Logest

Leaflet accompanying the packaging: information for the user

Warning! 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.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see point 2 "Blood clots").

One should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• One should keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug 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 point 4.

Table of contents of the leaflet

• 1. What is Logest and what is it used for
• 2. Important information before using Logest
• 3. How to use Logest
• 4. Possible side effects
• 5. How to store Logest
• 6. Contents of the packaging 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 using Logest

General notes

Before starting to take Logest, one should read the information about blood clots (thrombosis) in point 2. It is especially important to read about the symptoms of blood clots (see point 2 "Blood clots").
Logest should not be used 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 infection (AIDS) and sexually transmitted diseases.

When not to use Logest

Logest should not be used 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 use Logest:

• if the patient is hypersensitive 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 deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows they have a blood coagulation disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see point 2 "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had) 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 that 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) a type of migraine called "migraine with aura";
• if the patient has (or has had) pancreatitis with high levels of fats in the blood;
• if the patient has (or has had) severe liver disease (until liver function tests return to normal);
• if the patient has (or has had) benign or malignant liver tumors;
• if the patient has (or 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 are pregnant.

Logest should not be used 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 "Logest and other drugs").

Warnings and precautions

Before starting to take Logest, one should discuss it with their doctor or pharmacist.
When should one contact their doctor?
One should immediately contact their doctor

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

If Logest is used in any of the following cases, close medical supervision is necessary.

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

In certain situations, one should be particularly careful when using Logest or any other combined oral contraceptive. Regular medical examination may also be necessary. If any of the following conditions occur, one should inform their doctor before starting to take Logest. If these symptoms appear or worsen while taking Logest, one should also tell their doctor.

• if the patient smokes;
• if the patient has diabetes;
• if the patient is obese;
• if the patient has high blood pressure;
• if the patient has heart valve problems or heart rhythm disorders;
• if the patient has superficial thrombophlebitis (inflammation of the veins under the skin);
• if the patient has varicose veins;
• if there have been cases of blood clots, heart attacks, or strokes in close relatives;
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis.
• if the patient has a family history of breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has polycystic ovary syndrome;
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient needs to undergo surgery or will be immobilized for a long time (see point 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The doctor should be consulted to determine how soon Logest can be started after giving birth;
• if the patient has 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 the patient has skin discolorations (yellow-brown pigment spots, so-called chloasma) currently or in the past; in this case, one should avoid excessive exposure to the sun or ultraviolet radiation;
• if the patient experiences symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause breathing difficulties, one should immediately contact their doctor. Drugs containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

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

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thrombotic disease")
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thrombotic disease")

Not all patients who have had a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

One should remember that the overall risk of serious blood clots caused by Logest is small.

HOW TO RECOGNIZE BLOOD CLOTS

One should immediately contact their doctor 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
these symptoms?

• 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 changes in the leg, such as pallor, redness, or cyanosis.

• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• severe 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, or heaviness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking. Heart attack

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur most frequently in the first year of using 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 breaks loose 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 blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 using combined hormonal contraceptives.
If the patient stops using 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 associated with Logest is small, but certain factors can increase this risk. The risk is higher:

• if the patient is severely 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 a hereditary blood clotting disorder;
• if the patient needs to undergo 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 using Logest for a few weeks before surgery or immobilization. If the patient needs to stop using Logest, they should ask their doctor when they can resume taking the drug;
• 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 tell the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the use of 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 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 a heart attack or stroke associated with Logest is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.During the use of 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, the doctor may recommend using 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 having a heart attack or stroke;
• if the patient or someone in their immediate family has been diagnosed with 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 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 they gain significant weight.
In case of symptoms suggesting a blood clot, the patient should stop taking the tablets and consult their doctor immediately (see also "When to contact your doctor").

Logest and cancer

In women who use oral contraceptives, breast cancer is slightly more common than in women of the same age who do not use 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 frequently examined and breast cancer is detected earlier. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping the use of oral contraceptives.
In women who use combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the patient should immediately inform their doctor.
There are reports of a more frequent occurrence of cervical cancer in women who use oral contraceptives for a long time. However, this relationship may not be related to the use of the tablets but to sexual behavior or other factors.

Psychiatric disorders

Some women who use hormonal contraceptives, including Logest, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes and symptoms of depression occur, the patient should contact their doctor as soon as possible to receive further medical advice.

Logest and other drugs

The patient should tell their doctor or pharmacist about all drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Certain drugs may affect the level of Logest in the blood and may reduce its effectiveness. This applies to drugs 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), arthritis (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 drugs, 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 used 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 drugs. Logest can be resumed about 2 weeks after the end of treatment. See "When not to use Logest".
Note: The patient should read the information in the leaflets of other drugs 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 swallowed 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 using this drug.
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
It is generally not recommended to use Logest while 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 an intolerance to some sugars, they should contact their doctor before taking Logest.

When to contact your doctor

The patient should immediately contact their doctor if:

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

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

3. How to use Logest

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

How to use 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" at the end of the leaflet). The tablets should be taken in the order indicated on the packaging, every day, at approximately 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 when withdrawal bleeding usually occurs. Bleeding usually starts within 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 bleeding will occur approximately on the same days every month.

• Using Logest for the first time

If the patient has not used 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 the menstrual cycle; in this case, during the first cycle, the patient should use an additional mechanical contraceptive method for the first 7 days of tablet intake.
If the patient has used another combined oral contraceptive before
It is recommended to start taking Logest on the 1st day after taking the last tablet containing active substances of the previous combined oral contraceptive, but no later than on the 1st day after the usual break in taking tablets containing active substances or placebo in the previous combined oral contraceptive.
If the patient has used a progestogen-only tablet (minipill)
The patient can stop taking the minipill on any day and replace it with Logest at the same time. If the patient has sexual intercourse during the first 7 days of taking Logest, they should use additional contraceptive methods (mechanical methods).
If the patient has used injectable, implant, or intrauterine system contraception
The patient should start taking Logest on the day they would have had their next injection or on the day the implant or intrauterine system is removed. If the patient has sexual intercourse during the first 7 days of taking the tablets, they should use additional contraceptive methods (mechanical methods).
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy The patient can start taking Logest immediately. In this case, there is no need 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 between 21 and 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 tablet intake. If the patient has had sexual intercourse before starting the combined oral contraceptive, they should make sure they are not pregnant or wait for their first menstrual period.

Using more than the recommended dose of Logest

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

Stopping Logest

The patient can stop taking the drug 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 the use of this drug, the patient 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 particularly 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 one tablet from the pack

The patient should contact their doctor.

Missing one tablet in the first 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 tablets at the usual time. For the next 7 days, the patient should use additional contraceptive methods (mechanical methods).
If the patient had sexual intercourse during the week before missing the tablet, it is possible that they may become pregnant. The patient should contact their doctor immediately.

Missing one tablet in the second 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 tablets 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 has made other mistakes in taking the tablets or has missed more than one tablet, they should use additional mechanical contraceptive methods for 7 days.

Missing one tablet in the third 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 previous 7 days. If not, the patient 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 tablets at the usual time. The patient 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 tablet intake.
• 2. The patient can also stop taking the tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), and then continue taking the tablets from the next pack.

If the patient misses a tablet and does not experience the expected withdrawal bleeding during the first break after taking the tablets, it is possible that they are pregnant. The patient should contact their doctor before starting the next pack of Logest.

Scheme for missing a tablet

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 are related to the use of the Logest drug, you should consult your doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using the Logest drug".

Severe side effects

Severe side effects related to the use of the Logest drug and their symptoms have been described in the following sections of the leaflet: "Blood clots" / "Logest drug and cancer". You should read these sections to obtain 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 "Warnings and precautions" section).

Other possible side effects

The following symptoms have been reported by patients taking the Logest drug, although they may not have been caused by the drug:

• Frequently (more than 1 in 100 people):
• nausea, abdominal pain,
• weight gain,
• headache,
• mood changes, depressive mood,
• breast pain, breast tenderness.

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

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

Rarely (less than 1 in 1000 people):

• hypersensitivity,
• intolerance to contact lenses,
• weight loss,
• increased libido,
• discharge, breast secretion,
• erythema multiforme, erythema nodosum.
• 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 or 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 developing 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

The following are very rare side effects or side effects whose symptoms occur with a delay and are related to the use of combined oral contraceptives (see the "Contraindications" and "Warnings and precautions" sections):
Cancers

• The frequency of breast cancer is slightly higher in the group of patients using 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.

Other clinical conditions

• Women with increased hypertriglyceridemia (increased risk of pancreatitis during the use of 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, porphyria (a metabolic disorder), systemic lupus erythematosus (an immune system disease), hemolytic-uremic syndrome, Sydenham's chorea (a neurological disease), herpes gestationis (a 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 worsening of its symptoms.
In some people, during the use of the Logest drug, 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 or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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 drug.

5. How to store the Logest drug

The drug should be stored in a place invisible and inaccessible to children.
Do not store at a temperature above 25°C. Protect from light.
Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What the Logest drug contains

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

What the Logest drug looks like and what the packaging contains

White, round, sugar-coated tablet.
The sugar-coated tablets of the Logest drug 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.
Packaging size:
1 x 21 sugar-coated tablets
3 x 21 sugar-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.
Rua Quinta do Pinheiro, n.º 5
2794-003 Carnaxide
Portugal

Manufacturer:

Bayer AG
Müllerstraße, 178
13353 Berlin
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Portugal, the country of export:2494086
2494185
Parallel import authorization number:66/22
Translation of day abbreviations on the packaging:
DOM– Sunday, SEG– Monday, TER– Tuesday, QUA– Wednesday, QUI– Thursday, SEX– Friday,
SÁB– Saturday.
Leaflet approval date: 16.02.2023
[Information about the trademark]