizziness, presyncope (feeling faint)
• back pain
• nausea, vomiting, abdominal or pelvic pain, distended abdomen
• painful periods
• increased vaginal discharge
• tender and painful breasts
• spasm of the womb
• MIRENA INTRAUTERINE DELIVERY SYSTEM coming out by itself
• weight gain
• ovarian cysts

Uncommon

• loss of consciousness
• eczema (swelling of the skin)
• cervicitis (swelling of the cervix (neck of the womb)
• swelling of legs or ankles
• increased facial and body hair growth
• hair loss
• itchy skin
• increased skin pigmentation or skin discoloration, particularly on the face (chloasma)
• uterine perforation
• genital infections causing vaginal itching, pain on passing urine, lower abdominal pain due to inflammation of the womb, ovaries or fallopian tubes
• a womb infection or womb lining inflammation that could result in a foul-smelling vaginal discharge (endometritis)

Rare

• rashes, itching
• increased blood pressure

Consult your physician immediately if you experience any of the following
symptoms:

• signs of a blood clot in the lung include sharp pain in the chest, coughing blood or sudden shortness of breath
• swelling, pain, warmth and redness of arms and legs due to a blood clot in the leg.
• signs of a heart attack such as crushing chest pain or heaviness
• signs of strokes such as sudden severe headache, vomiting, dizziness, fainting, impaired speech, blurry vision, weakness, numbness or tingling of the face, arm or leg, particularly on one side of the body, vomiting, trouble understanding, trouble with walking and loss of balance
• signs of a blood clot in the eye such as sudden blurring of vision, eye pain or eye pressure
• allergic reactions such as itching, rashes, swelling of the face, lips, cheeks, tongue and/or throat
• if you develop mood swings and depression symptoms such as suicidal thoughts
• if you experience intense pain or fever soon after having a device inserted, you may have a severe infection that needs to be managed very away. sepsis, an extremely serious infection, can rarely happen
• severe pain and continuous bleeding, due to damage or a womb wall tear (perforation) signs and symptoms of perforation may include heavy bleeding upon insertion, significant pain, more pain than estimated and pain or bleeding that lasts for more than a few weeks, significant changes in your menstruation, pain experienced during sexual activity
• lower abdomen pain, fever or have missed a period or experiencing sudden bleeding may indicate an ectopic pregnancy (when the foetus develops outside the womb)
• if you have lower stomach pain or have painful or hard sex, you may have ovarian cysts or pelvic inflammatory disease. This is important because pelvic infections can lower your chances of becoming pregnant and raise your risk of an ectopic pregnancy

How To Manage Side Effects

Diarrhoea:

Drink plenty of water and fruit juice to keep yourself hydrated. Consult your
doctor if the diarrhoea doesn’t improve.

Nausea and vomiting:

Take the medicine, with or just after a meal. Stick to simple meals. Avoid
eating oily or spicy food. Consult your doctor if nausea and vomiting don’t
improve.

Headache:

Rest and relax. Drink plenty of electrolytes and water. If necessary, apply a
balm to the head to relieve the pain. Contact your doctor if the headache does
not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Contact your doctor if the dizziness
does not improve.

Skin rash and itching:

Hot water can irritate the skin, so avoid taking hot showers. Do not scratch the
affected area. Contact your doctor if the rashes and itching do not improve.

Warning & Precautions

!### Pregnancy

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use during pregnancy
or suspect that you may be pregnant. Consult your doctor before using MIRENA
INTRAUTERINE DELIVERY SYSTEM.

!### Breastfeeding

Small amount of active ingredient of this medicine is excreted into breast milk,
there is no potential risk to babies or newborns and breastfeeding can be
continued. Consult your doctor before placement MIRENA INTRAUTERINE DELIVERY
SYSTEM.

!### Driving and Using Machines

There are no known effects of MIRENA INTRAUTERINE DELIVERY SYSTEM on the ability
to drive or use machines.

!### Kidney

MIRENA INTRAUTERINE DELIVERY SYSTEM has not been studied in women with kidney
impairment. Consult your doctor before placement MIRENA INTRAUTERINE DELIVERY
SYSTEM.

!### Liver

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in patients with
liver problems or who have a liver tumour. Consult your doctor before placement
MIRENA INTRAUTERINE DELIVERY SYSTEM.

!### Allergy

Do not fix MIRENA INTRAUTERINE DELIVERY SYSTEM if you are allergic
(hypersensitive) to levonorgestrel or other ingredients of this medicine.

!### Heart Disease

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in patients with
endocarditis (inflammation of the inner lining of the heart due to bacterial
infection). Contact your doctor before placement MIRENA INTRAUTERINE DELIVERY
SYSTEM and it should be used with caution in patients with high blood pressure
or massive artery diseases, such as a heart attack, congenital heart disease or
heart valve diseases or any heart problems.

Others

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use if you:

• have or had the pelvic inflammatory disease (infection or inflammation of the female reproductive system)
• have an unexpected or painful vaginal discharge or vaginal itching, as these symptoms could be signs of an infection
• having or had womb lining inflammation after giving birth
• have or have recently had a uterus infection following delivery or an abortion during the past 3 months
• have or have ever had cervix (neck of your womb) inflammation
• have undergone or had an abnormal smear test (changes in the cervix)
• have uterus abnormalities, such as uterine fibroids, particularly those that enlarge the uterus cavity
• have an abnormal pattern of vaginal bleeding
• having a disease that makes you prone to infections. If you have this, a doctor will have informed you have or previously had, hormone-dependent cancer, such as breast cancer
• have or have ever had, any form of cancer, including blood (leukaemia), uterine or cervical cancer, unless in remission
• have or previously had trophoblastic diseases (development of a rare tumour group in early stages of pregnancy). If you have this, a doctor will have informed you about it
• have low immunity
• have lower genital tract infection
• have or develop migraine, feel dizzy, impaired vision, very severe headaches or if you get headaches more frequently than normal
• jaundice (yellowing of the skin or eyes)
• have abnormal blood lipid levels or have a family history of diabetes (high blood sugar levels)
• have had blood cancer (leukaemia) which now reoccurs
• are receiving long-term steroid therapy
• have a history of ovarian cysts or an ectopic pregnancy (foetus develops outside the womb), tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy.
• if you have experienced a massive artery disease, such as a stroke
• have or family history history of thrombosis (blood clots)
• having irregular bleeding
• have epilepsy (fits)
• HIV or AIDS or any other sexually transmitted infections
• smoke as it increases the risk of developing a heart attack, stroke or blood clot
• genital infections
• are overweight
• had a history of heavy menstrual blood flow
• have systemic lupus erythematosus
• are immobilized
• have major surgery or trauma
• have varicose veins
• wear contact lens
• have a history of depression
• have to undergo any blood test
• are scheduled for surgery
• a tendency to develop chloasma (brown patches on your face or body)

Use in paediatrics:

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in children and
adolescents before the first menstrual bleeding (menarche). Consult your doctor
for advice.

Use in geriatrics:

MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in postmenopausal
women. Consult your doctor for advice.

Interactions

A. Drug-Drug interactions:

Before placement MIRENA INTRAUTERINE DELIVERY SYSTEM, inform your doctor if you
are taking or have recently taken any other medicines, including medicines:

• medicines used to manage epilepsy (Ex. phenobarbital, phenytoin, carbamazepine, oxcarbazepine, topiramate, primidone)
• medicines used to manage tuberculosis (Ex. rifabutin, rifampicin)
• medicines used to manage HIV and hepatitis C virus infection (Ex. nevirapine, efavirenz, simeprevir)
• medicine used to manage fungal infections (Ex. griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)
• hormonal contrace
• medicines used to manage bacterial infections Ex. clarithromycin, erythromycin
• sedatives Ex. pentobarbital (used to induce sleep)
• medicines used to manage chest pain and high blood pressure Ex. diltiazem
• St John’s Wort (a herbal medicine used to manage depression)
• anticoagulants Ex. warfarin (a medicine used to manage blood clots)

Synopsis

Drug	:	Levonorgestrel
Pharmacological Category	:	Progestins
Therapeutic Indication	:	Prevents pregnancy, Manages heavy menstrual bleeding (menorrhagia) and in menopause
Dosage Forms	:	Tablet, Kit, Intra Uterine Delivery System

More Information

• Keep MIRENA INTRAUTERINE DELIVERY SYSTEM out of the sight and reach from children
• Store MIRENA INTRAUTERINE DELIVERY SYSTEM below 30°C
• Protect from moisture and direct sunlight

FAQs About MIRENA INTRAUTERINE DELIVERY SYSTEM

What is MIRENA INTRAUTERINE DELIVERY SYSTEM used for?

MIRENA INTRAUTERINE DELIVERY SYSTEM is an intrauterine delivery system (IUS)
that is placed inside the womb (uterus), where it slowly releases the hormone
levonorgestrel. MIRENA INTRAUTERINE DELIVERY SYSTEM is used as a long-term,
reversible and effective method of contrace
manage heavy menstrual bleeding (menorrhagia) and to protect the lining of your
womb during menopause as part of hormone replacement therapy (HRT). Consult your
doctor before placement.

How does MIRENA INTRAUTERINE DELIVERY SYSTEM work?

MIRENA INTRAUTERINE DELIVERY SYSTEM acts as a contrace
lining of the uterus; it manages pregnancy and manages sperm entry by thickening
the lining of the uterus; thus, MIRENA INTRAUTERINE DELIVERY SYSTEM inhibits
fertilization and it also blocks the release of eggs (ovulation). reduces heavy
menstrual bleeding by thinning the lining of the uterus. In menopause, MIRENA
INTRAUTERINE DELIVERY SYSTEM replaces hormones such as progesterone and manages
cancer by protecting the lining of the womb.

What does MIRENA INTRAUTERINE DELIVERY SYSTEM do to your period?

For the first 3 to 6 months after the device is fitted, many women experience
spotting (a tiny amount of blood loss). Others will experience heavy or
continuous bleeding. However, before a decrease in blood loss is observed, you
can experience an increase in bleeding, usually in the first 2 to 3 months.
Overall, you might experience fewer days of bleeding each month and eventually,
your periods might stop completely. This results from the hormone's impact on
the uterine lining (levonorgestrel). After 3 to 6 months, if a noticeable
decrease in blood loss has not been made, you should go for other managements.

What are the side effects of taking MIRENA INTRAUTERINE DELIVERY SYSTEM?

The most common side effects of taking MIRENA INTRAUTERINE DELIVERY SYSTEM are
irregular, mild or missing menstrual periods; irregular, mild or missing
menstrual periods, spotting, vaginal bleeding, vaginal and external genital
(vulva) infections caused by bacteria or fungi; and acne. Consult your physician
if any of the side effects worsen.

How often should I have the MIRENA INTRAUTERINE DELIVERY SYSTEM checked?

Usually, the MIRENA INTRAUTERINE DELIVERY SYSTEM should be evaluated six weeks
after placement, again at 12 months and then once a year until MIRENA
INTRAUTERINE DELIVERY SYSTEM is replaced.

How can I tell whether the MIRENA INTRAUTERINE DELIVERY SYSTEM is in place?

You can feel the two fine threads attached to the lowest part of the system
after each menstrual cycle. You will be shown how to do this by your doctor.
Avoid pulling the threads, as you can accidentally rip them out. Contact your
doctor or nurse right away if you can't feel the threads and in the meantime,
avoid having sexual relations or use a barrier method of contrace
condoms). It's possible that the threads easily entered the cervical canal or
womb. Your doctor or nurse might not be able to see the threads if they have
broken off or MIRENA INTRAUTERINE DELIVERY SYSTEM may have naturally exited your
body or, in rare instances, may have penetrated the womb's wall.

Useful Diagnostic Tests

• Complete blood count
• Blood glucose levels
• Liver function test