Jeanine

Package leaflet: Information for the user

Warning! Keep the package 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 medicine.
Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Jeanine is and what it is used for
2. Important information 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 medicine. Each tablet contains two different hormones: dienogest (a progestogen) and ethinylestradiol (an oestrogen).
When Jeanine is taken according to the recommendations 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 contraceptive tablets after failure of appropriate topical treatment or systemic antibiotic therapy.

2. Important information before using Jeanine

General notes
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Before starting to take 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”).
Skin changes related to acne 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 of starting therapy, and then at regular intervals.

When not to use Jeanine:

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

• if you are allergic to ethinylestradiol or dienogest, or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you are undergoing 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 that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition called hyperhomocysteinemia;
• if you have (or have previously had) a type of migraine called “migraine with aura”;
• if you currently 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 a hormone-dependent cancer (e.g. breast or genital organ cancer);
• if you have vaginal bleeding of unknown cause;
• if you are pregnant or suspect you might be pregnant.

If any of the symptoms listed above 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 and other medicines”).

Warnings and precautions

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

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When to contact your doctor:

Seek immediate medical attention:

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

For a description of the symptoms of these serious adverse effects, see “How to recognize blood clots”.

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

Tell your doctor if you have any of the following conditions.
If 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 veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if there is a family history of thrombosis, heart attack, or stroke;
• if you have migraines;
• if you have epilepsy;
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• if there is or has been 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 causing 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 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 appeared or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes gestationis, Sydenham’s chorea);
• if you have or have previously had skin discoloration (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, which may cause breathing difficulties – seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

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

BLOOD CLOTS

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

Blood clots may occur:

• in veins (referred to below as “venous thrombosis” or “venous thromboembolic disease”);
• in arteries (referred to below 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 caused by taking Jeanine is low.

HOW TO RECOGNIZE BLOOD CLOTS

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

Are you experiencing 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, e.g. paleness, redness, or blueness;

• sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden coughing without obvious cause, possibly with coughing up blood;

• sharp chest pain, which may worsen on deep breathing;

• severe dizziness or lightheadedness;

• 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 a respiratory tract infection (e.g. cold).

Symptoms most commonly affecting one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision;

• painless visual disturbances, which may progress to vision loss;

• chest pain, discomfort, pressure, or heaviness;
  Myocardial infarction (heart attack)

• squeezing or fullness sensation in the chest, arm, or below the breastbone;

• feeling of fullness, indigestion, or choking;

• discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach.

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BLOOD CLOTS IN VEINS
What could happen if blood clots form in the veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). Although these adverse effects 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 the development of 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 blood clots in the veins highest?
The risk of developing blood clots in the veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different medicine) after a break of four weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives at all.
If a woman stops taking Jeanine, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?
The risk depends on the natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.

• In the course of one year, about 2 out of 10,000 women who do not use 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 contraceptives containing dienogest and ethinylestradiol, such as Jeanine, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (see "Factors that increase the risk of blood clots" below).

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Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Jeanine is small, 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 of age). In this 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 plaster. It may be necessary to discontinue use of Jeanine several weeks before surgery or periods of immobility. If the patient must stop taking Jeanine, consult a doctor about when it is safe to restart.
• with increasing age (particularly 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, especially if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue use of Jeanine.
Inform the doctor if any of the above conditions change during treatment with Jeanine, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to 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 (over 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 a different 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 this 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 lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura; Page 6 of 18
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia 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 is diagnosed with 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 a doctor”).

Oral contraception and cancer
Breast cancer occurs slightly more frequently in women taking oral contraceptives than in 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 are examined more frequently, leading to earlier detection of breast cancer. The observed difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.

Rare cases of benign and, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform the doctor as soon as possible.
Malignant tumors may be life-threatening or fatal.

There are reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be due to the use of the tablets, 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 may 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 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),

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• 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 medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these may cause elevated liver function test results (increased levels of the liver enzyme AlAT).
The doctor will recommend an alternative method of contraception before starting treatment with the above-mentioned drugs.
Jeanine may be resumed approximately 2 weeks after stopping the treatment. See section “When not to use Jeanine”.

When to contact a doctor
Contact a doctor immediately if:

• any concerning changes in health occur, particularly any of the symptoms listed in this leaflet (see also: “Warnings and precautions” and “How to use Jeanine”);
• there is a history of thrombosis, heart attack, or stroke in close relatives;
• a breast lump is detected;
• other medicines are to be used (see also “Jeanine and other medicines”);
• immobilization is expected or surgery is planned (inform the doctor at least 4 weeks in advance);
• heavy vaginal bleeding occurs;
• tablets are missed in the first week of the cycle (each first week of subsequent months of using Jeanine) and intercourse occurred in the preceding 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 a doctor).

Stop taking Jeanine and contact a 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 a migraine attack,
• partial or complete loss of vision or double vision,
• slurred or lost speech,
• 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
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Jeanine should not be taken during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult a doctor immediately.

Breastfeeding
Jeanine is not recommended during breastfeeding.

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

Important information about certain 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 a doctor before taking Jeanine.

3. How to use Jeanine

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
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 describes 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 must not be
used, as Jeanine affects changes in body temperature and cervical mucus characteristics typical 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 use Jeanine

• When and how should the tablets be taken? The blister pack contains 21 coated tablets. Each tablet is marked on the packaging with the symbol of the day of the week on which it should be taken (see "Translation of symbols for days of the week located next to each tablet on the immediate packaging" at the end of this leaflet). 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. 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 occur approximately on the same days each month.
• Starting treatment with Jeanine for the first time

If no oral contraceptives have been used in the past month
Tablet taking should begin on day 1 of the natural menstrual cycle (i.e. the first day of menstrual
bleeding). Tablet taking may also begin between day 2 and day 5 of the cycle; in such a case,
additional mechanical contraception is recommended during the first cycle for the first 7 days of
tablet taking.
If previously using 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 after the usual tablet-free
interval (including placebo tablets) of the previous combined oral contraceptive.
If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill on any day and start taking Jeanine at the same time instead. If
sexual intercourse occurs during the first 7 days of taking Jeanine, additional contraceptive
methods (mechanical methods) should be used simultaneously.
If previously using injectable contraception, an implant, or a transdermal therapeutic system
releasing progestogen
Jeanine should be started on the day the next injection was due or on the day of removal of the
implant or system. If sexual intercourse occurs during the first 7 days of taking tablets, additional
contraceptive methods (mechanical methods) should be used simultaneously.
After childbirth, miscarriage, or induced abortion

• After a first-trimester miscarriage
  Jeanine may be started immediately. In this case, additional contraceptive methods are not
  necessary.
• After childbirth or second-trimester miscarriage
  For breastfeeding women, see section 2. "Breastfeeding".

Your doctor should advise you to start taking tablets between 21 and 28 days after childbirth or
second-trimester miscarriage. If tablet use is started later, your doctor should advise you to use
additional mechanical contraception for the first 7 days of tablet taking. If intercourse occurred
before starting the combined oral contraceptive, pregnancy should be ruled out or you should wait
until the first menstrual bleeding occurs.
If more Jeanine has been taken than recommended
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 more than the recommended
dose has been taken, or if someone else has taken it, inform your doctor.
Stopping further use of Jeanine
The medicine may be discontinued at any time. Your doctor will then suggest alternative
contraceptive methods.
If you stop taking the medicine because you wish to become pregnant, wait until natural
menstruation 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
effectiveness. The risk of pregnancy is particularly high if tablets are missed at the beginning or end
of the pack. In such a case, follow the rules below (see also the diagram below).
More than 1 tablet missed from the pack
Consult your doctor.
One tablet missed in 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 take the next 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.
Inform your doctor immediately. Also refer to the "Missed tablet management chart".
One tablet missed in 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 take the next 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 was missed, use additional
(mechanical) contraception for 7 days.
One tablet missed in the third week of taking the current pack
You may choose one of the following options without needing additional contraceptive methods,
provided correct dosing was maintained during the 7 days preceding the missed dose. Otherwise,
apply the first of the two options below and use additional contraception 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 next tablets at the usual time. Start the next pack immediately after finishing the current pack, i.e. 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, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue taking tablets from the next pack.

If you forget to take tablets and no expected bleeding occurs during the first tablet-free interval,
pregnancy may be possible. Contact your doctor before starting the next pack of medicine.
Missed tablet management chart
More than one tablet missed from the current pack – Seek advice from your doctor
Sexual intercourse occurred
Week 1.
in the week before missing the tablet
No sexual intercourse occurred

• Take the missed tablet
• Use additional contraceptive method for 7 days
• Finish taking tablets from the pack

Only one tablet missed (delay
Week 2.
greater than 12 hours but less
than 24 hours)

• Take the missed tablet

• Finish taking tablets from the pack

• Take the missed tablet

• Finish the pack

• Do not take a 7-day break

• Continue taking tablets from the next pack

Week 3.
or

• Discontinue remaining tablets in the pack
• Take a break (no more than 7 days, including the day the tablet was missed)
• Continue taking tablets from the next pack

Management in the following situations:

• Gastrointestinal disturbances (vomiting)
  If vomiting occurs, the active ingredients of Jeanine may not be completely absorbed. If vomiting
  occurs within 3 to 4 hours after taking a tablet, follow the recommendations for a missed tablet.
  In case of severe gastrointestinal disturbances, additional contraceptive methods should be used.
• Desire to delay the onset of bleeding
  To delay the onset of bleeding, start the next pack immediately after finishing the current pack,
  without a 7-day break. Tablets may be taken continuously until the pack is finished. If you wish
  bleeding to occur, simply stop taking tablets. During use of tablets from the next pack, slight
  bleeding or spotting may occur. The next pack should be started after a 7-day break.
• Desire to change the day of bleeding to another day of the week
  If tablets are taken as directed, bleeding occurs approximately on the same day every 4 weeks. To
  change the bleeding day to another day of the week, shorten the next tablet-free interval by as many
  days as you wish to shift the bleeding. For example, if bleeding usually starts on Fridays and you
  wish it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If a very
  short tablet-free interval is taken (e.g. 3 days or less), withdrawal bleeding may not occur during
  the break. Slight bleeding or spotting may occur during use of the next pack.
• Unexpected bleeding
  During the first few months of taking Jeanine, irregular genital bleeding (spotting or
  intermenstrual bleeding) may occur. Despite this, continue taking the tablets. Irregular genital
  bleeding usually resolves after 3 cycles of Jeanine use. If bleeding persists, becomes heavy, or
  recurs, inform your doctor.
• Absence of bleeding
  If all tablets were taken on time, there were no vomiting or severe diarrhoea, and no other
  medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking
  Jeanine.
  If withdrawal bleeding does not occur for two consecutive months, pregnancy may be possible.
  Inform your doctor immediately. 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 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
  No specific studies with Jeanine have been conducted in patients with renal impairment. Available
  data do not indicate the need for dose adjustment in this patient group.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Jeanine, medical advice should be sought.
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All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (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 using Jeanine”.
Serious adverse effects
Serious adverse effects associated with taking Jeanine and their accompanying symptoms are described in the following sections of this leaflet: “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 the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, which may cause breathing difficulties (see also section “Warnings and precautions”).
Other possible adverse effects
The symptoms listed below 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 discomfort and tenderness.

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

• vaginal inflammation 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,
• hair loss (loss of hair),
• rash (including macular rash),
• itching (sometimes generalized),
• changes in menstrual bleeding such as heavy, scanty, infrequent periods or complete absence of periods,
• intermenstrual bleeding from the vagina, uterine haemorrhage (irregular bleeding between periods),
• breast enlargement, including breast congestion and swelling,
• breast swelling,
• painful menstruation (painful periods),
• 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 fallopian tubes,
• urinary tract infections,
• cystitis (bladder inflammation),
• mastitis (inflammation of the breast),
• cervicitis (inflammatory condition 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 disturbances,
• aggression,
• stroke (reduced or interrupted blood supply to part of the brain),
• cerebral circulation disorders (disorders of blood flow to part 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,
• vertigo,
• hearing disorders,
• cardiovascular disorders (blood flow disorders 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 (the 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 insufficiency or venous 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 patches),
• pigmentary disturbances and/or discoloration,
• seborrhoea,
• dandruff,
• hirsutism (excessive hair growth),
• skin disorders, skin reactions, “orange peel” skin appearance,
• spider angioma,

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• back pain,

• bone and muscle complaints,

• 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 discharge),

• menstrual disorders,

• chest pain,

• swelling of hands and feet,

• flu-like illness,

• inflammation,

• fever,

• irritability,

• hypercholesterolaemia,

• increased blood triglyceride levels,

• presence 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 and blood clot in deep peripheral veins, clots travelling through the circulatory system (e.g. to the lungs, known as pulmonary embolism or lung 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),
• nipple discharge,
• fluid retention.

The risk 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 effects
Adverse effects of low frequency or with 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 “Warnings and precautions”):
Cancers

• A slightly increased number of breast cancer cases have been diagnosed in women using combined oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the number of diagnoses is small in relation to the overall risk of breast cancer. A causal relationship between breast cancer and combined oral contraceptives has not been established.
• liver tumours (benign and malignant)

Other
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• 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 whose relationship with 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 type of skin disease occurring 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 reduced contraceptive effectiveness may be caused by interactions of other medicines with oral contraceptives (e.g. St. John's wort (Hypericum perforatum), or drugs used for epilepsy, tuberculosis, HIV infection and other infections). See section “Jeanine with other medicines”.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 effects 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 packaging and other information

What Jeanine contains

• The active substances in this medicinal product are ethinylestradiol and dienogest. Each coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of micronized dienogest.
• Other ingredients are: maize starch, pregelatinized maize starch, maltodextrin, magnesium stearate, microcrystalline cellulose, coating: sucrose, liquid glucose, calcium carbonate, povidone K 25, povidone K 90, macrogol 35,000, macrogol 6,000, titanium dioxide (E 171), carnauba wax, talc.

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What Jeanine looks like and contents of the pack
White, round coated tablets.
Pack contains 1, 2 or 3 blisters of 21 coated tablets each.
PVC/PE/EVOH/PE/PCTFE/Al blisters in a cardboard carton.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
German marketing authorisation number (country of export): 53560.00.00
Parallel import authorisation number: 299/19
Translation of the day-of-the-week symbols printed next to each tablet on the immediate packaging:
Mo - Monday
Di - Tuesday
Mi - Wednesday
Do - Thursday
Fr - Friday
Sa - Saturday
So - Sunday
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