Logest

Patient Information Leaflet: User Information

Warning! The leaflet should be kept. 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.
• To a small extent, they 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").

The Leaflet Should Be Read Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Contents of the pack 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 (progestagen) and
ethinylestradiol (estrogen). Due to the low hormone content, Logest is classified as a low-dose medication.
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 familiarize yourself with the information about blood clots (thrombosis) in section 2. It is especially important to familiarize yourself with 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 coagulation 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 that 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)
• hyperhomocysteinemia
• if the patient has had a type of migraine called "migraine with aura";
• if the patient has had pancreatitis with high levels of triglycerides (fats) in the blood;
• if the patient has had severe liver disease (until liver function tests return to normal);
• if the patient has had benign or malignant liver tumors;
• if the patient has had 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 medications containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Logest and other medications").

Warnings and Precautions

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

• if you notice possible symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS". For a description of these serious side effects, see "HOW TO RECOGNIZE BLOOD CLOTS").

If you are taking Logest in any of the situations listed below, close medical supervision is necessary.

You Should 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 you have any of the conditions listed below, 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 (thrombophlebitis);
• if you have varicose veins;
• if there have been cases of blood clots, 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 body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder that affects 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 consult your doctor about when to 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 had skin discolorations (yellow-brown pigmentation, so-called chloasma) currently or in the past; you should then avoid excessive exposure to the sun or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications 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 known as "venous thromboembolism" or "deep vein thrombosis"),
• in arteries (also known as "arterial thrombosis" or "arterial occlusive disease").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember That the Overall Risk of Harmful Blood Clots Caused by Logest Is Small.

HOW TO RECOGNIZE BLOOD CLOTS

You should contact your doctor immediately if you notice any of the following symptoms.
Is the patient 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, especially if it is 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 cyanosis. Deep vein thrombosis
• 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 the patient is unsure, they should contact their 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). Pulmonary embolism

Symptoms usually occur in one eye:

• sudden loss of vision or;
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, tightness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack

BLOOD CLOTS IN VEINS

What Can Happen If Blood Clots Form in Veins?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they occur most often 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 the development of 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 Veins the Highest?

The risk of forming blood clots in veins 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 medication) 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 Factors Increase the Risk of Blood Clots in Veins?

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 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 out of 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 years old). In this case, the patient may have inherited coagulation 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 years old);
• 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 inform 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 the above conditions change while taking Logest, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What Can Happen If Blood Clots Form in Arteries?

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 old);
• 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 years old, 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 years old). In this case, the patient may also be at increased risk of having a 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 the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of the above conditions change while taking Logest, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.
If symptoms suggesting a blood clot occur, the patient should stop taking Logest and consult their doctor immediately (see also "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 patient should inform their doctor as soon as possible.
There have been reports of a higher incidence of cervical cancer in women taking oral contraceptives for an extended period. However, this association 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 patient should contact their doctor as soon as possible for further medical advice.

Logest and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Some medications may affect the level of Logest in the blood and may reduce its effectiveness. This applies to medications 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 medications, 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 degenerative joint disease (etoricoxib), other infectious diseases (e.g., griseofulvin), as well as preparations containing St. John's Wort (Hypericum perforatum), used mainly to treat depressive moods, and grapefruit juice.
Oral contraceptives may affect the metabolism of other medications, 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 medications 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 (increased liver enzyme activity). The doctor will recommend a different type of contraception before starting these medications. Logest can be resumed about 2 weeks after finishing the treatment. See "When not to take Logest".
Note: The patient should read the information in the leaflets of other medications they are taking to recognize possible interactions.

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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
Women who are pregnant should not take Logest. If the patient becomes pregnant while taking Logest, they should stop taking it immediately and contact their doctor. If the patient wants to become pregnant, they can stop taking Logest at any time (see "Stopping Logest").
Breastfeeding
Generally, Logest is not recommended for women who are breastfeeding. If the patient wants to take oral contraceptives while breastfeeding, they should contact their doctor.

Driving and Operating Machinery

No effect of Logest on the ability to drive and operate machinery has been observed.

Logest Contains Lactose Monohydrate (37.16 Mg) and Sucrose (19.66 Mg).

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Logest.

When to Contact Your Doctor

The patient should contact their doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms listed above that require special precautions;
• there have been cases of blood clots, heart attack, or stroke in close relatives;
• a breast lump is detected;
• they plan to take other medications (see also "Logest and other medications");
• they plan to have surgery or will be immobilized (they should inform their doctor at least 4 weeks in advance);
• they experience heavy vaginal bleeding;
• they miss a period and have not taken any tablets during the first week of the cycle (every first week of each month of Logest use), and they had sexual intercourse during the previous 7 days;
• they experience severe diarrhea;
• they do not have withdrawal bleeding within two months, or they suspect they may be pregnant (they should not start the next pack of Logest without their doctor's decision).

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

3. How to Take Logest

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The leaflet describes many situations in which Logest should not be taken or in which its effectiveness may be reduced. It also lists circumstances in which sexual intercourse should not be engaged in or in which additional contraceptive methods should be used, e.g., condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used, as Logest affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.

How to Take Logest

• When and how to take the tablets? The blister pack contains 21 sugar-coated tablets. Each tablet on the packaging is marked with the day of the week 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 each subsequent pack should always be started 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 the patient has not taken oral contraceptives in the last month
Tablet intake should be started on the 1st day of the natural menstrual cycle (i.e., the 1st day of menstrual bleeding). Tablet intake can also be started between the 2nd and 5th day of the menstrual cycle; in this case, during the first cycle, additional mechanical contraceptive methods should be used for the first 7 days of tablet intake.
If the patient has previously taken another combined oral contraceptive
It is recommended to start taking Logest on the 1st day after taking the last active tablet of the previous combined oral contraceptive, but no later than the 1st day after the usual break in taking active tablets or placebo in the previous combined oral contraceptive.
If the patient has previously taken a progestin-only pill (minipill)
The minipill can be stopped at any time, and Logest can be started at the same time. If sexual intercourse occurs during the first 7 days of taking Logest, additional contraceptive methods (mechanical methods) should be used.
If the patient has previously used injectable contraception, an implant, or an intrauterine system
Logest intake should be started on the day the next injection was scheduled or on the day the implant or intrauterine system is removed. If sexual intercourse occurs during the first 7 days of taking Logest, additional contraceptive methods (mechanical methods) should be used.
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy Logest can be started immediately. In this case, additional contraceptive methods are not necessary.
• After childbirth or miscarriage in the second trimester of pregnancy The doctor should inform the patient that tablet intake should be started between 21 and 28 days after childbirth or miscarriage in the second trimester of pregnancy. If Logest is started later, the doctor should inform the patient about the need for additional mechanical contraception during the first 7 days of tablet intake. If sexual intercourse has occurred before starting the combined oral contraceptive, the doctor should ensure that the patient is not pregnant or wait for the first menstrual period.

Overdose of Logest

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not yet started menstruating but have taken the medication by mistake.
There have been no reports of serious side effects after taking multiple Logest tablets at the same time. If a higher dose of Logest has been taken than recommended or if someone else has taken it, the patient should inform their doctor.

Stopping Logest

The medication can be stopped at any time. The doctor will recommend other contraceptive methods.
If the patient stops taking Logest because they want to become pregnant, they should wait until they have had a natural menstrual period. This will help determine the expected date of delivery. In case of any doubts about taking this medication, the patient should consult their doctor or pharmacist.

Missing a Dose of Logest

If it has been less than 12 hourssince the missed tablet, the contraceptive effectiveness of Logest is maintained. The patient should 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 the missed tablet, the effectiveness of Logest may be reduced. The more consecutive tablets are missed, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is especially high if tablets are missed at the beginning or end of the pack. In this case, the patient should follow the rules below (see also the scheme below).

Missing More Than 1 Tablet from the Pack

The patient should contact their doctor.

Missing 1 Tablet in the 1st Week of Taking Logest from the Current Pack

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and subsequent tablets should be taken at the usual time. For the next 7 days, additional contraceptive methods (mechanical methods) should be used.
If sexual intercourse occurred during the week preceding the missed tablet, it is possible that the patient may become pregnant. The patient should contact their doctor immediately.

Missing 1 Tablet in the 2nd Week of Taking Logest from the Current Pack

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and subsequent tablets should be taken at the usual time. The contraceptive effectiveness of Logest is maintained, and there is no need to use additional contraceptive methods. However, if there have been previous errors in dosing or if more than 1 tablet has been missed, the patient should use an additional (mechanical) contraceptive method for 7 days.

Missing 1 Tablet in the 3rd Week of Taking Logest from the Current Pack

The patient can choose one of the following options without the need for additional contraceptive methods, provided that the correct dosing schedule has been followed for the 7 days preceding the missed dose. If not, the patient should 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 subsequent 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 during the intake of tablets from the second pack, spotting or bleeding may occur. The next pack is started after a 7-day break.
• 2. The patient can also not take any more tablets from the current pack, take a 7-day or shorter break (the patient should also count the day the tablet was missed), and then continue taking tablets from the next pack.

If the patient forgets to take a tablet and does not have withdrawal bleeding during the first break, it is possible that they are pregnant. Before starting the next pack of Logest, the patient should contact their doctor.

Scheme for Missing a Tablet

Procedure in Case of:

• gastrointestinal disturbances (vomiting)If vomiting occurs, the active substances of Logest may not be fully absorbed. If vomiting occurs within 3 to 4 hours after taking a tablet, the patient should follow the instructions for missing a tablet. In case of severe gastrointestinal disturbances, additional contraceptive methods should be used.

In case of any doubts about taking this medication, the patient should consult their doctor or pharmacist.

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 thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please 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 the "Warnings and precautions" section).

Other Possible Adverse Reactions

The following symptoms have been reported by patients taking Logest, although they may not have been caused by the medicine.
Common (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 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 more 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 the "Contraindications" and "Warnings and precautions" sections):
Cancers

• The incidence of breast cancer is slightly higher in women who use oral contraceptives. Since breast cancer is rare in women under 40, 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 a causal relationship with the use of oral contraceptives has not been confirmed: jaundice and/or itching associated with bile stasis, gallstones, a metabolic disorder called porphyria, systemic lupus erythematosus (an immune system disease), hemolytic-uremic syndrome, Sydenham's chorea (a neurological disease), pregnancy herpes (a skin disease that occurs 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, pharmacist, or nurse 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
By reporting adverse reactions, more information can be gathered on the safety of the medicine.

5. How to Store Logest

The medicine should be stored in a place that is out of sight and reach of children.
Do not store above 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the packaging. 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 medicines that are no longer needed. 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.
A cardboard sachet is attached to the packaging, in which the blister should be placed.
Package size:
1 x 21 sugar-coated tablets
3 x 21 sugar-coated tablets
For more detailed information, please contact a doctor, the marketing authorization holder, or the parallel importer.

Marketing Authorization Holder in Belgium, the Country of Export:

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

Manufacturer:

Bayer AG, Müllerstrasse 178, 13353 Berlin, Germany

Parallel Importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Belgian marketing authorization number, the country of export: BE174124

Parallel Import Authorization Number: 267/24

Translation of Day Symbols on the Packaging

MAA, LUN, MON

• Monday DIN, AR, 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: 02.07.2024

[Information about the trademark]