Ieanine

Leaflet accompanying the packaging: information for the user

Jeanine, 0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest

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 you need to.
• If you have 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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 unsuccessful 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 veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood coagulation disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, 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 ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which 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 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 genitals 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 use Jeanine, you should discuss it with your doctor or pharmacist.
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 clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots (thrombosis)").

In order to get a description of the serious side effects mentioned, see "How to recognize the formation of blood clots".
If you are taking oral contraceptives in any of the following situations, 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 diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have 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 disease of 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, 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 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 facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen the 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 hormonal therapy. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form

• 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 people recover fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or very rarely fatal.

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

HOW TO RECOGNIZE THE FORMATION OF BLOOD CLOTS

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 suffer
from these symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• 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, such as pallor, redness, or cyanosis;

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms 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 can occur most often in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins of 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 medicine) 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 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/m2);
• 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 years old). In this case, the patient may have inherited coagulation disorders;
• if the patient needs to have surgery, is 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 resume taking the medicine;
• 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.

Traveling by air (>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 apply to the patient, even if they are not sure. The doctor may decide to stop the patient from taking Jeanine.
If any of the above conditions change while taking Jeanine, such as the patient starting to smoke, someone in their immediate family being diagnosed with a blood clot without a known cause, or the patient gaining significant weight, they should tell their doctor.

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 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 a heart attack or stroke associated with taking Jeanine is very small, but it may increase:

• with age (over approximately 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 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 particularly severe, the risk of blood clots may be even higher.
Tell your doctor if any of the above conditions change while taking Jeanine, such as the patient starting to smoke, someone in their immediate family being diagnosed with a blood clot without a known cause, or the patient gaining significant weight.

In case of symptoms suggesting a blood clot, thrombosis, or stroke, stop taking the tablets and consult 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 if 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 in them. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after 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, 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 taken 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 or symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Jeanine and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the levels of this medicine in your 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 antifungal medicines 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, cyclosporine, melatonin, midazolam, theophylline, and tizanidine.

Do not take Jeanine if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may cause elevated liver function test results (elevation of liver enzyme ALT). Your doctor will recommend a different type of contraception before starting these medicines. You can resume taking Jeanine about 2 weeks after finishing treatment. See section "When not to use Jeanine".
When to contact a doctor
You should contact your doctor immediately if:

• you notice any 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 found;
• you plan to take other medicines (see also "Jeanine and other medicines");
• you are going to have surgery or be immobilized (you should inform your doctor at least 4 weeks in advance);
• you have heavy vaginal bleeding;
• you missed tablets in the first week of the cycle (every first week of the month) and had sex during the previous 7 days;
• you have severe diarrhea;
• you have not had withdrawal bleeding within 2 months or suspect you are pregnant (do not start the next pack without consulting your doctor).

Stop taking Jeanine and consult a doctor immediately if you notice symptoms suggesting a blood clot, heart attack, or stroke:

• cough without an obvious cause,
• severe chest pain that may radiate to the left arm,
• shortness of breath,
• headache with unprecedented severity or 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 or swelling.

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 baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not take Jeanine if you are pregnant or think you may be pregnant. If you suspect you are pregnant, you should consult your doctor as soon as possible.
Breastfeeding
Jeanine should not be used 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 you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking Jeanine.

3. How to use Jeanine

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, 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 medicine may be reduced. It also lists circumstances in which you 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 cervical mucus properties characteristic of the menstrual cycle.

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

How to use Jeanine

• When and how to take the tablets? The blister pack contains 21 coated tablets. On the packaging, each tablet is marked with the day of the week on which it should be taken. The tablets should be taken in the order indicated on the packaging, every day, at approximately 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 when 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 at the same time every month.

First-time use of Jeanine If you did not use oral contraceptives in the last month

• Take the first tablet on the first day of your natural menstrual cycle (i.e., on the first day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of your menstrual cycle; in this case, during the first cycle, you should use additional mechanical contraception for the first 7 days of taking the tablets.

If you used another combined oral contraceptive
It is recommended to start taking Jeanine on the first day after taking the last active tablet of the previous combined oral contraceptive, but no later than the first day of the usual break in taking active tablets or placebo from the previous combined oral contraceptive.
If you used a progestogen-only tablet (mini-pill)
You can stop taking the mini-pill at any time and start taking Jeanine at the same time. If you have sex during the first 7 days of taking Jeanine, you should also use other contraceptive methods (mechanical methods).
If you used injectable contraception, an implant, or an intrauterine system

Start taking Jeanine on the day you would have had your next injection or on the day the implant or system is removed. If you have sex 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, you do not need to use additional contraceptive methods.

• After childbirth or miscarriage in the second trimester of pregnancy Women who are breastfeeding, see section 2 "Breastfeeding".

Your 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, your 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 sex before starting to take the combined oral contraceptive, your doctor should ensure that you are not pregnant or wait for your first menstrual period.

In case of overdose

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 medicine by mistake. There are no reports of serious side effects after taking multiple tablets of Jeanine at the same time. If you have taken more tablets than recommended or someone else has taken them, you should inform your doctor.

Stopping Jeanine

The medicine can be stopped at any time. Your doctor will recommend other contraceptive methods.
If you stop taking Jeanine because you want to become pregnant, you should wait until you 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 you missed 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 you missed a tablet, the effectiveness of Jeanine may be reduced. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness. There is a particularly high risk of becoming pregnant 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

Consult your doctor.

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

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

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

Take the missed tablet as soon as possible (even if it means taking two 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 contraceptive methods.
However, if you made mistakes when taking the tablets earlier or missed more than 1 tablet, you should use additional mechanical contraception 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 7 days before missing the dose. If not, you should follow the first of the two options below and use additional contraception 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 tablets 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-taking days.

• 2. You can also not take the remaining tablets from the current pack, take a break (not more than 7 days, counting from the day you missed the tablet), and then continue taking the tablets from the next pack.

If you forget to take a tablet and do not have withdrawal bleeding during the first break, you may be pregnant. You should consult your doctor before starting the next pack.

Scheme for missing a 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 opakowania

Pominięta tylko 1 tabletka
(spóźnienie większe
niż 12 godzin, ale
mniejsze niż 24 godziny)
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, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially serious or persistent ones, or changes in your health that you think are related to the use of the Jeanine drug, you should consult a doctor. In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the 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 associated with the use of the Jeanine drug and their symptoms have been described in the following sections of the leaflet: "Oral contraception and thrombosis" 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 urticaria, which may cause difficulty breathing (see also the "Warnings and precautions" section).

Other possible side effects

Below are the symptoms 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 (vaginal 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, such as heavy, scanty, or infrequent menstrual bleeding, and complete absence of bleeding,
• 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 general 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),
• breast inflammation (mastitis),
• cervicitis (cervical inflammation),
• fungal infections,
• oral thrush,
• influenza,
• 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 trembling of the image seen) 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 (lowest level to which blood pressure falls between heartbeats),
• orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position),
• hot flashes,
• varicose veins,
• disorders of vein function or vein pain,
• asthma,
• hyperventilation,
• gastritis (stomach inflammation),
• enteritis (intestinal inflammation),
• indigestion,
• skin reactions,
• skin diseases, including allergic dermatitis, neurodermatitis, and/or atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (skin discoloration on the face),
• changes in pigmentation and/or discoloration,
• hirsutism (excessive hair growth),
• alopecia (hair loss),
• skin disorders, skin reactions, "orange peel" skin appearance,
• telangiectasia (dilation of small blood vessels),
• back pain,
• musculoskeletal disorders,
• muscle pain,
• arm and leg pain,
• cervical dysplasia (abnormal growth of cells on the surface of the cervix),
• adnexal pain or cysts (ovarian and fallopian tube disorders),
• breast cysts,
• fibrocystic breast disease,
• painful intercourse,
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• edema of the hands and feet,
• flu-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolemia,
• increased triglyceride levels in the blood,
• revealing the presence of an additional 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 peripheral veins, blood clots moving through the bloodstream (e.g., to the lungs, known as pulmonary embolism or pulmonary infarction), myocardial infarction caused by blood clots, stroke caused by obstruction of blood vessels to or in the brain.

Frequency not known (cannot be estimated from the 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 further 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 "When not to use the Jeanine drug" and "Warnings and precautions" sections):

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 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 not known.
• 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 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
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

InteractionsIntermenstrual bleeding and/or contraceptive failure 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide 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 at a temperature below 25°C. Store in the original packaging to protect from light. Do not use the Jeanine drug after the expiration date stated on the packaging. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of micronized dienogest.
• Other ingredients of the drug are: lactose monohydrate, cornstarch, maltodextrin, magnesium stearate, sucrose, glucose syrup, calcium carbonate, povidone K 25, macrogol 35,000, carnauba wax, titanium dioxide (E171).

What the Jeanine drug looks like and what the package contains

White, round, coated tablets. The package contains 1, 2, or 3 blisters of 21 coated tablets each. Blister pack of PVC/Al foil in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer AG Kaiser-Wilhelm-Allee 1 51373 Leverkusen Germany

Manufacturer

Bayer Weimar GmbH und Co. KG Döbereinerstrasse 20 99427 Weimar Germany For more detailed information about this drug, please contact the local representative of the marketing authorization holder: Bayer Sp. z o.o. Al. Jerozolimskie 158 02-326 Warszawa tel. 0 22 572 35 00

Date of the last update of the leaflet: