Logest

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate 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 for the same medicinal product.
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 blood clots in veins and arteries, particularly 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 user suspects symptoms of a blood clot (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 for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are identical.
• 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 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 preparation.
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 these conditions, 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 HIV infection (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 these conditions, inform your doctor. Your doctor will discuss with you which other method of contraception may be more suitable.

Do not use Logest:

• if you are hypersensitive to ethinylestradiol or gestodene or any of the excipients 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 blood clotting disorders—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 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 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 ever had) 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 have had or currently have a hormone-dependent cancer (e.g. breast or genital organ cancer);
• if you have unexplained vaginal bleeding;
• if you are pregnant or suspect you may be pregnant.

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 2, "Logest with other medicines").

Warnings and precautions
Before starting to use Logest, discuss this with your doctor or pharmacist.

When to contact your doctor
Seek immediate medical advice if:

• you notice possible symptoms of a blood clot, which may indicate you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section 2, "Blood clots". For a description of symptoms of these serious adverse effects, see section 2, "How to recognize blood clots".

Special and regular medical monitoring is required if you use Logest in any of the following circumstances.

Tell your doctor if you have any of the following conditions. In certain situations, special 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 before starting Logest if you have any of the following conditions. If any of these symptoms 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 problems,
• if you have inflammation of the veins under the skin (superficial thrombophlebitis),
• 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 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 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 have recently given birth, 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 discoloration (yellow-brown pigmentation 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 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 hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious problems.
Blood clots may occur:

• in veins (called "venous thrombosis" or "venous thromboembolic disease")
• in arteries (called "arterial thrombosis" or "arterial thromboembolic disease")

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 caused by using Logest is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

Do you experience any of these symptoms? What might be the likely cause?

• swelling of the leg(s) 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, e.g. paleness, redness, or blueness
• sudden unexplained shortness of breath or rapid breathing Pulmonary embolism
• sudden coughing without an obvious cause, possibly with 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 infections (e.g. cold).

Symptoms most commonly affecting one eye: Retinal vein thrombosis

• sudden vision loss or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss

VENOUS BLOOD CLOTS
What could 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 occur most frequently 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 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 developing blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the natural risk of 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 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 medical history of the woman (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Logest is small, however,
some 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 family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue the use of Logest several weeks before surgery or during immobilization. If the patient needs to 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 given birth within the last few weeks. 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, particularly 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 the use of Logest. Inform the doctor if any of the above conditions change during treatment with Logest, e.g. 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 the arteries?
As with venous blood clots, arterial clots can cause 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 small, but may increase:

• with age (over 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 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 been diagnosed with high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during
treatment with Logest, e.g. 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 section 2, "When to contact a 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 use them. It is not known whether this difference is
due solely to the use of hormonal contraceptives. The reason may also be that women using hormonal contraception are examined more frequently, leading to earlier detection of breast cancer. The described 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 tumours have been reported in women using combined oral contraceptives, which caused life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be informed as soon as possible.
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 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 low mood. Depression can be severe and 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 or recently taken, as well as any medicines you plan to take.
Some medicines may affect the blood concentration of Logest and may reduce its effectiveness.
This includes 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, e.g. clarithromycin, erythromycin), heart disease, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem), arthritis and joint degeneration (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, 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 medicines. Logest may be restarted approximately 2 weeks after stopping the treatment. See section 2, "When not to use Logest".
Note: Check 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 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 3, "Stopping 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 operating machinery
No effects of Logest on the ability to drive and operate machinery have 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 this medicine.
When to contact a doctor
Contact a doctor immediately if:

• you notice any worrying changes in your health, particularly any of the symptoms listed above as requiring special caution;
• there are cases of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• you plan to take other medicines (see also section 2, "Logest and other medicines");
• immobilization is possible or surgery is planned (inform the doctor at least 4 weeks in advance);
• you experience severe vaginal bleeding;
• you miss tablets in the first week of the cycle (each first week of consecutive months of Logest use), and had intercourse in the previous 7 days;
• you have acute diarrhoea;
• 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 use Logest

This medicine should always be taken exactly as directed by your doctor. In case of 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 in 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 cannot be used, as Logest affects changes in body temperature and cervical mucus characteristics typical of the menstrual cycle.

How to take Logest

• When and how should you take the tablets?
• The blister pack contains 21 coated tablets. Each tablet is marked on the pack with a day of the week indicating when it should be taken (see "Translation of the day symbols next to each tablet on the immediate packaging" in section 6 at the end of this leaflet). Tablets must be taken in the order indicated on the pack, every day at approximately the same time, swallowing each 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 during which withdrawal bleeding usually occurs. Bleeding usually begins 2–3 days after taking the last tablet and may continue into 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 contraceptives were taken in the previous month
Tablet intake should begin on Day 1 of the natural menstrual cycle (i.e. the first day of menstrual bleeding). Alternatively, tablets may 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 Day 1 after taking 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 regimen.

If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill on any day and start taking Logest instead 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.

If previously using a progestogen-releasing injectable, implant, or transdermal therapeutic system
Start taking Logest on the day the next injection was due, or on the day of implant or system removal. 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 abortion

• After a first-trimester miscarriage – Logest may be started immediately. In this case, additional contraceptive methods are not required.
• After childbirth or a second-trimester miscarriage – Your doctor will advise starting tablet intake between 21 and 28 days after childbirth or second-trimester miscarriage. If tablet intake is started later, your doctor will advise using an additional mechanical contraceptive method for the first 7 days of tablet intake. If sexual intercourse occurred before starting the combined oral contraceptive, pregnancy must be ruled out, or you should wait until the first natural menstrual period occurs.

Taking more Logest than recommended
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took the medicine. There are no reports of serious adverse effects after taking multiple tablets of Logest at once. If you or someone else has taken more than the recommended dose, 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 the medicine because you wish to become pregnant, wait until your next natural menstrual period occurs. This will help determine the expected date of delivery. In case of any doubts regarding the use of 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 greater the risk of reduced contraceptive effect. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of a pack. In such cases, follow the instructions below (see also the diagram below).

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

One tablet missed during 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.

One tablet missed during 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 required. 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 Week 3 of the current pack
You may choose one of the following options without needing additional contraceptive methods, provided correct dosing was maintained 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), and 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 have occurred. Contact your doctor before starting the next pack.

Missed tablet management chart

What to do in the following situations:

• 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 instructions for a missed tablet. In case of severe gastrointestinal disturbances, use additional contraceptive methods.

• Desire to delay 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 desired time. To induce bleeding, simply stop taking tablets. During intake of the next pack, slight bleeding or spotting may occur. The subsequent 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, withdrawal bleeding occurs approximately on the same day every 4 weeks. To shift 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 want 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. 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 directed. Irregular vaginal bleeding usually resolves after 3 cycles of taking Logest. 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 directed.

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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers 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 the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Logest".
Serious adverse reactions
Serious adverse reactions 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 seek immediate medical advice if necessary.
Seek immediate medical advice 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 2, "Warnings and precautions").
Other possible adverse reactions
The symptoms listed below have been reported by women 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:
  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 ischaemic attack (TIA)
  o 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 clot occurrence).
Description of selected adverse reactions
Below are very rare adverse reactions or those with delayed onset associated with the use of combined oral contraception (see section 2, "When not to take 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 small. A causal relationship with the use of combined oral contraceptives 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 immune system disorder), 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 trigger or worsen symptoms.
Other adverse reactions may occur in some individuals during treatment with Logest.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions helps provide more information on the safety of this medicine.

5. How to store Logest

Keep the medicine out of the sight and reach of children.
Store below 25°C. Protect from light.
Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information
What Logest contains
The active substances are gestodene (0.075 mg) and ethinylestradiol (0.02 mg).
Other ingredients are:
Core: monohydrate lactose, maize 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 carton.
Pack sizes:
21 coated tablets
3x21 coated tablets
For more detailed information, please contact 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 A.G.
Müllerstrasse 178
13353 Berlin
Germany

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Belgium, country of export: BE174124
Parallel import authorisation number: 99/25

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