Jeanine

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Jeanine (Maxim)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Jeanine and Maxim are different trade names for the same medicinal product.
Important information regarding combined hormonal contraceptives

• When used correctly, they represent one of the most reliable reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following an interval of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are similar.
• If the user experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Jeanine is and what it is used for

Jeanine is a combined oral contraceptive. Each tablet contains two different hormones: micronized dienogest (a progestogen) and ethinylestradiol (an estrogen).
When Jeanine is taken as directed in this leaflet, the likelihood of becoming pregnant is very low.
Indications
Prevention of pregnancy.
Treatment of moderate acne in women who have decided to use oral contraceptives after failure of appropriate topical treatment or oral antibiotic therapy.

2. Important information before using Jeanine

General notes
Before starting treatment with Jeanine, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Acne-related changes usually improve within three to six months of treatment and may continue to improve even after six months. The patient should discuss with her doctor the need to continue treatment after three to six months, and then at regular intervals.

When not to use Jeanine:
Do not use Jeanine if any of the following conditions apply to you. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are hypersensitive (allergic) to ethinylestradiol, micronized dienogest, or to any of the excipients listed in section 6.1;
• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions which may increase the risk of arterial blood clots:
  o severe diabetes with blood vessel damage
  o very high blood pressure
  o very high levels of fats in the blood (cholesterol or triglycerides)
  o a condition called hyperhomocysteinaemia
• if you have (or have previously had) a type of migraine called "migraine with aura";
• if you have (or have previously had) severe liver disease (until liver function tests return to normal);
• if you have had or currently have benign or malignant liver tumours;
• if you currently have or have previously had hormone-dependent cancer (e.g. breast or genital organ cancer);
• if you have vaginal bleeding of unknown cause;
• if pregnancy has been confirmed or is suspected.

If any of the above symptoms occur for the first time while taking Jeanine, stop taking the medicine immediately and consult your doctor. During this time, use non-hormonal methods of contraception.
Do not use Jeanine in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Jeanine with other medicines").

Warnings and precautions
Before starting Jeanine, discuss this with your doctor or pharmacist.

When to contact your doctor:
Seek immediate medical attention if:

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

For a description of the symptoms of these serious adverse events, see "How to recognize a blood clot".

Special and regular medical monitoring is required if you are taking oral hormonal contraceptives and any of the following apply.

Tell your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Jeanine, inform your doctor.

• if you smoke,
• if you have diabetes,
• if you are obese,
• if you have high blood pressure,
• if you have heart valve disorders or heart rhythm problems,
• if you have inflammation of the superficial veins under the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if there have been cases of thrombosis, heart attack, or stroke in close relatives,
• if you have migraines,
• if you have epilepsy,
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis,
• if there is a history of breast cancer in your close family,
• 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 affecting the body's natural defence system),
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure),
• if you have sickle cell anaemia (an inherited disorder of red blood cells),
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots"),
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Jeanine,
• if you have a condition that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham's chorea),
• if you currently have or have previously had skin discolouration (yellow-brown pigmentation, so-called chloasma); in such cases, avoid excessive exposure to sunlight 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, possibly causing breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

If any of the above symptoms occur for the first time, recur, or worsen during treatment with Jeanine, contact your doctor.

BLOOD CLOTS
Using combined hormonal contraceptives such as Jeanine increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.

Blood clots may occur:

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

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots associated with the use of Jeanine is low.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attention if you experience any of the following symptoms.

Do you experience any of these symptoms? Likely cause?

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

  • Pain or tenderness in the leg, which may occur only when standing or walking
  • Increased warmth in the affected leg
  • Change in skin colour of the leg, such as pallor, redness, or blueness

• Sudden unexplained shortness of breath or rapid breathing
  Pulmonary embolism

• Sudden cough without obvious cause, possibly with coughing up blood

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

• Severe dizziness or vertigo

• Rapid or irregular heartbeat

• Severe stomach pain

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

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

• Sudden loss of vision, or
• Painless visual disturbances, which may progress to vision loss

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis), although these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Jeanine, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on a woman's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Jeanine is low, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In such case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Jeanine several weeks before surgery or during immobilization. If the patient must stop taking Jeanine, consult the doctor about when it is safe to resume taking the medicine.
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Jeanine.
Inform the doctor if any of the above conditions change during treatment with Jeanine, for example, if a close family member develops unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can cause serious consequences, such as myocardial infarction (heart attack) or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Jeanine is very low, but it may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Jeanine, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder such as 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 further increased.
Inform the doctor if any of the above conditions change during treatment with Jeanine, for example, if the patient starts smoking, a close family member develops unexplained thrombosis, or if the patient gains significant weight.

If symptoms suggesting thrombosis occur, stop taking the tablets and consult a doctor immediately (see also "When to contact the doctor").

Oral contraception and cancer
Women who use oral contraceptives have a slightly higher incidence of breast cancer compared to women of the same age who do not use them. It is not known whether this difference is solely due to the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception undergo more frequent medical examinations, leading to earlier detection of breast cancer. This difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Rare cases of benign or, even more rarely, malignant liver tumors, which may lead to life-threatening intra-abdominal bleeding, have been reported in women using combined oral contraceptives. If severe upper abdominal pain occurs, the patient should contact the doctor immediately.

Malignant tumors may be life-threatening or lead to death.

There have been reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to taking the pills, but rather to sexual behavior or other factors.

Psychiatric disorders
Some women using 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, contact the doctor as soon as possible for further medical advice.

Jeanine and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Some medicines may affect the blood concentration of Jeanine, reduce its contraceptive effectiveness, 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 (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, hypertension (calcium channel blockers, e.g. verapamil, diltiazem)
• arthritis, osteoarthritis (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.

Jeanine should not be used in patients with hepatitis C who are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause elevated liver function tests (increased levels of the liver enzyme AlAT). The doctor will recommend another type of contraception before starting these medicines. Jeanine may be resumed approximately 2 weeks after stopping treatment. See section "When not to use Jeanine".

When to contact the doctor
Contact the doctor immediately if:

• worrying changes in health occur, especially any of the symptoms listed in this leaflet (see also: "When to be cautious when using Jeanine" and "How to use Jeanine");
• there is a history of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• the patient plans to take other medicines (see also "Using Jeanine with other medicines");
• immobilization or planned surgical procedure (inform the doctor at least 4 weeks in advance);
• there is heavy vaginal bleeding;
• tablets are missed in the first week of the cycle (each first week in consecutive months of taking Jeanine), and intercourse occurred in the previous 7 days;
• acute diarrhoea occurs;
• withdrawal bleeding does not occur in two consecutive months or pregnancy is suspected (do not start the next pack without consulting the doctor).

Stop taking Jeanine and contact the doctor as soon as possible if any symptoms suggesting possible thrombosis, heart attack, or stroke occur:

• cough without apparent cause,
• severe chest pain, possibly radiating to the left arm,
• shortness of breath,
• headache of unusual severity or migraine attack,
• partial or complete loss of vision or double vision,
• slurred speech or loss of ability to speak,
• sudden sensory disturbances (hearing, smell, or touch),
• dizziness or fainting,
• numbness or weakness of part of the body,
• severe abdominal pain,
• severe pain or swelling in the legs.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Jeanine should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult the doctor immediately.

Breastfeeding
Jeanine is not recommended during breastfeeding.

Driving and operating machinery
No influence of Jeanine on the ability to drive or operate machinery has been observed.

Important information about some ingredients of Jeanine
Jeanine contains sucrose and liquid glucose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking Jeanine.

3. How to use Jeanine

This medicine should always be taken in accordance with the instructions provided by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
This leaflet describes many situations in which you should stop taking Jeanine or in which the effectiveness of the medicine may be reduced.
It also specifies circumstances in which sexual intercourse should be avoided or additional contraceptive methods (e.g. condoms or other mechanical methods) should be used.
The calendar method and the temperature method should not be used, as Jeanine affects changes in body temperature and cervical mucus properties characteristic of the menstrual cycle.
Jeanine, like other oral contraceptives, does not protect against infection with the HIV virus (AIDS) or sexually transmitted diseases.

How to take Jeanine

• When and how should the tablets be taken?

The blister pack contains 21 coated tablets. Each tablet in the pack is marked with the symbol of the day of the week on which it should be taken (see “Translation of day-of-the-week symbols on each tablet in the immediate packaging” at the end of this leaflet). The tablets should be taken in the order indicated on the pack, every day at approximately the same time, with a small amount of liquid if needed. One tablet should be taken daily for 21 consecutive days. Each subsequent pack should be started after a 7-day break, during which no tablets are taken and during which withdrawal bleeding usually occurs. Bleeding usually begins 2–3 days after taking the last tablet and may continue into the start of the next pack. This means that each new pack should always be started on the same day of the week, and bleeding will generally occur on approximately the same days each month.

• Starting Jeanine for the first time

If no combined oral contraceptives have been used in the previous month
Tablet-taking should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual bleeding). Tablets may also be started between days 2 and 5 of the cycle. In this case, additional mechanical contraception is recommended during the first cycle for the first 7 days of tablet intake.
If a different combined oral contraceptive has been used previously
It is recommended to start taking Jeanine on day 1 after the last active tablet of the previous combined oral contraceptive, but no later than day 1 after the usual tablet-free or placebo interval of the previous combined oral contraceptive.
If a progestogen-only pill (mini-pill) has been used previously
You may stop taking the mini-pill on any day and start taking Jeanine at the same time of day instead. If sexual intercourse occurs during the first 7 days of taking Jeanine, another method of contraception (mechanical methods) should be used simultaneously.
If contraception has previously been administered via injection, implant, or intrauterine system releasing progestogen
Jeanine should be started on the day the next injection would have been administered, or on the day of removal of the implant or system. If sexual intercourse occurs during the first 7 days of taking the tablets, another method of contraception (mechanical methods) should be used simultaneously.
After childbirth, miscarriage, or induced abortion

• After a first-trimester abortion
  Jeanine may be started immediately. In this case, additional contraceptive methods are not necessary.
• After childbirth or second-trimester abortion
  For breastfeeding women, see section 2, “Breast-feeding”. Your doctor will advise you to start taking tablets between 21 and 28 days after childbirth or second-trimester abortion. If tablet-taking is started later, your doctor will advise you to use additional mechanical contraception for the first 7 days of tablet intake. If sexual intercourse occurred before starting the combined oral contraceptive, pregnancy should be ruled out or you should wait until the first natural menstrual period occurs.

If you take more Jeanine than you should
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken this medicine. There are no reports of severe adverse effects after taking multiple tablets of Jeanine at once. If you or someone else has taken more than the recommended dose, you should contact your doctor immediately.

Stopping further use of Jeanine
You may stop taking the medicine at any time. Your doctor will then suggest alternative contraceptive methods.
If you stop taking the medicine because you wish to become pregnant, you should wait until your next natural menstrual period occurs. This will help determine the expected date of delivery.

Missed dose of Jeanine
If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Jeanine is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.
If more than 12 hours have passed since the missed tablet, the effectiveness of Jeanine may be reduced. The more consecutive tablets missed, the greater the risk of reduced contraceptive effect. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. In such cases, follow the rules outlined below (see also the chart below).
More than 1 tablet missed from the pack
You should consult your doctor.
One tablet missed during the first week of taking the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the following tablets at the usual time. Use additional contraceptive methods (mechanical methods) for the next 7 days.
If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred. You should contact your doctor immediately. You should also refer to the “Missed tablet management chart” below.
One tablet missed during the second week of taking the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the following tablets at the usual time. The contraceptive effectiveness of Jeanine is maintained, and additional pregnancy prevention methods are not necessary.
However, if previous dosing errors occurred or more than one tablet has been missed, use an additional (mechanical) contraceptive method for 7 days.
One tablet missed during the third week of taking the current pack
You may choose one of the following options without needing additional contraceptive methods, provided that correct dosing was followed during the 7 days preceding the missed dose. Otherwise, follow the first of the two options listed below and use an additional contraceptive method for the next 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the remaining tablets at the usual time. Start the next pack immediately after finishing the current one, without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but spotting or bleeding may occur during tablet-taking days.
2. Alternatively, you may stop taking tablets from the current pack, take a 7-day or shorter break (including the day on which the tablet was missed), and then continue with the next pack. If you forget to take tablets and no expected bleeding occurs during the first tablet-free interval, pregnancy may have occurred. You should contact your doctor before starting the next pack.

Missed tablet management chart
[Note: The chart is not included in the provided text but would typically be presented visually in the leaflet.]

The following occurred
Week 1: Sexual intercourse occurred during the week
preceding the missed tablet
No sexual intercourse occurred

• Take the missed tablet
• Use an additional contraceptive method for 7 days
• Continue taking tablets from the same pack
  Missed only 1 tablet (delay
  Week 2.
• Take the missed tablet
  greater than 12
• Continue taking tablets from the pack
  hours but less than 24 hours)
• Take the missed tablet
• Finish the pack
• Do not take a 7-day break
• Continue with tablets from the next pack
  Week 3. or
• Discard the remaining tablets in the pack
• Take a break (no longer than 7 days, counting from the day the tablet was missed)
• Continue with tablets from the next pack

Management in the following situations:

• Gastrointestinal disturbances (vomiting)
  If vomiting occurs, the active substances in Jeanine may not be completely absorbed. If vomiting occurs within 3 to 4 hours after taking the tablet, follow the instructions for a missed tablet. In case of severe gastrointestinal disturbances, additional contraceptive methods should be used.

• Intention to delay withdrawal bleeding
  To delay the onset of withdrawal bleeding, start the next pack immediately after finishing the current one, without taking a 7-day break. Tablets may be taken for as long as desired. If withdrawal bleeding is desired, simply stop taking the tablets. During the use of tablets from the next pack, light bleeding or spotting may occur. The next pack should be started after a 7-day break.

• Intention to change the day of withdrawal bleeding to another day of the week
  When taking tablets as directed, bleeding usually occurs approximately on the same day every 4 weeks. To change the day of bleeding to another day of the week than that resulting from the current regimen, shorten the next tablet-free interval by as many days as the desired shift in the bleeding date. For example, if bleeding usually starts on Fridays but should start on Tuesdays (3 days earlier), begin the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days or less), withdrawal bleeding may not occur during this period. Light bleeding or spotting may occur during the use of the next pack.

• Occurrence of unexpected bleeding
  During the first few months of taking Jeanine, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur. Despite this, continue taking the tablets as prescribed. Irregular vaginal bleeding usually resolves after 3 cycles of Jeanine use. If bleeding persists, becomes heavy, or recurs, consult a physician.

• Absence of withdrawal bleeding
  If all tablets have been taken correctly, without vomiting or severe diarrhea, and no other medications have been used concurrently, the likelihood of pregnancy is very low. Continue taking Jeanine as directed.

If withdrawal bleeding does not occur in two consecutive months, pregnancy is possible. Immediately inform your doctor. Do not start the next pack of Jeanine until your doctor has ruled out pregnancy.

Additional information for specific patient groups

Children and adolescents
Jeanine is indicated only after the onset of menstruation.

Elderly patients
Not applicable. Jeanine is not indicated for use in postmenopausal women.

Patients with hepatic impairment
Jeanine is contraindicated in women with severe liver disease. See also section 2 "When not to use Jeanine."

Patients with renal impairment
Specific studies with Jeanine have not been conducted in patients with renal impairment. Available data do not indicate the need for treatment modification in this patient group.

4. Possible adverse reactions

Like all medicines, Jeanine may cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially severe or persistent ones, or any changes in health status that the patient considers related to the use of Jeanine, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Jeanine".

Serious adverse reactions

Serious adverse reactions associated with taking Jeanine and their accompanying symptoms are described in the following sections of this leaflet: "How to recognize the occurrence of blood clots" and "Oral contraception and cancer". Please read these sections for additional information and consult your doctor immediately if necessary.

Seek immediate medical attention if any of the following symptoms of angioedema occur: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, which may cause difficulty breathing (see also section "Warnings and precautions").

Other possible adverse reactions

The following symptoms have been reported by women taking Jeanine, although they may not necessarily have been caused by the medicine.

Common (more than 1 in 100, but less than 1 in 10 people):

• headache,
• breast pain, including breast discomfort and tenderness.

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

• vaginitis and/or vulvovaginitis (inflammatory conditions of the genital organs),
• vaginal candidiasis (yeast infection) or other fungal infections of the vagina,
• increased appetite,
• depressed mood,
• dizziness,
• migraine,
• high or low blood pressure,
• abdominal pain, including upper and lower abdominal pain, discomfort and/or bloating,
• nausea, vomiting or diarrhoea,
• acne,
• alopecia (hair loss),
• rash (including maculopapular rash),
• itching (sometimes generalized),
• changes in menstrual bleeding such as heavy, light, infrequent or absent periods,
• intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods),
• breast enlargement, including breast congestion and swelling,
• breast swelling,
• painful menstruation (dysmenorrhoea),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including asthenia (weakness) and malaise,
• changes in body weight (including weight gain, weight loss and weight fluctuations).

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

• inflammation of the ovaries and/or fallopian tubes,
• urinary tract infections,
• cystitis (bladder inflammation),
• mastitis (inflammation of the breast),
• cervicitis (inflammation of the cervix),
• fungal infections,
• oral herpes,
• influenza,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infection,
• uterine leiomyoma,
• fibroadenoma of the breast,
• anaemia,
• hypersensitivity (allergic reaction),
• virilization (development of male secondary sexual characteristics in women),
• anorexia (severe loss of appetite),
• depression,
• psychiatric disorders,
• insomnia,
• sleep disorders,
• aggression,
• stroke (reduced or interrupted blood supply to part of the brain),
• cerebral circulation disorders (disorders of blood flow to parts of the brain),
• dystonia (sustained muscle contractions causing twisting or abnormal postures),
• dry or irritated eyes,
• oscillopsia (subjective sensation of oscillating vision) or other visual disturbances,
• sudden hearing loss,
• tinnitus,
• dizziness,
• hearing disorders,
• cardiovascular disorders (disorders of blood supply to the heart),
• tachycardia (rapid heartbeat),
• venous and arterial thromboembolic events*
• pulmonary embolism (blood clot travelling to the lungs),
• thrombophlebitis (vein inflammation including blood clots),
• elevated diastolic pressure (lowest level to which blood pressure drops between heartbeats),
• orthostatic hypotension (dizziness or fainting upon standing from sitting or lying down),
• hot flushes,
• varicose veins,
• venous dysfunction or vein pain,
• asthma,
• hyperventilation,
• gastritis (inflammation of the stomach lining),
• enteritis (inflammation of the intestine),
• indigestion,
• skin reactions,
• skin disorders including allergic dermatitis, neurodermatitis and/or atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (pigmented facial patch),
• pigmentary disturbances and/or hyperpigmentation,
• seborrhoea,
• pityriasis,
• hirsutism (excessive hair growth),
• skin disorders, skin reactions, "orange peel" skin appearance,
• spider angioma,
• back pain,
• bone and muscle discomfort,
• muscle pain,
• pain in arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix),
• pain or cysts of the uterine appendages (ovaries and fallopian tubes),
• breast cysts,
• fibrocystic breast changes,
• painful sexual intercourse,
• galactorrhea (milk secretion),
• menstrual disorders,
• chest pain,
• swelling of arms and legs,
• flu-like illnesses,
• inflammation,
• fever,
• irritability,
• hypercholesterolaemia,
• increased blood triglyceride levels,
• revelation of supernumerary breast tissue.

* Estimated frequency from epidemiological studies covering the group of combined oral contraceptives. The term "venous and arterial thromboembolic events" includes: any obstruction or clot in deep peripheral veins, clots travelling 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 within 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 (urticaria, nodular erythema, erythema multiforme),
• breast discharge,
• fluid retention.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Description of selected adverse reactions

Adverse reactions with low frequency or delayed onset, considered to be associated with the group of combined oral contraceptives, are listed below (see also sections "When not to use Jeanine" and "When to take special care with Jeanine"):

Cancer

• A slightly increased number of breast cancer diagnoses has been observed in women using combined oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the overall number of diagnoses remains small in relation to the total risk of breast cancer. A causal relationship between combined oral contraceptives and breast cancer has not been established.

• liver tumours (benign and malignant).

Other

• Women with hypertriglyceridaemia (increased blood fat levels, increasing the risk of pancreatitis during use of combined oral contraceptives),
• High blood pressure,
• Occurrence or worsening of symptoms, the relationship of which to COC use is not established: jaundice and/or pruritus associated with cholestasis (blocked bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (chronic autoimmune disease); haemolytic-uraemic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a skin disorder occurring during pregnancy); otosclerosis associated with hearing loss;
• In women with hereditary angioedema (characterized by sudden swelling, e.g. of eyes, lips, throat, etc.), exogenous estrogens may trigger or worsen angioedema symptoms;
• Liver function disorders;
• Changes in glucose tolerance or effects on peripheral insulin resistance;
• Crohn's disease, ulcerative colitis;
• Chloasma.

Interactions

Intermenstrual bleeding and/or reduced contraceptive effectiveness may be caused by interactions with other medicines (e.g. St John's wort (Hypericum perforatum), or drugs used to treat epilepsy, tuberculosis, HIV infection and other infections). See section "Taking Jeanine with other medicines".

Reporting of adverse reactions

If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Jeanine

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use Jeanine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Jeanine contains

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

What Jeanine looks like and contents of the pack
White, round coated tablets.
Pack: 1 blister containing 21 coated tablets.
A cardboard sachet is included with the pack, in which the blister should be placed.
PVC/PE/EVOH/PE/PCTFE/Aluminum blisters in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Germany, country of export:
Jenapharm GmbH & Co. KG
Otto-Schott-Straße 15
07745 Jena
Germany
Manufacturer:
Bayer Weimar GmbH und Co. KG
Döbereiner Straße 20
99427 Weimar
Germany
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
German (country of export) marketing authorization number: 53560.00.00
Parallel import authorization number: 179/20
Translation of weekday symbols next to each tablet on the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday