Logest

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language
Logest (Minigeste)
0.075 mg + 0.02 mg, coated tablets
Gestodenum + Ethinylestradiolum
Logest and Minigeste are different trade names for the same medicinal product.
Important information about combined hormonal contraceptives

• When used correctly, they are among the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing 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 your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

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

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms appear similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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 any of the conditions listed below apply to you. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative contraceptive method 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 any of the following conditions apply to you. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable.
When not to 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 your blood vessels; in the deep 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 are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a myocardial infarction (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 currently have or have previously had a hormone-dependent cancer (e.g. breast cancer 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 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 events, see "How to recognize a blood clot". If you are taking Logest under any of the circumstances listed below, close and regular medical monitoring 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 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 superficial thrombophlebitis (inflammation of veins under the skin), or 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 (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 disorder of red blood cells),
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots"),
• if you have recently given birth, as you are 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, herpes gestationis, Sydenham's chorea),
• if you have developed or have previously developed skin pigmentation (yellow-brown discolouration, 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 that may cause 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 contraception. 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 events")

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
It should be remembered that the overall risk of harmful blood clots caused by using Logest is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling in one or both legs, and/or swelling along a vein in the leg or foot, 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 discolouration

BLOOD CLOTS IN VEINS
What could happen if blood clots form in 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 taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different medicine) 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?
The risk depends on a woman’s 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 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 medical history of the woman (see “Factors that increase the risk of blood clots”, below).

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

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs or other organs at a young age (e.g. below 50 years of age). In such case, the patient may have an inherited clotting disorder;
• if the patient requires 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 immobilization. If the patient needs to stop taking Logest, ask the doctor when it is safe to restart the medication.
• with increasing age (especially above 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, particularly if the patient has another mentioned risk factor. 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 relative 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 may 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 myocardial infarction or stroke associated with the use of Logest is very low, but it may increase:

• with age (above approximately 35 years);
• if the patient smokes cigarettes. While 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 relative has had myocardial infarction or stroke at a young age (below 50 years). In this case, the patient may also be at increased risk of myocardial infarction 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, 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 is particularly severe, the risk of developing blood clots may be further increased. Inform the doctor if any of the above conditions change during treatment with Logest, e.g. the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or 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 use 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 the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception undergo more frequent examinations, 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 and, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, contact a doctor as soon as possible.
There are 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 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 a doctor as soon as possible for further medical advice.

Logest and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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 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 degenerative joint diseases (etoricoxib), other infections (e.g. griseofulvin), as well as products containing St John's wort (Hypericum perforatum), used mainly for 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 AlAT activity). The doctor will recommend another type of contraception before starting these medicines. Logest may be restarted approximately 2 weeks after completing treatment. See section "When not to take 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 breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 "Discontinuing Logest").
Breast-feeding
Logest is generally not recommended while breast-feeding. If the patient wishes to use contraceptive tablets during breast-feeding, 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 and sucrose
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:

• 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 is possible or surgery is planned (inform the doctor at least 4 weeks in advance);
• heavy vaginal bleeding occurs;
• tablets are missed in the first week of the cycle (each first week of consecutive months of Logest use) and intercourse occurred in the preceding 7 days;
• severe 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 use Logest

This medicine should always be taken according to the doctor's instructions. 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 describes 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 should 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 on the pack with the symbol of the day of the week on which it should be taken (see: "Translation of day-of-the-week symbols on the immediate packaging" at the end of this leaflet). Tablets should 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 begins 2–3 days after taking the last tablet and may continue into the start 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 contraceptives have been taken in the past month
Tablets should be started on the first day of the natural menstrual cycle (i.e. the first day of menstrual bleeding). Alternatively, tablets may be started between days 2 and 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. However, this should not be later than the first day 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 of day. 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 contraception, implant, or transdermal therapeutic system releasing progestogen
Start taking Logest on the day the next injection would have been due, or on the day of removal of the implant or system. If sexual intercourse occurs during the first 7 days of taking the tablets, 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 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 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, ensure that pregnancy has not occurred, or wait until the first natural menstrual period occurs.

Taking more Logest than recommended
Symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet reached menarche but have accidentally taken the medicine. There are no reports of severe adverse effects after taking multiple tablets of Logest at once. If more than the recommended dose has been taken, or if 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 your 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 has 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 has 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 in 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 following 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 be possible. Inform your doctor immediately.

One tablet missed in 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 following 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 in the 3rd week 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 prior to the missed tablet. 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 following tablets at the usual time. Start the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but spotting or breakthrough 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 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

Instructions in the following situations:

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

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

• Desire to change the day of the week when withdrawal bleeding occurs
  When taking tablets as directed, withdrawal bleeding usually occurs approximately on the same day every 4 weeks. To change the day of the week when bleeding occurs, shorten the next tablet-free interval by as many days as you wish to shift the timing of the bleeding.
  For example, if bleeding usually starts on Fridays and you wish it to start on Tuesdays (3 days earlier), begin 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 period. Light bleeding or spotting may occur during the use of the next pack.

• Occurrence of 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 withdrawal bleeding
  If all tablets have been taken correctly at the right time, without vomiting, severe diarrhea, or concomitant use of other medications, the likelihood of pregnancy is very low. Continue taking Logest as scheduled.

If withdrawal bleeding does not occur in two consecutive cycles, pregnancy is possible. Immediately inform your doctor. Do not start the next pack of Logest until pregnancy has been ruled out by a physician.

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 to be related to the use of Logest, medical advice should be sought from a doctor.
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, please refer to section 2, "Important information before taking Logest".
Serious adverse reactions
Serious adverse reactions associated with the use of Logest and their accompanying symptoms are described in the following sections of this leaflet: "Blood clots" / "Logest and cancer". Please read these sections for further information and consult your doctor immediately if necessary.
You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, possibly causing difficulty breathing (see also section "Warnings and precautions").
Other possible adverse reactions
The symptoms listed below have been reported by patients taking Logest, although they may not 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, known as transient ischaemic attack o blood clots in the liver, stomach and intestines, kidneys or eyes

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 reactions
Below are very rare adverse reactions or those with delayed onset associated with the use of combined oral contraception (see section "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 in relation to the general risk of breast cancer. A causal relationship with the use of combined oral contraceptive products is unknown.
• Liver tumours (benign and malignant).

Other clinical conditions

• Women with increased hypertriglyceridaemia (increased risk of pancreatitis during use of oral contraceptives).

• Hypertension.

• Occurrence or worsening of conditions for which a causal relationship with the use of oral contraceptives 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 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 to provide more information on the safety of the 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 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. These measures will help protect the environment.

6. Contents of the packaging 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, 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 tablets.
Logest coated tablets are packed in PVC/Aluminium blisters within a cardboard box.
Pack sizes:
1x21 coated tablets
3x21 coated tablets

For further detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Portugal, country of export:
Bayer Portugal, Lda.
Avenida Vitor Figueiredo nº4- º 4 floor
2790-255 Carnaxide
Portugal

Manufacturer:
Bayer A.G.
Muellerstrasse, 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
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation number in Portugal, country of export:
Parallel import authorisation number: 86/24

Translation of weekday symbols on the immediate packaging:
SEG - Monday
TER - Tuesday
QUA - Wednesday
QUI - Thursday
SEX - Friday
SÁB - Saturday
DOM - Sunday