Logest

Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Logest (Meliane)
0.075 mg + 0.02 mg, coated tablets
Gestodenum + Ethinylestradiolum
Logest and Meliane are different brand names of the same medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "BLOOD CLOTS").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that it can be read again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed strictly for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Logest is and what it is used for
2. Important information before taking Logest
3. How to take Logest
4. Possible side effects
5. How to store Logest
6. Contents of the pack and other information

1. What Logest is and what it is used for

Logest is a combined oral contraceptive used to prevent pregnancy.
Each tablet contains a small amount of two different hormones: gestodene (a progestogen) and
ethinylestradiol (an oestrogen). Due to its low hormone content, Logest is classified as a low-dose medicine.
Oral contraception is a highly effective method of preventing pregnancy. When oral hormonal contraceptives are used correctly, 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 particularly important to be aware of the symptoms
of blood clots (see section 2 "BLOOD CLOTS").
Do not use Logest if you have any of the conditions listed below. If you have any of the conditions
listed below, inform your doctor. Your doctor will discuss with you which alternative method of
contraception may be more suitable.
Logest, like other oral contraceptive medicines, does not protect against infection with the
HIV virus (AIDS) or sexually transmitted diseases.

When not to use Logest
Do not use Logest if you have any of the following conditions. If you have any of the conditions
listed below, inform your doctor. Your doctor will discuss with you which alternative method of
contraception may be more suitable.
When not to use Logest:

• if you are allergic to ethinylestradiol or gestodene or any of the ingredients of Logest;
• if you currently have (or have ever had) a blood clot in a vein of your leg (deep vein thrombosis), in your lungs (pulmonary embolism), or in another organ;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section 2 "BLOOD CLOTS");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinaemia
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you have had or currently have pancreatitis with elevated triglyceride (fat) levels in the blood;
• if you have had or currently have severe liver disease (until liver function tests return to normal);
• if you have had or currently have benign or malignant liver tumours;
• if you currently have or have had hormone-dependent cancer (e.g. breast or genital organ cancer);
• if you have unexplained vaginal bleeding;
• if pregnancy has been confirmed or is suspected.

Do not use Logest if you have hepatitis C and are taking antiviral medicines containing
ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir
with velpatasvir and voxilaprevir (see also section "Logest with other medicines").

Warnings and precautions
Before starting to use Logest, discuss this with your doctor or pharmacist.
When should you contact your doctor?
Seek immediate medical advice if:

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

Special and regular medical monitoring is required if you use Logest in any of the following
situations.
Tell your doctor if you have any of the following conditions.
In certain situations, particular caution is required when using Logest or any other combined oral
contraceptive. Regular check-ups by your doctor may also be necessary. Inform your doctor if you
have any of the conditions listed below before starting Logest. If any of these conditions develop
or worsen during treatment with Logest, inform your doctor immediately.

• if you smoke,
• if you have diabetes,
• if you are obese,
• if you have high blood pressure,
• if you have heart valve disorders or heart rhythm disturbances,
• if you have inflammation of veins under the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if there have been cases of thrombosis, heart attack or stroke in close family members,
• if you have migraines,
• if you have epilepsy,
• if you have elevated blood fat levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis,
• if you have a personal or family history of breast cancer,
• if you have liver or gallbladder disease,
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• if you have polycystic ovary syndrome,
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system),
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure),
• if you have sickle cell anaemia (an inherited red blood cell disorder),
• if you require surgery or will be immobile for a prolonged period (see section 2 "BLOOD CLOTS"),
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Logest,
• if you have a condition that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham's chorea),
• if you have or have ever had skin pigmentation disorders (yellow-brown pigment changes, so-called chloasma); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation,
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, possibly causing breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Logest is associated with an increased risk of
blood clots compared to not using such medicines. In rare cases, a blood clot may block a blood
vessel and cause serious problems.
Blood clots may occur:

• in veins (referred to as "venous thromboembolism" or "venous thromboembolic disease"),
• in arteries (referred to as "arterial thromboembolism" or "arterial thromboembolic events").

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood
clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with the use of Logest is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg and/or swelling along a vein in the leg or foot, especially if accompanied by: Deep vein thrombosis

• pain or tenderness in the leg, which may occur only when standing or walking,

• increased warmth in the affected leg,

• change in skin colour of the leg, such as pallor, redness or blueness.

• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism

• sudden cough without obvious cause, possibly accompanied by coughing up blood;

• sharp chest pain, which may worsen on deep breathing;

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe stomach pain. If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

Symptoms most commonly affecting one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision, or

• painless visual disturbances, which may progress to vision loss.

• chest pain, discomfort, pressure, heaviness; Myocardial infarction

• sensation of tightness or fullness in the chest, arm or below the breastbone;

• feeling of fullness, indigestion or choking;

• discomfort in the lower part of the body radiating to the back, jaw, throat, arm or stomach;

• sweating, nausea, vomiting or dizziness;

• extreme weakness, anxiety or shortness of breath;

• rapid or irregular heartbeat.

VENOUS BLOOD CLOTS
What can happen if blood clots form in the veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Logest, the risk of blood clots returns to normal within a few weeks.

What does the risk of venous blood clots depend on?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs while using Logest is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Logest, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots," below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Logest is small, but certain factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have inherited clotting disorders;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Logest several weeks before surgery or immobilization. If the patient must stop taking Logest, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of developing 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 listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Logest.
Inform the doctor if any of the above conditions change during treatment with Logest, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences, such as myocardial infarction (heart attack) or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Logest is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Logest, smoking should be avoided. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high blood lipid levels (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Logest, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
If symptoms suggesting thrombosis occur, stop taking the tablets and consult a doctor immediately (see also “When to contact the doctor”).

Logest and cancer
Breast cancer occurs slightly more frequently in women who take oral contraceptives than in women of the same age who do not. It is not known whether this difference is solely due to the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception undergo more frequent medical examinations, leading to earlier detection of breast cancer. This difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Rare cases of benign and, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives. These tumours have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, contact a doctor immediately.

There have been reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be directly related to taking the pills, but rather to sexual behaviour or other factors.

Psychiatric disorders
Some women using hormonal contraceptives, including Logest, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

Logest and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.

Some medicines may affect the blood concentration of Logest and may reduce its effectiveness. These include medicines used to treat: epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (e.g. rifampicin), HIV/HCV infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole), bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin), heart disease and high blood pressure (calcium channel blockers such as verapamil, diltiazem), inflammation and joint degeneration (etoricoxib), other infections (e.g. griseofulvin), as well as products containing St John’s wort (Hypericum perforatum), commonly used for depressive mood, and grapefruit juice.

Oral contraceptives may affect the metabolism of other medicines, leading to increased (e.g. cyclosporine) or decreased (e.g. lamotrigine) plasma and tissue concentrations.

Logest may also affect melatonin, midazolam, theophylline, and tizanidine.

Do not use Logest if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause abnormal liver function test results (increased liver enzyme activity AlAT). The doctor will recommend another form of contraception before starting these antiviral treatments. Logest may be resumed approximately 2 weeks after completing antiviral treatment. See section “When not to use Logest”.

Note: Read the package leaflets of other medicines being used to identify possible interactions.

Logest with food and drink
Logest may be taken with or without food. If needed, the tablet may be taken with water.
Do not take Logest with grapefruit juice.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Logest must not be used during pregnancy. If the patient becomes pregnant while taking Logest, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Logest at any time (see section: “Stopping Logest”).

Breastfeeding
Logest is generally not recommended during breastfeeding. If the patient wishes to use contraceptive tablets while breastfeeding, she should consult her doctor.

Driving and using machines
No effects of Logest on the ability to drive or operate machinery have been observed.

Logest contains monohydrate lactose (37.16 mg) and sucrose (19.66 mg).
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

When to contact the doctor
Contact the doctor immediately if:

• any worrying changes in health occur, particularly any of the symptoms listed above as requiring special caution;
• there is a history of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• other medicines are to be used (see also “Logest and other medicines”);
• immobilization or planned surgery is expected (inform the doctor at least 4 weeks in advance);
• there is heavy vaginal bleeding;
• tablets are missed in the first week of the cycle (each first week of consecutive months of Logest use), and sexual intercourse occurred in the preceding 7 days;
• acute diarrhoea occurs;
• withdrawal bleeding does not occur in two consecutive months, or pregnancy is suspected (do not start the next pack without consulting a doctor).

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

3. How to take Logest

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Logest or in which its effectiveness may be reduced. It also specifies circumstances when sexual intercourse should be avoided or additional contraceptive methods (e.g. condoms or other mechanical methods) should be used. The calendar method and temperature measurement method are not suitable, because Logest affects body temperature changes and cervical mucus properties characteristic of the menstrual cycle.

How to take Logest tablets

• When and how should the tablets be taken?
  The blister pack contains 21 coated tablets. Each tablet is marked on the packaging with the day of the week it should be taken (see “Explanation of symbols for days of the week on the immediate packaging” in section 6 at the end of this leaflet). Tablets should be taken in the order indicated on the pack, every day at approximately the same time, swallowed with a small amount of liquid if necessary. One tablet should be taken daily for 21 consecutive days. 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 into the beginning of the next pack. This means that each new pack should always be started on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.

• Starting Logest for the first time

If no oral hormonal contraceptives have been used in the past month
Tablet intake should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual bleeding). Tablets may also be started between day 2 and day 5 of the cycle; in this case, an additional mechanical contraceptive method should be used during the first 7 days of tablet intake in the first cycle.

If previously using another combined oral contraceptive
It is recommended to start taking Logest on the first day after taking the last active tablet of the previous combined oral contraceptive, but no later than the first day after the usual tablet-free or placebo interval of the previous combined oral contraceptive.

If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill on any day and instead start taking Logest at the same time. If sexual intercourse occurs during the first 7 days of taking Logest, an additional contraceptive method (mechanical method) should be used simultaneously.

If previously using injectable, implant, or intrauterine hormonal contraception releasing progestogen
Start taking Logest on the day the next injection would have been given, or on the day of implant or device removal. If sexual intercourse occurs during the first 7 days of tablet intake, an additional contraceptive method (mechanical method) should be used simultaneously.

After childbirth, miscarriage, or induced abortion

• After a first-trimester miscarriage
  Logest may be started immediately. In this case, additional contraceptive methods are not necessary.

• After childbirth or second-trimester miscarriage
  Your doctor will advise you to start taking tablets between 21 and 28 days after childbirth or second-trimester miscarriage. If starting later, your doctor will advise using an additional mechanical contraceptive method for the first 7 days of tablet intake. Before starting the combined oral contraceptive, ensure that you are not pregnant, either by confirming the absence of pregnancy or waiting for the onset of the first natural menstrual bleeding.

Taking more than the recommended dose of Logest
Symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken the medicine. There are no reports of severe adverse effects after taking multiple tablets of Logest at once. If you have taken more than the recommended dose or someone else has taken the medicine, inform your doctor immediately.

Stopping Logest
The medicine may be discontinued at any time. Your doctor will then suggest alternative contraceptive methods.
If you stop taking Logest because you wish to become pregnant, wait until the onset of natural menstruation. This will help determine the expected date of delivery. If you have any doubts about using this medicine, consult your doctor or pharmacist.

Missed dose of Logest

If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Logest is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.

If more than 12 hours have passed since the missed tablet, the effectiveness of Logest may be reduced. The more consecutive tablets missed, the higher the risk of reduced contraceptive protection. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. In such cases, follow the rules below (see also the chart below).

More than one tablet missed from the pack
Consult your doctor.

One tablet missed during the 1st week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the next tablets at the usual time. Use additional contraceptive methods (mechanical methods) for the next 7 days.
If sexual intercourse occurred in the week before the missed tablet, pregnancy is possible. Inform your doctor immediately.

One tablet missed during the 2nd week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the next tablets at the usual time. The contraceptive effectiveness of Logest is maintained, and additional contraceptive methods are not necessary. However, if previous dosing errors occurred or more than one tablet was missed, use an additional (mechanical) contraceptive method for 7 days.

One tablet missed during the 3rd week of the current pack
You may choose one of the following options without needing additional contraceptive methods, provided that correct dosing was followed during the 7 days preceding the missed dose. Otherwise, follow the first of the two options below and use an additional contraceptive method for the next 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time) and continue taking the next tablets at the usual time. Start the next pack immediately after finishing the current one, i.e. without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but spotting or bleeding may occur during tablet intake.

2. Alternatively, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue with the next pack.

If you forget to take tablets and do not have expected bleeding during the first tablet-free interval, pregnancy may have occurred. Contact your doctor before starting the next pack.

Missed tablet management chart

In the event of:

• Gastrointestinal disturbances (vomiting)
  If vomiting occurs, the active substances in Logest may not be fully absorbed. If vomiting occurs within 3 to 4 hours after taking a tablet, follow the recommendations for a missed tablet. In case of severe gastrointestinal disturbances, use additional contraceptive methods.

• Desire to delay the onset of bleeding
  To delay bleeding, start the next pack immediately after finishing the current one, without a 7-day break. Tablets may be taken continuously until the pack is finished. If you wish for bleeding to occur, simply stop taking tablets. During intake of the next pack, slight bleeding or spotting may occur. The following pack should be started after a 7-day break.

• Desire to change the day of bleeding to another day of the week
  If tablets are taken as directed, bleeding occurs approximately on the same day every 4 weeks. To change the bleeding day to another day of the week, shorten the next tablet-free interval by the number of days you wish to shift the bleeding. For example, if bleeding usually starts on Fridays and you wish it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during the break. Slight bleeding or spotting may occur during the next pack.

• Unexpected bleeding
  During the first few months of taking Logest, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur. Despite this, continue taking the tablets as prescribed. Irregular vaginal bleeding usually resolves after 3 cycles of Logest use. If bleeding persists, becomes heavy, or recurs, inform your doctor.

• Absence of bleeding
  If all tablets were taken on time, there were no vomiting or severe diarrhoea, and no other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking Logest as usual. If menstrual bleeding does not occur for two consecutive months, pregnancy is possible. Inform your doctor immediately. Do not start the next pack of Logest until your doctor has ruled out pregnancy.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status which the patient considers to be related to the use of Logest, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Logest".
Serious adverse effects
Serious adverse effects associated with taking Logest and their accompanying symptoms are described in the following sections of this leaflet: "BLOOD CLOTS" / "Logest and cancer". Please read these sections for additional information and consult your doctor immediately if necessary.
Contact your doctor immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, which may cause breathing difficulties (see also section "Warnings and precautions").
Other possible adverse effects
The symptoms listed below have been reported by patients taking Logest, although they may not necessarily have been caused by the medicine.
Common (more than 1 in 100 people):

• nausea, abdominal pain,
• weight gain,
• headache,
• mood changes, depressive mood,
• breast pain, breast tenderness.

Uncommon (more than 1 in 1,000 people and less than 1 in 100 people):

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

Rare (less than 1 in 1,000 people):

• hypersensitivity,
• intolerance to contact lenses,
• weight loss,
• increased libido,
• vaginal discharge, galactorrhoea,
• nodular erythema, 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)
  • myocardial infarction
  • stroke
  • mini-stroke or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach and intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).
Description of selected adverse effects
Below are very rare adverse effects or those with delayed onset associated with the use of combined oral contraceptives (see section "When not to use Logest" and "Warnings and precautions"):

Neoplasms

• The incidence of breast cancer is slightly higher in women using oral contraceptives. As breast cancer is rare in women under 40 years of age, the overall risk remains low. A causal relationship with the use of combined oral contraceptive products has not been established.
• Liver tumours (benign and malignant).

Other clinical conditions

• Women with inherited hypertriglyceridaemia (increased risk of pancreatitis during use of oral contraceptives).
• Hypertension.
• Occurrence or worsening of conditions for which a causal relationship with oral contraceptive use has not been confirmed: jaundice and/or pruritus associated with cholestasis, gallstones, a metabolic disorder called porphyria, systemic lupus erythematosus (an autoimmune disease), haemolytic uraemic syndrome, Sydenham's chorea (a neurological disorder), herpes gestationis (a skin condition occurring during pregnancy), hearing loss associated with otosclerosis, cervical cancer.
• Disorders of liver function.
• Combined oral contraceptives may affect insulin resistance and glucose tolerance.
• Crohn's disease and ulcerative colitis.
• Common cold.

In women with hereditary angioedema, exogenous estrogens may cause the onset or worsening of symptoms.
Other adverse effects may occur in some individuals during treatment with Logest.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Logest

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Logest contains
The active substances are gestodene (0.075 mg) and ethinylestradiol (0.02 mg).
Other components of the medicine are:
Core: monohydrate lactose, corn starch, povidone 25 000, magnesium stearate.
Coating: sucrose, povidone 700 000, macrogol 6000, calcium carbonate, talc, montanoglycol wax.

What Logest looks like and contents of the pack
White, round coated tablet.
Logest coated tablets are packed in blisters. The blisters are placed in a cardboard box.
A cardboard sachet is included in the package, in which the blister should be stored.

Pack sizes:
1 x 21 coated tablets
3 x 21 coated tablets

For more detailed information, please consult your doctor, the marketing authorisation holder, or the parallel importer.

Marketing Authorisation Holder in Belgium, country of export:
Bayer SA-NV, Jan Mommaertslaan 14, 1831 Diegem (Machelen), Belgium

Manufacturer:
Bayer AG, Müllerstrasse 178, 13353 Berlin, Germany

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

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

Belgium, country of export, marketing authorisation number: BE174124
Parallel import authorisation number: 267/24

Translation of the weekday symbols printed next to each tablet on the immediate packaging
MAA, LUN, MON - Monday
DIN, AR, DIE - Tuesday
WOE, MER, MIT - Wednesday
DON, JEU, DON - Thursday
VRI, VEN, FRE - Friday
ZAT, SAM, SAM - Saturday
ZON, DIM, SON - Sunday