Logest

Patient Information Leaflet

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 brand names for the same medicine.

Important information about combined hormonal contraceptives

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

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please 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 are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Logest is and what it is used for

Logest is a combined oral contraceptive used to prevent pregnancy.
Each tablet contains a small amount of two different hormones: gestodene (a progestogen) and
ethinylestradiol (an oestrogen). Because of its low hormone content, Logest is classified as a low-dose medicine.
Oral contraception is a highly effective method of preventing pregnancy. When oral hormonal contraceptives are used correctly, the likelihood of becoming pregnant is very low.

2. Important information before using Logest

General notes
Before starting to take Logest, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Do not use Logest if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.
Logest, like other oral 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 the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

When not to use Logest:

• if you are 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 presence of antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have 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, which may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinemia;
• 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 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 "Logest with other medicines").

Warnings and precautions
Talk to your doctor or pharmacist before starting Logest.

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 the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). For a description of symptoms of these serious adverse effects, see "How to recognize a blood clot".

Special and regular medical supervision is required if you use Logest in any of the following circumstances.
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 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),
• if you have varicose veins,
• if there has been a history of thrombosis, heart attack, or stroke in close relatives,
• if you have migraines,
• if you have epilepsy,
• if you have high blood fat levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis.
• if you have a personal or family history of breast cancer,
• if you have liver or gallbladder disease,
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• if you have polycystic ovary syndrome,
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system),
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure),
• if you have sickle cell anaemia (an inherited 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 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 occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham's chorea),
• if you have or have previously had skin pigmentation disorders (yellow-brown pigment changes, 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 urticaria, possibly causing breathing difficulties – seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Logest is associated with an increased risk of blood clots compared to not using such 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 A BLOOD CLOT
Seek immediate medical advice if you experience any of the following symptoms.

Do you experience any of these symptoms?
Likely cause?

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

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

• increased warmth in the affected leg;

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

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

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

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

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe abdominal pain.

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

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

• sudden loss of vision or

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

• chest pain, discomfort, pressure, or heaviness;
  Myocardial infarction (heart attack)

• squeezing or fullness in the chest, arm, or below the breastbone;

• feeling of fullness, indigestion, or choking;

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

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to 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 woman stops taking Logest, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual'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 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 who are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Logest, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of 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 relative of the patient has had 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, if she is immobilised 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 immobilisation. If the patient needs to stop taking Logest, she should ask her doctor when she can restart taking the medicine.
• with increasing age (particularly over the age of 35);
• if the patient has recently 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, especially if the patient has another risk factor listed above. It is important to inform the doctor if any of the listed factors apply to the patient, even if she is uncertain. The doctor may decide to discontinue the use of Logest. The patient should inform her 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 the arteries?
As with venous blood clots, arterial blood 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 myocardial infarction or stroke associated with the use of
Logest is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Logest, 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 (under 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, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is
particularly severe, the risk of blood clots may be further increased. The patient should
inform her doctor if any of the above conditions change during treatment with
Logest, e.g. if she starts smoking, if a close relative is diagnosed with unexplained
thrombosis, or if she gains significant weight.
If symptoms suggestive of thrombosis occur, the patient should stop taking the tablets
and consult her doctor immediately (see also "When to contact the doctor").
Logest and cancer
Breast cancer occurs slightly more frequently in women who take oral contraceptives
than in women of the same age who do not use them. It is not known whether this difference is
due solely to the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception are examined more frequently and breast cancer is detected earlier.
The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.
Rare cases of benign or, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives, which have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the patient should inform her doctor as soon as possible.
There have been reports of an 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, the patient should contact her doctor as soon as possible for further medical advice.
Logest and other medicines
The patient should inform her doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Some medicines may affect the blood levels of Logest and may reduce its effectiveness.
These include medicines used to treat: epilepsy (e.g. primidone, phenytoin, barbiturates,
carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (e.g. rifampicin), HIV/HCV infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole), bacterial infections (macrolide antibiotics e.g. clarithromycin, erythromycin), heart disease, high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem), inflammation and degeneration of joints (etoricoxib), other infectious diseases (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, causing their plasma and tissue concentrations to increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).
Logest may also affect: melatonin, midazolam, theophylline, tizanidine.
Logest should not be used 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 activity of liver enzymes AlAT). The doctor will recommend another type of contraception before starting these medicines. Logest may be restarted approximately 2 weeks after stopping the treatment. See section "When not to use Logest".
Note: The patient should 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.
Logest should not be taken simultaneously 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 her doctor or pharmacist before using this medicine.
Pregnancy
Pregnant women must not take Logest. If the patient becomes pregnant while taking Logest, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Logest at any time (see section: "Stopping Logest").
Breast-feeding
Logest is generally not recommended during breast-feeding. If the patient wishes to take contraceptive tablets while breast-feeding, she should consult her doctor.
Driving and using machines
No effect of Logest on the ability to drive and use machines has been observed.
Logest contains monohydrate lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking the medicine.
When to contact the doctor
The patient should contact her doctor immediately if:

• she notices any worrying changes in her health, particularly any of the symptoms listed above as requiring special caution;
• there have been cases of thrombosis, heart attack or stroke in close relatives;
• a breast lump is detected;
• she plans to take other medicines (see also "Logest and other medicines");
• immobilisation is expected or a surgical procedure is planned (the doctor should be informed at least 4 weeks in advance);
• she experiences heavy vaginal bleeding;
• she misses tablets in the first week of the cycle (each first week of subsequent months of taking Logest) and had intercourse in the previous 7 days;
• she has acute diarrhoea;
• withdrawal bleeding does not occur in two consecutive months or if she suspects she is pregnant (do not start the next pack without the doctor's advice).

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

3. How to use Logest

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

How to take Logest

• When and how should the tablets be taken?

Each blister pack contains 21 coated tablets. Each tablet is marked with the day of the week on which it should be taken (see "Translation of symbols indicating days of the week 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, swallowed 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 typically 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 bleeding will generally occur around the same days each month.

• First-time use of Logest

If no oral hormonal contraceptives were used in the previous month
Tablet intake should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual bleeding). Tablets may also be started between day 2 and day 5 of the cycle; in this case, during the first cycle, an additional mechanical contraceptive method is recommended 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 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 discontinue 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, another contraceptive method (mechanical method) should be used simultaneously.
If previously using injectable, implant, or intrauterine hormonal contraception releasing progestogen
Logest should be started 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, another contraceptive method (mechanical method) should be used simultaneously.
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 intercourse occurred before starting the combined oral contraceptive, pregnancy must be ruled out or you must wait until the first natural menstrual bleed occurs.

Overdose of Logest
Symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took the medicine. There are no reports of severe 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
You may discontinue the medicine at any time. Your doctor will then recommend alternative contraceptive methods. If you stop taking Logest because you wish to become pregnant, wait until the next natural menstrual period occurs. This will help determine the expected date of delivery. If you have any doubts about using this medicine, consult your doctor or pharmacist.

Missed dose of Logest
If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Logest is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.
If more than 12 hours have passed since the missed tablet, the effectiveness of Logest may be reduced. The more consecutive tablets missed, the higher the risk of reduced contraceptive protection. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. In such cases, follow the instructions below (see also the chart below).

More than 1 tablet missed from the current pack
Consult your doctor.

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

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

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

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. Start the next pack immediately after finishing the current one, 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, discontinue taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue with tablets from the next pack.

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

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

Management in case of:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Logest may not be fully 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.

Sexual intercourse occurred
in the week preceding
the missed tablet
No – Yes

Week 1

• Take the missed tablet
• Use additional contraception for 7 days
• Finish the pack

One tablet missed (delay
greater than 12 hours,
but less than 24 hours)
Week 2

• Take the missed tablet
• Finish the pack

Week 3

• Take the missed tablet
• Continue with the next pack without a 7-day break
  OR
• Discard remaining tablets in the pack
• Take a break (no longer than 7 days, including the day of the missed tablet)
• Continue with the next pack

• Delaying the onset of withdrawal bleeding

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

• Changing the day of the week on which bleeding occurs

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

• Absence of bleeding

If all tablets were taken on time, there were no 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 cycles, pregnancy is possible. Inform your doctor immediately. Do not start the next pack of Logest until your doctor has ruled out pregnancy.

4. Possible adverse effects

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

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

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

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

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

• hypersensitivity,
• intolerance to contact lenses,
• weight loss,
• increased libido,
• vaginal discharge, galactorrhoea,
• nodular erythema, erythema multiforme.
• harmful blood clots in a vein or artery, for example: 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 intestine, 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 their occurrence).
Description of selected adverse effects
Below are very rare adverse effects or those with delayed onset associated with the use of combined oral contraception (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. Since breast cancer is rare in women under 40 years of age, the overall risk remains low.

• The causal relationship with combined oral contraceptive products is unknown.

• Liver tumours (benign and malignant).

Other clinical conditions

• Women with inherited hypertriglyceridaemia (increased risk of pancreatitis when using 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 induce or exacerbate symptoms.
Other adverse effects may occur in some individuals during treatment with Logest.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 the medicine.

5. How to store the medicine 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This 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 (0.02 mg).
Other components of the medicine are:
Core: monohydrate lactose, corn starch, povidone 25 000, magnesium stearate.
Coating: sucrose, povidone 700 000, macrogol 6000, calcium carbonate, talc, montanoglycol wax.

What Logest looks like and contents of the packaging
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 packaging, into which the blister should be placed.

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

For more detailed information, please contact the physician, the marketing authorization holder, or the parallel importer.

Marketing Authorization Holder in Portugal, country of export:
Bayer Portugal, Lda.
Rua Quinta do Pinheiro, n.º 5
2794-003 Carnaxide
Portugal

Manufacturer:
Bayer AG
Müllerstraße, 178
13353 Berlin
Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

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

Marketing Authorization Number in Portugal, country of export: 2494086
Parallel Import Authorization Number: 66/22

Translation of the abbreviations for days of the week printed on each tablet in the immediate packaging:
DOM – Sunday, SEG – Monday, TER – Tuesday, QUA – Wednesday, QUI – Thursday, SEX – Friday, SÁB – Saturday.