Levosert - Levonorgestrel uses, dose and side effects

Levosert is an effective, long-acting and reversible contraceptive. Levosert prevents pregnancy by thinning the endometrium, by making the normal mucus in the cervix thicker so that sperm can not get through to fertilize the egg, and by preventing ovulation ( ovulation ) in certain women. The T-shaped body also affects the uterine lining locally.

Treatment of heavy menstrual bleeding

Levosert is also suitable for reducing menstrual bleeding. It can therefore be used if you suffer from heavy menstrual bleeding. This is called menorrhagia . The hormone in Levosert works by thinning the uterine lining, so that the monthly bleeding is reduced.

Levosert is used as a contraceptive or for heavy menstrual bleeding for a period of 6 years or until it is removed.

Children and young people

Levosert should not be used before the first menstrual period ( menarche ).

What you need to know before you use Levosert

Your doctor or nurse will examine you before taking Levosert to make sure Levosert is right for you. This includes pelvic examinations and may also include other examinations such as breast examinations, if your doctor or nurse deems it appropriate.

Genital infections must be treated before Levosert is used.

Tell your doctor or nurse who is taking Levosert if you have epilepsy , as seizures may occur during the injection. However, this is rare. Some women may feel dizzy after the procedure. This is normal and your doctor or nurse will ask you to rest for a while.

Not all women can use Levosert.

Do not use Levosert if you

is pregnant or thinks you may be pregnant;
have or have had inflammatory disease of the pelvis;
have an unusual or unpleasant vaginal discharge or vaginal itching , as this may indicate infection;
have or have had inflammation of the uterine lining after childbirth;
has or has had an infection in the womb after childbirth or after an abortion during the last 3 months;
have or have had inflammation of the cervix;
have or have had an abnormal cell sample (changes in the cervix);
have or have had liver problems;
has an abnormal uterus, including benign growths in the uterus (fibroids), especially those that distort the uterine cavity;
has an abnormal bleeding pattern;
have a condition that makes you susceptible to infection . You should have been told to do so by a doctor;
have or have had hormone-dependent cancers, such as breast cancer;
has or has had any type of cancer or suspected cancer including blood ( leukemia ), uterine or cervical cancer, unless it is in remission (no cancer cells can be detected in the body anymore and you have no symptoms);
have or have had a trophoblast disease (a pregnancy-related tumor disease in which the tumor arises when cells from the tissue that form the placenta begin to divide uncontrollably). You should have been told to do so by a doctor;
is allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Like other hormonal contraceptives Levosert not protect against HIV – infection ( AIDS ) or other sexually transmitted diseases ( chlamydia , genital herpes , genital warts, gonorrhea , hepatitis B and syphilis ). You need to use a condom to protect yourself against these diseases.

Levosert should not be used as an emergency contraceptive (after unprotected intercourse).

Talk to your doctor before using Levosert if you:

have or develop migraines , dizziness, blurred vision, unusually severe headaches or if you get a headache more often than before;
have yellow-toned skin or yellow-toned whites of the eyes (jaundice);
have diabetes (too high blood sugar level), have high blood pressure or abnormal levels of blood fats;
have had cancer that affects the blood (including leukemia ) which is now in remission (no cancer cells can be detected in the body anymore and you have no symptoms);
undergoing long-term treatment with cortisone;
have ever had an ectopic pregnancy (the fetus develops outside the uterus) or have had ovarian cysts;
has or has had a serious vascular disease, such as a heart attack or stroke;
have had blood clots ( thrombosis );
take other medicines as some medicines may stop Levosert from working properly;
have irregular bleeding;
get seizures ( epilepsy ).

If you have or have had any of the above conditions, your doctor will decide if you can use Levosert.

You must also tell your doctor if any of these conditions occur for the first time after taking Levosert.

The following signs and symptoms may mean that you have an ectopic pregnancy and that you should go to the hospital immediately (see also the section “Pregnancy, breast-feeding and fertility”):

Your periods have stopped and you then have persistent bleeding or pain.
You get severe or persistent pain in the lower abdomen.
You think you are pregnant and bleeding and feeling dizzy.
You have performed a pregnancy test that showed that you are pregnant.

You should see a doctor or nurse as soon as possible if you experience painful leg swelling, sudden chest pain or difficulty breathing as these symptoms may be signs of a blood clot. It is important that any blood clots are treated immediately.

You must also see a doctor immediately if you experience persistent lower abdominal pain, fever, pain during intercourse or abnormal bleeding. If you experience severe pain or fever shortly after taking Levosert, you may have a serious infection that needs to be treated immediately.

You must see a doctor immediately if you can no longer feel the threads in your vagina. This may be a sign of expulsion. You can check by gently inserting a finger into the vagina and feeling for the threads at the top of the vagina near the cervix. Do not pull on the threads as you may pull out the Levosert. Avoid intercourse or use a barrier contraceptive (eg condoms) until healthcare professionals have checked that the intrauterine insert remains.

Mental disorders:

Some women who use hormonal contraceptives, including Levosert, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Levoert and smoking

Women should quit smoking. Smoking increases the risk of heart attack, stroke or blood clots.

Use of tampons and menstrual cups

The use of sanitary napkins is recommended. If tampons or menstrual cups are used, you should change them carefully so that you do not pull on Levosert threads.

Other medicines and Levosert

The effectiveness of hormonal contraceptives such as Levosert may decrease when taking drugs that increase the amount of enzymes from the liver. Tell your doctor if you are using:

phenobarbital, phenytoin or carbamazepine (to treat epilepsy );
griseofulvin (against fungus);
rifampicin or rifabutin ( antibiotics );
nevirapine or efavirenz (for HIV ).

Tell your doctor if you are taking, have recently taken or might take any other medicines. Levosert should not be taken at the same time as other hormonal contraceptives.

Pregnancy, breastfeeding and fertility

Levosert should not be used if you are pregnant or think you may be pregnant.

Can I get pregnant while using Levosert?

It is very rare for women with Levosert to become pregnant.

A missed period does not have to mean that you are pregnant. It happens that some women do not menstruate when they use the product.

If you have not had a menstrual period in 6 weeks, you should consider performing a pregnancy test. If it shows that you are not pregnant, you do not need to perform an additional test, unless you get other pregnancy symptoms, e.g. nausea, fatigue or tense breasts.

Contact a doctor immediately if you become pregnant with the insert inserted, so that ectopic pregnancy can be ruled out and Levosert can be removed to reduce the risk of spontaneous miscarriage.

What should I do if I want children?

If you want to have children, ask your doctor to remove Levosert. You will regain your normal fertility level very soon after the post is removed.

Can I breast-feed while using Levosert?

Very low levels of the hormone et in Levosert are found in breast milk, but the levels are lower than when other hormonal contraceptives are used. No risks to the newborn are expected. If you want to breastfeed your baby, you should discuss this with your doctor.

Driving and using machines

There are no known effects on the ability to drive and use machines.

Levosert contains barium sulphate

Levosert’s T-shaped body contains barium sulphate to be seen on X-ray.

How to use Levosert

The insert can only be inserted by a doctor or specially trained nurse (see instructions for insertion in the package).

They will explain the deposit procedure and possible risks associated with its use. Your doctor or nurse will examine you before taking Levosert. Ask them if you are unsure about the use.

During the deposit, a slight discomfort can be experienced. Tell your doctor if you feel any pain.

The insert should either be inserted during menstruation or within seven days from the start of menstruation. If you already have a post and it’s time to replace it, you do not need to wait for your period.

If you have just given birth, wait at least 6 weeks before taking Levosert. Levosert can sometimes be inserted immediately after an abortion, provided you have no genital infection .

Tell your doctor or nurse who is taking Levosert if you suffer from seizures ( epilepsy ) as a seizure may occur during insertion, although it is rare.

Some women may feel dizzy after the post is inserted. This is normal and your doctor will ask you to rest for a while.

In very rare cases, part or all of the insert may puncture the uterine wall during insertion. If this happens, the post will be removed.

How fast should Levosert start working?

Contraceptive

You are protected against pregnancy as soon as the post is inserted. The risk of becoming pregnant is approximately 2 in 1,000 during the first year. The error rate can increase if Levosert comes out on its own or by puncturing a hole in the uterine wall.

Heavy menstrual bleeding

Levosert usually results in a significant reduction in menstrual bleeding within 3 to 6 months of treatment.

How often should I have the post checked?

You should usually have the post checked 6 weeks after the deposit, again after 12 months and then once a year until it is removed.

How do I know if the post is in place?

After each period, you can feel the two thin threads that are attached to the lower part of the insert. Your doctor will show you how to do this.

Do not pull on the threads as you may end up pulling out the post. Contact a doctor or nurse as soon as possible if you can not feel the threads, and refrain from intercourse in the meantime or use barrier contraceptives (eg condoms). It is possible that the threads have only been pulled up in the uterus or cervical canal. If the threads still cannot be found by a doctor or nurse, they may have ruptured or Levosert may have come out on its own, or in rare cases it may have perforated the uterine wall ( perforation of the uterus, see section 4).

You should also see a doctor if you feel the lower part of the post itself or if you or your partner feel pain or discomfort during intercourse.

What happens if the post comes out by itself?

If the post comes out in whole or in part, you may not be protected against pregnancy. It is rare but possible that this can happen during your period without you noticing it. An unusual increase in the amount of bleeding during menstruation may be a sign that this has happened. Tell your doctor or healthcare provider if you notice any unexpected changes in your bleeding pattern.

If you stop using Levosert

Your doctor can remove the post at any time. It is very easy to remove it. It is very important to use another type of contraceptive during the week before removal unless you plan to have a new insert or intrauterine contraceptive inserted immediately. Intercourse during this week can lead to pregnancy after Levosert is removed.

How will Levosert affect my period?

For all users of Levosert:

Many women experience spotting (a small amount of blood) during the first 3–6 months after inserting the insert. Others experience prolonged or heavy bleeding. However, you may experience an increase in bleeding, usually during the first 2 to 3 months, before a decrease in bleeding is achieved. It is likely that you will have fewer bleeding days each month and in the end you may not have any periods at all. This is due to the effect of the hormone (levonorgestrel) on the lining of the uterus.

If you have been given Levosert for heavy menstrual bleeding:

Levosert usually results in a significant reduction in menstrual bleeding within 3 to 6 months of treatment. However, you may experience an increase in bleeding, usually during the first 2 to 3 months, before a decrease in bleeding is achieved. If a marked decrease in blood volume is not achieved after 3 to 6 months, alternative treatments should be considered.

If you have been taking Levosert for a fairly long time and suddenly start having bleeding problems, contact your doctor or healthcare professional for advice.

If you have any further questions on the use of this product, ask your doctor.

Also contact a doctor immediately if you get:

painful swelling in the legs,
sudden chest pain,
respiratory distress,

as these symptoms may be signs of a blood clot.

Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

The side effects with Levosert are most common during the first months after insertion of the insert and then diminish over time.

Contact a doctor or nurse immediately if you experience any of the following serious side effects:

Severe pain or fever that occurs shortly after insertion may mean that you have a serious infection that needs to be treated immediately. In rare cases, a very severe infection ( sepsis ) can occur.
Severe pain and persistent bleeding as this may be a sign of injury or hole in the uterine wall ( perforation ). Perforation is less common, and usually occurs in connection with the insertion of Levosert, although perforation may not be detected until a later time. Levosert stuck outside the uterus is not effective in preventing pregnancy and must be removed as soon as possible; in very rare cases, this requires surgery . The risk of perforationis low, but it is elevated in lactating women and women who have given birth within 36 weeks before insertion and may be increased in women with the uterus fixed and reclining (fixed retroverted uterus). If you suspect that your uterus has been perforated, seek the advice of a healthcare provider immediately and inform them that you have Levosert inserted, especially if it was not these healthcare providers who inserted it.Possible signs and symptoms of perforation may include:
- severe pain (such as menstrual pain) or worse pain than expected
- heavy bleeding (after insertion)
- pain or bleeding that lasts longer than a few weeks
- sudden menstrual changes
- pain at sex
- you can no longer feel the Levosert threads (see section 3 How to use Levosert – How do I know if the post is in place?).

Pain in the lower abdomen, especially if you also have a fever or have not had your period or if you have unexpected bleeding, as this may be a sign of ectopic pregnancy. The absolute risk of ectopic pregnancy in Levosert users is low. When a woman becomes pregnant while using Levosert, there is still an increased relative probability of ectopic pregnancy.
Pain in the lower abdomen or pain or discomfort during intercourse as this may be a sign of ovarian cysts or pelvic inflammatory disease. This is important because pelvic inflammatory disease can reduce your chances of having children and can increase the risk of ectopic pregnancy.

Very common (affects more than 1 in 10 women) side effects may include:

menstrual changes. You may experience spotting, shorter or longer periods, painful periods. Although treatment with Levosert usually results in a marked reduction in menstrual bleeding within 3 to 6 months, you may have an increased bleeding, usually during the first 2 to 3 months, before a reduction in bleeding is achieved. Menstruation can stop completely. If a marked reduction in bleeding is not achieved after 3 to 6 months, alternative treatments should be considered.
ovarian cysts. There are fluid-filled sacs in the ovary;
bacterial or fungal infection of the vagina and external genitalia ( vulva );
pimples ( acne );
pain or bleeding during insertion.

Common (affects up to 1 in 10 women) side effects may include:

depression, anxiety or other mood swings;
decreased sex drive;
headache;
migraine;
fainting (presyncope);
dizziness;
abdominal, pelvic or back pain;
abdominal discomfort;
nausea;
swollen abdomen;
vomiting;
painful menstruation;
increased flows;
tense, sore breasts;
pain during intercourse;
uterine cramps;
that Levosert comes out of himself;
weight gain.

Uncommon (affects up to 1 in 100 women) side effects may include:

genital infections that can cause: itching in the vagina, pain when urinating or pain in the lower abdomen after inflammation of the uterus, ovaries or fallopian tubes;
fainting;
eczema;
inflammation of the cervix (cervicitis);
swollen legs or ankles;
increased hair growth on the face and body;
hair loss;
skin itching ( pruritus );
discolored skin or increased amount of skin pigments, especially on the face (chloasma);
ectopic pregnancy;
perforation in the uterine wall (see “serious side effects” above).

Rare (affects up to 1 in 1,000 women) side effects may include:

rash, itching

Severe pain or fever that develops shortly after insertion may mean that you have a serious infection that needs to be treated immediately. In rare cases, a very severe infection ( sepsis ) can occur.

How to store Levosert

Store in the original package. Store the inner packaging in the carton. Sensitive to light. Do not open the package with Levosert. This should only be done by your doctor or healthcare professional.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and outer carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

Levosert contains 52 mg of levonorgestrel, the active substance. The hormone is found in a substance called polydimethylsiloxane. This is surrounded by a membrane (casing) which is also made of polydimethylsiloxane.

What the medicine looks like and contents of the pack

Levosert consists of a T-shaped body of a plastic called polyethylene. The body with the hormone is a post for releasing the hormone gradually inside the uterus.
The insert has two thin threads of polypropylene and phthalocyanine blue, attached to the lower part of the frame. They facilitate removal and allow you or your doctor to check that the insert is in place.The body with the hormone is a post for releasing the hormone gradually inside the uterus.

Pack sizes:

An intrauterine post with insertion tool.

Multiple pack of five packs with one intrauterine insert and one insertion tool.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Gedeon Richter Plc.

Gyömrői out 19-21.

1103 Budapest

Hungary

Manufacturer

Odyssea Pharma SA

Rue du Travail 16

4460 Grace Hollogne

Belgium