Logest

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Logest(Meliane), 0.075 mg + 0.02 mg, sugar-coated tablets
Gestodene + Ethinylestradiol
Logest and Meliane are different trade names for the same drug.

Important Information About Combined Hormonal Contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or when 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 blood clot symptoms have occurred (see section 2 "Blood Clots").

It is Necessary to Carefully Read the Contents of the Leaflet Before Using the Medication, 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 medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 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 small 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 other 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), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, presence of 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 (or has ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of an impending heart attack) or a transient ischaemic attack (temporary stroke-like 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);
• hyperhomocysteinaemia;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if the patient has (or has ever had) severe liver disease (until liver function tests have returned to normal);
• if the patient has (or has ever had) liver tumours (benign or malignant);
• if the patient has (or has ever had) a hormone-dependent tumour (cancer of the breast or genital organs);
• 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, paritaprevir, ritonavir, and dasabuvir, or glecaprevir or pibrentasvir (see also section "Logest and other medications").

Warnings and Precautions

Before starting to use Logest, the patient should discuss this with their doctor or pharmacist.
When to contact a doctor?

• if the patient notices 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 (Thrombosis)");

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

The Patient Should Inform Their Doctor if They Have Any of the Following Conditions.

In certain situations, the patient should exercise extra caution when using 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 use Logest. If these symptoms appear or worsen during the use of Logest, the patient should also inform 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 irregular heart rhythm;
• if the patient has superficial thrombophlebitis (inflammation of the veins just under the skin);
• if the patient has varicose veins;
• if there have been cases of blood clots, heart attack, or stroke in close relatives;
• if the patient has migraines;
• if the patient has epilepsy;
• if the patient has elevated levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if there is a history of breast cancer in the patient's family;
• 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 defence system);
• if the patient has haemolytic uraemic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle-cell anaemia (an inherited disease of the red blood cells);
• if the patient needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood Clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor about when to start using Logest after giving birth;
• if the patient has a disease that first appeared or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria, chloasma, Sydenham's chorea);
• if the patient has experienced changes in skin pigmentation (brown patches, so-called chloasma), currently or in the past; in this case, the patient should avoid excessive exposure to the sun or ultraviolet radiation.

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 the veins (also known as "venous thromboembolism" or "deep vein thrombosis"),
• in the arteries (also known as "arterial thromboembolism").

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

It Should be Remembered that the Overall Risk of Developing a Harmful Blood Clot Due to Logest is Small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

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 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;
• change in the colour of the leg, e.g. pale, red, or purple.

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.

Pulmonary embolism

Symptoms usually occur in one eye:

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

Retinal vein thrombosis (blood clot in the eye)

• chest pain, discomfort, pressure, heaviness;
• feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body, radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;

Heart attack

• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.

BLOOD CLOTS IN VEINS

What Can Happen if a Blood Clot Forms 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 of the leg or foot, it can lead to the development of 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 Veins the Highest?

The risk of forming a blood clot 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 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 years old). In this case, the patient may have an inherited 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 using it;
• with increasing 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.

Factors that 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.

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 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.When using 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 immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);

and

• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, irregular heart rhythm 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 using Logest, e.g. if they start smoking, if someone in their immediate family has a blood clot without a known cause, or if they gain significant weight.
In the event of symptoms suggesting a blood clot, the patient should stop taking the tablets and consult their doctor immediately (see also "When to contact a doctor").

Logest and Cancer

Women who use oral contraceptives have a slightly higher risk of breast cancer than 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 likely to have regular check-ups and breast cancer may be detected earlier. This difference in breast cancer risk decreases gradually and disappears within 10 years of stopping the use of oral contraceptives.
Women who use combined oral contraceptives have a rare increased risk of benign or, even more rarely, malignant liver tumours, 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 are reports of a higher incidence of cervical cancer in women who use oral contraceptives for a long time. However, this association may not be related to the use of the tablets but to sexual behaviour or other factors.

Psychological Disorders

Some women who use 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 Medications

The patient should inform 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. This applies to medications used to treat: epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (e.g. rifampicin), HIV/HCV infection (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, paritaprevir, ritonavir, and dasabuvir, or glecaprevir or pibrentasvir, as this may cause elevated liver function tests (increased levels of the liver enzyme ALT). 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.

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 using 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
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 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 attention;
• there have been cases of blood clots, heart attack, or stroke in close relatives;
• a breast lump has been detected;
• they plan to use other medications (see also "Logest and other medications");
• they will be immobilized or are planning 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 month) and have had sexual intercourse during the previous 7 days;
• they experience severe diarrhoea;
• they do not experience withdrawal bleeding within two months or suspect they may be pregnant (they should not start the next pack without consulting their doctor). 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 situations in which the patient should not have sexual intercourse or should use additional contraceptive methods, such as condoms or other barrier methods. The calendar method and the temperature method cannot be used because 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 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 usually starts 2-3 days after taking the last tablet and may continue 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.

• Using Logest for the first time If the patient did not use 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 method of contraception for the first 7 days of tablet use.
If the patient used another combined oral contraceptive previously
The patient should start using 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 used a progestogen-only tablet (minipill) previously
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 method of contraception (barrier methods).
If the patient used injectable, implant, or intrauterine contraception previously

• 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 should start taking the tablets 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 use. If the patient has had sexual intercourse before starting to use 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 yet started their periods but have taken the medication by mistake.
There have been no reports of serious side effects after taking multiple Logest tablets at the same time. If 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. The doctor will recommend another contraceptive method.
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. 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 pregnancy 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 consult 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 then take the next tablets at the usual time. For the next 7 days, the patient should use an additional method of contraception (barrier 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 inform their doctor as soon as possible.

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 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 one tablet, they should use an additional (mechanical) method of contraception 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 7 days preceding the missed dose. If not, the patient should follow the first of the two options below and use an additional method of contraception 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 then take the next tablets at the usual time. The patient should start the next pack of tablets immediately after finishing the current one, without the usual 7-day break. Withdrawal bleeding will occur after finishing the second pack, but the patient may experience spotting or bleeding during tablet use.
• 2. The patient can also stop taking the tablets from the current pack and have a 7-day or shorter break (including the day the tablet was missed), after which they can 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, it is possible that they are pregnant. Before starting the next pack of Logest, the patient should consult their doctor.

4. Possible side effects

Like any medicine, 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 developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to point 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 a doctor immediately.

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:
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 multiforme, erythema nodosum.
• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke symptoms, known as transient ischemic attack o 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 point 2 for more information on risk factors for developing blood clots and symptoms of blood clots).

Description of selected side effects

The following very rare side effects or side effects with delayed symptoms are related to the use of combined oral contraception (see "When not to use the Logest drug" and "Warnings and precautions"):
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 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 during the use of oral contraceptives).
• Hypertension.
• Occurrence or worsening of conditions for which a 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 occurring during pregnancy), hearing loss associated with otosclerosis, cervical cancer.
• In women with hereditary angioedema (characterized by swelling of the eyes, lips, throat, etc.), exogenous estrogens may cause or worsen symptoms of this disease.
• 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 or worsen symptoms of this disease.
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 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 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 package. The expiration date indicates the last day of the given month.
Drugs should not be thrown into 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 (0.020 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 wax.

What the Logest drug looks like and what the package contains

White, round, sugar-coated tablet.
The sugar-coated tablets of the Logest drug are packaged in blisters. The blisters are placed in a cardboard box.
A cardboard sachet is attached to the package, in which the blister should be placed.
Package 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 Belgium, the country of export:

Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium

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
Belgian marketing authorization number:BE174124
Parallel import authorization number:298/17
Translation of the day of the week symbols on the packaging:
ZON, DIM, SON– Sunday
MAA, LUN, MON– Monday
DIN, MAR, DIE– Tuesday
WOE, MER, MIT– Wednesday
DON, JEU, DON– Thursday
VRI, VEN, FRE– Friday
ZAT, SAM, SAM– Saturday.
Leaflet approval date: 07.09.2022
[Information about the trademark]