Logest

Patient Information Leaflet: User Information

Important Note: Keep the leaflet. Information on the immediate packaging in a foreign language.

Logest (Minigeste)

0.075 mg + 0.02 mg, sugar-coated tablets

Gestodene + Ethinylestradiol
Logest and Minigeste 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").

It is essential to carefully read the leaflet before taking the drug, 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 medicine has been prescribed for 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 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 (progestogen) and
ethinylestradiol (estrogen). Due to the low 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 excipients 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 a blood clotting disorder - for example, 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 (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) pancreatitis with high levels of triglycerides (fats) in the blood;
• if the patient has (or has had in the past) severe liver disease (until liver function tests return to normal);
• if the patient has (or has had in the past) benign or malignant liver tumors;
• if the patient has (or has had in the past) 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 medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Logest and other medicines").

Warnings and precautions

Before starting to take Logest, the patient should discuss it with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should contact their doctor immediately

• if they notice any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "BLOOD CLOTS"). To find a description of these serious side effects, see "HOW TO RECOGNIZE A BLOOD CLOT".

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

The patient should tell their doctor if they have any of the following conditions.

In certain situations, the patient should be particularly careful when taking Logest or any other combined oral contraceptive. Regular medical check-ups may also be necessary. If any of the following conditions are present, the patient should inform their doctor before starting to take Logest. If these symptoms occur or worsen while taking Logest, the patient should also inform their doctor.

• if they smoke;
• if they have diabetes;
• if they are overweight;
• if they have high blood pressure;
• if they have heart valve problems or heart rhythm disorders;
• if they have superficial thrombophlebitis (inflammation of the veins under the skin);
• if they have varicose veins;
• if there have been cases of blood clots, heart attack, or stroke in their close relatives;
• if they have migraines;
• if they have epilepsy;
• if they have elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis.
• if they or their close relatives have had breast cancer in the past or present;
• if they have liver or gallbladder disease;
• if they have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if they have polycystic ovary syndrome;
• if they have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if they have sickle cell anemia (a genetic disorder that affects red blood cells);
• if they will be having surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if they have recently given birth, as they are at increased risk of blood clots. The patient should ask their doctor how soon they can start taking Logest after giving birth.
• if they 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 they have or have had skin discolorations (yellow-brown pigment spots, so-called chloasma); they should avoid excessive exposure to the sun or ultraviolet radiation.
• if they experience symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, they should contact their 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 thromboembolism").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

The patient should contact their doctor immediately if they 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 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,
• change in skin color of 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 stomach 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

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 of the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to 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 the 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 than when 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 of blood clots due to 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/m);
• if someone in the patient's close family has had a blood clot in their leg, lung, or other organ at a young age (e.g., under 50 years old). In this case, the patient may have an inherited blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• 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.
Long-haul flights (>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 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 close 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 a blood clot forms in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over approximately 35 years old);
• if the patient smokes.While taking a hormonal contraceptive like Logest, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, their 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 close 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 close 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 called atrial fibrillation);
• 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.
The patient should inform their doctor if any of these conditions change while taking Logest, e.g., if they start smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if they gain significant weight.
If symptoms suggesting a blood clot occur, the patient should stop taking the tablets and consult their doctor immediately (see also "When to contact a doctor").

Logest and cancer

Women who take oral contraceptives have a slightly higher risk 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 who use hormonal contraceptives are more likely to have regular check-ups and breast cancer is detected earlier. The described difference in breast cancer incidence decreases gradually and disappears within 10 years of 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 who have taken oral contraceptives for a long time. However, this association may not be related to the use of the tablets but to sexual behavior or other factors.

Psychiatric disorders

Some women who take hormonal contraceptives, including Logest, have reported depression or mood swings. 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 medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the levels 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungals, 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), and 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 medicines 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 medicines. 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 medicines they are taking to recognize possible interactions.

Logest with food and drink

Logest can be taken with or without food. If necessary, the patient can take the tablet with a small amount of water.
Logest should not be taken with grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
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 using machines

No effects of Logest on the ability to drive or use machines have been observed.
Logest contains lactose monohydrate and sucrose.If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Logest.

When to contact a doctor

The patient should contact their doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms mentioned above that require special precautions;
• there have been cases of blood clots, heart attack, or stroke in their close relatives;
• a breast lump is detected;
• they plan to take other medicines (see also "Logest and other medicines");
• they will be immobilized or plan to have surgery (they should inform their doctor at least 4 weeks in advance);
• they experience heavy vaginal bleeding;
• they miss a period and have had sex in the past 7 days;
• they have severe diarrhea;
• they do not have a withdrawal bleed within two months or suspect they may be pregnant (they should not start the next pack of Logest without consulting their doctor).

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 exactly as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The leaflet describes many situations in which the patient should not take Logest or in which the effectiveness of the drug may be reduced. It also lists circumstances in which the patient should not have sex or should use additional contraceptive methods, such as condoms or other barrier methods. The calendar method and temperature measurement method cannot be used because Logest affects the changes in temperature and the 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, the patient should 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 starts on average 2-3 days after taking the last tablet and may still occur after starting the next pack. This means that the patient should always start each subsequent pack on the same day of the week and that bleeding will occur at about the same time every month.
• Taking Logest for the first time

If the patient did not take oral contraceptives in the last month
The patient should start taking the tablets on the 1st day of their natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). The patient can also start taking the tablets between the 2nd and 5th day of their menstrual cycle; in this case, during the first cycle, they should use an additional, mechanical contraceptive method for the first 7 days of taking the tablets.
If the patient previously took 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 previously took a progestogen-only pill (minipill)
The patient can stop taking the minipill at any time and start taking Logest at the same time. If the patient has sex within the first 7 days of taking Logest, they should use an additional contraceptive method (barrier methods).
If the patient previously used injectable, implant, or intrauterine system contraception

• After a miscarriage in the first trimester of pregnancy Logest can be started immediately. In this case, it is not necessary to use additional contraceptive methods.
• After childbirth or miscarriage in the second trimester of pregnancy The doctor should inform the patient that they should start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester of pregnancy. If the patient starts taking the tablets later, the doctor should inform them about the need to use additional mechanical contraception for the first 7 days of taking the tablets. If the patient has had sex before starting the combined oral contraceptive, they should make sure they are not pregnant or wait for their first menstrual period.

What to do if too much Logest is taken

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

Stopping Logest

The patient can stop taking Logest at any time. Their 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 delivery date. If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

Missing a dose of Logest

If it has been less than 12 hourssince the patient missed a 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 patient missed a tablet, the effectiveness of Logest may be reduced. The more tablets the patient misses, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is especially high if the patient misses tablets 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 take the next ones at the usual time. For the next 7 days, the patient should use additional contraceptive methods (barrier methods).
If the patient had sex during the week before missing the tablet, it is possible that they may become pregnant. The patient should contact their doctor as soon as possible.

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 take the next ones at the usual time. The contraceptive effectiveness of Logest is maintained, and there is no need to use additional contraceptive methods. However, if the patient made mistakes when taking the tablets before or missed more than 1 tablet, they 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 they have taken the tablets correctly for the 7 days preceding the missed dose. If not, they should follow the first of the two options below and use an additional contraceptive method for 7 days.

• 1. The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. They should start the next pack of tablets immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but the patient may experience spotting or bleeding during the days they are taking the tablets.
• 2. The patient can also stop taking the tablets from the current pack and have a 7-day or shorter break (the patient should also count the day they missed the tablet), after which they should continue taking the tablets from the next pack.

If the patient forgets to take a tablet and does not have a withdrawal bleed 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

What to do in case of:

• gastrointestinal disorders (vomiting)If vomiting occurs, the active substances of Logest may not be fully absorbed. If vomiting occurs within 3-4 hours after taking a tablet, the patient should follow the instructions for missing a tablet. In case of severe gastrointestinal disorders, the patient should use additional contraceptive methods.
• planning to delay the start of the menstrual periodTo delay the start of the menstrual period, the patient should finish the current pack and start the next one immediately, without a 7-day break. The patient can take tablets for as long as they like until they want to have a period. If they want to have a period, they simply stop taking the tablets. The next pack should be started after a 7-day break.
• planning to change the day of the menstrual period to a different day of the weekIf the patient takes the tablets as directed, the menstrual period will occur on approximately the same day of the week every 4 weeks. To change the day of the menstrual period to a different day of the week, the patient should shorten the next tablet-free interval by the number of days they want to postpone their period. For example, if the menstrual period usually starts on Fridays and they want it to start on Tuesdays (3 days earlier), they should start the next pack 3 days earlier than usual. If the patient has a very short tablet-free interval (e.g., 3 days or less), they may not have withdrawal bleeding during that time. Spotting or bleeding may occur while taking the tablets from the next pack.
• experiencing unexpected bleedingDuring the first few months of taking Logest, the patient may experience irregular vaginal bleeding (spotting or breakthrough bleeding). Despite this, the patient should continue taking the tablets. Irregular vaginal bleeding usually stops after 3 cycles of taking Logest. If the bleeding continues, becomes heavy, or recurs, the patient should contact their doctor.
• not having a menstrual periodIf the patient has taken all the tablets correctly and has not had vomiting or severe diarrhea, and has not taken any other medicines, the risk of pregnancy is very low. The patient should continue taking Logest. If the patient does not have a withdrawal bleed within two months, they may be pregnant. The patient should contact their doctor immediately. The patient should not start the next pack of Logest until their doctor has ruled out pregnancy.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially serious or persistent ones, or changes in your health that you think may be related to the use of Logest, you should consult your doctor.
In all women taking 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 different risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Logest".

Severe Side Effects

Severe side effects associated with the use of Logest and their symptoms are described in the following sections of the leaflet: "BLOOD CLOTS" / "Logest and cancer". You should read these sections to get additional information and, if necessary, consult your doctor immediately.
You should immediately contact your doctor if you experience 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 section "Warnings and precautions").

Other Possible Side Effects

Below are symptoms 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-like symptoms, known as a transient ischemic attack, blood clots in the liver, stomach, or intestine, kidneys, or eye.

The likelihood of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Description of Selected Side Effects

Below are very rare side effects or side effects whose symptoms occur with a delay and are associated with the use of combined oral contraception (see the section "When not to take Logest" and "Warnings and precautions"):
Cancers

• The frequency of breast cancer is slightly higher in the group of patients taking oral contraceptives. 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 taking 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 people, during the use of Logest, other side effects may occur.

Reporting Side Effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects 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 side effects, you 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.
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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. 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, corn starch, povidone 25,000, magnesium stearate.
Coating:sucrose, povidone 700,000, macrogol 6000, calcium carbonate, talc, montan glycol wax.

Appearance and Package Contents of Logest

White, round, film-coated tablet.
Logest film-coated tablets are packaged in PVC/Al 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 film-coated tablets
3 x 21 film-coated tablets
To obtain more detailed information, you should contact your doctor, the marketing authorization holder, or the parallel importer.

Marketing Authorization Holder in Portugal, the Country of Export:

Bayer Portugal, Lda., Avenida Vitor Figueiredo nº4 - 4º piso, 2790-255 Carnaxide, Portugal

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
Portuguese marketing authorization number: 2494086
2494185

Parallel Import Authorization Number: 287/22

Translation of Day Symbols on the Packaging

SEG

• Monday TER
• Tuesday QUA - Wednesday QUI
• Thursday SEX
• Friday SÁB
• Saturday DOM - Sunday

Leaflet Approval Date: 22.01.2024

[Information about the trademark]