Logest

Leaflet accompanying the packaging: information for the user

Logest, 0.075 mg + 0.02 mg, coated tablets
Gestodene + Ethinylestradiol

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.
• Cautiousness and consultation with a doctor are necessary if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Logest and what is it used for
• 2. Important information before 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 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 using 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 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 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 needs to undergo surgery or will be immobilized for a long time (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of arterial thrombosis:
• severe diabetes with vascular damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• hyperhomocysteinemia
• if the patient has had a type of migraine called "migraine with aura";
• if the patient has had pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if the patient has had severe liver disease (until liver function test results return to normal);
• if the patient has had benign or malignant liver tumors;
• if the patient has been diagnosed with 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 used 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 section "Logest and other medications").

Warnings and precautions

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

• if they notice possible symptoms of blood clots, which may indicate that they have blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see section 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 situations, 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 cautious when using Logest or any other combined oral contraceptives. Regular medical check-ups may also be necessary. If any of the following conditions occur, the patient should inform their doctor before starting to take Logest. If these symptoms appear or worsen while taking Logest, the patient should also tell their doctor.

• if they smoke;
• if they have diabetes;
• if they are obese;
• 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 thrombosis, heart attack, or stroke in close relatives;
• if they have migraines;
• if they have epilepsy;
• if they 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 they or a close relative have had breast cancer;
• 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 need to undergo 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 consult their doctor to find out how soon they can start taking Logest after giving birth;
• if they have a disease that first appeared 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 sunlight or ultraviolet radiation;
• if they experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause breathing difficulties, they should contact their doctor immediately. Estrogen-containing medications 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 form

• in veins (also known as "venous thromboembolism" or "venous thrombosis")
• in arteries (also known as "arterial thrombosis" or "arterial thromboembolism")

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

It should be remembered that the total risk of harmful blood clots caused by Logest is small.

HOW TO RECOGNIZE BLOOD CLOTS

The patient 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

• swelling of the legs and/or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased temperature in the affected leg
• skin color change in the leg, such as pallor, redness, or 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
Retinal vein thrombosis
(blood clot in the eye)
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may progress to loss of vision
• chest pain, discomfort, pressure, or heaviness
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone Myocardial infarction

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 most often occur 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 moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

The risk of forming 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 medication) 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 affects 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 significantly overweight (body mass index (BMI) over 30 kg/m);
• 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 hereditary coagulation disorders;
• 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 medication;
• with age (especially over 35 years old);
• if the patient recently gave 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 thrombosis 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 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 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 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);
• 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 thrombosis without a known cause, or if they gain significant weight.
If symptoms suggesting thrombosis 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 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 who use 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 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 immediately inform their doctor.
There have been reports of a higher incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this relationship may not be related to taking the tablets but to sexual behavior or other factors.

Psychiatric disorders

Some women taking hormonal contraceptives, including Logest, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes and 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.
Certain medications may affect the level of Logest in the blood and may reduce its effectiveness. These include 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 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), inflammation and degenerative joint disease (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 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 used 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 in the blood (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 the end of treatment. See section "When not to use 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. If necessary, the patient can drink a small amount of water with the tablet.
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 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 section: "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 influence of Logest on the ability to drive and use machines has 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 worrying changes in their health, especially any of the symptoms mentioned above that require special caution;
• there have been cases of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• they plan to take other medications (see also "Logest and other medications");
• they will be immobilized or are scheduled for 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 month) and had sexual intercourse during the previous 7 days;
• they have severe diarrhea;
• they do not experience withdrawal bleeding within two months or suspect they may be 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 medication 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 medication may be reduced. It also lists circumstances in which the patient should not have sexual intercourse or should use additional contraceptive methods, such as condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used because Logest affects temperature changes and cervical mucus properties characteristic of the menstrual cycle.

How to use Logest

• When and how to take the tablets?

The blister pack contains 21 coated tablets. On the packaging, each tablet is marked with the day of the week it should be taken. 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 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 the patient should always start each subsequent pack on the same day of the week and that bleeding will occur at approximately the same time 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, an additional mechanical contraceptive method should be used for the first 7 days of tablet intake.
If the patient has previously used 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 used a progestogen-only tablet (minipill)
The patient can stop taking the minipill on any day and start taking Logest at the same time. If the patient has sexual intercourse during the first 7 days of taking Logest, they should use an additional mechanical contraceptive method.
If the patient has previously used injectable, implant, or intrauterine system contraception

• After a miscarriage in the first trimester: The patient can start taking Logest immediately. In this case, it is not necessary to use additional contraceptive methods.
• After childbirth or miscarriage in the second trimester: The doctor should inform the patient that they can start taking Logest 21-28 days after childbirth or miscarriage in the second trimester. 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

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 severe side effects after taking multiple Logest tablets at once. If the patient has taken more than the recommended dose, they 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 a natural menstrual period. This will help determine the expected date of delivery. If the patient has any doubts about using this medication, 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 tablet 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. There is a particularly high risk of becoming pregnant 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 consult 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 then take the next tablets at the usual time. For the next 7 days, the patient should use an additional mechanical contraceptive method.
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 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 then 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 made mistakes when taking the tablets earlier 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 been taking the tablets correctly for the previous 7 days. If not, they should follow the first of the two options below and use an additional mechanical 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 then take the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but 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 break (no more than 7 days, counting from 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 withdrawal bleeding during the first break after taking the tablets, 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

Consult a doctor
Missed more than
1 tablet from the current
pack
had sexual intercourse in the week before missing the tablet
Week 1.
did not have sexual intercourse in the week before missing the tablet
Tell the patient to take the missed tablet and use additional contraception for 7 days
Continue with the rest of the pack

• take the missed tablet
• continue with the rest of the pack

Week 3.

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 severe and persistent ones, or changes in your health that you think are related to the use of the Logest drug, you should consult a doctor. All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using the Logest drug".

Severe side effects

Severe side effects associated with the use of the Logest drug and their symptoms are 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, immediately consult a doctor. You should immediately contact a doctor if you experience any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria 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:

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

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

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

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 or 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 you have any other risk factors (refer to 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 associated with the use of combined oral contraception (refer to the "Contraindications" and "Warnings and precautions" sections):

Cancers

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

Other clinical conditions

• Women with increased hypertriglyceridemia (increased risk of pancreatitis when using oral contraceptives).
• Hypertension.
• Occurrence or worsening of conditions for which the causal relationship with the use of oral contraception has not been confirmed: jaundice and/or itching associated with bile stasis, gallstones, metabolic disease called porphyria, systemic lupus erythematosus (a disease of the immune system), hemolytic-uremic syndrome, Sydenham's chorea (a neurological disease), herpes gestationis (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 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, phone: +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. Side effects can also be reported to the marketing authorization holder.

5. How to store the Logest drug

The drug should be stored out of sight and reach of children. Do not store above 25°C. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist 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 (0.020 mg). The other ingredients of the drug are: Core:lactose monohydrate, corn starch, povidone 25,000, magnesium stearate. Coating:sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, talc, montan glycol wax.

What Logest looks like and what the package contains

White, round, film-coated tablet. Logest film-coated tablets are packaged in PVC/Al blisters. The blisters are placed in a cardboard box. Package size: 1x21 film-coated tablets 3x21 film-coated tablets Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer AG Kaiser-Wilhelm-Allee 1 51373 Leverkusen Germany

Manufacturer

Bayer AG Müllerstrasse 178 13353 Berlin Germany For more detailed information, please contact your doctor or local representative of the marketing authorization holder. Bayer Sp. z o.o. Al. Jerozolimskie 158 02-326 Warsaw, Poland phone: (0-22) 572 35 00 Date of the last update of the leaflet: