Logest

Warning! Keep the 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 brand names of the same medicinal product.
Important information about combined hormonal contraceptives

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

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

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms appear identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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 become familiar with 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 alternative 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 alternative method of contraception may be more suitable.

Do not use Logest:

• if you are allergic to ethinylestradiol or gestodene or any of the ingredients of Logest;
• if you currently have (or have ever had) a blood clot in 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 previously had) 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 hyperhomocysteinaemia
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you have previously had or currently have pancreatitis associated with elevated triglyceride (fat) levels in the blood;
• if you have previously had or currently have severe liver disease (until liver function tests return to normal);
• if you have previously had or currently have benign or malignant liver tumours;
• if you currently have or have previously had a hormone-dependent cancer (e.g. breast or genital organ cancer);
• if you have unexplained vaginal bleeding;
• if pregnancy is confirmed or 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 and 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 blood clots, 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 the symptoms of these serious adverse effects, see "HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS".

Special and regular medical supervision is required if you use Logest in any of the following situations.
Tell your doctor if you have any of the following conditions.
Particular 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 if you have any of the following conditions before starting Logest. 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 abnormalities,
• 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 (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 natural defence system),
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure),
• if you have sickle cell anaemia (an inherited red blood cell disorder),
• if you require surgery or will be immobile for a prolonged period (see section 2 "BLOOD CLOTS"),
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Logest,
• if you have a condition that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, herpes gestationis, Sydenham's chorea),
• if you currently have or have previously had skin pigmentation disorders (yellow-brown discoloration, so-called chloasma); in such cases, avoid excessive exposure to sunlight or ultraviolet radiation,
• if you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, which 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 increases the risk of blood clots compared to not using such medication. 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 after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with the use of Logest is low.

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

Do you experience any of these symptoms? Possible cause:

• swelling in the leg and/or swelling along a vein in the leg or foot, especially if accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may occur only when standing or walking,
• increased warmth in the affected leg,
• change in skin colour of the leg, e.g. paleness, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden cough without obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen on deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

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 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 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 taking 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 patient 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 the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with taking 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 norgestrel will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Logest, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

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

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In such cases, 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 stop taking Logest several weeks before surgery or periods of immobility. If the patient must stop taking Logest, ask the doctor when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of developing 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 present.
It is important to inform the doctor if any of the above 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 a close family member develops 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 lead to serious consequences, such as heart attack or stroke.

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

• with age (particularly over about 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Logest, smoking should be avoided. If the patient cannot stop smoking and is over 35 years old, the doctor may recommend using another form 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 such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorders 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, for example, if the patient starts smoking, a close family member develops unexplained thrombosis, or if the patient gains significant weight.
If symptoms suggestive of thrombosis occur, stop taking the tablets immediately and consult a doctor without delay (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 undergo more frequent medical examinations, leading to earlier detection of breast cancer. This difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

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

There have been reports of an increased incidence of cervical cancer in women using oral contraceptives for a long time. However, this association may not be due to the tablets themselves, 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 may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

Logest and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Some medicines may affect the blood levels of Logest and 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 blood and tissue concentrations.
Logest may also affect melatonin, midazolam, theophylline, and tizanidine.

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

Note: Always read the package leaflets of other medicines being taken 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 plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Logest must not be used during pregnancy. If pregnancy occurs while taking Logest, stop taking it immediately and consult a 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 during breast-feeding. If the patient wishes to use contraceptive tablets while breast-feeding, she should consult her doctor.

Driving and operating machinery
Logest has no known effect on the ability to drive or operate machinery.

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 a doctor immediately if:

• any worrying changes in health occur, particularly any of the symptoms listed above as requiring special caution;
• there is a history of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• other medicines are to be taken (see also “Logest and other medicines”);
• immobilization is expected 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 subsequent months of Logest use) and sexual 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 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. If in doubt, consult your doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Logest or in which its effectiveness may be reduced. It also indicates circumstances when sexual intercourse should be avoided or when additional contraceptive methods (e.g. condoms or other mechanical methods) should be used. The calendar method and temperature-based methods cannot be used, as Logest affects body temperature and cervical mucus characteristics associated with the menstrual cycle.

How to take Logest tablets

• When and how should the tablets be taken?
  The blister pack contains 21 coated tablets. Each tablet is marked with the day of the week on which it should be taken (see "Translation of weekday symbols on the immediate packaging" in section 6 at the end of this leaflet). Tablets must be taken in the order indicated on the pack, daily at approximately the same time, swallowing with a small amount of liquid if necessary. One tablet should be taken daily for 21 consecutive days. Each new 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 start of the next pack. This means that each new pack must 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 contraceptives have been used in the previous month
Tablet taking should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual bleeding). Tablets may also be started between day 2 and day 5 of the cycle; in this case, an additional mechanical contraceptive method should be used during the first cycle for 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 taking the last active tablet of the previous combined oral contraceptive, but no later than on day 1 after the usual tablet-free interval (including placebo tablets) of the previous combined oral contraceptive.

If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill on any day and start taking Logest 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 intrauterine hormonal system releasing a progestogen
Start taking Logest on the day the next injection would have been given, 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 induced abortion

• After 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, pregnancy must be ruled out or you must wait for the first natural menstrual bleeding.

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 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 recommend 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 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 protection. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of a 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 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 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 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 has been 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 preceding 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 next tablets at the usual time. Start the next pack immediately after finishing the current pack, 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 do not experience expected bleeding during the first tablet-free interval, pregnancy may have occurred. Contact your doctor before starting the next pack.

What to do if you miss a tablet – flowchart

In the following situations:

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

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

• Desire to change the day of bleeding to another day of the week
  If tablets are taken as directed, bleeding occurs approximately every 4 weeks on the same day. To shift the bleeding day, shorten the next tablet-free interval by the number of days you wish to shift the bleeding. For example, if bleeding usually starts on Fridays and you wish it to start on Tuesdays (3 days earlier), 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 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. Despite this, continue taking the tablets as prescribed. Irregular vaginal bleeding usually resolves after 3 cycles of Logest. If bleeding persists, becomes heavy, or recurs, inform your doctor.

• Absence of 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 menstrual bleeding does not occur for two consecutive months, pregnancy is possible. Inform your doctor immediately. Do not start the next pack of Logest until your doctor has ruled out pregnancy.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe or persistent ones, or any changes in health 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 various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Logest".
Serious adverse effects
Serious adverse effects associated with taking Logest and their accompanying symptoms are described in the following sections of this leaflet: "BLOOD CLOTS" / "Logest and cancer". Please read these sections for additional information and seek immediate medical advice 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 urticaria, which may cause breathing difficulties (see also section "Warnings and precautions").
Other possible adverse effects
The symptoms listed below have been reported by patients taking Logest, although they may not necessarily have been caused by the medicine.
Common (more than 1 in 100 people):

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

Uncommon (more than 1 in 1,000 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 or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach and intestines, kidneys or eye.

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

Neoplasms

• The incidence of breast cancer is slightly higher among 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 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 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 trigger or worsen symptoms.
Other adverse effects not listed here may occur in individual patients during treatment with Logest.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Logest

Keep the 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 the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Logest contains
The active substances are gestodene (0.075 mg) and ethinylestradiol (0.02 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 tablet.
Logest coated tablets are packed in PVC/Al blisters. The blisters are placed in a cardboard box.
A cardboard sachet is included in the package, in which the blister should be placed.
Pack sizes:
1 x 21 coated tablets
3 x 21 coated tablets

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

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

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

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

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

Portugal, country of export, marketing authorisation number: 2494086
Parallel import authorisation number: 287/22

Translation of the weekday symbols printed next to each tablet on the immediate packaging
SEG - Monday
TER - Tuesday
QUA - Wednesday
QUI - Thursday
SEX - Friday
SÁB - Saturday
DOM - Sunday