Logest

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Logest(Meliane)

0.075 mg + 0.02 mg, sugar-coated tablets

Gestodene + Ethinylestradiol
Logest and Meliane are different trade names for the same drug.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2, "Blood clots").

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Logest and what is it used for
• 2. Important information before taking Logest
• 3. How to take Logest
• 4. Possible side effects
• 5. How to store Logest
• 6. Package contents and other information

1. What is Logest and what is it used for

Logest is a combined oral contraceptive used to prevent pregnancy.
Each tablet contains a small amount of two different hormones. These are: gestodene (progestogen)
and ethinylestradiol (estrogen). Due to the small hormone content, Logest is classified as
a low-dose drug.
Oral contraception is a very effective method of preventing pregnancy. During correct
use of oral hormonal contraceptives, the likelihood of becoming pregnant is very low.

2. Important information before taking Logest

General notes

Before starting to take Logest, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2, "Blood clots").
Logest should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

Logest, like other oral contraceptives, does not protect against HIV (AIDS) and sexually transmitted diseases.

When not to take Logest

Logest should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
When not to take Logest:

• if there is hypersensitivity to ethinylestradiol or gestodene or any of the components of Logest;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobilized for a long time (see section 2, "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of arterial thrombosis:
• severe diabetes with vascular damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinemia;
• if the patient has had (or has) a type of migraine called "migraine with aura";
• if the patient has had (or has) pancreatitis with high levels of fats (triglycerides) in the blood;
• if the patient has had (or has) severe liver disease (until liver function test results return to normal);
• if the patient has had (or has) benign or malignant liver tumors;
• if the patient has had (or has) a hormone-dependent tumor (breast or genital cancer);
• if the patient has unexplained vaginal bleeding;
• if the patient is pregnant or suspects they may be pregnant.

Logest should not be taken if the patient has hepatitis C and is taking antiviral drugs containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section 2, "Logest and other medicines").

Warnings and precautions

Before starting to take Logest, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?

• if the patient notices possible symptoms of blood clots, which may indicate that they have blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see section 2, "Blood clots"). To get a description of these serious side effects, see section 2, "How to recognize blood clots".

If Logest is taken in any of the following situations, close medical supervision is necessary.
Tell your doctor if you have any of the following conditions.In certain situations, you should be particularly careful when taking Logest or any other combined oral contraceptive. Regular medical check-ups may also be necessary. If any of these conditions occur, you should inform your doctor before starting to take Logest. If these symptoms occur or worsen while taking Logest, you should also tell your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have heart valve problems or heart rhythm disorders;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if there have been cases of thrombosis, heart attack, or stroke in close relatives;
• if you have migraines;
• if you have epilepsy;
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis.
• if you or a close relative have had breast cancer;
• if you have liver or gallbladder disease;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have polycystic ovary syndrome;
• if you have systemic lupus erythematosus (a disease that affects the natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you need to have surgery or will be immobilized for a long time (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should ask your doctor how soon you can start taking Logest after giving birth;
• if you have a disease that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea);
• if you have or have had skin discolorations (yellow-brown pigmentation spots, so-called chloasma); you should avoid excessive sun exposure or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or breathing, you should contact your doctor immediately. Estrogen-containing drugs may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Logest, is associated with an increased risk of blood clots, compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also called "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also called "arterial thromboembolism" or "arterial occlusion")

Not everyone who has a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Logest is small.

HOW TO RECOGNIZE BLOOD CLOTS

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering from

• swelling of the legs and/or swelling along a vein in the leg or foot, deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased temperature in the affected leg
• skin color change in the leg, such as pallor, redness, or discoloration
• sudden unexplained shortness of breath or rapid breathing
• sudden unexplained cough, which may be accompanied by coughing up blood
• sharp chest pain, which may worsen with deep breathing
• severe dizziness or fainting
• rapid or irregular heartbeat
• severe abdominal pain

If you are unsure, you should contact your doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Symptoms usually occur in one eye:
Retinal vein thrombosis
(blood clot in the eye)

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not taking combined hormonal contraceptives.
If the patient stops taking Logest, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Logest is small.

• During a year, about 2 in 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 in 10,000 women taking combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 in 10,000 women taking combined hormonal contraceptives containing gestodene, such as Logest, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Logest is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, the patient may have hereditary blood clotting disorders;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Logest for a few weeks before surgery or immobilization. If the patient needs to stop taking Logest, they should ask their doctor when they can resume taking it;
• with age (especially over 35);
• if the patient has recently given birth. The risk of blood clots increases with the number of risk factors present in the patient. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. It is essential to tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop Logest. The patient should inform their doctor if any of these conditions change while taking Logest, e.g., if someone in their immediate family is diagnosed with thrombosis without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with Logest is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Logest, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder);
• if the patient has diabetes.

If the patient has more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.
Tell your doctor if any of these conditions change while taking Logest, e.g., if the patient starts smoking, someone in their immediate family is diagnosed with thrombosis without a known cause, or if the patient gains significant weight.
If symptoms suggesting a blood clot occur, stop taking the tablets and consult a doctor immediately (see also section 2, "When to contact your doctor").

Logest and cancer

Women taking oral contraceptives have a slightly higher incidence of breast cancer than women of the same age who do not take them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women taking hormonal contraceptives are more frequently examined and breast cancer is detected earlier. The described difference in breast cancer incidence decreases gradually and disappears within 10 years after stopping oral contraceptives.
Rarely, cases of benign or, even more rarely, malignant liver tumors have been reported in women taking combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the doctor should be informed immediately.
There are reports of a higher incidence of cervical cancer in women taking oral contraceptives for a long time. However, this relationship may not be related to taking the tablets but to sexual behavior or other factors.

Psychiatric disorders

Some women taking hormonal contraceptives, including Logest, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the doctor should be contacted immediately for further medical advice.

Logest and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the level of Logest in the blood and may reduce its effectiveness. These include medicines used to treat: epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (e.g., rifampicin), HIV/HCV infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungal drugs, e.g., itraconazole, voriconazole, fluconazole), bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin), heart disease, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem), inflammation and joint degeneration (etoricoxib), other infectious diseases (e.g., griseofulvin), as well as products containing St. John's wort (Hypericum perforatum), used mainly to treat depressive moods and grapefruit juice.
Oral contraceptives may affect the metabolism of other medicines, whose levels in the blood and tissues may increase (e.g., cyclosporin) or decrease (e.g., lamotrigine). Logest may also affect melatonin, midazolam, theophylline, and tizanidine.
Logest should not be taken if the patient has hepatitis C and is taking antiviral drugs containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results in the blood (increased liver enzyme activity). The doctor will recommend a different type of contraception before starting these medicines. Logest can be resumed about 2 weeks after finishing the treatment. See section 2, "When not to take Logest".
Warning: you should read the information in the leaflets of other medicines you are taking to recognize possible interactions between them.

Logest with food and drink

Logest can be taken with or without food, and the tablet can be taken with a small amount of liquid if necessary. Logest should not be taken with grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Women who are pregnant should not take Logest. If you become pregnant while taking Logest, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Logest at any time (see section 3, "Stopping Logest").
Breastfeeding
Generally, Logest is not recommended for women who are breastfeeding. If you want to take oral contraceptives while breastfeeding, you should contact your doctor.

Driving and using machines

No effect of Logest on the ability to drive and use machines has been observed.

Logest contains lactose monohydrate and sucrose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Logest.

When to contact your doctor

You should contact your doctor immediately if:

• you notice any worrying changes in your health, especially any of the symptoms mentioned above that require special caution;
• there have been cases of thrombosis, heart attack, or stroke in close relatives;
• a breast lump has been detected;
• you plan to take other medicines (see also section 2, "Logest and other medicines");
• you plan to have surgery or will be immobilized (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;
• you missed a tablet in the first week of the cycle (every first week of the month) and had intercourse during the previous 7 days;
• you experience severe diarrhea;
• you do not have withdrawal bleeding within two months or suspect you may be pregnant (do not start the next pack of Logest without your doctor's decision).

The situations and symptoms mentioned above are described in more detail in other parts of this leaflet.

3. How to take Logest

This medicine should always be taken as directed by your doctor. If you are unsure, you should contact your doctor or pharmacist.
The leaflet describes many situations in which you should not take Logest or in which the effectiveness of the medicine may be reduced. It also lists circumstances in which you should not have intercourse or should use additional contraceptive methods, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used because Logest affects the changes in temperature and properties of cervical mucus characteristic of the menstrual cycle.

How to take Logest

• When and how to take the tablets? -
• The blister pack contains 21 sugar-coated tablets. On the packaging, each tablet is marked with the day of the week on which it should be taken (see "Translation of day of the week symbols on the packaging" in section 6 at the end of the leaflet). The tablets should be taken in the order indicated on the packaging, every day, at about the same time, with a small amount of liquid if necessary. For 21 consecutive days, take 1 tablet per day. Each subsequent pack should be started after a 7-day break, during which no tablets are taken and withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last tablet and may still occur after starting the next pack. This means that you should always start each subsequent pack on the same day of the week, and bleeding will occur at about the same time every month.
• Taking Logest for the first time -

If you did not take oral contraceptives in the last month
Take the first tablet in the pack on the first day of your period (the first day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of your period; in this case, use an additional, mechanical contraceptive method during the first 7 days of tablet intake.
If you were taking another combined oral contraceptive
Start taking Logest on the first day after taking the last active tablet from your previous contraceptive. However, do not start later than the first day after the usual break in taking active tablets or placebo from your previous contraceptive.

• If you were taking a progestogen-only pill (minipill)
  You can stop taking the minipill on any day and start taking Logest at the same time. If you have intercourse during the first 7 days of taking Logest, use an additional contraceptive method (mechanical methods).
• If you were using contraceptive injections, an implant, or an intrauterine system releasing progestogen
  Start taking Logest on the day you would have had your next injection or on the day the implant or intrauterine system is removed. If you have intercourse during the first 7 days of taking the tablets, use an additional contraceptive method (mechanical methods).
• After childbirth, miscarriage, or abortion

After a miscarriage in the first trimester of pregnancy- You can start taking Logest immediately. In this case, you do not need to use additional contraceptive methods.
After childbirth or miscarriage in the second trimester of pregnancy- Your doctor should inform you that you can start taking the tablets between 21 and 28 days after childbirth or miscarriage in the second trimester. If you start taking the tablets later, your doctor should advise you to use an additional mechanical contraceptive method during the first 7 days of tablet intake. If you have had intercourse before starting the combined oral contraceptive, make sure you are not pregnant or wait for your first menstrual period.

What to do if you take more Logest than you should

You may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not started menstruating yet but have taken the medicine by mistake.
There are no reports of serious side effects after taking multiple Logest tablets at the same time. If you have taken more Logest than you should, contact your doctor.

What to do if you stop taking Logest

The medicine can be stopped at any time. Your doctor will recommend other contraceptive methods. If you stop taking Logest because you want to become pregnant, you should wait until you have had a natural menstrual period. This will help determine the expected date of delivery. If you have any doubts about taking this medicine, you should contact your doctor or pharmacist.

What to do if you miss a dose of Logest

If it has been less than 12 hourssince you missed a tablet, the contraceptive effectiveness of Logest is maintained. Take the missed tablet as soon as possible and take the next one at the usual time.
If it has been more than 12 hourssince you missed a tablet, the effectiveness of Logest may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. There is a particularly high risk of pregnancy if you miss tablets at the beginning or end of the pack. In this case, follow the rules below (see also the scheme below).

Missed more than 1 tablet from the pack

Contact your doctor.

Missed 1 tablet in the 1st week of taking Logest from the current pack

Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next tablets at the usual time. Use additional contraceptive methods (mechanical methods) for the next 7 days.
If you had intercourse during the week before missing the tablet, it is possible that you may become pregnant. Contact your doctor immediately.

Missed 1 tablet in the 2nd week of taking Logest from the current pack

Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next tablets at the usual time. The contraceptive effectiveness of Logest is maintained, and there is no need to use additional contraceptive methods. However, if you made mistakes when taking the tablets earlier or missed more than 1 tablet, use an additional (mechanical) contraceptive method for 7 days.

Missed 1 tablet in the 3rd week of taking Logest from the current pack

You can choose one of the following options without the need for additional contraceptive methods, provided that you have taken the tablets correctly during the 7 days preceding the missed dose. If not, follow the first of the two options below and use an additional contraceptive method for 7 days.

• 1. Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but you may experience spotting or bleeding during tablet intake.
• 2. You can also not take any more tablets from the current pack, take a 7-day or shorter break (including the day you missed the tablet ), and then continue taking the tablets from the next pack.

If you forget to take a tablet and do not have withdrawal bleeding during the first break, you may be pregnant. Before starting the next pack of Logest, contact your doctor.

Scheme for missed tablets

4. Possible Adverse Reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any adverse reactions occur, especially severe and persistent ones or changes in
health status that the patient considers related to the use of Logest, a doctor should be consulted.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Logest".

Severe Adverse Reactions

Severe adverse reactions associated with the use of Logest and their symptoms are described in the following sections of the leaflet: "Blood clots" / "Logest and cancer". These sections should be read to obtain additional information and, if necessary, consult a doctor immediately.
A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also section 2, "Warnings and precautions").

Other Possible Adverse Reactions

The following symptoms have been reported by patients taking Logest, although they may not have been caused by the medicine.
Frequent (more than 1 in 100 people):

• nausea, abdominal pain,
• weight gain,
• headache,
• mood changes, depressive mood,
• breast pain, breast tenderness.

Uncommon (more than 1 in 1000 people and less than 1 in 100 people):

• vomiting, diarrhea,
• fluid retention,
• migraine,
• decreased libido,
• breast enlargement,
• rash, hives.

Rare (less than 1 in 1000 people):

• hypersensitivity,
• intolerance to contact lenses,
• weight loss,
• increased libido,
• discharge, breast secretion,
• erythema nodosum, erythema multiforme,
• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) in the lungs (e.g., pulmonary embolism) heart attack stroke mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack blood clots in the liver, stomach, and intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Description of Selected Adverse Reactions

The following are very rare adverse reactions or reactions whose symptoms occur with a delay and are associated with the use of combined oral contraception (see section 2, "When not to use Logest" and "Warnings and precautions"):
Tumors

• The frequency of breast tumors is slightly higher in the group of patients using oral contraception. Since the occurrence of breast cancer in women under 40 is rare, the risk is small in relation to the overall risk of breast cancer. The causal relationship with the use of combined oral contraceptives is unknown.
• Liver tumors (benign and malignant).

Other Clinical Conditions

• Women with increased hypertriglyceridemia (increased risk of pancreatitis when using oral contraceptives).
• Hypertension.
• Occurrence or worsening of conditions for which the causal relationship with the use of oral contraceptives has not been confirmed: jaundice and/or itching associated with bile stasis, gallstones, metabolic disease called porphyria, systemic lupus erythematosus (immune system disease), hemolytic-uremic syndrome, Sydenham's chorea (neurological disease), pregnancy herpes (skin disease occurring during pregnancy), hearing loss associated with otosclerosis, cervical cancer.
• Liver function disorders.
• Combined oral contraceptives may affect insulin resistance and glucose tolerance.
• Crohn's disease and ulcerative colitis.
• Chloasma.

In women with hereditary angioedema, exogenous estrogens may cause the occurrence or exacerbation of its symptoms.
In some individuals, during the use of Logest, other adverse reactions may occur.

Reporting Adverse Reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the doctor or pharmacist should be informed. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions can help gather more information on the safety of the medicine.

5. How to Store Logest

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the box and blister. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package Contents and Other Information

What Logest Contains

The active substances are gestodene (0.075 mg) and ethinylestradiol (0.02 mg).
The other ingredients of the medicine are:
Core:lactose monohydrate, cornstarch, povidone 25,000, magnesium stearate.
Coating:sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, talc, montan wax.

Appearance and Package Contents of Logest

White, round, sugar-coated tablet.
Logest sugar-coated tablets are packaged in blisters. The blisters are placed in a cardboard box.
Package size:
21 sugar-coated tablets
3x21 sugar-coated tablets
To obtain more detailed information, contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

Bayer SA-NV
Jan Mommaertslaan 14
1831 Diegem (Machelen)
Belgium

Manufacturer:

Bayer A.G.
Müllerstrasse 178
13353 Berlin
Germany

Parallel Importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Marketing Authorization Number in Belgium, the Country of Export: BE174124

Parallel Import Authorization Number: 99/25

Translation of day-of-the-week symbols on the packaging:
MAA/LUN/MON – Monday
DIN/MAR/DIE – Tuesday
WOE/MER/MIT – Wednesday
DON/JEU/DON – Thursday
VRI/VEN/FRE – Friday
ZAT/SAM/SAM – Saturday
ZON/DIM/SON – Sunday

Leaflet Approval Date: 17.03.2025

[Information about the trademark]