Lemena

Package Leaflet: Information for the Patient

Lemena, 75 micrograms, coated tablets

Desogestrel

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Lemena and what is it used for
• 2. Important information before taking Lemena
• 3. How to take Lemena
• 4. Possible side effects
• 5. How to store Lemena
• 6. Contents of the pack and other information

1. What is Lemena and what is it used for

Lemena is used to prevent pregnancy.
The tablets contain a small amount of the female sex hormone, progestogen, called desogestrel. For this reason, Lemena is also called a progestogen-only pill or mini-pill. Unlike combined contraceptive pills, mini-pills do not contain estrogen, the other female sex hormone.
The way most mini-pills work is mainly by stopping sperm from entering the cervix. Unlike combined contraceptives, they do not always prevent the release of an egg from the ovary. Lemena is different from other mini-pills in that, like combined contraceptives, it usually prevents the release of an egg from the ovary. As a result, Lemena is a very effective contraceptive.
Unlike combined pills, it can be used by women who cannot tolerate estrogens and by breastfeeding women. The biggest inconvenience when taking Lemena may be irregular bleeding. Bleeding may also not occur at all.
The chance of becoming pregnant while taking Lemena, provided you have taken the tablets correctly and have not missed any, is very low.

2. Important information before taking Lemena

Like other hormonal contraceptives, Lemena does not protect against HIV (AIDS) or other sexually transmitted diseases.

When not to take Lemena

Do not take Lemena if you have any of the conditions listed below. If you have any of these conditions, tell your doctor before taking Lemena. Your doctor may recommend a non-hormonal method of contraception.

• If you are allergic to desogestrel, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
• If you have a current venous thromboembolic disease. Venous thromboembolic disease is a condition where blood clots form in the veins, e.g., in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have jaundice (yellowing of the skin) or severe liver disease, and liver function has not returned to normal.
• If you have or have had a hormone-dependent tumor, such as some types of breast cancer.
• If you have vaginal bleeding of unknown cause.

If any of these conditions occur for the first time while taking Lemena, you should contact your doctor immediately.

Warnings and precautions

When taking Lemena in any of the following situations, close medical supervision is required.
Before taking Lemena, discuss this with your doctor:

• if you have ever had breast cancer
• if you have ever had liver cancer, as the effect of Lemena cannot be ruled out
• if you have ever had venous thromboembolic disease
• if you have diabetes
• if you have epilepsy (see "Lemena and other medicines")
• if you have tuberculosis (see "Lemena and other medicines")
• if you have high blood pressure
• if you have or have had chloasma (yellowish-brown spots, discoloration on the skin, especially on the face), in which case you should avoid excessive exposure to sunlight or ultraviolet radiation.

If you take Lemena in any of these situations, you may need close monitoring. Your doctor will explain how to proceed.

Psychiatric disorders

Some women taking hormonal contraceptives, including Lemena, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Decreased bone mass

Estrogens play an important role in maintaining normal bone mass. During treatment with Lemena, the level of natural estrogen (estradiol) in the blood is comparable to that in the first half of a woman's natural cycle, but lower than in the second half of the natural cycle. It is not known whether this has any effect on bone mass.

Breast cancer

Every woman is at risk of breast cancer, whether or not she is taking contraceptive pills. Breast cancer is more common in women taking contraceptive pills than in women of the same age who are not taking them. After stopping the pill, the risk gradually decreases, and after 10 years of stopping the pill, it is the same as for women who have never taken the pill. Breast cancer is less common in women under 40, but the risk increases with age. Therefore, more cases of breast cancer are diagnosed in women taking contraceptive pills at an older age. The length of time you take the pill does not seem to be important.
For every 10,000 women taking the pill for up to 5 years, from age 16 to 20, there is less than 1 extra case of breast cancer in the next 10 years compared to 4 cases of breast cancer normally diagnosed in this age group. Similarly, for every 10,000 women taking the pill for up to 5 years, from age 20 to 30, there are 5 extra cases of breast cancer compared to 44 cases normally diagnosed in this age group. For every 10,000 women taking the pill for up to 5 years, from age 30 to 40, there are 20 extra cases of breast cancer compared to 160 cases normally diagnosed in this age group.
The risk of breast cancer in women taking progestogen-only pills, such as Lemena, is similar to that in women taking combined pills, but the data are not conclusive.
It appears that in women taking contraceptive pills, breast cancer is usually less advanced than in women who do not take the pill.
It is not known whether this difference is caused by the pill. The reason may be earlier detection of breast cancer, as women taking the pill are more likely to have regular check-ups.

Venous thromboembolic disease

Venous thromboembolic disease is a condition where a blood clot forms, which can block a blood vessel. Sometimes it can occur in the deep veins of the legs (deep vein thrombosis). If the clot breaks loose from where it formed, it can travel to the lungs and block a pulmonary artery, forming a pulmonary embolism. This can lead to death. Venous thromboembolic disease is very rare. It can also occur if you are not taking contraceptive pills. It can also occur during pregnancy. The risk of venous thromboembolic disease is higher in women taking contraceptive pills than in those who are not taking them. It is thought that the risk of venous thromboembolic disease in women taking progestogen-only pills, such as Lemena, is lower than in women taking combined contraceptive pills that contain estrogen.

Children and adolescents

There are no available clinical data on the efficacy and safety of Lemena in adolescents under 18 years of age.

Lemena and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including herbal medicines and medicines obtained without a prescription.
Some medicines may interfere with the proper functioning of Lemena. This applies to medicines used to:

• treat epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, and phenobarbital)
• treat tuberculosis (e.g., rifampicin, rifabutin)
• treat HIV (e.g., ritonavir) or other infectious diseases (e.g., griseofulvin)
• treat stomach disorders (activated charcoal)
• treat depressive states (products containing St. John's Wort Hypericum perforatum).

Your doctor will advise whether you need to use additional contraceptive methods, and if so, for how long.
Lemena may also affect the action of other medicines, making them stronger (e.g., cyclosporine) or weaker.

Vaginal bleeding

While taking Lemena, vaginal bleeding may occur irregularly. This may be light spotting or heavy bleeding. Bleeding may also not occur at all.
Irregular bleeding does not mean that the contraceptive effect of Lemena is reduced. Usually, no action is needed, and you should continue taking Lemena. You should contact your doctor if the bleeding is very heavy and prolonged.

Functional ovarian cysts

During the use of all contraceptives that contain small amounts of hormones, small fluid-filled cysts called functional ovarian cysts may develop in the ovaries. They usually disappear on their own. In some cases, they may cause mild abdominal pain. Rarely, they may require surgical intervention.

Pregnancy and breastfeeding

Pregnancy
Before taking any medicine, consult your doctor or pharmacist.
Do not take Lemena if you are pregnant or think you may be pregnant.
Breastfeeding
Before taking any medicine, consult your doctor or pharmacist.
Lemena can be used during breastfeeding. It does not seem to affect milk production or quality. However, a decrease in milk production has been reported in some cases during treatment with Lemena. A small amount of the active substance of Lemena is excreted in breast milk.
The health of children breastfed for 7 months by mothers taking Lemena was studied up to the age of 2.5 years. No effect on growth and development was found in the observed children.

Driving and using machines

It has not been found that Lemena affects alertness or concentration.

Lemena contains lactose monohydrate and soybean oil

The medicine contains lactose monohydrate (milk sugar) and soybean oil.
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Do not take the medicine if you are allergic to peanuts or soy.

When to contact your doctor

Regular check-ups

During treatment with Lemena, your doctor will recommend regular check-ups. The frequency and nature of these check-ups will depend on your individual characteristics.

Contact your doctor immediately:

• if you experience symptoms of venous thromboembolic disease, such as severe pain or swelling in one leg, unusual chest pain, shortness of breath, unusual cough, especially with bloody sputum
• if you experience sudden severe abdominal pain or jaundice (you may notice yellowing of the skin, whites of the eyes, or dark urine, indicating possible liver problems)
• if you find a lump in your breast
• if you experience sudden severe pain in the lower abdomen or stomach area (indicating a possible ectopic pregnancy)
• if you are to be immobilized or have surgery (you should consult your doctor at least 4 weeks in advance)
• if you experience unusual heavy vaginal bleeding
• if you suspect you are pregnant.

3. How to take Lemena

When and how to take Lemena

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The pack contains 28 tablets.

• Take one tablet every day at the same time. Swallow the tablet whole with water.
• The blister pack is marked with the days of the week and arrows to show the order in which the tablets should be taken. Each day corresponds to one tablet.
• Every time you start a new pack of Lemena, take a tablet from the top row. Do not start with any tablet. For example, if you start taking Lemena on a Wednesday, you must take the tablet from the top row marked as "Wed" (Wednesday).
• Continue taking the tablets, one every day, until the pack is empty, always following the direction of the arrows. Looking at the pack, you can easily check if you have taken the tablet for that day.
• During treatment with Lemena, bleeding may occur, but you should continue taking the tablets as usual.
• After finishing the tablets in the pack, start taking the tablets from a new pack of Lemena the next day, without interruption and without waiting for bleeding to occur.

When to start the first pack of Lemena

• If you are not currently taking (or have not taken in the last month) hormonal contraceptivesWait for your period to start. On the first day of your period, take the first tablet of Lemena. You do not need to use additional contraceptive methods. You can also start taking the tablets between the 2nd and 5th day of your cycle, but in this case, you should use an additional non-hormonal contraceptive method, such as a condom, for the first 7 days.
• If you have been taking combined pills, a vaginal ring, or a transdermal patchIf you have a break in taking the pills, vaginal ring, or transdermal patch:
• Start taking Lemena no later than the day after taking the last active tablet, removing the vaginal ring, or patch, or after using the last active tablet of your current contraceptive method.
• If you follow the above instructions, make sure to use an additional non-hormonal contraceptive method for the first 7 days of tablet-taking.

If you do not have a break in taking the pills, vaginal ring, or transdermal patch:

• Start taking Lemena the day after taking the last active tablet from your current contraceptive pack or the day the vaginal ring or patch is removed (this means no break in taking the pills, ring, or patch).
• If your current contraceptive pack contains inactive tablets as well, you can start taking Lemena the day after taking the last active tablet (if in doubt, ask your doctor or pharmacist).
• If you follow the above instructions, you do not need to use an additional contraceptive method.
• If you have been taking other progestogen-only pills (mini-pills)You can switch to Lemena at any time. You do not need to use additional contraceptive methods.
• If you have been taking injections, an implant, or an intrauterine system that releases progestogenStart taking Lemena on the day you would have had your next injection or on the day the implant or intrauterine system is removed. You do not need to use additional contraceptive methods.
• After childbirthYou can start taking Lemena 21 to 28 days after giving birth. If the time since giving birth is longer, you should use an additional non-hormonal contraceptive method during the first cycle, for the first 7 days of tablet-taking. However, if you have had sex, you should check if you are pregnant before starting Lemena. Information for breastfeeding women is provided in section 2, subsection "Pregnancy and breastfeeding". You can also consult your doctor.
• After a miscarriage or abortionConsult your doctor.

Missed pill

If the delay in taking a pill is less than 12 hours:

• Take the missed pill as soon as you remember, and take the next pill at the usual time. Lemena will still protect you from pregnancy.

If the delay in taking a pill is more than 12 hours:

• If the delay in taking a pill is more than 12 hours, you may not be fully protected against pregnancy. The more pills you miss, the greater the risk that you may become pregnant.
• Take the missed pill as soon as you remember, and take the next pill at the usual time. This may mean taking two pills on the same day. This is not harmful. If you have missed more than one pill, there is no need to take the previously missed pills. Continue taking the pills as usual, but you should also use an additional non-hormonal contraceptive method, such as a condom, for the next 7 days.
• If the delay in taking a pill is more than 12 hours and you have had sex, it is safer to use emergency contraception. Consult your pharmacist or doctor.
• If you have missed one or more pills in the first week of taking Lemena and have had sex in the week before missing the pills, it is possible that you have become pregnant. Consult your doctor.

What to do if you vomit or need to take activated charcoal

If you vomit or take activated charcoal within 3-4 hours of taking a tablet of Lemena, or if you experience severe diarrhea, there is a risk that the active substance will not be fully absorbed. Follow the instructions for missing a pill, as described above.

What to do if you take more Lemena than you should

There are no reports of serious harmful effects from taking too many Lemena tablets at once. Symptoms that may occur include nausea, vomiting, and vaginal bleeding in young girls. For further information, consult your doctor.

What to do if you stop taking Lemena

You can stop taking Lemena at any time. From the day you stop taking Lemena, you are no longer protected against pregnancy.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Lemena can cause side effects, although not everybody gets them.
Tell your doctor if you notice any side effects, especially if they are severe or persistent.

Serious side effects

Serious side effects associated with Lemena have been described in section 2.
For more information, read the subsections "Breast cancer", "Venous thromboembolic disease", and "When not to take Lemena". Read this section carefully, and if necessary, consult your doctor immediately.

Other possible side effects

While taking Lemena, vaginal bleeding may occur at irregular intervals (see section 2).

How often do other side effects occur?

Common(may affect up to 1 in 10 people):
mood changes, depression, decreased libido, headaches, nausea, acne, breast pain, irregular bleeding or absence of bleeding, weight gain.
Uncommon(may affect up to 1 in 100 people):
vaginitis, intolerance to contact lenses, vomiting, hair loss, painful bleeding, ovarian cysts, fatigue.
Rare(may affect up to 1 in 1,000 people):
rash, hives, painful red lumps on the skin (erythema nodosum).
In addition to the above side effects, breast discharge or leakage may occur. You should contact your doctor immediately if you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• or hives and difficulty breathing.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lemena

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP".
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lemena contains

The active substance is desogestrel (75 micrograms).
The other ingredients are lactose monohydrate, cornstarch, povidone K30, d-α-tocopherol (E 307), soybean oil, colloidal silicon dioxide, anhydrous colloidal silicon dioxide, stearic acid, hypromellose 2910, macrogol 400, titanium dioxide (E 171)

What Lemena looks like and contents of the pack

One blister pack of Lemena contains 28 white, round, coated tablets.
Each pack contains 1 or 3 PVC/PVDC/Aluminum blisters. The blisters may be placed in a storage case.
Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina s/n, Poligono Industrial Navatejera
Villaquilambre, 24193 León
Spain
Date of last revision of the leaflet: October 2024