YASMINELLE

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Yasminelle (Aliane)
0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Yasminelle and Aliane are different brand names of 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 blood clots (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, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. 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 Yasminelle is and what it is used for
2. Important information before taking Yasminelle
   When not to use Yasminelle
   Do not use Yasminelle:
   Warnings and precautions
   BLOOD CLOTS
   Yasminelle and cancer
   Breakthrough bleeding
   What to do if no withdrawal bleeding occurs
   Yasminelle and other medicines
   Laboratory tests
   Pregnancy
   Breast-feeding
   Driving and operating machinery
3. How to take Yasminelle
   When to start the first blister pack
   Taking more Yasminelle than you should
   If you forget to take Yasminelle
   What to do if you vomit or have severe diarrhoea
   Delayed onset of withdrawal bleeding: what you should know
   Changing the first day of withdrawal bleeding: what you should know
   Stopping Yasminelle
4. Possible side effects
5. How to store Yasminelle
6. Contents of the pack and other information

1. What Yasminelle is and what it is used for

• Yasminelle is a contraceptive tablet and is used to prevent pregnancy.
• Each coated tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• Contraceptive tablets containing two hormones are known as "combined" pills.

2. Important information before using Yasminelle

General notes
Before starting to take Yasminelle, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section "BLOOD CLOTS").
Before you can start taking Yasminelle, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, if necessary, carry out other examinations.
This leaflet describes several situations in which you should stop using Yasminelle or in which the effectiveness of Yasminelle may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the rhythm method or temperature-based methods. These methods may be unreliable because Yasminelle alters the monthly changes in body temperature and cervical mucus.
Yasminelle, like other hormonal contraceptive products, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Yasminelle
Do not use Yasminelle if you have any of the conditions listed below. 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.

Do not use Yasminelle:

• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, rash or swelling;
• if you currently have (or have ever had) a blood clot in the deep veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in another organ;
• if you know you have a clotting disorder—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 (or have had in the past) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you have had (or currently have) liver tumour;
• if you have had (or currently have) or if there is suspicion of breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding.

Do not use Yasminelle if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir (see also section "Yasminelle with other medicines").

Additional information for special populations
Children and adolescents
Yasminelle is not intended for use in girls whose menstrual cycles have not yet started.

Older women
Yasminelle is not intended for use after menopause.

Women with liver function disorders
Do not take Yasminelle if you have liver disease. See also sections "When not to use Yasminelle" and "Warnings and precautions".

Women with kidney function disorders
Do not take Yasminelle if you have kidney failure or acute kidney failure. See also sections "When not to use Yasminelle" and "Warnings and precautions".

Warnings and precautions
When to contact your doctor
You should contact your doctor immediately

• if you notice possible symptoms of blood clots, which may indicate that 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 the development of blood clots".

Tell your doctor if you have any of the following conditions.
In certain situations, special care is required when using Yasminelle or any other combined hormonal contraceptive, and regular medical check-ups may be necessary. If any of these conditions develop or worsen during treatment with Yasminelle, you should also inform your doctor.

• if there is a personal or family history of breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• 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 have high blood fat levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "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 Yasminelle;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Yasminelle with other medicines");
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• if you have a condition that first appeared during pregnancy or during previous use of sex hormones (for example, hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder with sudden, involuntary movements));
• if you have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as "pregnancy mask"). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, estrogen-containing medicines may trigger or worsen angioedema symptoms. You should seek immediate medical attention if you experience symptoms such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with difficulty breathing.

BLOOD CLOTS
Using combined hormonal contraceptives such as Yasminelle 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 from 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 using Yasminelle is small.

HOW TO RECOGNIZE THE DEVELOPMENT OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.
Is the patient experiencing any of these symptoms? Likely reason
for the patient's
condition?

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

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

• 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 occur most frequently 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 venous blood clots the highest?
The risk of developing blood clots in 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 another product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives.
If a woman stops taking Yasminelle, the risk of blood clots returns to normal levels within a few weeks.

What determines the risk of developing blood clots?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Yasminelle is low.

• In 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 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 one year, about 9–12 out of 10,000 women who use combined contraceptives containing drospirenone, such as Yasminelle, will develop blood clots.

The risk of developing blood clots depends on the individual's personal medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Yasminelle is small, however
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had 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 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 Yasminelle several weeks before surgery or immobilization. If the patient must

discontinue taking Yasminelle, ask the doctor when it is safe to resume taking the
medication;

• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the
patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots,
particularly if the patient has another risk factor listed above.
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 Yasminelle.
Inform the doctor if any of the above conditions change during treatment with Yasminelle, for example, 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 lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It should be emphasized that the risk of heart attack or stroke associated with the use of Yasminelle is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Yasminelle, 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 (valvular heart disease, 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 Yasminelle, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Yasminelle and cancer
In women using combined oral contraceptives, breast cancer is observed slightly more frequently, but it is not known whether this is caused by taking the pills. For example, it may be that more tumors are detected in women using combined oral contraceptives because they are examined more frequently by their doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine your breasts regularly and contact your doctor if you feel any lumps.
Benign liver tumors have been reported in women using oral contraceptives, and malignant liver tumors have been reported very rarely. If you experience an unusual, severe abdominal pain, contact your doctor immediately.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasminelle, 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 your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Yasminelle, you may experience unexpected bleeding (bleeding outside the week of the break). If such bleeding lasts longer than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if no bleeding occurs during the break week
If all tablets have been taken according to the schedule, without vomiting or severe diarrhea, and no other medications have been taken, the likelihood of pregnancy is very low. If the expected bleeding does not occur twice in a row, this may indicate pregnancy. Contact your doctor immediately. Do not start the next pack until it is confirmed that you are not pregnant.

Yasminelle and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctor, including a dentist or pharmacist, who prescribes another medicine, that you are using Yasminelle. They will advise whether you need to use additional contraceptive methods (e.g. condoms), and if so, for how long.

Some medicines may:

• affect the blood concentration of Yasminelle;
• make it less effective in preventing pregnancy;
• cause unexpected bleeding.

This applies to medicines used in the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g. rifampicin);
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• pulmonary hypertension (bosentan);
• herbal products containing St. John’s wort ( Hypericum perforatum ).

Yasminelle may affect the action of other medicines, for example:

• those containing cyclosporine;
• antiepileptic lamotrigine (may lead to increased frequency of seizures);
• theophylline (used for breathing problems);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Yasminelle if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir, as this may cause elevated liver function tests (increased levels of liver enzyme ALT). The doctor will recommend another type of contraception before starting these medicines. Yasminelle may be resumed approximately 2 weeks after completing treatment. See section “When not to use Yasminelle”.
Before taking any medicine, consult your doctor or pharmacist.

Yasminelle with food and drink
Yasminelle may be taken independently of meals. If necessary, it can be taken with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that you are taking Yasminelle, as oral contraceptives may affect the results of certain tests.

Pregnancy
Yasminelle must not be used during pregnancy. If the patient becomes pregnant while taking Yasminelle, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may discontinue Yasminelle at any time (see also section “Discontinuing Yasminelle”).
Before taking any medicine, consult your doctor or pharmacist.

Breast-feeding
Yasminelle is generally not recommended during breast-feeding. If the patient wishes to take Yasminelle while breast-feeding, she should contact her doctor.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
There is no information suggesting that Yasminelle affects the ability to drive or operate machinery.

Yasminelle contains monohydrate lactose.
If the patient has an intolerance to certain sugars, she should contact her doctor before taking Yasminelle.

3. How to take Yasminelle

Take one Yasminelle tablet daily, with or without food, and with a small amount of water if needed. The tablets should be taken at approximately the same time each day.
The blister pack contains 21 coated tablets. Each tablet is marked with the symbol of the day of the week on which it should be taken. For example, if you start on Wednesday, take the tablet marked "MI" (which stands for Wednesday – see "Translation of weekday symbols on the blister pack" at the end of this leaflet). Proceed in the direction of the arrow on the blister pack until all 21 tablets have been taken.
After this, do not take any tablets for 7 days. During this 7-day break (also called the tablet-free week), withdrawal bleeding usually begins. This so-called "withdrawal bleeding" typically starts on the 2nd or 3rd day of the tablet-free week.
On the 8th day after taking the last Yasminelle tablet (i.e., after the 7-day break), start a new blister pack regardless of whether bleeding has stopped or not. This means each new blister pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days of the week within each 28-day cycle.
If you take Yasminelle as directed, you are protected against pregnancy even during the 7 days when you are not taking tablets.

When to start the first blister pack

• If you have not used any hormonal contraceptive in the previous month: Begin taking Yasminelle on the first day of your cycle (i.e., the first day of your menstrual period). If you start Yasminelle on the first day of your period, you are protected against pregnancy immediately. You may also start on days 2 to 5 of your cycle, but in this case, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined vaginal contraceptive ring or transdermal patch: You may start Yasminelle the day after taking the last active tablet from your previous pack, but no later than the day after completing the tablet-free interval of your previous contraceptive (or after the last inactive tablet of your previous contraceptive). If switching from a combined vaginal ring or transdermal patch, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen): You may switch at any time from progestogen-only pills (or on the day of removal of an implant or intrauterine system, or on the scheduled day of the next injection). However, in all cases, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days of taking Yasminelle tablets.
• After miscarriage: Follow your doctor's advice.
• After childbirth: You may start taking Yasminelle between 21 and 28 days after delivery. If you start later than 28 days after delivery, you must use a barrier method (e.g., condoms) for the first 7 days of taking Yasminelle. If you have had sexual intercourse after childbirth but before (re)starting Yasminelle, you must first ensure that you are not pregnant or wait until your next menstrual period.

If you are unsure when to start taking the medicine, consult your doctor.

• If you are breastfeeding and wish to (re)start taking Yasminelle after childbirth: Please read section "Breast-feeding".

Overdose of Yasminelle
There have been no reports of serious harmful effects from taking too many Yasminelle tablets.
If several tablets are taken at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken the medicine.
If an overdose of Yasminelle tablets is taken or if a child swallows any of the tablets, consult your doctor or pharmacist immediately.

Missed dose of Yasminelle

• If less than 12 hours have passed since you missed a tablet, your protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the next tablets at your usual time.
• If more than 12 hours have passed since you missed a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of pregnancy.

The risk of inadequate protection is greatest if you miss tablets at the beginning or end of the pack. Therefore, follow the rules below (see also the chart below):

• More than one tablet missed in this pack: Contact your doctor.
• One tablet missed in Week 1: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time and use additional contraceptive precautions (e.g., condoms) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, be aware that there is a risk of pregnancy. In this case, contact your doctor.
• One tablet missed in Week 2: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced, and no additional precautions are needed.
• One tablet missed in Week 3: You have two options:
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at your usual time. Do not take a tablet-free break; instead, start the next blister pack immediately.

Withdrawal bleeding will most likely occur at the end of the second pack, but spotting or breakthrough bleeding may occur during the second pack.

2. Alternatively, you may stop taking tablets from the current pack and proceed directly to the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start the new pack on your usual starting day, you may shorten the tablet-free interval to less than 7 days.

If you follow either of these options, protection against pregnancy will be maintained.

• If you missed any tablet in the pack and did not have withdrawal bleeding during the first tablet-free interval, this may indicate pregnancy. Contact your doctor before starting the next pack.

What to do if you vomit or have severe diarrhoea
If you vomit within 3 to 4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active ingredients have not been completely absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given under "Missed dose of Yasminelle".

Delaying withdrawal bleeding: what you should know
Even though it is not recommended, it is possible to delay withdrawal bleeding by starting a new Yasminelle blister pack immediately, skipping the tablet-free interval until the end of the second pack. Spotting or breakthrough bleeding may occur during the second pack. After the usual 7-day tablet-free interval, you must start taking tablets from the next blister pack.
You should consult your doctor for advice before deciding to delay withdrawal bleeding.

Changing the day of onset of withdrawal bleeding: what you should know
If you take the tablets as instructed, withdrawal bleeding will begin during the tablet-free week. If you wish to change this day, you can do so by shortening (but never lengthening – the tablet-free interval must not exceed 7 days) the tablet-free interval. For example, if your tablet-free interval normally starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister 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 interval. Spotting or breakthrough bleeding may occur instead.
If you are unsure how to proceed, contact your doctor.

Stopping Yasminelle
You may stop taking Yasminelle at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Yasminelle and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

All women taking 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 Yasminelle".

The following adverse effects have been associated with the use of Yasminelle.

Common adverse effects (occur in 1 to 10 out of every 00 people):

• mood swings
• headache
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
• weight gain

Uncommon adverse effects (occur in 1 to 10 out of every 1000 people):

• candidiasis (fungal infection)
• herpes simplex
• allergic reactions
• increased appetite
• depression, nervousness, sleep disturbances
• sensations of tingling and numbness, dizziness
• visual disturbances
• heart rhythm disorders or abnormally rapid heartbeat
• blood clot (thrombosis) in the lung (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or urticaria with breathing difficulties (angioedema), hair loss (alopecia), eczema (rash), itching, skin rashes, dry skin, seborrhoeic skin disorders (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• urinary bladder infection
• breast lump (benign and malignant), galactorrhea (milk discharge in women not breastfeeding), ovarian cysts, sudden facial flushing, absence of menstruation, very heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou test), decreased sexual desire
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

Rare adverse effects (occur in 1 to 10 out of every 10,000 people):

• asthma
• hearing impairment
• nodular erythema (a skin condition characterized by red, painful nodules)
• erythema multiforme (a rash presenting as redness or ulceration)
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis)
• in the lungs (e.g. pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye

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

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 to provide more information on the safety of the medicine.

5. How to store Yasminelle

Keep Yasminelle out of sight and reach of children.
There are no special storage requirements.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month indicated.
Medicines must 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 pack and other information

What Yasminelle contains

• The active substances in this medicine are ethinylestradiol ( Ethinylestradiolum ) and drospirenone ( Drospirenonum ). Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• Other components of the medicine are: lactose monohydrate, maize starch, magnesium stearate, hypromellose, talc, titanium dioxide (E 171), and colouring agent: iron oxide red (E 172).

What Yasminelle looks like and contents of the pack

• Each Yasminelle blister pack contains 21 light pink coated tablets.
• Yasminelle tablets are film-coated tablets; the tablet core is covered with a coating. The tablets are light pink, round, with convex surfaces, and one side is embossed with the letters "DS" within a regular hexagon.
• Yasminelle is available in packs containing 1 or 3 blisters, each blister containing 21 tablets.

For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Austria, country of export:
Bayer Austria Ges.m.b.H.
1160 Vienna, Austria
Manufacturer:
Bayer AG
13353 Berlin, Germany
Bayer Weimar GmbH & Co KG
99427 Weimar, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorisation number, country of export: 1-26450
Parallel import authorisation number: 105/22
This medicinal product is authorised for sale in the European Economic Area under the following names:

• Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, Greece, Spain, Netherlands, Ireland, Lithuania, Luxembourg, Latvia, Malta, Germany, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden, Italy: Yasminelle
• France: Jasminelle

Translation of the weekday abbreviations printed next to each tablet on the immediate packaging:
MO - Monday
DI - Tuesday
MI - Wednesday
DO - Thursday
FR - Friday
SA - Saturday
SO - Sunday