Iasminelle

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Yasminelle, 0.02 mg + 3 mg, film-coated tablets

Ethinylestradiol + Drospirenone

Important information about combined hormonal contraceptives

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

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• A doctor or pharmacist should be consulted if there are any further doubts.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, the doctor, pharmacist, or nurse should be told. See section 4.

Table of contents of the leaflet

• 1. What is Yasminelle and what is it used for ......................................................... 1
• 2. Important information before taking Yasminelle ..................................................... 1 When not to take Yasminelle ................................................................................... 1Do not take Yasminelle .............................................................................................. 1Warnings and precautions ......................................................................................... 1BLOOD CLOTS ............................................................................................................. 1Yasminelle and cancer ................................................................................................... 1Irregular bleeding ................................................................................................... 1What to do if bleeding does not occur during the break week ............................ 1Yasminelle and other medicines ................................................................................................... 2Laboratory tests .............................................................................................................. 2Pregnancy ..................................................................................................................................... 2Breastfeeding ................................................................................................................. 2Driving and using machines .......................................................................... 2
• 3. How to take Yasminelle .................................................................................................. 2 When can the first blister be started ................................................................................. 2What to do if more tablets than recommended are taken ...................................... 2What to do if a tablet is missed ................................................................................... 2What to do if vomiting or severe diarrhea occurs ................................................. 2Delaying the start of withdrawal bleeding: what you need to know ......................... 2Changing the first day of withdrawal bleeding: what you need to know ........................ 2Stopping Yasminelle ............................................................................ 2
• 4. Possible side effects ............................................................................................. 2
• 5. How to store Yasminelle ........................................................................................ 2
• 6. Contents of the pack and other information....................................................................... 2

1. What is Yasminelle and what is it used for

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

2. Important information before taking Yasminelle

General notes

Before starting to take Yasminelle, you should read the information about blood clots in section 2. It is especially important to read the symptoms of a blood clot (see section 2 "BLOOD CLOTS").
Before you can start taking Yasminelle, your doctor will ask you some questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and may do other tests if necessary.
This leaflet describes several situations where you should stop taking Yasminelle or where the reliability of Yasminelle may be reduced. In such situations, you should either not have sex or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Yasminelle alters the monthly changes in body temperature and cervical mucus.

Yasminelle, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Yasminelle

You should not take Yasminelle if you have any of the conditions listed below. If you have any of the conditions listed below, you should tell your doctor. Your doctor will discuss with you which other contraceptive method would be more suitable for you.

Do not take Yasminelle:

• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). May cause: itching, rash, or swelling;
• if you currently have (or have had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• if you have had a heart attack or stroke;
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• if you have any of the following diseases that 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 you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have had) a liver tumor;
• if you have (or have had) or suspected breast or genital cancer;
• if you have any unexplained vaginal bleeding.

Do not take Yasminelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Yasminelle and other medicines").
Additional information for special populations
Children and adolescents
Yasminelle is not intended for use in girls who have not yet started their menstrual cycles.
Women of childbearing age
Yasminelle is not intended for use after menopause.
Women with liver disease
Yasminelle should not be taken if you have liver disease. See also sections "When not to take Yasminelle" and "Warnings and precautions".
Women with kidney disease
Yasminelle should not be taken if you have kidney failure or acute kidney failure. See also sections "When not to take Yasminelle" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor
Seek medical attention immediately

• if you notice any of the following symptoms of a blood clot, which could indicate that you have a blood clot in the leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "BLOOD CLOTS"). To find out about the symptoms of these serious side effects, see "HOW TO RECOGNIZE A BLOOD CLOT".

Tell your doctor if you have any of the following conditions.

In some situations, you need to be extra careful when taking Yasminelle or any other combined hormonal contraceptive, and you may need to be regularly checked by your doctor. If these symptoms occur or worsen while taking Yasminelle, you should also tell your doctor.

• if there is a history of breast cancer in your family;
• 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 hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have been told 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 need to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if you are immediately after childbirth, as you are at increased risk of blood clots. You should talk to your doctor about how soon you can start taking Yasminelle after childbirth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Yasminelle and other medicines");
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria (a blood disorder), herpes during pregnancy (a skin rash with blisters during pregnancy), Sydenham's chorea (a nerve disorder that causes sudden movements of the body);
• if you have or have had chloasma (skin discoloration, especially on the face and neck, so-called "pregnancy patches"). If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing, seek medical attention immediately. Estrogen-containing medications may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

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

• in the veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in the arteries (also known as "arterial thromboembolism" or "arterial thrombosis"). Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of a blood clot due to Yasminelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek medical attention immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pallor, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough without obvious cause, which may be accompanied by coughing up blood;

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins

• Taking 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 occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, this can lead to deep vein thrombosis.
• If a blood clot moves from the leg to the lungs, this 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 veins highest

The risk of blood clots in veins is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Yasminelle, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

The risk depends on your natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs due to Yasminelle is small.

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

The risk of blood clots depends on your 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 due to Yasminelle is small, but some factors may increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Yasminelle for a few weeks before surgery or immobilization. If you need to stop taking Yasminelle, ask your doctor when you can restart it;
• with age (especially over 35 years);
• if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in you.
Taking a long-haul flight (more than 4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
Tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop you from taking Yasminelle.
Tell your doctor if any of the above conditions change while taking Yasminelle, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries

Similarly 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 noted that the risk of heart attack or stroke due to Yasminelle is very small, but it may increase:

• with age (over about 35 years);
• if you smoke. If you are taking a hormonal contraceptive like Yasminelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years). In this case, you may also be at increased risk of heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, heart rhythm disturbance called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
Tell your doctor if any of the above conditions change while taking Yasminelle, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Yasminelle and cancer

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

Mental disorders

Some women taking 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, you should contact your doctor as soon as possible for further medical advice.

Irregular bleeding

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

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

If you have taken all the tablets as directed, have not vomited, or have not had severe diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.
If the expected bleeding does not occur twice in a row, it may mean that you are pregnant.
You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Yasminelle and other medicines

Always tell your doctor which medicines or herbal products you are already taking.
You should also tell any other doctor or dentist prescribing a new medicine that you are taking Yasminelle. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long.
Some medicines may:

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

This applies to medicines 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 actionof other medicines, 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)

Do not take Yasminelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may cause elevated liver function tests (increased levels of the liver enzyme ALT).
Your doctor will recommend a different type of contraception before starting these medicines.
You can restart Yasminelle about 2 weeks after finishing treatment. See section "When not to take Yasminelle".
Before taking any medicine, consult your 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 required, you should tell your doctor or laboratory staff that you are taking Yasminelle, as oral contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not take Yasminelle. If you become pregnant while taking Yasminelle, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Yasminelle at any time (see also "Stopping Yasminelle", page 2).
Before taking any medicine, consult your doctor or pharmacist.

Breastfeeding

Yasminelle is not recommended during breastfeeding. If you want to take Yasminelle while breastfeeding, you should contact your doctor.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

There is no information to suggest that taking Yasminelle affects your ability to drive or use machines.

Yasminelle contains lactose monohydrate

If you are intolerant to some sugars, you should contact your doctor before taking Yasminelle.

3. How to take Yasminelle

Take one Yasminelle tablet every day, with a small amount of water if necessary. You can take the tablets with or without food, but you should take them at the same time every day.
The blister pack contains 21 film-coated tablets. Each tablet has the day of the week printed on it. If, for example, you start on a Wednesday, take the tablet with "Wednesday" printed on it (see: "Translation of the names of the days of the week printed on each tablet" at the end of the leaflet and on the blister pack). Move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During this 7-day break (also called the withdrawal week), you should start bleeding. 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), start a new blister pack, regardless of whether bleeding has stopped or not. This means that you will start each blister pack on the same day of the week and that withdrawal bleeding should occur on the same days of the week in a 28-day cycle.
If you take Yasminelle in this way, you will also be protected from pregnancy during the 7 days when you are not taking tablets.

When can the first blister be started

• If you are not taking a hormonal contraceptive in the previous month.

Take Yasminelle on the first day of your cycle (i.e., the first day of your period). If you take Yasminelle on the first day of your period, you are immediately protected from pregnancy. You can also start on days 2-5 of your cycle, but you will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.

• Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.You 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 last inactive tablet or the day after the removal of the vaginal ring or patch. If you are changing from a progestogen-only injection, you can start taking Yasminelle on the day the next injection is due.
• Changing from a progestogen-only pill (mini-pill), injection, implant, or intrauterine system.You can start taking Yasminelle on any day of the mini-pill cycle, on the day the implant or intrauterine system is removed, or on the day the next injection is due, but you must use additional contraceptive methods (e.g., condoms) for the first 7 days.
• After a miscarriage.Follow your doctor's advice.
• After childbirth.You can start taking Yasminelle between 21 and 28 days after giving birth. If you start later than 28 days, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Yasminelle. If you have had sex after childbirth and before restarting Yasminelle, you should make sure you are not pregnant or wait for your first menstrual period.

If you are unsure when to start, you should consult your doctor.

• If you are breastfeeding and want to start taking Yasminelle (again) after childbirth.Read the section "Breastfeeding", page 2.

What to do if more tablets than recommended are taken

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

What to do if a tablet is missed

• If it has been less than 12 hourssince the missed tablet, contraceptive protection is not reduced. Take the tablet as soon as possible and continue taking the rest of the tablets at the usual time.
• If it has been more than 12 hourssince the missed tablet, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of pregnancy.

The risk of reduced contraceptive protection is highest if you miss a tablet at the beginning or end of the blister pack. Therefore, you should follow these rules (see also the diagram):

• Missed more than one tablet in this blister packContact your doctor.
• Missed one tablet in week 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Continue taking the rest of the tablets at the usual time and use additional contraceptive methods(e.g., condoms) for the next 7 days. If you had sex in the week before missing the tablet, you should be aware that there is a risk of pregnancy. In this case, you should contact your doctor.
• Missed one tablet in week 2. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Continue taking the rest of the tablets at the usual time. Contraceptive protection is not reduced, and you do not need to use additional contraceptive methods.
• Missed one tablet in week 3. You have two options to choose from:
• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Continue taking the rest of the tablets at the usual time. Do not take a break, just go straight to the next blister pack.

Most likely, withdrawal bleeding will occur at the end of the second blister pack, but you may experience spotting or breakthrough bleeding during the second blister pack.

• 2. You can also stop taking the tablets from the blister pack and go straight to the 7-day break ( make a note of the day you missed the tablet). If you want to start the next blister pack on your usual start day, you can make the break shorter than 7 days.

If you follow these rules, contraceptive protection will be maintained.

• If you miss any of the tablets from the blister pack and do not have withdrawal bleeding during the first break, it may mean that you are pregnant. You should contact your doctor before starting the next blister pack.

4. Possible side effects

Like all medicines, Yasminelle can cause side effects, although not everybody gets them. If you experience any side effects, especially serious or persistent ones, or changes in your health that you think may be related to the use of Yasminelle, you should consult your doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before taking Yasminelle".

Severe side effects

You should immediately contact your doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing (see also the section "Warnings and precautions").
The following side effects have been associated with the use of Yasminelle.
Common side 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 side 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, diarrhea, constipation
• hair loss (alopecia), eczema, itching, rash, dry skin, seborrheic dermatitis
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast lump (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden reddening of the face, absence of periods, very heavy periods, discharge, vaginal dryness, lower abdominal pain (pelvis), abnormal Pap smear, decreased libido
• fluid retention, lack of energy, strong thirst, increased sweating
• weight loss.

Rare side 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-like 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 side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects, you can help gather more information on the safety of the medicine.

5. How to store Yasminelle

Store the medicine in a place out of sight and reach of children.
There are no special precautions for storing the medicinal product.
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 that are no longer needed. This will help protect the environment.

6. Contents of the pack 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: core: lactose monohydrate, corn starch, magnesium stearate (E 470b), coating: hypromellose (E 464), talc (E 553b), titanium dioxide (E 171), and colorant: iron oxide red (E 172).

What Yasminelle looks like and contents of the pack

• Each blister of Yasminelle contains 21 pale pink film-coated tablets.
• Yasminelle tablets are film-coated tablets; the core of the tablet 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 blisters, each of 21 tablets.

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

Marketing authorization holder in Ireland, the country of export:

Bayer Limited
1st Floor, The Grange Offices
The Grange, Brewery Road, Stillorgan
Co Dublin, A94 H2K7, Ireland

Manufacturer:

Bayer AG, Mullerstrasse 178, 13353 Berlin, Germany
Bayer Weimar GmbH und Co. KG, Döbereinerstr. 20, 99427 Weimar, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Ireland, the country of export, authorization number: PA 1410/024/001

Parallel import authorization number: 136/21

This medicinal product is authorized 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, Slovenia, Sweden, Italy: Yasminelle
• France: Jasminelle

Translation of the names of the days of the week on the blister pack:

Monday

• Monday
• Tuesday
• Wednesday
• Thursday
• Friday
• Saturday
• Sunday

Date of revision of the leaflet: 13.06.2024

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