Ieanine

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Jeanine (Maxim)

0.03 mg + 2 mg, chewable 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.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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. Package contents 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: 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 treatment or oral antibiotic therapy.

2. Important information before using Jeanine

General notes

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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 changes usually improve 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 following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to ethinylestradiol or dienogest or any of the other ingredients of this drug (listed in point 6);
• 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 point "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 (temporary stroke symptoms);
• if the patient has any of the following diseases that may increase the risk of a blood clot in an artery: severe diabetes with blood vessel damage, very high blood pressure, very high levels of fats in the blood (cholesterol or triglycerides), or a disease called 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 may be pregnant.

If any of these symptoms occur for the first time while taking Jeanine, the drug should be stopped immediately and a doctor should be consulted. During this time, non-hormonal methods of contraception should be used.
Jeanine should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir, 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.
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When should you contact your doctor?
You should see your doctor immediately

• if you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

To get a description of the serious adverse reactions listed, see "How to recognize a blood clot".
If you are taking oral contraceptives in any of the following situations, close medical supervision is necessary.

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

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

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have heart valve problems 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 blood clots, 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 family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you or a close relative have had 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 systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder 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 about 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 discolorations (yellow-brown pigment spots, so-called chloasma) currently or in the past; you should then avoid excessive exposure to the sun or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing drugs may cause or worsen symptoms of both hereditary and acquired angioedema.

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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 them. 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 thromboembolism" or "venous thrombotic disease"),
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thrombotic disease").

Not everyone recovers fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots caused by taking Jeanine is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, e.g., pallor, redness, or discoloration pulmonary embolism
• 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 the patient is unsure, they should see their 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).
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)
• chest pain, discomfort, pressure, heart attack
• a feeling of squeezing or fullness in the chest, arm, or below the breast;
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the lower body radiating to the back, jaw, throat, arm, and stomach; Page 4 18

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 thromboembolism). Although these adverse reactions are rare, they can occur. 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 moves 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 a blood clot 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 affects 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 in 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During the year, about 5-7 in 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During the year, about 8-11 in 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).

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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 severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in their legs, lungs, or other organs at a young age (e.g., under 50). 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 due to injury or illness or has a leg in a cast. It may be necessary to stop taking Jeanine for a few weeks before surgery or immobilization. If the patient stops taking Jeanine, they should ask their doctor when they can resume taking the drug;
• 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.

Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these factors are present, even if the patient is unsure. The doctor may decide to stop Jeanine.
The patient should tell their doctor if any of the above conditions change while taking Jeanine, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains 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 have 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 like 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). 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 particularly severe, the risk of blood clots may be even higher.
The patient should tell their doctor if any of the above conditions change while taking Jeanine, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

In case of symptoms suggesting a blood clot, the patient should stop taking the tablets and consult their 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 often examined and breast cancer is detected earlier. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years of stopping oral contraceptives.
In women taking combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, the patient should inform their doctor as soon as possible.
Malignant tumors can be life-threatening or fatal.
There have been reports of a more common 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, the patient should contact their doctor as soon as possible for further medical advice.

Jeanine and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Some drugs may affect the level of this drug in the blood, reduce the effectiveness of contraception, and 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 antifungals such as itraconazole, voriconazole, fluconazole),
• bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin),

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• 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, 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.
Jeanine can be resumed about 2 weeks after finishing the treatment. See "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 "Warnings and precautions" and "How to use Jeanine");
• there have been cases of blood clots, heart attack, or stroke in close relatives;
• a breast lump has been detected;
• you plan to take other medications (see also "Jeanine and other drugs");
• you plan to have surgery or be immobilized (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;
• you missed tablets in the first week of taking Jeanine and had sex during the previous 7 days;
• you experience severe diarrhea;
• you have not had withdrawal bleeding within 2 months or suspect you may be 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 blood clot, 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 or swelling.

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
Pregnancy
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Jeanine should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, the patient should consult their doctor as soon as possible.
Breastfeeding
Jeanine is not recommended during breastfeeding.

Driving and using machines

No effects of Jeanine on the ability to drive and use machines have been found.

Important information about some ingredients of Jeanine

Jeanine contains sucrose and liquid glucose.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Jeanine.

3. How to use Jeanine

This drug should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The leaflet describes many situations in which the patient should stop taking Jeanine or in which the effectiveness of the drug may be reduced. It also lists circumstances in which the patient should not have sex or should use additional contraceptive methods, such as 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) and sexually transmitted diseases.

How to use Jeanine

• When and how to take the tablets? The blister pack contains 21 chewable 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, at about the same time, with a small amount of liquid if necessary. For 21 consecutive days, 1 tablet should be taken 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 2-3 days after taking the last tablet and may still occur after starting the next pack. This means that the patient should always start each subsequent pack on the same day of the week, and bleeding will occur at about the same time every month.
• Using Jeanine for the first time

If the patient did not take oral contraceptives in the last month
Taking the tablets should be started on the 1st day of the natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). Taking the tablets can also be started 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 the patient previously took 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 the patient previously took a progestogen-only pill (mini-pill)
The patient can stop taking the mini-pill at any time and start taking Jeanine at the same time. If the patient has sex during the first 7 days of taking Jeanine, they should also use other contraceptive methods (mechanical methods).
If the patient previously used injectable contraception, an implant, or an intrauterine system
Taking Jeanine should be started on the day when the next injection was scheduled or on the day the implant or intrauterine system is removed. If the patient has sex during the first 7 days of taking the tablets, they should also use other contraceptive methods (mechanical methods).
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy The patient can start taking Jeanine immediately. In this case, there is no need 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 the patient that they should start taking the tablets 21 to 28 days after childbirth or miscarriage in the second trimester of pregnancy. If the patient starts taking the tablets later, the doctor should inform them about the need to use additional mechanical contraception for the first 7 days of taking the tablets. If the patient has had sex before starting to take the combined oral contraceptive, they should make sure they are not pregnant or wait for their first menstrual period.

In case of overdose of Jeanine

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not yet started menstruating but have taken the drug by mistake.
There have been no reports of serious adverse reactions after taking multiple tablets of Jeanine at the same time. If the patient has taken a larger dose of the drug than recommended or someone else has taken it, they should inform their doctor.

Stopping Jeanine

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

Missing a dose of Jeanine

If it has been less than 12 hourssince the missed tablet, the contraceptive effectiveness of Jeanine is maintained. The patient 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 the missed tablet, the effectiveness of Jeanine may be reduced. The more consecutive tablets are missed, the higher the risk of reduced contraceptive effectiveness. The risk of becoming pregnant is particularly high if the patient misses tablets at the beginning or end of the pack. In this case, the patient should follow the rules below (see also the scheme below).

Missing more than 1 tablet from the pack

The patient should consult their doctor.
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Missing 1 tablet in the first week of taking Jeanine from the current pack

The patient should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next one at the usual time. For the next 7 days, the patient should use additional mechanical contraceptive methods.
If the patient had sex during the week before missing the tablet, it is possible that they may become pregnant. The patient should contact their doctor immediately. The patient should also see "Scheme of action in case of a missed tablet".

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

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

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

The patient can choose one of the following options without the need for additional contraceptive methods, provided that they have been taking the tablets correctly for the 7 days preceding the missed dose. If not, the patient 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 one 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 during tablet-taking, spotting or bleeding may occur.
• 2. The patient can also stop taking the tablets from the current pack, take a break (not more than 7 days, counting from the day the tablet was missed), and then continue taking the tablets from the next pack.

If the patient forgets to take the tablets and does not have the expected withdrawal bleeding during the first break, it is possible that they are pregnant. Before starting the next pack of Jeanine, the patient should contact their doctor.

Scheme of action in case of a missed tablet

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Missed more than 1 tablet from the current pack
Consult a doctor
Had sex in the week before missing the tablet
Week 1.
Did not have sex

• take the missed tablet
• use additional contraceptive methods for 7 days
• finish the pack

Missed only 1 tablet (delay of more than 12 hours, but less than 24 hours)

• take the missed tablet
• finish the pack

Week 2.

• take the missed tablet
• finish the pack
• do not take a 7-day break
• continue with the next pack

Week 3.
or

• stop taking the tablets from the current pack
• take a break (not more than 7 days, counting from the day the tablet was missed)
• continue with the next pack

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that you consider related to the use of the Jeanine drug, you should consult a doctor.
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In all women using combined hormonal contraceptives, there is 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 sections of the leaflet: “Blood clots” and “Oral contraception and tumors”. You should read these sections to obtain additional information and, if necessary, consult a doctor immediately.
You should immediately contact a doctor 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 breathing difficulties (see also the section “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.
Frequent (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 (thrush) 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 complete absence of bleeding,
• intermenstrual bleeding, metrorrhagia (irregular bleeding between periods),
• breast enlargement, including engorgement and swelling of the breast,
• breast tenderness,
• painful menstruation (dysmenorrhea),
• 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 (urinary bladder inflammation),

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• mastitis (breast inflammation),
• cervicitis (cervical inflammation),
• fungal infections,
• oral thrush,
• flu,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infections,
• uterine fibroids,
• breast lipoma,
• 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 positioning),
• dry or irritated eyes,
• oscillopsia (subjective sensation of image vibration) or other vision disorders,
• 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,
• enteritis,
• indigestion,
• skin reactions,
• skin diseases, including allergic dermatitis, neurodermatitis, and/or atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (pigmentation on the face),
• changes in pigmentation and/or discoloration,
• seborrhea,
• dandruff,
• excessive hair growth,
• skin disorders, skin reactions, "orange peel" skin appearance,
• telangiectasia,

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• 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 (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast disease,
• painful intercourse,
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• swelling of the arms and legs,
• flu-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolemia,
• increased triglyceride levels in the blood,
• revealing the presence of an accessory breast.
• * 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 the deep veins of the limbs, blood clots moving through the bloodstream (e.g., to the lungs, called pulmonary embolism or pulmonary infarction), 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 (sexual desire),
• 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 of symptoms that are considered related to the group of combined oral contraceptives have been listed below (see also the section "When not to use the Jeanine drug" and "Warnings and precautions"):
Cancers

• The number of breast cancer cases in women using combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40, 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.
• liver tumors (benign and malignant)

Other
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• Women with hypertriglyceridemia (increased fat levels 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 resolved: jaundice and/or itching associated with cholestasis (blocked bile flow); cholelithiasis; metabolic disorders such as porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a blood clotting disorder); neurological disorders called Sydenham's chorea; herpes gestationis (a skin disease that occurs during pregnancy); otosclerosis associated with hearing loss
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store the Jeanine drug

The drug should be stored 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 indicates the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 dienogest. One film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of micronized dienogest.
• Other ingredients of the drug are: cornstarch, pregelatinized cornstarch, maltodextrin, magnesium stearate, microcrystalline cellulose, coating: sucrose, liquid glucose, calcium carbonate, povidon K 25, povidon K 90, macrogol 35,000, macrogol 6,000, titanium dioxide (E 171), carnauba wax, talc.

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What the Jeanine drug looks like and what the package contains

White, round film-coated tablets.
The package contains 1, 2, or 3 blisters of 21 film-coated tablets each.
PVC/PE/EVOH/PE/PCTFE/Al blisters in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the 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:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Germany, the country of export: 53560.00.00

Parallel import authorization number: 299/19

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: 08.08.2024

[Information about the trademark]
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