Iasminelle

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Yasminelle(Aliane)

0.02 mg + 3 mg, coated tablets

Ethinylestradiol + Drospirenone
Yasminelle and Aliane are different trade names for the same drug.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or when resuming use after a break of 4 weeks or more.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient

• One should keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Yasminelle and what is it used for
• 2. Important information before using Yasminelle

When not to use Yasminelle

Do not use Yasminelle:

Warnings and precautions

BLOOD CLOTS

Yasminelle and cancer

Irregular bleeding

What to do if bleeding does not occur during the break week

Yasminelle and other drugs

Lab tests

Pregnancy

Breastfeeding

Driving and using machines

• 3. How to use Yasminelle

When to start the first blister

Overdose of Yasminelle

Missed dose of Yasminelle

What to do if vomiting or severe diarrhea occurs

Delaying the onset of withdrawal bleeding: what to know

Changing the first day of withdrawal bleeding: what to know

Stopping Yasminelle

• 4. Possible side effects
• 5. How to store Yasminelle
• 6. Contents of the packaging and other information

1. What is Yasminelle and what is it used for

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

2. Important information before using Yasminelle

General notes

Before starting to take Yasminelle, one should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see "BLOOD CLOTS").
Before starting to use Yasminelle, the doctor will ask a few questions about the patient's health and the health of their close relatives. The doctor will also measure blood pressure and, if necessary, perform other tests.
This leaflet describes several situations in which one should stop using Yasminelle or in which the reliability of Yasminelle may be reduced. In such situations, one should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. One should not use the calendar method or the temperature measurement method. These methods may be unreliable because Yasminelle modifies 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

One should not use Yasminelle if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

Do not use Yasminelle:

• if the patient is allergic to ethinylestradiol or drospirenone or any of the other ingredients of this drug (listed in section 6). May cause: itching, rash or swelling;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have a disorder that affects blood clotting - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see "BLOOD CLOTS");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) liver disease, and liver function is still abnormal;
• if the patient has kidney problems (kidney failure);
• if the patient has (or has had in the past) liver cancer;
• if the patient has (or has had in the past) or suspects they have breast or genital cancer;
• if the patient has any unexplained vaginal bleeding.

One should not use Yasminelle if the patient has hepatitis C and is taking antiviral drugs containing ombitasvir, paritaprevir, ritonavir, and dasabuvir (see also "Yasminelle and other drugs").
Additional information for special populations
Children and adolescents
Yasminelle is not intended for use in girls who have not yet started their menstrual cycle.
Older women
Yasminelle is not intended for use after menopause.
Women with liver disease
One should not take Yasminelle if they have liver disease. See also "When not to use Yasminelle" and "Warnings and precautions".
Women with kidney disease
One should not take Yasminelle if they have kidney failure or acute kidney failure. See also "When not to use Yasminelle" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor
One should immediately contact a doctor

• if the patient notices possible symptoms of a blood clot, which may indicate that they have a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS").

To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

One should tell their doctor if they have any of the following conditions.

In certain situations, one should be particularly careful when using Yasminelle or any other combined hormonal contraceptive, and regular medical check-ups may also be necessary. If these symptoms occur or worsen while using Yasminelle, one should also tell their doctor.

• if there is a history of breast cancer in the family;
• if they have liver or gallbladder disease;
• if they have diabetes;
• if they have depression;
• if they have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if they have sickle cell anemia (a genetic disorder of red blood cells);
• if they have a high level of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• if they need to undergo surgery or will be immobilized for a long time (see "BLOOD CLOTS");
• if they are immediately after childbirth, as they are at increased risk of blood clots. One should consult their doctor for information on how soon they can start taking Yasminelle after childbirth;
• if they have superficial thrombophlebitis (blood clots in the veins under the skin);
• if they have varicose veins;
• if they have epilepsy (see "Yasminelle and other drugs");
• if they have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if they have a disease that first appeared during pregnancy or while taking sex hormones (e.g., hearing loss, porphyria (a blood disorder), herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a neurological disorder that causes sudden movements of the body));
• if they have chloasma (skin discoloration, especially on the face and neck, also known as melasma). If so, they should avoid direct exposure to sunlight or ultraviolet radiation;
• if they have hereditary angioedema, estrogen-containing drugs may cause or worsen the symptoms of angioedema. One should immediately contact their doctor if they experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or breathing with a rash.

BLOOD CLOTS

The use of combined hormonal contraceptives such as Yasminelle is associated with an increased risk of blood clots, compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form:

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism" or "arterial occlusive disease")

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It is essential to remember that the overall risk of harmful blood clots caused by Yasminelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

One should immediately contact a doctor if they notice any of the following symptoms.

Is the patient experiencing any of these symptoms? What is the likely cause of the patient's condition?

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

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur.

Most often, they occur in the first year of using combined hormonal contraceptives.

• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Yasminelle, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

The risk depends on the natural risk of developing venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots associated with Yasminelle is small.

• Within a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• Within a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• Within a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Yasminelle, will develop blood clots.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Yasminelle is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a genetic blood clotting disorder;
• if the patient needs to undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop using Yasminelle for a few weeks before surgery or immobilization. If the patient needs to stop using Yasminelle, they should ask their doctor when they can resume using the drug;
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-distance air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
One should tell their doctor if any of these risk factors are present, even if they are not sure. The doctor may decide to stop using Yasminelle.
One should inform their doctor if any of the above conditions change while using Yasminelle, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery

Similar to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It should be emphasized that the risk of a heart attack or stroke associated with Yasminelle is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive like Yasminelle, it is recommended to quit smoking. If the patient is unable to quit 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 someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
One should inform their doctor if any of the above conditions change while using Yasminelle, e.g., if the patient starts smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Yasminelle and cancer

Women using combined hormonal contraceptives, such as Yasminelle, may have a slightly higher risk of breast cancer, but it is not known if this is caused by the pills. For example, more tumors may be detected in women using combined hormonal contraceptives because they are examined by their doctors more often. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is essential to regularly examine the breasts and contact the doctor if any lumps are found.
Women using the pill have also been reported to have, in rare cases, benign liver tumors and, in even rarer cases, malignant liver tumors. If they experience unusual, severe stomach pain, they should contact their doctor.

Psychiatric disorders

Some women using hormonal contraceptives, including Yasminelle, have reported depression or mood swings. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, one should contact their doctor as soon as possible for further medical advice.

Irregular bleeding

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

What to do if bleeding does not occur during the break week

If all the pills have been taken according to the schedule, no vomiting or severe diarrhea has occurred, and no other drugs have been taken, it is very unlikely that the patient is pregnant. If the expected bleeding does not occur twice in a row, it may mean that the patient is pregnant. One should immediately contact their doctor. One should not start the next blister until they are sure they are not pregnant.

Yasminelle and other drugs

One should always inform their doctor about any other drugs or herbal products they are already taking.
One should also tell any other doctor, including their dentist or pharmacist, who prescribes another drug that they are using Yasminelle. They may say that additional contraceptive products (e.g., condoms) should be used, and if so, for how long.
Some drugs may:

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

This applies to drugs used to treat:

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

Yasminelle may affect the action of other drugs, such as:

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

One should not use Yasminelle if they have hepatitis C and are taking antiviral drugs containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, as this may cause elevated liver function test results (increased levels of the liver enzyme ALT). The doctor will suggest another type of contraception before starting these drugs. One can resume using Yasminelle about 2 weeks after finishing the treatment. See "When not to use Yasminelle".
Before using any drug, one should consult their doctor or pharmacist.

Yasminelle with food and drink

Yasminelle can be taken with or without food, but if necessary, it can be taken with a small amount of water.

Lab tests

If a blood test is necessary, one should tell their doctor or laboratory staff that they are taking Yasminelle, as oral contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not take Yasminelle. If the patient becomes pregnant while using Yasminelle, they should stop using the drug immediately and contact their doctor. If the patient wants to become pregnant, they can stop using Yasminelle at any time (see also "Stopping Yasminelle").
Before using any drug, one should consult their doctor or pharmacist.

Breastfeeding

Yasminelle is not recommended for use during breastfeeding. If the patient wants to take Yasminelle while breastfeeding, they should contact their doctor.
Before using any drug, one should consult their doctor or pharmacist.

Driving and using machines

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

Yasminelle contains lactose monohydrate.

If the patient does not tolerate some sugars, they should contact their doctor before using Yasminelle.

3. How to use Yasminelle

One should take one Yasminelle tablet daily, with a small amount of water if necessary. The tablets can be taken with or without food, but they should be taken daily, approximately at the same time.
The blister pack contains 21 coated tablets. Each tablet is marked with a symbol of the day of the week on which it should be taken. If, for example, one starts on a Wednesday, they should take the tablet marked with the symbol "WED" (Wednesday) (see "Translation of day-of-the-week symbols on the packaging" at the end of the leaflet). One should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, one should not take any tablets for 7 days. During this 7-day break (also called the break week), bleeding should start. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the break week.
On the 8th day after taking the last Yasminelle tablet (i.e., after the 7-day break), one should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that one should start each blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days of the week in the 28-day cycle.
If one uses Yasminelle in this way, they are also protected against pregnancy during the 7 days when they are not taking tablets.

When to start the first blister

• If no hormonal contraceptive has been used in the previous month.Yasminelle should be started on the first day of the cycle (i.e., the first day of menstruation). If Yasminelle is started on the first day of menstruation, one is immediately protected against pregnancy. One can also start between days 2-5 of the cycle, but in that case, additional protection (e.g., condoms) should be used for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.One can start taking Yasminelle the next day after taking the last active tablet from the previous pack, but no later than the day after the end of the previous contraceptive's tablet-free period (or the last inactive tablet). When switching from a combined hormonal contraceptive vaginal ring or patch, one should follow their doctor's advice.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen).One can switch at any time from a mini-pill (from an implant or intrauterine system on the day it is removed, or from an injection when the next injection is scheduled) but in all cases, additional protection (e.g., condoms) should be used for the first 7 days of tablet-taking.
• After a miscarriageOne should follow their doctor's advice.
• After childbirthAfter childbirth, one can start taking Yasminelle from the 21st to the 28th day after delivery. If one starts later than 28 days, they should use a barrier method (e.g., condoms) for the first 7 days of Yasminelle use. If one has had sexual intercourse after childbirth before (re)starting Yasminelle, they should first ensure they are not pregnant or wait for their first menstrual period.

If the patient is unsure when to start, they should consult their doctor.

• If the patient is breastfeeding and wants to start taking Yasminelle (again) after childbirth.One should read the section "Breastfeeding".

Overdose of Yasminelle

There are no reports of serious harmful effects from taking too many Yasminelle tablets at once.
If several tablets are taken at the same time, symptoms may occur such as nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their menstrual cycle, but have taken the drug by mistake.
If too many Yasminelle tablets have been taken or if a child has swallowed some, one should consult their doctor or pharmacist.

Missed dose of Yasminelle

• If it has been less than 12 hourssince the missed tablet, contraceptive protection is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If it has been more than 12 hourssince the missed tablet, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of pregnancy.

The risk of reduced contraceptive protection is highest if tablets are missed at the beginning or end of the blister pack. Therefore, one should follow the rules below (see also the diagram below):

• More than one tablet has been missed in this blister packOne should contact their doctor.
• A tablet has been missed in week 1.The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and additional protection(e.g., condoms) should be used for the next 7 days. If sexual intercourse has occurred in the week before the missed tablet, one should be aware that there is a risk of pregnancy. In this case, one should contact their doctor.
• A tablet has been missed in week 2.The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Contraceptive protection is not reduced, and no additional protection is needed.
• A tablet has been missed in week 3.There are two options to choose from:
• 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. One should not take a break in tablet-taking, just go straight to the next blister pack.

It is likely that withdrawal bleeding will occur at the end of the second blister pack, but one may experience spotting or breakthrough bleeding during the second blister pack.

• 2. One can also stop taking tablets from the blister pack and go straight to the 7-day tablet-free period (make a note of the day the tablet was missed). If one wants to start the next blister pack on their usual start day, the tablet-free period can be shortened to less than 7 days.

If one follows one of these rules, contraceptive protection will be maintained.

• If the patient has missed a tablet from the blister pack and withdrawal bleeding has not occurred during the first tablet-free period, it may mean that they are pregnant. One should contact their doctor before starting the next blister pack.

What to do if vomiting or severe diarrhea occurs

If vomiting occurs within 3-4 hours after taking a tablet or if severe diarrhea occurs, there is a risk that the active substances from the tablet have not been fully absorbed into the body.
The situation is similar to that of a missed tablet. After vomiting or diarrhea, one should take another tablet from a spare blister pack as soon as possible. If possible, this should be done within 12 hoursof the normal time of tablet-taking. If this is not possible or more than 12 hours have passed, one should follow the advice given in "Missed dose of Yasminelle".

Delaying the onset of withdrawal bleeding: what to know

Even though it is not recommended, it is possible to delay the onset of withdrawal bleeding by going straight to a new Yasminelle blister pack without taking a break, up to the end of the second blister pack. One may experience spotting or breakthrough bleeding during the second blister pack. After the usual 7-day tablet-free period, one should starttaking tablets from the next blister pack.
One can ask their doctor for advice before deciding to delay the onset of withdrawal bleeding.

Changing the first day of withdrawal bleeding: what to know

If one is taking the tablets according to the instructions, withdrawal bleeding will start during the tablet-free week. If one wants to change this day, they do so by shortening (but never lengthening - maximum 7 days!) the tablet-free period. For example, if the tablet-free period starts on a Friday and one wants to change the day to Tuesday (3 days earlier), they should start the new blister pack 3 days earlier than usual. If the tablet-free period is significantly shortened (e.g., 3 days or less), withdrawal bleeding may not occur during the tablet-free period. One may experience spotting or breakthrough bleeding.
If the patient is unsure what to do, they should contact their doctor.

Stopping Yasminelle

One can stop using Yasminelle whenever they want. If they do not want to become pregnant, they should consult their doctor about other effective birth control methods. If they want to become pregnant, they should stop using Yasminelle and wait for their menstrual period before trying to conceive. This way, it is easier to calculate the expected due date.
In case of any doubts related to the use of this drug, one should consult their doctor or pharmacist.

4. Possible Undesirable Effects

Like all medicines, Yasminelle can cause undesirable effects, although not everybody gets them. If you experience any undesirable effects, especially serious or persistent ones, or changes in your health that you think may be due to Yasminelle, you should consult your doctor.
All women taking combined hormonal contraceptive products have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Yasminelle".
The following undesirable effects have been associated with the use of Yasminelle.
Common Undesirable Effects(occurring in 1 to 10 out of every 100 people):

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

Uncommon Undesirable Effects(occurring in 1 to 10 out of every 1,000 people):

• candidiasis (fungal infection)
• herpes simplex
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling and numbness, dizziness
• vision problems
• heart rhythm disorders or extremely rapid heart rate
• blood clots (thrombosis) in the lung (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat), and/or difficulty swallowing or urticaria with difficulty breathing (angioedema), hair loss (alopecia), eczema (dermatitis), itching, rashes, dry skin, seborrheic dermatitis
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast tumor (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden facial flushing, absence of periods, very heavy periods, discharge, vaginal dryness, lower abdominal pain (pelvis), abnormal Pap smear, decreased libido
• fluid retention, lack of energy, strong desire, increased sweating
• weight loss.

Rare Undesirable Effects(occurring in 1 to 10 out of every 10,000 people):

• asthma
• hearing impairment
• erythema nodosum (a skin condition characterized by red, painful nodules)
• erythema multiforme (a rash in the form of 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 symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting Undesirable Effects

If you experience any undesirable effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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.
By reporting undesirable effects, you can help provide more information on the safety of this medicine.

5. How to Store Yasminelle

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Yasminelle Contains

• The active substances of Yasminelle are ethinylestradiol (Ethinylestradiolum) and drospirenone (Drospirenonum). Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• Other ingredients of Yasminelle are: lactose monohydrate, cornstarch, magnesium stearate, hypromellose, talc, titanium dioxide (E 171), and the colorant: iron oxide red (E 172).

What Yasminelle Looks Like and What the Package Contains

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

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Austria, the 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian Marketing Authorization Number:1-26450

Parallel Import Authorization Number: 105/22

This medicinal product is authorized for sale in the Member States of 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 Day of the Week Indication on the Packaging:

MO- Monday
DI- Tuesday
MI- Wednesday
DO- Thursday
FR- Friday
SA- Saturday
SO- Sunday.
Date of Leaflet Approval: 23.02.2022
[Information on trademark protection]