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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 contraception (used to manage pregnancy), to manage heavy menstrual 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 contraception and manages heavy menstrual bleeding (menorrhagia)
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 contraceptive by thinning the 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 contraceptive method (a medicine used to manage pregnancy)
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 contraception (used to manage pregnancy), to 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 contraceptive by thinning the 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 contraception (such as 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.

References

1. KD Tripathi. Estrogens, Progestins and Contraceptives. Essentials of medical pharmacology. Seventh edition. 2013. Page – 322.

2. Health Quality Ontario. Levonorgestrel-Releasing Intrauterine System (52 mg) for Idiopathic Heavy Menstrual Bleeding: A Health Technology Assessment. Ontario Health Technology Assessment Series. November 2016. [Accessed on 11th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5159479

3. Odyssea Pharma SA. Electronic Medicines Compendium (EMC). [Revised in July 2022] [Accessed on 11th August 2022] https://www.medicines.org.uk/emc/files/pil.1789.pdf

4. Bayer Oy. Electronic Medicines Compendium (EMC). [Revised in June 2022] [Accessed on 11th August 2022] https://www.medicines.org.uk/emc/files/pil.1132.pdf

5. Bayer Oy. Health Products Regulatory Authority (HPRA). [Revised in December 2019] [Accessed on 11th August 2022] https://www.hpra.ie/img/uploaded/swedocuments/e2d46b10-9199-490b-9323-f2c95bc026c0.pdf

6. Odyssea Pharma. U.S. Food & Drug Administration. [Revised in October 2019] [Accessed on 11th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206229s008lbl.pdf

7. Bayer Inc. Levonorgestrel. [Revised in September 2021] [Accessed on 11th August 2022] https://www.bayer.com/sites/default/files/mirena-pm-en.pdf

8. Bayer (Pty) Ltd. Levonorgestrel. [Revised in June 2019] [Accessed on 11th August 2022] https://www.bayer.com/sites/default/files/MIRENA_EN_PIL.pdf

9. Bayer HealthCare Pharmaceuticals Inc. Levonorgestrel. [Revised in August 2021] [Accessed on 11th August 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dcbd6aa2-b3fa-479a-a676-56ea742962fc&##

Useful Diagnostic Tests

Complete blood count
Blood glucose levels
Liver function test

Author Details

Written By Dr. Dhivakaran R - BDS

Reviewed For Accuracy By Dr. Jaya Prabakaran - MBBS, MD (Diabetology and Family Medicine)

Last updated on 29 Nov 2022 | 05:41 PM(IST)

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