Ieanine

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging 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 section 2 "BLOOD CLOTS").

You should carefully read the contents of the leaflet before using the medicine, 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 medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 section 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: 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

Before starting to take Jeanine, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 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 the 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 the patient is allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in section 6)

• if the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows they have a blood clotting disorder - for example, deficiency of protein C, deficiency of protein S, deficiency of antithrombin III, presence of factor V Leiden or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section "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 ischaemic attack (temporary stroke-like 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);
• a disease called hyperhomocysteinaemia;
• 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 tests have returned to normal);
• if the patient has (or has had in the past) benign or malignant liver tumours;
• if the patient has (or has had in the past) a hormone-dependent tumour (breast cancer or cancer of the genital organs);
• 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 medicine should be stopped immediately and a doctor 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/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Jeanine and other medicines").

Warnings and precautions

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

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

To find a description of the serious side effects listed, see "How to recognize a blood clot".
If you are taking oral contraceptives in any of the situations listed below, close medical supervision is necessary.

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 inflammation of the veins under the skin (thrombophlebitis);
• 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 told you have high levels of fats in the blood (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia 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 defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle-cell disease (an inherited disease of the red blood cells);
• if you need to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if you have recently given birth, as you are at a higher 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 gestationis, Sydenham's chorea);
• if you have ever had skin discolorations (yellow-brown pigment spots, so-called chloasma) and you are taking Jeanine, you should avoid excessive exposure to the sun or ultraviolet radiation;
• if the patient experiences symptoms of angio-oedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, they should contact their doctor immediately. Medicines containing estrogens may cause or worsen the symptoms of both hereditary and acquired angio-oedema.

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

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Jeanine, is associated with an increased risk of blood clots compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Jeanine is small.

HOW TO RECOGNIZE A BLOOD CLOT

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 be suffering from
these symptoms?

• 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 the colour of the skin of the leg, such as paleness, redness, or discoloration;
• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without obvious cause, 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 contact 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).

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. They are most likely to occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this can lead to deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, this 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 using combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher than when not using combined hormonal contraceptives.
If the patient stops using Jeanine, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with 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/m2);
• if someone in the patient's close family 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 blood clotting disorder;
• 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 needs to stop taking Jeanine, they should ask their doctor when they can restart the medicine;
• with increasing age (especially over 35 years of age);
• 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 (more than 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is important to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Jeanine.
If any of the above conditions change while taking Jeanine, e.g. the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over about 35 years of age);
• if the patient smokes.While taking a hormonal contraceptive like Jeanine, 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 a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years of age). In this case, the patient may also be at a higher risk of having a heart attack or stroke;
• if the patient or someone in their close family has 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 a blood clot may be even higher.
If any of the above conditions change while taking Jeanine, e.g. the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or the patient gains weight significantly.

In case of symptoms suggesting a blood clot, a heart attack, or a stroke, stop taking Jeanine and contact a doctor immediately (see also "When to contact a 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 examined more frequently 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 tumours 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 tumours can be life-threatening or cause death.
There are reports of a more frequent occurrence of cervical cancer in women taking oral contraceptives for a long time. However, this relationship may not be related to taking the tablets, but to sexual behaviour 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 medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the level of this medicine in the blood, reduce the effectiveness of contraception, and cause unexpected bleeding. These include

• medicines used to treat:
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• tuberculosis (e.g. rifampicin)
• HIV and HCV infections (so-called 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)
• certain heart conditions, 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 medicines, such as lamotrigine, cyclosporin, melatonin, midazolam, theophylline, and tizanidine.
Jeanine should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may cause elevated liver function tests (increase in liver enzyme ALT).
The doctor will recommend a different type of contraception before starting these medicines.
Jeanine can be restarted about 2 weeks after the end of treatment. See section "When not to use Jeanine".

When to contact a doctor

The patient should contact their doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms listed in this leaflet (see also "When to be careful while taking Jeanine" and "How to take Jeanine");
• there have been cases of blood clots, heart attack, or stroke in close relatives;
• a breast lump has been found;
• they plan to take other medicines (see also "Jeanine and other medicines");
• they are going to have surgery or are going to be immobilized (they should inform their doctor at least 4 weeks in advance);
• they experience heavy vaginal bleeding;
• they missed tablets in the first week of the cycle (every first week of the month while taking Jeanine) and had sex during the previous 7 days;
• they experience severe diarrhoea;
• they have not had withdrawal bleeding within 2 weeks of taking the last tablet or suspect they are pregnant (they should not start the next pack without consulting their doctor).

Stop taking Jeanine and contact a doctor immediately if you notice any symptoms that may indicate a blood clot, a heart attack, or a stroke:

• cough without obvious cause,
• severe chest pain that may radiate to the left arm,
• shortness of breath,
• headache of unprecedented severity or a migraine attack,
• partial or complete loss of vision or double vision,
• slurred speech or loss of speech ability,
• sudden disturbances of sensory organs (hearing, smell, or sensation),
• 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 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 taking this medicine.
Pregnancy
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 or use machines have been observed.

Important information about some of the ingredients of Jeanine

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

3. How to take Jeanine

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt, 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 medicine may be reduced. It also lists situations in which the patient should not have sex or should use additional methods of contraception, e.g. condoms or other mechanical methods. The calendar method and the temperature 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 other 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 the day of the week 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, 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.
Withdrawal bleeding usually starts 2-3 days after taking the last tablet and may still occur after starting the next pack. This means that each subsequent pack should always be started on the same day of the week, and bleeding will also occur at about the same time every month.

• Starting Jeanine for the first time

If the patient has not taken oral contraceptives in the last month
Tablet-taking should be started on the 1st day of the natural menstrual cycle (i.e. on the 1st day of menstrual bleeding). Tablet-taking 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 during the first 7 days of tablet-taking.
If the patient has previously taken 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 has previously taken a progestogen-only tablet (mini-pill)
The patient can stop taking the mini-pill on any day 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 methods of contraception (mechanical methods).
If the patient has previously used injectable contraception, an implant, or an intrauterine system

• After a miscarriage in the first trimester of pregnancy

Taking Jeanine can be started immediately. In this case, there is no need to use additional methods of contraception.

• After childbirth or miscarriage in the second trimester of pregnancy

For breastfeeding women, see section 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 during 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

The patient may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their periods, but have taken the medicine by mistake.
There are no reports of serious side effects after taking multiple tablets of Jeanine at the same time. If the patient has taken more tablets than recommended or someone else has taken them, they should inform their doctor.

Stopping Jeanine

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

Missing a dose of Jeanine

If it has been less than 12 hourssince the patient missed a 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 patient missed a tablet, the effectiveness of Jeanine may be reduced. The more tablets that 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.

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 2 tablets at the same time), and take the next tablets at the usual time. For the next 7 days, the patient should use additional mechanical methods of contraception.
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 as soon as possible. The patient should also see the "Scheme for missing a tablet" below.

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 2 tablets at the same time), and take the next tablets at the usual time. The contraceptive effectiveness of Jeanine is maintained, and there is no need to use additional methods of contraception.
However, if the patient made mistakes when taking the tablets earlier or missed more than 1 tablet, they should use additional mechanical methods of contraception 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 methods of contraception, provided that the correct dosing schedule has been followed for the 7 days preceding the missed dose. If this is not the case, the patient should follow the first of the two options below and use an additional method of contraception for 7 days.

• 1. Take the missed tablet as soon as possible (even if it means taking 2 tablets at the same time), and take the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, i.e. without the usual 7-day break. Withdrawal bleeding will occur after finishing the second pack, but while taking the tablets, 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 tablets and does not have withdrawal bleeding during the first break, it is possible that they are pregnant. Before starting the next pack of Jeanine, the patient should consult their doctor.

Scheme for missing a tablet

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

or
Week 3.

• 1. Take the missed tablet as soon as possible (even if it means taking 2 tablets at the same time), and take the next tablets at the usual time. Start taking the tablets from the next pack immediately after finishing the current one, i.e. without the usual 7-day break. Withdrawal bleeding will occur after finishing the second pack, but while taking the tablets, 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.

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 serious and persistent ones, or changes in your health that you think are related to the use of the Jeanine drug, consult your doctor.
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 more 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 more information and, if necessary, consult your doctor immediately.
Immediately contact your 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 difficulty breathing (see also "Warnings and precautions").

Other possible side effects

The following symptoms have been reported by patients taking the Jeanine drug, although they may not have been caused by the drug.

• 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,
• Decreased 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/or complete absence of menstrual bleeding,

and/or

• Intermenstrual bleeding, metrorrhagia (irregular bleeding between periods),
• Breast enlargement, including breast congestion and swelling,
• Breast tenderness,
• Painful menstruation (dysmenorrhea),
• Vaginal discharge,
• Ovarian cysts,
• Pelvic pain,
• Fatigue, including asthenia (weakness) and malaise,
• Changes in body weight (including weight gain, weight loss, and fluctuations in body weight).

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

• Oophoritis and salpingitis,
• Urinary tract infections,
• Cystitis (urinary bladder infection),
• Mastitis (breast infection),
• Cervicitis (inflammation of the cervix),
• 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),
• Cerebrovascular 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,
• Dizziness,
• 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 a blood clot),
• 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;
• Vein 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);
• Pigmentation changes and/or discoloration;
• Seborrhea;
• Dandruff;
• Excessive hair growth;
• Skin disorders, skin reactions, "orange peel" skin appearance;
• Spider angioma;
• Back pain;
• Musculoskeletal disorders;
• Muscle pain;
• Pain in the arms and legs;
• Cervical dysplasia (abnormal cell growth on the surface of the cervix);
• Pain or cysts on the adnexa (ovaries and fallopian tubes);
• Breast cysts;
• Fibrocystic breast disease;
• Painful intercourse;
• Milk secretion;
• Menstrual disorders;
• Chest pain;
• Swelling of the hands and feet;
• Flu-like illnesses;
• Inflammation;
• Fever;
• Irritability;
• Hypercholesterolemia;
• Increased triglyceride levels in the blood;
• Discovery of an extra breast.
• *Estimated frequency, from epidemiological studies involving a group of combined oral contraceptives. The term "Venous and arterial thromboembolic events" includes: any blockage 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 blockage 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 a low frequency or delayed onset of symptoms that are considered related to the group of combined oral contraceptives have been listed below (see also "When not to use the Jeanine drug" and "Warnings and precautions"):
Tumors

• The number of breast cancer cases 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.
• Liver tumors (benign and malignant).

Other

• Women with hypertriglyceridemia (increased 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 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 type of 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 decreased effectiveness of the contraceptive may be caused by the effect of other drugs on oral contraceptives (e.g., St. John's Wort (Hypericum perforatum), or drugs for epilepsy, tuberculosis, HIV, and other infections). See section "Jeanine drug and other drugs".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, 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 means the last day of the given month.
Medicines should not be disposed of via wastewater 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 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 25, povidence K 90, macrogol 35000, macrogol 6000, carnauba wax, talc, titanium dioxide (E 171).

What the Jeanine drug looks like and what the packaging contains

White, round film-coated tablets.
The packaging contains 1, 2, or 3 blisters of 21 film-coated tablets. The packaging includes a cardboard sachet in which the blister should be placed.
PVC/PE/EVOH/PE/PCTFE/Al blisters 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
D-99427 Weimar
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:53560.00.00
Parallel import authorization number:26/20

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: 03.02.2025

[Information about the trademark]