LEMENA

Patient Information Leaflet

Lemena, 75 micrograms, coated tablets
Desogestrel
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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.

Contents of the leaflet:

1. What Lemena is and what it is used for
2. What you need to know before you take 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 Lemena is and what it is used for

Lemena is used to prevent pregnancy.
Lemena tablets contain a small amount of a female sex hormone, a progestogen called desogestrel. For this reason, Lemena is known as a progestogen-only pill or a "mini-pill". Unlike combined oral contraceptives, mini-pills do not contain oestrogen, the other female sex hormone.
The mechanism of action of most mini-pills primarily involves preventing sperm migration through the cervical canal. In contrast to combined oral contraceptives, they do not always suppress the maturation of the egg cell. Lemena differs from other mini-pills in that, like combined contraceptives, it usually suppresses the maturation of the egg cell. As a result, Lemena is a highly effective contraceptive.
Unlike combined contraceptives, it can be used by women who are intolerant to oestrogens and by breastfeeding women. The most common inconvenience during treatment with Lemena may be irregular bleeding. Bleeding may also not occur at all.
The likelihood of becoming pregnant while correctly taking Lemena, provided no tablet has been missed, is very low.

2. Important information before using Lemena

Like other hormonal contraceptives, Lemena does not protect against HIV (AIDS) infection or other sexually transmitted diseases.
When not to use Lemena
Do not use Lemena if any of the conditions listed below apply. If any of these conditions are present, inform your doctor before starting Lemena. Your doctor may advise using a non-hormonal method of contraception.

• If the patient is allergic to desogestrel, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
• Current venous thromboembolic disease. Venous thromboembolic disease involves the formation of blood clots blocking veins, for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If the patient has or has previously had jaundice (yellowing of the skin) or severe liver disease, and liver function has not returned to normal.
• If the patient has or is suspected of having a tumour dependent on sex hormones, such as certain types of breast cancer.
• If the patient has vaginal bleeding of unknown cause.

If any of these conditions occur for the first time during use of Lemena, contact a doctor immediately.
Warnings and precautions
If Lemena is used in any of the situations listed below, close medical supervision is required. Discuss the following with your doctor before starting Lemena:

• if the patient has ever had breast cancer
• if the patient has had liver cancer, as a potential influence of Lemena cannot be excluded
• if the patient has ever had venous thromboembolic disease
• if the patient has diabetes
• if the patient has epilepsy (see section "Lemena with other medicines")
• if the patient has tuberculosis (see section "Lemena with other medicines")
• if the patient has high blood pressure (hypertension)
• if the patient has or has previously had chloasma (yellowish-brown patches, skin discoloration, especially on the face); in such cases, excessive exposure to sunlight or ultraviolet radiation should be avoided.

If Lemena is used under any of these conditions, the patient may require careful monitoring. Your doctor will advise on the appropriate course of action.
Psychiatric disorders
Some women using hormonal contraceptives, including Lemena, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.
Reduced bone mass
Oestrogens play an important role in maintaining normal bone mass. During use of Lemena, the concentration of the natural oestrogen, estradiol, in plasma is comparable to its concentration in the first half of the natural cycle, but reduced compared to its concentration in the second half of the natural cycle. It is unknown whether this affects bone mass.
Breast cancer
All women are at risk of developing breast cancer, regardless of whether they use contraceptive pills. Breast cancer occurs slightly more frequently in women using contraceptive pills than in women of the same age who do not use them. After stopping contraceptive pills, this risk gradually decreases, and after 10 years, the risk is the same for women who used pills and those who never used them. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, a higher number of breast cancer cases occur in older women using contraceptive pills. The duration of use of contraceptive pills is not of major significance.
Among 10,000 women using contraceptive pills for no more than 5 years, in the age group under 20 years, fewer than 1 additional case of breast cancer was diagnosed per 10 years after stopping the pills, compared to 4 cases usually diagnosed in this age group. Similarly, among 10,000 women using contraceptive pills for up to 5 years in the age group under 30 years, 5 additional cases of breast cancer were diagnosed compared to 44 cases usually diagnosed in this group. Among 10,000 women using contraceptive pills for up to 5 years in the age group over 40 years, 20 more cases of breast cancer were diagnosed compared to 160 cases usually diagnosed.
The risk of breast cancer in women using progestogen-only pills, such as Lemena, appears similar to that in women using combined pills, but data are not conclusive.
In women using contraceptive pills, diagnosed breast cancer appears to be generally less advanced than in women who did not use contraceptive pills. It is unclear whether this difference is caused by the use of contraceptive pills. The reason may be earlier diagnosis due to more frequent examinations in women using contraceptive pills.
Venous thromboembolic disease
Venous thromboembolic disease involves the formation of a blood clot that may block a blood vessel. It may sometimes occur in the deep veins of the lower limbs (deep vein thrombosis). If the clot detaches from its site of origin, it may travel to the lungs and block the pulmonary artery, causing a pulmonary embolism, which may be fatal. Venous thromboembolic disease is very rare. It may also develop in women not using contraceptive pills and may occur during pregnancy. The risk of venous thromboembolic disease is higher in women using contraceptive pills than in those who do not. It is believed that the risk of venous thromboembolic disease in women using progestogen-only contraceptives, such as Lemena, is lower than in women using combined oral contraceptives containing oestrogens. If symptoms of venous thromboembolic disease occur, contact a doctor immediately (see section "When to contact a doctor").
Children and adolescents
There are no available clinical data on the efficacy and safety of use in adolescents under 18 years of age.
Lemena with other medicines
Inform your doctor or pharmacist about any medicines currently used, recently used, or planned for use, including herbal medicines and over-the-counter medicines.
Some medicines may interfere with the proper functioning of Lemena. This includes medicines used:

• in the treatment of epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, and phenobarbital)
• in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
• in HIV infections (e.g. ritonavir) or other infectious diseases (e.g. griseofulvin)
• for stomach disorders (activated charcoal)
• for depressive disorders (products containing St John's wort Hypericum perforatum).

Your doctor will advise whether additional contraceptive methods are needed and, if so, for how long.
Lemena may also affect the way some medicines work in the body, either increasing their effect (e.g. drugs containing cyclosporine) or reducing their effectiveness.
Vaginal bleeding
Irregular vaginal bleeding may occur during use of Lemena. This may be light spotting or heavy bleeding. Bleeding may also not occur at all.
Irregular bleeding does not mean that the contraceptive effectiveness of Lemena is reduced. Usually, no action is required, and treatment with Lemena should be continued. Contact your doctor if bleeding is very heavy and prolonged.
Functional ovarian cysts
During use of all hormonal contraceptives containing low hormone doses, small fluid-filled sacs called functional ovarian cysts may develop in the ovaries. These usually resolve spontaneously. In some cases, they may cause mild abdominal pain. Rarely, surgical intervention may be required.
Pregnancy and breastfeeding
Pregnancy
Consult a doctor or pharmacist before taking any medicine.
Do not use Lemena if the patient is pregnant or suspects she may be pregnant.
Breastfeeding
Consult a doctor or pharmacist before taking any medicine.
Lemena may be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a decrease in milk production has occasionally occurred during use of Lemena. A small amount of the active substance in Lemena is excreted in breast milk.
The health of children breastfed for 7 months by mothers taking Lemena was monitored until the children reached 2.5 years of age. No effect on growth and development was observed in these children.
Driving and using machines
No effects of Lemena on alertness or concentration have been observed.
Lemena contains monohydrate lactose and soybean oil
This medicine contains monohydrate lactose (milk sugar) and soybean oil.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
Do not use the medicine if the patient has a known hypersensitivity to peanuts or soy.
When to contact a doctor
Regular check-ups
During use of Lemena, your doctor will recommend regular check-ups. The frequency and nature of these examinations will generally depend on individual patient characteristics.
Contact a doctor immediately if:

• the patient experiences symptoms of venous thromboembolic disease, such as severe pain or swelling in either leg, unusual chest pain, shortness of breath, or unusual cough, especially with coughing up blood
• the patient experiences sudden, severe stomach pain or jaundice (the patient may notice yellowing of the skin, whites of the eyes, or dark urine, indicating possible liver dysfunction)
• the patient detects a breast lump
• the patient experiences sudden or severe pain in the lower abdomen or stomach area (suggesting possible ectopic pregnancy)
• the patient is to be immobilized or undergo surgery (consult your doctor at least four weeks in advance)
• the patient experiences unusual, heavy vaginal bleeding
• the patient suspects she is pregnant.

3. How to use Lemena

When and how to use Lemena
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The Lemena 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 abbreviations of the days of the week and arrows indicating the order of tablet intake. Each day corresponds to one tablet.
• Each time starting a new pack of Lemena, take the tablet from the top row. Do not start from any random tablet. For example, if starting treatment on Wednesday, the patient should take the tablet in the top row marked “Wed” (Wednesday).
• Continue taking the medicine, one tablet daily, until the pack is empty, always following the direction indicated by the arrows. Looking at the blister pack, it is easy to check whether the tablet for a given day has already been taken.
• Bleeding may occur while taking Lemena; however, continue taking the tablets as usual.
• After finishing all tablets in the pack, start taking 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 the patient is not currently taking (or has not taken in the last month) hormonal contraceptives Wait for the onset of menstruation. Take the first tablet of Lemena on the first day of the menstrual period. There is no need to use additional contraceptive methods. Treatment may also be started between day 2 and day 5 of the cycle; however, in this case, an additional mechanical contraceptive method is recommended for the first 7 days of tablet intake.
• If the patient previously used combined oral contraceptives, a vaginal ring, or a transdermal patch If the patient has a break from taking tablets, using a vaginal ring, or a transdermal patch:
  • Treatment with Lemena can be started no later than the next day after taking the last active tablet, removing the vaginal ring, or removing the transdermal patch, or after taking the last inactive tablet of the currently used contraceptive.
• If the above instructions are followed, an additional mechanical contraceptive method should be used for the first 7 days of tablet intake.

If the patient does not have a break from taking tablets, using a vaginal ring,
or a transdermal patch:

• Start taking Lemena the day after taking the last active tablet of the currently used contraceptive pack, or on the day of removal of the vaginal ring or transdermal patch (this means no break in treatment).
• If the current contraceptive pack also contains inactive tablets, Lemena may be started the day after taking the last active tablet (if in doubt about which tablet is meant, consult a doctor or pharmacist).
• If the above instructions are followed, there is no need to use an additional contraceptive method.
  • If the patient previously used progestogen-only pills (mini-pills) Switching from mini-pills can be done on any day. There is no need to use additional contraceptive methods.
  • If the patient previously used progestogen-releasing injections, an implant, or an intrauterine system Start taking Lemena on the day the next injection was due, or on the day of removal of the implant or intrauterine system. There is no need to use additional contraceptive methods.
  • After childbirth Lemena may be started 21 to 28 days after childbirth. If the period since childbirth is longer, an additional mechanical contraceptive method should be used during the first cycle, for the first 7 days of tablet intake. However, if sexual intercourse has occurred, pregnancy should be ruled out before starting Lemena. Information for breastfeeding women is provided in section 2, under “Pregnancy and breastfeeding”. Additionally, consult a doctor.
  • After miscarriage or abortion Consult a doctor.

Missed dose of Lemena
If the delay in taking the tablet is less than 12 hours:

• Take the missed tablet as soon as remembered, and take the next tablet at the usual time. Lemena will continue to provide protection against pregnancy.

If the delay in taking the tablet is more than 12 hours:

• If the delay in taking the tablet exceeds 12 hours, the patient may not be adequately protected against pregnancy. The greater the number of missed tablets, the higher the risk of pregnancy.
• Take the missed tablet as soon as remembered, and take the next tablet at the usual time. This may mean taking two tablets on the same day. This is not harmful. If more than one tablet has been missed, there is no need to take previously missed tablets. Continue taking tablets as usual, but also use an additional contraceptive method, such as a condom, for the next 7 days.
• If the delay in taking the tablet is more than 12 hours and sexual intercourse has occurred, emergency contraception should be considered. Consult a pharmacist or doctor.
• If the patient missed one or more tablets during the first week of treatment and had sexual intercourse in the week preceding the missed dose, pregnancy may have occurred. Consult a doctor.

What to do in case of vomiting or activated charcoal use
If vomiting or activated charcoal use occurs within 3–4 hours
after taking a Lemena tablet, or if severe diarrhoea occurs, there is a risk that the active substance
has not been completely absorbed. Follow the instructions for missed doses given above.
Taking more than the recommended dose of Lemena
There have been no reports of serious harmful adverse effects caused by taking
too many Lemena tablets at once. Symptoms that may occur include: nausea, vomiting,
and vaginal bleeding in young girls. For further information, consult a doctor.
Discontinuing use of Lemena
Lemena may be discontinued at any time. From the day treatment is stopped,
the patient is no longer protected against pregnancy.
If you have any further doubts regarding the use of this medicine, consult a
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should inform your doctor if you experience any adverse reactions, especially if they are severe or persistent.

Severe adverse reactions
Severe adverse reactions associated with the use of Lemena are described in section 2.
For additional information, please refer to the subsections "Breast cancer", "Venous thromboembolic disease" and "When not to use Lemena". Please read this section carefully and seek immediate medical advice if necessary.

Other possible adverse reactions
Irregular vaginal bleeding may occur during treatment with Lemena (see section 2).

How often do other adverse reactions occur?

Common (may affect less than 1 in 10 women):
mood changes, depressed mood, decreased sexual desire (libido), headache, nausea, acne, breast pain, irregular bleeding or absence of bleeding, weight gain.

Uncommon (may affect less than 1 in 100 women):
vaginitis, contact lens intolerance, vomiting, hair loss, painful bleeding, ovarian cysts, fatigue.

Rare (may affect less than 1 in 1,000 women):
rash, urticaria, painful red-purple nodules on the skin (erythema nodosum).

In addition to the adverse reactions listed above, 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 urticaria and breathing difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Lemena

Keep this medicine out of sight and reach of children.
Store below 30°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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: monohydrate lactose, corn starch, povidone K30,
d-α-tocopherol (E 307), soybean oil, colloidal hydrated silica, colloidal anhydrous silica,
stearic acid, hypromellose 2910, macrogol 400, titanium dioxide (E 171).

What Lemena looks like and contents of the pack
One blister of Lemena contains 28 white, round coated tablets.
Each pack contains 1 or 3 PVC/PVDC/Aluminium blisters. The blisters may be placed in a carton for blister storage.
Not all pack sizes may be marketed.

Marketing Authorisation 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