Microval Side Effects

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Answer side-effect and tolerability questions around microval, including expected changes, warning signs and safe escalation guidance.

What is Microval?

Microval contains the active ingredient Levonorgestrel.

• Active ingredient — Levonorgestrel
• Registration number — A56/32.9/1048
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• AVIBELA contains levonorgestrel and is a hormone-releasing system placed in your uterus by your healthcare provider to prevent pregnancy for up to 6 years
• AVIBELA can also be used to treat heavy menstrual bleeding (heavy periods)
• AVIBELA contains 52 mg of levonorgestrel, which is released slowly over 6 years
• AVIBELA can be removed by your healthcare provider at any time
• AVIBELA can be used whether or not you have given birth to a child. AVIBELA is a small, flexible plastic T-shaped system that slowly releases a progestin hormone called levonorgestrel that is often used in birth control pills. Because AVIBELA releases levonorgestrel into your uterus, only small amounts of the hormone enter your blood. AVIBELA does not contain estrogen. Two thin threads are attached to the stem (lower end) of AVIBELA. The threads are the only part of AVIBELA you can feel when AVIBELA is in your uterus; however, unlike a tampon string, the threads do not extend outside your body. AVIBELA is small and flexible. How does AVIBELA work for birth control? AVIBELA may work for birth control in several ways including thickening of cervical mucus, inhibiting sperm movement, reducing sperm survival, and thinning the lining of your uterus. It is not known exactly how these actions work together to prevent pregnancy. How does AVIBELA work for heavy menstrual bleeding? The hormone in AVIBELA, levonorgestrel, acts by controlling the monthly development of the womb (uterus) lining, making it thinner, so that there is less bleeding every month

Interactions and medicines to check

The approved leaflet names these interactions.

• if you take any medicine which has an effect on the liver enzymes i.e. o primidone (used to treat seizures and shakiness) o barbiturates e.g. phenobarbitone (used to treat sleep disorders, anxiety, migraine) o phenytoin, carbamazepine, felbamate (used to treat epilepsy) o rifampicin (used to treat tuberculosis) o topiramate (used to treat epilepsy and migraines) o griseofulvin (used to treat fungus infections of nails, scalp, and skin) o rifabutin (used to prevent bacterial infections in patients with human immunodeficiency virus (HIV) infection o nevirapine (used to treat HIV) infection o efavirenz (used to treat HIV infection) o products containing St. John’s wort

Who should take extra care

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• below the age of 16 years

Use with care, and tell your doctor, if

• had a heart attack
• had a stroke
• were born with heart disease or have problems with your heart valves
• have problems with blood clotting or take medicine to reduce clotting
• have high blood pressure
• recently had a baby or if you are breastfeeding
• have severe migraine headaches or partial loss of vision associated with migraine headaches
• have severe or frequent headaches
• have AIDS, HIV, or any other sexually transmitted infection. Special care should be taken with AVIBELA:
• if you develop blood clots with symptoms including pain in one leg and/or swelling, sudden severe pain in the chest which may extend to the left arm, sudden breathlessness, sudden onset of coughing, any unusual, severe, long-lasting headache, sudden partial or complete loss of eye sight, double-vision, slurred speech or struggling to communicate, sensation that the environment is moving or spinning, collapse with or without a fit, weakness or marked numbness suddenly affecting one side of or one part of the body, involuntary or uncontrollable movements or actions of the body, severe pain in abdomen caused by a condition called ‘acute’ abdomen
• if you develop blood clots in your eyes with symptoms like unexplained partial or complete loss of eyesight, bulging eyes or double vision, swelling of your optic nerve which may affect your vision or sudden change in eyesight due to a condition called retinal vascular lesions
• if you have been born with heart disease or have problems with your heart valves
• you may feel like fainting or experience lower than normal heart rate when the IUD is being inserted
• if you suffer from diabetes, your blood glucose levels should be monitored as AVIBELA may affect your glucose tolerance
• if you experience abnormal/changes in your period bleeding pattern, like spotting, irregular bleeding, heavy bleeding, infrequent menstrual periods, or absence of menstrual period. During the first 3 – 6months of AVIBELA use, you may experience more than normal bleeding or spotting days and abnormal bleeding patterns may develop. Thereafter, the number of bleeding and spotting days may be less, but bleeding may still be irregular
• if you experience a heavier menstrual flow or unexplained bleeding, especially if you experience more cramping, it may indicate that AVIBELA has come out and you should be evaluated by your doctor
• if you develop lower abdominal pain or pain in your pelvis, fever, chill, unusual and smelly vaginal discharge, unexplained bleeding, sores on your genitals or experience pain during sex, notify your doctor immediately. You may have developed a condition called pelvic inflammatory disease
• if you had multiple sexual partners or your partner had multiple sex partners, you may be at risk to develop a sexually transmitted disease (STD). AVIBELA does not protect against STDs, and you may have a higher risk to develop the condition called pelvic inflammatory disease or inflammation of the womb. You may also have a higher risk to develop these conditions again, if you previously had any of these. Also, if you have blood cancer, AIDS or using illegal substances via injection, you may also have a higher risk to develop these conditions. These conditions may also be without any symptoms but can cause damage to your female reproductive organs
• if you develop a bacterial infection called actinomycosis. Symptoms include hard lump in the jaw that is not usually painful, muscle spasms or “locked jaw”, draining sores in the skin, fever, mild or no pain, swelling or a hard, red to reddish-purple lump on the face or upper neck and weight loss
• AVIBELA may be expelled (come out) partially or completely, and may no longer be effective as birth control
• AVIBELA may perforate (pierce) your womb wall or cervix, mostly during insertion. If you experience severe pain and continued bleeding after insertion, please contact your doctor immediately, as delay in removal of AVIBELA may result in moving of the IUD outside your womb, adhesions (bands of scar like tissue), inflammation of the intestines, piercing/perforation of intestines, blockages in intestines, abscesses, and damage to the internal organs of the body
• if you have lower abdominal pain, in connection with missed periods or if your period starts and you did not have any periods while AVIBELA was inserted, you may have developed a pregnancy outside of your womb. You should contact your doctor immediately. This may affect your fertility
• you may develop cysts on your ovaries; however, they usually disappear in 2 – 3 months. Symptoms of ovarian cysts include pain in your pelvis, abdominal pain, and painful sex
• if you have breast cancer you should not use any form of hormonal birth-control, as some of the breast cancers are sensitive to these hormones
• if you are a woman in menopause
• if you have a pigmentation disorder of the skin, called chloasma, in which large brown patches form on the skin. Avoid exposure to the sun or ultraviolet light. Children and adolescents

Pregnancy and breastfeeding

• AVIBELA should not be inserted if you are or suspect you are pregnant
• If you suspect you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before AVIBELA is inserted
• If possible, also do a urine pregnancy test
• If you get pregnant while using AVIBELA, you may have an ectopic pregnancy
• This means that the pregnancy is not in the uterus
• Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy

Common side effects of Microval

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• ectopic pregnancy: If you get pregnant while using AVIBELA, you might have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death
• intrauterine pregnancy risks: There are also risks if you get pregnant while using AVIBELA and the pregnancy is in the uterus. Severe infection, miscarriage, premature labour, premature delivery, and even death can occur with pregnancies that continue with an intrauterine system (IUD). Because of this, your healthcare provider may try to remove AVIBELA, even though removing it may cause a miscarriage. If AVIBELA cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy. If, after seeing your healthcare provider, you choose to continue your pregnancy, see your healthcare provider regularly. Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection. It is not known if AVIBELA can cause long-term effects on the foetus if it stays in place during a pregnancy
• life-threatening infection: Life-threatening infection can occur within the first few days after AVIBELA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after AVIBELA is placed
• pelvic inflammatory disease (PID) or endometritis: Some IUD users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy, or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
• perforation: AVIBELA may partially go into the wall of the uterus (become embedded) or go completely through the wall of the uterus (perforate). If this occurs, AVIBELA may no longer prevent pregnancy. If perforation occurs, AVIBELA may move outside the uterus and can cause internal scarring, infection, or damage to other organs
• You may need surgery to have AVIBELA removed if it is embedded, or perforation occurs. The risk of perforation is increased in breastfeeding women
• expulsion: AVIBELA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if AVIBELA comes out. If you think that AVIBELA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
• cysts on the ovary: Some women using AVIBELA develop a painful cyst on the ovary. These cysts usually disappear on their own in 2 – 3 months. However, a cyst can cause pain and sometimes cysts will need surgery
• changes in bleeding: You may have bleeding and spotting between menstrual periods, especially during the first 3 -to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare provider if the bleeding remains heavier than usual or increases after it has been light for a while
• These are all serious side effects. You may need urgent medical attention. Very common and common side effects of AVIBELA include:
• vaginal infection caused by bacteria, yeast infection of the outer part of your vagina (vulvovaginal)
• anxiety, depression, mood changes, sleeplessness, lower sex drive
• headache, migraine (a severe headache, often accompanied by nausea and sensitivity to light and sound), near fainting, dizziness, fainting
• nausea, pain/discomfort in your abdomen, bloating and swelling in the belly area, constipation, indigestion, diarrhoea, vomiting
• acne (pimples), hair loss
• back pain, pain in legs or arms
• severe and frequent menstrual cramps and pain during your period, pain during sex, breast pain/tenderness, pain/discomfort in your pelvis, spasm of your womb (uterus), discharge from your vagina, dryness/discomfort of your vagina and genital area, menstrual bleeding that lasts more than 7 days, bleeding after having sex (not related to your period), funny odour from your vagina, any vaginal/womb bleeding unrelated to your normal period, including spotting, infrequent menstrual periods, heavy menstrual bleeding
• weight gain, abnormal ovaries as detected by ultrasound
• bleeding after device has been inserted, device is expelled (ejected), pain during the procedure of inserting the device, device moved from where it was placed. Uncommon and rare side effects include:
• worsening of a mental disorder called bipolar disorder (episodes of mood swings, ranging from depressive lows to manic highs), feeling suicidal
• excessive hair growth of dark coarse hair in a male-like pattern, i.e. around mouth, chin, face, chest and back
• greasy hair
• infection of the connective tissue next to your womb, infection of the fallopian tubes or other parts of the female reproductive organs, menstrual cycle is shorter than 21 days
• swelling of the abdomen and swelling of the hands and feet

Bleeding, cycle and hormonal changes

Changes to bleeding and to the menstrual cycle are among the most commonly reported experiences with hormonal contraception, and they are one of the main reasons people stop a method. Knowing what pattern to expect with Microval makes it easier to tell an expected change from one worth checking.

Bleeding patterns can include lighter or shorter periods, irregular spotting between periods, or periods stopping altogether. Which of these is expected depends on the method, and on how long it has been used.

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

What happens after stopping or changing the method?

What happens after stopping or changing Microval depends on the method. Some methods stop working as soon as they are removed or discontinued; others take longer to clear. This matters both for side effects and for whether you are still protected against pregnancy.

Contraceptive cover

If you are changing method, there is often a window where you need additional protection. Getting that timing right is the single most important part of switching — ask a pharmacist, nurse or doctor to confirm it for your specific change rather than working it out from a general description.

Side effects and cycle after stopping

Side effects linked to a hormonal method usually ease once the hormone clears, though the time this takes varies by method. Cycles may take several months to settle into their own pattern, and that pattern may not be the same as before the method was started.

When to contact a healthcare professional urgently

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

Related pages

• Triphasil side effects

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