Jeanine

Patient Information Leaflet

Keep this leaflet! The packaging label is in a foreign language.
Jeanine (Maxim)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Jeanine and Maxim are different brand names for the same medicine.
Important information about 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 your doctor if you suspect symptoms of a blood clot (see section 2 "BLOOD CLOTS").

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

• Keep this leaflet so that you can 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 medicine. Each tablet contains two different hormones: dienogest (a progestogen) and ethinylestradiol (an oestrogen).
When Jeanine is taken according to the instructions in this leaflet, the likelihood of becoming pregnant is very low.
Indications
Pregnancy prevention.
Treatment of moderate acne in women who have decided to use oral contraceptive tablets 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 symptoms usually improve within three to six months of treatment and may continue to improve even after six months. You should discuss with your 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 you have any of the conditions listed below. If you have any of these conditions, 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 deep 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 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 had in the past) 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 currently have (or have ever had) a type of migraine called “migraine with aura”;
• if you have had or currently have severe liver disease (until liver function tests return to normal);
• if you have had or currently have benign or malignant liver tumours;
• if you have had or currently have 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 may be pregnant.

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 treatment with Jeanine, discuss this with your doctor or pharmacist.

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

• you notice symptoms suggesting a blood clot, which may indicate a blood clot in the leg (deep vein thrombosis), in the 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 the occurrence of blood clots”.

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

Tell your doctor if you have any of the following conditions.
If any of these symptoms develop 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 disturbances;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if there is a family history of blood clots, 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 you have a family history of 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 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 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 ever had skin pigmentation disorders (yellow-brown discolouration, 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 that may cause 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 symptoms listed above occur for the first time, recur, or worsen during treatment with Jeanine, contact your doctor.

BLOOD CLOTS
Using combined hormonal contraceptives such as Jeanine is associated with an increased 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 THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

Do you experience any of these symptoms? What is the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, particularly if accompanied by:
  Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt while standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as pallor, redness, or blueness;
• sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism
• sudden cough without an obvious cause, which may be associated with coughing up blood;
• 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 a respiratory tract infection (e.g. cold).

BLOOD CLOTS IN VEINS
What can happen if blood clots develop 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 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 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?
The risk depends on the woman's 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 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 small, however
some 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 relative of the patient has been diagnosed with blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, if she is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Jeanine for several weeks before surgery or immobilisation. If the patient must stop taking Jeanine, ask the doctor when it is safe to restart.
• with increasing age (particularly over 35 years);
• if the patient has recently 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 mentioned risk factor.
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, e.g. if a close relative is diagnosed with 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 note that the risk of heart attack or stroke associated with the use of Jeanine is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While 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 relative 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 relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, 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 is 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, e.g. if the patient starts smoking, if a close relative 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 who take oral contraceptives than in women of the same age who do not. 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 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 and, even more rarely, malignant liver tumours 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 tumours can be life-threatening or fatal.

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 directly related to taking the tablets, but rather to sexual behaviour 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 taken, recently taken, or planned to be taken.

Some medicines may affect the blood levels of this drug, 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 (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics such as clarithromycin, erythromycin)
• certain heart conditions, hypertension (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.

Jeanine must 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 another form of contraception before starting treatment with these medicines.
Jeanine may be resumed approximately 2 weeks after stopping treatment. See section “When not to use Jeanine”.

When to contact a doctor
Contact the doctor immediately if:

• worrying changes in health occur, especially any of the symptoms listed in this leaflet (see also: “When to take special care with Jeanine” and “How to use Jeanine”);
• cases of thrombosis, heart attack or stroke occur in close relatives;
• a breast lump is detected;
• other medicines are to be used (see also “Jeanine and other medicines”);
• immobilisation is possible 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 Jeanine use) 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 the doctor’s advice).

Stop taking Jeanine and contact a doctor as soon as possible if 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 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
Do not take Jeanine 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 effects of Jeanine on the ability to drive and operate machinery have been observed.

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

3. How to take Jeanine

This medicine should always be taken exactly as instructed 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 under 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 cannot be
used, as Jeanine affects changes in body temperature and cervical mucus 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 take Jeanine

• When and how should the tablets be taken?

The blister pack contains 21 coated tablets. Each tablet is marked on the packaging with a symbol
indicating 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).
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 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 taken 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 Day 2 and Day 5 of the menstrual cycle; in such
cases, additional mechanical contraception is recommended during the first 7 days of tablet taking
in the first cycle.
If previously using another combined oral contraceptive
It is recommended to start taking Jeanine on Day 1 after taking 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 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, implant or intrauterine hormonal contraception 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

Breastfeeding women – see section 2. "Breastfeeding".
Your doctor should advise that tablet taking should begin between 21 and 28 days after childbirth
or second-trimester miscarriage. If starting later, your doctor should advise using additional
mechanical contraception for the first 7 days of tablet taking. If sexual intercourse occurred before
starting the combined oral contraceptive, pregnancy should be ruled out or wait until the first
menstrual bleeding 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 Jeanine tablets at once. If you have taken more than the
recommended dose, or if someone else has taken it, inform your doctor.
Stopping treatment with 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 your next natural
menstrual period. This will help determine the expected date of delivery.
Missed dose of Jeanine
If less than 12 hours have passed since you missed a tablet, the contraceptive effectiveness of
Jeanine is maintained. Take the missed tablet as soon as possible and take the next tablet at your
usual time.
If more than 12 hours have passed since you missed a tablet, the effectiveness of Jeanine may be
reduced. The more tablets you miss consecutively, 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 a pack. In such cases, follow the rules below (see also the chart 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 continue taking 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 continue taking the next tablets at the usual time. The contraceptive effectiveness of Jeanine is
maintained and additional contraceptive 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 before the missed dose. Otherwise,
follow 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.
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.
Missed tablet management chart
More than 1 tablet missed from the current pack → Seek medical advice
Sexual intercourse occurred in the week preceding the missed tablet → Yes
Week 1.
No

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

Only one tablet missed (delay >12 hours, but <24 hours)
Week 2. – 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 of the missed tablet)
• Continue taking tablets from the next pack

Managing the following situations:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Jeanine may not be fully absorbed. If vomiting occurs
within 3 to 4 hours after taking a tablet, follow the instructions for a missed tablet. If you have
severe gastrointestinal disturbances, use additional contraceptive methods.

• Intention to delay 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. Spotting or light bleeding may occur during tablet
taking. The next pack should be started after a 7-day break.

• Intention 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 the
number of days 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 the
tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during the
break. Spotting or light bleeding may occur during the next pack.

• 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 taking Jeanine. If bleeding persists, becomes heavy or
recurs, inform your doctor.

• Absence of bleeding

If all tablets were taken on time, there were no episodes of vomiting or severe diarrhoea, and no
other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking
Jeanine as scheduled.
If withdrawal bleeding does not occur in two consecutive months, pregnancy is 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 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
No specific studies have been conducted with Jeanine in patients with renal impairment. Available
data do not indicate a need for dose adjustment in this patient group.

4. Possible adverse effects

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

All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in 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 taking Jeanine".

Serious adverse effects
Serious adverse effects 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 carefully 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
Below are symptoms reported by patients 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 breast tenderness

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

• Vaginitis and/or vulvovaginitis (inflammation 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 (alopecia)
• Rash (including maculopapular rash)
• Itching (sometimes generalized)
• Changes in menstrual bleeding such as heavy, light, infrequent periods or complete absence of 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):

• Oophoritis and salpingitis (inflammation of ovaries and 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 (fibroids)
• 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)
• Cerebrovascular disorders (disorders of blood flow to the brain)
• Dystonia (sustained muscle contractions causing twisting movements 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 (blood flow disturbances to the heart)
• Tachycardia (rapid heartbeat)
• Venous and arterial thromboembolic events*
• Pulmonary embolism (blood clot travelling to the lungs)
• Thrombophlebitis (vein inflammation with blood clots)
• Elevated diastolic blood 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 dysfunction or venous pain
• Asthma
• Hyperventilation
• Gastritis (inflammation of the stomach lining)
• Enteritis (inflammation of the intestine)
• Dyspepsia
• Skin reactions
• Skin disorders including allergic dermatitis, neurodermatitis and/or atopic dermatitis, eczema, psoriasis
• Excessive sweating
• Chloasma (pigmented facial patches)
• Pigmentation disorders and/or discoloration
• Seborrhoea
• Dandruff
• Hirsutism (excessive hair growth)
• Skin disorders, skin reactions, "orange peel" skin appearance
• Spider angioma (vascular spider)
• Back pain
• Musculoskeletal complaints
• Muscle pain
• Pain in arms and legs
• Cervical dysplasia (abnormal cell growth on the surface of the cervix)
• Pain or cysts in the adnexa (ovaries and fallopian tubes)
• Breast cysts
• Fibrocystic breast changes
• Painful sexual intercourse
• Galactorrhea (milk discharge)
• Menstrual disorders
• Chest pain
• Swelling of arms and legs
• Flu-like illness
• Inflammation
• Fever
• Irritability
• Hypercholesterolaemia
• Increased blood triglyceride levels
• Discovery of supernumerary breast tissue

*Estimated frequency from epidemiological studies covering 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, called pulmonary embolism or pulmonary infarction), myocardial infarction caused by blood clots, stroke caused by blockage of blood vessels to or in the brain.

Frequency not known (cannot be estimated from available data):

• Mood changes
• Decreased or increased libido (sex drive)
• Contact lens intolerance
• Skin changes (urticaria, nodular erythema, erythema multiforme)
• Nipple discharge
• Fluid retention

The likelihood of developing blood clots may be higher if the patient has 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 with low frequency or delayed onset, considered associated with the group of combined oral contraceptives, are listed below (see also sections "When not to take Jeanine" and "Warnings and precautions"):

Neoplasms

• A slightly increased number of diagnosed breast cancer cases has been observed in women using combined oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the number of diagnoses remains small relative to the overall 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 conditions whose relationship with COCs is not established: jaundice and/or itching 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 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 with other medicines taken concomitantly with oral contraceptives (e.g. St John's wort (Hypericum perforatum), antiepileptic drugs, tuberculosis medications, HIV medications, and other antiviral agents). See section "Jeanine with other medicines".

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 effects helps provide more information on the safety of medicine use.

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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Jeanine contains

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

What Jeanine looks like and contents of the packaging
White, round coated tablets.
Packaging contains 1, 2 or 3 blisters with 21 coated tablets each. A cardboard sleeve is included with the package, in which the blister should be placed.
PVC/PE/EVOH/PE/PCTFE/Al blisters in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization 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
D-99427 Weimar
Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Germany, country of export: 53560.00.00
Parallel Import Authorization Number: 26/20
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday