Logest

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the outer packaging is 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 regarding 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 use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user 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 to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Logest is and what it is used for
2. What you need to know before taking Logest
3. How to take Logest
4. Possible side effects
5. How to store Logest
6. Contents of the package 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 other method of contraception may be more suitable.
Logest, like other oral contraceptives, 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 conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other method of contraception may be more suitable.
When not to use Logest:

• if you are hypersensitive to ethinylestradiol or gestodene or any of the components of Logest;
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "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 that 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 hyperhomocysteinemia;
• 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 associated 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 diagnosed 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 symptoms suggesting a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots"). For a description of symptoms of these serious adverse effects, see "How to recognize a blood clot".

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

• 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 superficial thrombophlebitis (inflammation of veins under the skin),
• if you have varicose veins,
• if there have been cases of thrombosis, heart attack, or stroke in close relatives,
• if you have migraines,
• if you have epilepsy,
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis,
• if you have or have had breast cancer in your close family,
• 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 hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure),
• if you have sickle cell anaemia (an inherited disorder of red blood cells),
• if you require surgery or will be immobile for a prolonged period (see section 2. "Blood clots"),
• if you are in the immediate postpartum period, as you are then at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Logest,
• if you have a condition that first appeared 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 changes (yellow-brown discoloration, 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 hives, 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 complications.
Blood clots may occur

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

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 A BLOOD CLOT
Seek immediate medical advice if you experience 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, Deep vein thrombosis especially if accompanied by:

• 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 bluish discoloration.

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

• sudden cough without obvious cause, possibly associated with coughing up blood;

• sharp chest pain, which may worsen with 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 infections (e.g. cold).
Symptoms most commonly occur in one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss.
• chest pain, discomfort, pressure, heaviness; Myocardial infarction

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (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 the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it can 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 developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased 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 factors influence the risk of developing blood clots in veins?
The risk depends on a woman'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 associated with the use of Logest is low.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a 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 medical history of the woman (see "Factors that increase the risk of developing 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 significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative 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 an inherited blood clotting disorder;
• 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 stop taking 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. The risk of blood clots increases with the number of risk factors present. Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor. It is important to inform the doctor if any of these factors apply, 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 an unexplained blood clot occurs in a close relative 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 cause serious consequences, such as 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 Logest use is very low, but may increase:

• with age (above approximately 35 years);

• if the patient smokes. When using a hormonal contraceptive such as Logest, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using a different type of contraception;

• if the patient is overweight;

• if the patient has high blood pressure;

• if a close relative 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 relative has high levels of blood lipids (cholesterol or triglycerides);

• if the patient suffers from migraines, particularly migraines with aura;

• if the patient has heart disease (valve disorder, heart rhythm disorder known 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 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, if an unexplained clot occurs in a close relative, or if the patient gains significant weight.
If symptoms suggestive of 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 taking oral contraceptives than in women of the same age who do not use them. It is not known whether this difference is solely due to hormonal contraceptives. It may also be due to the fact that women using hormonal contraception are examined more frequently, leading to earlier detection of breast cancer. The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which have caused life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform the doctor as soon as possible.
There are reports of increased incidence of cervical cancer in women using oral contraceptives for a long time. However, this association may not be related to taking the pills, but rather to sexual behavior or other factors.
Psychiatric disorders
Some women using hormonal contraceptives, including Logest, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.
Logest and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Some medicines may affect the blood levels 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, e.g. itraconazole, voriconazole, fluconazole), bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin), heart diseases, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem), inflammation and degenerative joint diseases (etoricoxib), other infections (e.g. griseofulvin), as well as products containing St John's wort (Hypericum perforatum), used mainly for treating depressive mood, and grapefruit juice.
Oral contraceptives may affect the metabolism of other medicines, increasing (e.g. cyclosporine) or decreasing (e.g. lamotrigine) their 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 they may cause abnormal liver function test results (increased liver enzyme activity AlAT). The doctor will recommend another type of contraception before starting these medicines. Logest may be resumed approximately 2 weeks after completing treatment. See section "When not to use Logest".
Note: Read the information in the 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 have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Logest must not be taken 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 use of Logest").
Breastfeeding
Logest is generally not recommended during breastfeeding. If the patient wishes to take contraceptive tablets while breastfeeding, she should consult her doctor.
Driving and using machines
No effect of Logest on the ability to drive and use machines has been observed.
Logest contains monohydrate lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking the medicine.
When to contact the doctor
Contact the doctor immediately if:

• worrying changes in health occur, especially 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 is expected or surgery is planned (inform the doctor at least 4 weeks in advance);
• severe vaginal bleeding occurs;
• tablets are missed in the first week of the cycle (each first week in consecutive months of Logest use) and intercourse occurred in the previous 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 the doctor's advice).

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

3. How to use Logest

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Logest or in which the effectiveness of the medicine may be reduced. It also indicates circumstances under which 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 must not be used, as Logest affects changes in body temperature and cervical mucus characteristics associated with the menstrual cycle.

How to take Logest

• When and how should the tablets be taken?

Each blister pack contains 21 coated tablets. Each tablet is marked with the day of the week on which it should be taken (see "Translation of weekday symbols next to each tablet on the primary packaging" at the end of this leaflet). Tablets must be taken in the order indicated on the pack, every day at approximately the same time, with a small amount of liquid if needed. 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 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 is recommended during the first 7 days of tablet intake.
If previously using another combined oral contraceptive
It is recommended to start taking Logest on day 1 after the last active tablet of the previous combined oral contraceptive. However, it should not be later than day 1 after the usual tablet-free or placebo interval of the previous combined oral contraceptive.
If previously using a progestogen-only pill (minipill)
You may stop taking the minipill on any day and start taking Logest at the same time instead. If sexual intercourse occurs during the first 7 days of taking Logest, an additional contraceptive method (mechanical method) should be used.
If previously using injectable, implant, or intrauterine system releasing progestogen
Start taking Logest on the day the next injection would have been administered, or on the day of removal of the implant or system. If sexual intercourse occurs during the first 7 days of tablet intake, an additional contraceptive method (mechanical method) should be used.
After childbirth, miscarriage, or induced abortion

• After first-trimester miscarriage
  Logest may be started immediately. In this case, additional contraceptive methods are not required.
• 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 tablet intake is started later, your doctor will advise using additional mechanical contraception for the first 7 days of tablet intake. If intercourse has occurred before starting the combined oral contraceptive, pregnancy should be ruled out or wait until the first natural menstrual period occurs.

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

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 next natural menstrual period occurs. 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 continue taking 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 when 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 1 tablet missed from the current pack
Consult your doctor.

1 tablet missed in week 1 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 may have occurred. Inform your doctor immediately.

1 tablet missed in week 2 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 there were previous dosing errors or more than one tablet was missed, use an additional (mechanical) contraceptive method for 7 days.

1 tablet missed in week 3 of the current pack
One of the following options may be chosen without the need for additional contraceptive methods, provided that correct dosing has been followed during the 7 days preceding the missed dose. Otherwise, apply 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 tablets from the next pack.

If you forget to take tablets and no withdrawal bleeding occurs during the first tablet-free interval, pregnancy may be possible. Contact your doctor before starting the next pack.

Missed tablet management chart
More than 1 tablet missed from current pack → Seek medical advice

Management in case of:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Logest may not be completely 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 withdrawal bleeding

To delay withdrawal 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 to have a bleed, simply stop taking tablets. During intake of the next pack, light bleeding or spotting may occur. The next pack should be started after a 7-day break.

• Desire to change the day of withdrawal bleeding to another day of the week

If tablets are taken as directed, bleeding occurs approximately every 4 weeks on the same day. To shift the bleeding day to another day of the week, shorten the next tablet-free interval by as many days as 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 this interval. Light 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. Nevertheless, 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 withdrawal bleeding

If all tablets were taken on time, there were no episodes of vomiting or severe diarrhoea, and no other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking Logest as scheduled.
If withdrawal 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 that 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 carefully for additional information and consult your doctor immediately if necessary.

Seek immediate medical attention 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 difficulty breathing (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 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,
  • transient ischaemic attack (TIA) or temporary stroke-like symptoms,
  • blood clots in the liver, stomach and intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of their occurrence).

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 sections "When not to use Logest" and "Warnings and precautions"):

Neoplasms

• The incidence of breast cancer is slightly higher in women using oral contraceptives. However, since 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 due to 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.
• Liver function disorders.
• 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 those not listed in this leaflet, inform your doctor or pharmacist. 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, phone: +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 the medicine.

5. How to store Logest

Keep this medicine out of the 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 will 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 (0.020 mg).
The other ingredients 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 pouch 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
Kouterveldstraat 7A 301
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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Belgium, country of export: BE174124
Parallel Import Licence Number: 298/17

Translation of the weekday symbols printed next to each tablet in the immediate 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