Ieanine

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Jeanine(Maxim)

0.03 mg + 2 mg, effervescent tablets

Ethinylestradiol + Dienogest
Jeanine and Maxim are different trade names for the same drug.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see point 2 "Blood clots").

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See point 4.

Table of contents of the leaflet:

• 1. What is Jeanine and what is it used for
• 2. Important information before using Jeanine
• 3. How to use Jeanine
• 4. Possible side effects
• 5. How to store Jeanine
• 6. Contents of the packaging and other information

1. What is Jeanine and what is it used for

Jeanine is a combined oral contraceptive. Each tablet contains two different hormones. These are: micronized dienogest (progestogen) and ethinylestradiol (estrogen).
When using Jeanine according to the recommendations listed in this leaflet, the likelihood of becoming pregnant is very low.

Indications for use

Prevention of pregnancy.
Treatment of moderate acne in women who have decided to use oral contraceptives after failure of appropriate local or oral antibiotic therapy.

2. Important information before using Jeanine

General notes

Before starting to take Jeanine, you should familiarize yourself with the information about blood clots in point 2. It is especially important to familiarize yourself with the symptoms of blood clots (see point 2 "Blood clots").
Acne usually improves within 3 to 6 months of treatment and may continue to improve even after 6 months. The patient should discuss with their doctor the need to continue treatment after 3 to 6 months from its start, and then at regular intervals.

When not to use Jeanine:

Jeanine should not be used if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if there is hypersensitivity (allergy) to ethinylestradiol, micronized dienogest, or any of the excipients listed in point 6.1;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of arterial thrombosis: severe diabetes with vascular damage, very high blood pressure, very high levels of fats in the blood (cholesterol or triglycerides), hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) severe liver disease (until liver function test results return to normal);
• if the patient has (or has had in the past) benign or malignant liver tumors;
• if the patient has (or has had in the past) a hormone-dependent tumor (breast or genital cancer);
• if the patient has bleeding from the genital tract of unknown cause;
• if the patient is pregnant or suspects they are pregnant. If any of these symptoms occur for the first time while taking Jeanine, the drug should be stopped immediately and a doctor consulted. During this time, non-hormonal methods of contraception are used.

Jeanine should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Jeanine and other drugs").

Warnings and precautions

Before starting to take Jeanine, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

In order to get a description of the serious side effects listed, see "How to recognize the occurrence of blood clots".
If you are taking oral contraceptives in any of the following situations, medical supervision is necessary.

You should tell your doctor if you have any of the following conditions.

If these symptoms appear or worsen while taking Jeanine, you should also tell your doctor.

• if you smoke;
• if you have diabetes;
• if you are obese;
• if you have high blood pressure;
• if you have heart valve defects or heart rhythm disorders;
• if you have superficial thrombophlebitis (inflammation of the 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 been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you or a close relative have had breast cancer in the past or currently have it;
• if you have liver or gallbladder disease;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you need to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• if you have recently given birth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Jeanine after giving birth;
• if you have a disease that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea);
• if you have or have had skin discoloration (yellow-brown pigment spots, so-called chloasma); you should avoid excessive exposure to the sun or ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause breathing difficulties, you should contact your doctor immediately. Drugs containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

If any of the above symptoms occur for the first time, recur, or worsen while taking Jeanine, you should contact your doctor.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Jeanine, is associated with an increased risk of blood clots compared to not using therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

Not all patients who have had a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or even fatal.

Remember that the total risk of harmful blood clots caused by taking Jeanine is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to suffer

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt while standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). Although these side effects are rare, they most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not taking combined hormonal contraceptives.
If the patient stops taking Jeanine, the risk of blood clots returns to normal within a few weeks.

What determines the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.

• During the year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During the year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During the year, about 8-11 out of 10,000 women who use combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Jeanine, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Jeanine is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have hereditary coagulation disorders;
• if the patient needs to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell your doctor if any of these factors apply to you, even if you are not sure. Your doctor may decide to stop taking Jeanine.
You should tell your doctor if any of the above conditions change while taking Jeanine, e.g., if someone in your immediate family is diagnosed with thrombosis without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with taking Jeanine is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes.While taking a hormonal contraceptive, such as Jeanine, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher. You should tell your doctor if any of the above conditions change while taking Jeanine, e.g., if you start smoking, someone in your immediate family is diagnosed with thrombosis without a known cause, or if you gain significant weight.

In case of symptoms suggesting thrombosis, embolism, or stroke, you should stop taking the tablets and consult your doctor immediately (see also "When to contact your doctor").

Oral contraception and cancer

In women taking oral contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women taking hormonal contraceptives are more frequently examined and breast cancer is detected earlier. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping oral contraceptives.
Rarely, cases of benign or, even more rarely, malignant liver tumors have been reported in women taking combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should inform your doctor as soon as possible.
Malignant tumors can be life-threatening or cause death.
There are reports of a more frequent occurrence of cervical cancer in women who have been taking oral contraceptives for a long time. However, this relationship may not be related to taking the tablets but to sexual behavior or other factors.

Psychiatric disorders

Some women taking hormonal contraceptives, including Jeanine, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Jeanine and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
Some drugs may affect the level of this drug in the blood, may reduce the effectiveness of contraception, and may cause unexpected bleeding. These include

• drugs used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g., rifampicin)
• HIV and HCV infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, azole antifungal drugs such as itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin)
• certain heart diseases, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
• arthritis, degenerative joint disease (etoricoxib)
• St. John's wort (Hypericum perforatum)
• grapefruit juice. Oral contraceptives may affect the metabolism of other drugs, such as lamotrigine, cyclosporine, melatonin, midazolam, theophylline, and tizanidine.

Jeanine should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause elevated liver function test results (increased ALT enzyme levels). The doctor will recommend a different type of contraception before starting these drugs. You can resume taking Jeanine about 2 weeks after finishing the treatment. See point "When not to use Jeanine".

When to contact your doctor

You should contact your doctor immediately if:

• you notice worrying changes in your health, especially any of the symptoms listed in this leaflet (see also "When to be careful when taking Jeanine" and "How to take Jeanine");
• there have been cases of thrombosis, heart attack, or stroke in close relatives;
• a breast lump has been detected;
• you plan to take other drugs (see also "Taking Jeanine with other drugs");
• you are going to have surgery or be immobilized (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;
• you missed a tablet in the first week of the cycle (every first week of consecutive months of taking Jeanine), and you had sexual intercourse during the previous 7 days;
• you experience severe diarrhea;
• you do not have withdrawal bleeding within the next two months or suspect you are pregnant (you should not start the next pack without your doctor's decision).

You should stop taking Jeanine and contact your doctor immediately if you notice symptoms suggesting a possible thrombosis, heart attack, or stroke:

• cough without a clear cause,
• severe chest pain that may radiate to the left arm,
• shortness of breath,
• headache of unprecedented severity or migraine attack,
• partial or complete loss of vision or double vision,
• slurred speech or loss of speech ability,
• sudden disturbances of the senses (hearing, smell, or touch),
• dizziness or fainting,
• numbness or weakness of part of the body,
• severe abdominal pain,
• severe pain or swelling of the legs.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this drug.
Pregnancy
You should not take Jeanine if you are pregnant or suspect you are pregnant. If you suspect you are pregnant, you should consult your doctor as soon as possible.
Breastfeeding
Jeanine is not recommended during breastfeeding.

Driving and using machines

No effect of Jeanine on the ability to drive and use machines has been found.

Important information about some ingredients of Jeanine

Jeanine contains sucrose and liquid glucose.
If you have been diagnosed with intolerance to some sugars in the past, you should contact your doctor before taking Jeanine.

3. How to take Jeanine

This drug should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult your doctor or pharmacist.
The leaflet describes many situations in which you should stop taking Jeanine or in which the effectiveness of the drug may be reduced. It also lists circumstances in which you should not have sexual intercourse or should use additional contraceptive methods, e.g., condoms or other mechanical methods. The calendar method and temperature measurement method cannot be used because Jeanine affects temperature changes and the properties of cervical mucus characteristic of the menstrual cycle.

Jeanine, like other oral contraceptives, does not protect against HIV (AIDS) or sexually transmitted diseases.

How to take Jeanine

• When and how to take the tablets? The blister pack contains 21 effervescent tablets. On the packaging, each tablet is marked with a symbol of the day of the week on which it should be taken (see "Translation of day symbols on the packaging" at the end of the leaflet). The tablets should be taken in the order indicated on the packaging, every day, approximately at the same time, with a small amount of liquid if necessary. For 21 consecutive days, take 1 tablet per day. Each subsequent pack should be started after a 7-day break, during which no tablets are taken and withdrawal bleeding usually occurs. Bleeding

usually starts within 2-3 days after taking the last tablet and may still occur after starting the next pack. This means that you should always start each subsequent pack on the same day of the week, as well as that bleeding will occur approximately on the same days every month.

• Starting Jeanine for the first time

If you did not take oral contraceptives in the last month
Take the tablets starting on the 1st day of your natural menstrual cycle (i.e., the first day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of the menstrual cycle; in this case, during the first cycle, additional mechanical contraception should be used for the first 7 days of taking the tablets.
If you were taking another combined oral contraceptive
It is recommended to start taking Jeanine on the 1st day after taking the last tablet containing active substances of the previous combined oral contraceptive, but no later than on the 1st day after the usual break in taking tablets containing active substances or placebo of the previous combined oral contraceptive.
If you were taking a progestogen-only tablet (minipill)
You can stop taking the minipill on any day and start taking Jeanine at the same time. If you have sexual intercourse during the first 7 days of taking Jeanine, you should also use other contraceptive methods (mechanical methods).
If you were using injections, an implant, or an intrauterine system
Take Jeanine starting on the day when the next injection was scheduled or on the day the implant or system is removed. If you have sexual intercourse during the first 7 days of taking the tablets, you should also use other contraceptive methods (mechanical methods).
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy You can start taking Jeanine immediately. In this case, it is not necessary to use additional contraceptive methods.
• After childbirth or miscarriage in the second trimester of pregnancy Breastfeeding women, see point 2. "Breastfeeding". The doctor should inform you that you should start taking the tablets between 21 and 28 days after childbirth or miscarriage in the second trimester of pregnancy. If you start taking the tablets later, the doctor should inform you about the need to use additional mechanical contraception for the first 7 days of taking the tablets. If you have had sexual intercourse before starting to take the combined oral contraceptive, you should make sure you are not pregnant or wait for your first menstrual period.

In case of taking a higher dose of Jeanine than recommended

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not started menstruating yet but have taken the drug by mistake.
There are no reports of severe side effects after taking multiple tablets of Jeanine at the same time. If you have taken a higher dose of the drug than recommended or someone else has taken it, you should inform your doctor.

Stopping Jeanine

The drug can be stopped at any time. The doctor will recommend other contraceptive methods.
If you stop taking Jeanine because you want to become pregnant, you should wait until you have a natural menstrual period. This will help determine the expected date of birth.

Missing a dose of Jeanine

If it has been less than 12 hourssince missing a tablet, the contraceptive effectiveness of Jeanine is maintained. You should take the missed tablet as soon as possible and take the next one at the usual time.
If it has been more than 12 hourssince missing a tablet, the effectiveness of Jeanine may be reduced. The more consecutive tablets you miss, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is especially high if you miss tablets at the beginning or end of the pack. In this case, you should follow the rules below (see also the scheme below).

Missing more than 1 tablet from the pack

You should consult your doctor.

Missing 1 tablet in the first week of taking Jeanine from the current pack

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. For the next 7 days, you should use additional contraceptive methods (mechanical methods).
If you had sexual intercourse during the week before missing the tablet, it is possible that you may become pregnant. You should contact your doctor immediately. You should also review the "Scheme of action in case of a missed tablet".

Missing 1 tablet in the second week of taking Jeanine from the current pack

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. The contraceptive effectiveness of Jeanine is maintained, and there is no need to use additional contraceptive methods.
However, if you made mistakes in dosing earlier or missed more than 1 tablet, you should use additional (mechanical) contraceptive methods for 7 days.

Missing 1 tablet in the third week of taking Jeanine from the current pack

You can choose one of the following options without the need for additional contraceptive methods, provided that you have been taking the tablets correctly for the previous 7 days. If not, you should follow the first of the two options below and use an additional contraceptive method for 7 days.

• 1. Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, i.e., without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but you may experience spotting or bleeding during tablet intake.
• 2. You can also not take the remaining tablets from the current pack, take a break of 7 days or less (you should also count the day you missed the tablet ), and then continue taking the tablets from the next pack. If you miss a tablet and do not have withdrawal bleeding during the first break, it is possible that you are pregnant. Before starting the next pack of Jeanine, you should contact your doctor.

Scheme of action in case of a missed tablet

odbył się
Tydzień 1.
stosunek płciowy w tygodniu
poprzedzającym pominięcie tabletki
nie odbył się

• przyjąć pominiętą tabletkę
• zastosować dodatkową metodę antykoncepcji przez 7 dni
• dokończyć przyjmowanie tabletek z Pominięta tylko 1 tabletka (spóźnienie większe niż 12 godzin, ale mniejsze niż 24 godziny) opakowania Tydzień 2.
• przyjąć pominiętą tabletkę
• dokończyć przyjmowanie tabletek z opakowania
• przyjąć pominiętą tabletkę
• dokończyć opakowanie
• nie robić 7-dniowej przerwy
• kontynuować przyjmowanie tabletek z następnego opakowania Tydzień 3. albo
• odstawić pozostałe tabletki z opakowania
• zrobić przerwę (nie więcej niż 7 dni, licząc z dniem pominięcia tabletki)
• kontynuować przyjmowanie tabletek z następnego opakowania

4. Possible side effects

Like all medicines, the Jeanine drug can cause side effects, although not everybody gets them. If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to the use of the Jeanine drug, consult your doctor.
All women using combined hormonal contraceptives are at an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thromboembolism). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using the Jeanine drug".

Severe side effects

Severe side effects related to the use of the Jeanine drug and their symptoms have been described in the following parts of the leaflet: "How to recognize the occurrence of blood clots" and "Oral contraception and tumors". Read these sections to get additional information and, if necessary, consult your doctor immediately.
Consult your doctor immediately if you experience any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing (see also "Warnings and precautions").

Other possible side effects

Below are symptoms reported by patients taking the Jeanine drug, although they may not have been caused by the drug.
Common(more than 1 in 100, but less than 1 in 10 people):

• headache,
• breast pain, including discomfort and breast tenderness.
• Uncommon(more than 1 in 1000, but less than 1 in 100 people):
• vaginitis and/or vulvovaginitis (inflammatory conditions of the genital organs),
• vaginal candidiasis (yeast infection) or other fungal infections of the vagina,
• increased appetite,
• depressed mood,
• dizziness,
• migraine,
• high or low blood pressure,
• abdominal pain, including upper and lower abdominal pain, discomfort, and/or bloating,
• nausea, vomiting, or diarrhea,
• acne,
• hair loss (alopecia),
• rash (including patchy rash),
• itching (sometimes all over the body),
• changes in bleeding patterns, such as heavy, scanty, or infrequent menstrual bleeding, and amenorrhea (absence of menstruation),
• intermenstrual bleeding, metrorrhagia (irregular menstrual bleeding),
• breast enlargement, including engorgement and swelling of the breast,
• breast tenderness,
• dysmenorrhea (painful menstruation),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including asthenia (weakness) and malaise,
• weight changes (including weight gain, weight loss, and fluctuations in weight).

Rare(more than 1 in 10,000, but less than 1 in 1000 people):

• ovarian and fallopian tube inflammation,
• urinary tract infections,
• cystitis (inflammation of the bladder),
• mastitis (breast inflammation),
• cervicitis (inflammation of the cervix),
• fungal infections,
• oral thrush,
• flu,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infections,
• uterine fibroids,
• breast fibroadenoma,
• anemia,
• hypersensitivity (allergic reaction),
• masculinization in women (development of male secondary sex characteristics),
• anorexia (severe loss of appetite),
• depression,
• psychiatric disorders,
• insomnia,
• sleep disorders,
• aggression,
• stroke (reduced or interrupted blood flow to a part of the brain),
• cerebral circulatory disorders (disorders of blood flow to a part of the brain),
• dystonia (persistent muscle contractions causing, e.g., twisting or abnormal posturing),
• dry or irritated eyes,
• oscillopsia (subjective sensation of image vibration) or other vision disturbances,
• sudden hearing loss,
• tinnitus,
• vertigo,
• hearing disorders,
• cardiovascular disorders (disorders of blood flow to the heart),
• tachycardia (rapid heart rate),
• venous and arterial thromboembolic events*
• pulmonary embolism (blood clot moving to the lungs),
• thrombophlebitis (inflammation of a vein with blood clots),
• increased diastolic blood pressure (the lowest level to which blood pressure drops between heartbeats),
• orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position),
• hot flashes,
• varicose veins,
• venous disorders or vein pain,
• asthma,
• hyperventilation,
• gastritis (inflammation of the stomach lining),
• enteritis (inflammation of the intestines),
• indigestion,
• skin reactions,
• skin diseases, including allergic dermatitis, neurodermatitis, and/or atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (skin discoloration on the face),
• skin pigmentation changes and/or discoloration,
• seborrhea,
• dandruff,
• excessive hair growth,
• skin disorders, skin reactions, "orange peel" skin appearance,
• hemangioma (a type of non-cancerous growth),
• back pain,
• musculoskeletal disorders,
• muscle pain,
• arm and leg pain,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• adnexal pain or cysts (ovarian and fallopian tube disorders),
• breast cysts,
• fibrocystic breast disease,
• painful intercourse,
• galactorrhea (spontaneous milk production),
• menstrual disorders,
• chest pain,
• edema of the arms and legs,
• flu-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolemia,
• increased triglyceride levels in the blood,
• accessory breast tissue.
• * Estimated frequency, from epidemiological studies involving a group of combined oral contraceptives. The term "Venous and arterial thromboembolic events" includes: any obstruction and blood clot in deep peripheral veins, blood clots moving through the bloodstream (e.g., to the lungs, known as pulmonary embolism, or heart attack caused by blood clots), stroke caused by obstruction of blood vessels to or in the brain. Frequency not known(cannot be estimated from available data):
• mood changes,
• decreased or increased libido (sex drive),
• intolerance to contact lenses,
• skin changes (hives, erythema multiforme, Stevens-Johnson syndrome),
• breast discharge,
• fluid retention.

The likelihood of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).
Description of selected side effects
Side effects with low frequency or delayed onset, which are considered related to the group of combined oral contraceptives, are listed below (see also "When not to use the Jeanine drug" and "When to exercise special caution when using the Jeanine drug"):
Tumors

• The number of breast cancer cases diagnosed in women using combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40 years of age, the number of diagnoses is small compared to the overall risk of breast cancer. The causal relationship between breast cancer and combined oral contraceptives is unknown.

Other

• Women with hypertriglyceridemia (elevated levels of fats in the blood, increasing the risk of pancreatitis when using combined oral contraceptives),
• Hypertension,
• Occurrence or worsening of symptoms whose relationship to the use of COCs is not established: jaundice and/or itching associated with cholestasis (obstructed bile flow); cholelithiasis; metabolic disorders such as porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a type of skin disease that occurs during pregnancy); otosclerosis-related hearing loss;
• In women with hereditary angioedema (characterized by sudden swelling, e.g., of the eyes, lips, throat, etc.), exogenous estrogens may provoke or exacerbate symptoms of angioedema;
• Liver function disorders;
• Changes in glucose tolerance or effects on peripheral insulin resistance;
• Crohn's disease, ulcerative colitis;
• Chloasma.

Interactions
Intermenstrual bleeding and/or reduced effectiveness of the contraceptive may be caused by the effect of other medicines on oral contraceptives (e.g., St. John's Wort (Hypericum perforatum), or drugs for epilepsy, tuberculosis, HIV, and other infections). See section "Using the Jeanine drug with other medicines".

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store the Jeanine drug

Store the drug out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use the Jeanine drug after the expiration date stated on the packaging.
The expiration date is the last day of the given month.
Do not dispose of medicines in the sewage system or household waste containers. Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What the Jeanine drug contains

• The active substances of the Jeanine drug are ethinylestradiol and micronized dienogest. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of micronized dienogest.
• Other ingredients of the drug are: microcrystalline cellulose, cornstarch, pregelatinized cornstarch, maltodextrin, magnesium stearate, coating: sucrose, liquid glucose, calcium carbonate, povidence K 90, povidence K 25, macrogol 35000, macrogol 6000, talc, carnauba wax, titanium dioxide (E 171).

What the Jeanine drug looks like and what the packaging contains

White, round film-coated tablets.
Packaging: 1 blister pack containing 21 film-coated tablets.
A cardboard wallet is provided to store the blister pack.
Blisters are made of PVC/PE/EVOH/PE/PCTFE/Aluminum in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Jenapharm GmbH & Co. KG
Otto-Schott-Straße 15
07745 Jena
Germany

Manufacturer:

Bayer Weimar GmbH und Co. KG
Döbereiner Straße 20
99427 Weimar
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 53560.00.00
Parallel import authorization number: 179/20

Translation of day of the week symbols on the packaging:

Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday

Date of leaflet approval: 27.05.2025

[Information about trademark]