Iasmin

Leaflet accompanying the packaging: information for the user

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

Yasmin

0.03 mg + 3 mg, film-coated tablets

Ethinylestradiol+ Drospirenone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

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.
• You should be vigilant and consult a doctor if you suspect that you have symptoms of blood clots (see section 2 "Blood clots").

Table of contents of the leaflet:

• 1. What is Yasmin and what is it used for
• 2. Important information before using Yasmin When not to use Yasmin Warnings and precautions BLOOD CLOTS Yasmin and cancer Mental disorders Intermenstrual bleeding What to do if bleeding does not occur during the break week Yasmin and other medicines Yasmin with food and drink Laboratory tests Pregnancy Breast-feeding Driving and using machines Yasmin contains lactose monohydrate
• 3. How to use Yasmin When can the first blister be started? Taking more than the prescribed dose of Yasmin Missing a dose of Yasmin What to do if vomiting or severe diarrhea occurs Delaying the start of menstruation: what you need to know Changing the first day of menstruation: what you need to know Stopping Yasmin
• 4. Possible side effects

• 5. How to store Yasmin
• 6. Contents of the pack and other information

1. What is Yasmin and what is it used for

• Yasmin 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 using Yasmin

General notes

Before starting to take Yasmin, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start using Yasmin, your doctor will ask you a few questions about your health and about the health of your close relatives. Your doctor will also measure your blood pressure and, if necessary, perform other examinations.
This leaflet describes several situations in which you should stop using Yasmin or in which the effectiveness of Yasmin may be reduced. In such situations, you should either not have sexual intercourse 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 Yasmin modifies the monthly changes in body temperature and cervical mucus.

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

When not to use Yasmin

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

Do not use Yasmin:

• if you currently have (or have ever 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 disorder that affects blood clotting - 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 "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• 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 in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) severe liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have had in the past) a liver tumor;
• if you have (or have had in the past) breast cancer or cancer of the genital organs, or if it is suspected that you have it;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). You may experience itching, rash, or swelling. Do not use Yasmin in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Yasmin and other medicines").

Additional information for special populations

Children and adolescents
Yasmin is not intended for use in girls who have not yet started their menstrual cycle.
Women of advanced age
Yasmin is not intended for use after menopause.
Women with liver disease
You should not take Yasmin if you have liver disease. See also sections "When not to use Yasmin" and "Warnings and precautions".
Women with kidney disease
You should not take Yasmin if you have kidney failure or acute kidney failure. See also sections "When not to use Yasmin" and "Warnings and precautions".

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately

• if you notice any of the possible signs of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

In order to understand the description of the serious side effects mentioned below, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

Before starting to use Yasmin, you should discuss this with your doctor. In some situations, you should be particularly careful when using Yasmin or any other combined hormonal contraceptive, and you may also need to be regularly examined by your doctor. If these symptoms occur or worsen while using Yasmin, you should also tell your doctor.

• if you or a close relative have had 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 hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure),
• if you have sickle cell anemia (a hereditary disease of red blood cells),
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. 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 have just given birth, as you are at increased risk of blood clots. You should consult your doctor about how soon you can start taking Yasmin after giving birth,
• if you have superficial thrombophlebitis (blood clots in the veins under the skin),
• if you have varicose veins,
• if you have epilepsy (see "Yasmin 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 while taking sex hormones [e.g., hearing loss, porphyria (a blood disease), herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a nervous system disease that causes sudden movements of the body)],
• if you have experienced skin discoloration (yellow-brown pigmentation, so-called chloasma), you should avoid excessive exposure to the sun or ultraviolet radiation,
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Yasmin, 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 occur:

• in the veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in the arteries (also known as "arterial thromboembolism").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of harmful blood clots caused by Yasmin is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering from

• swelling of one leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may be Deep vein thrombosis

felt only when standing or walking,

• increased temperature in the affected leg,
• change in the color of the leg skin, such as pallor, redness, or cyanosis.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain. If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold). Pulmonary embolism

Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, or pressure;
• a feeling of tightness or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the lower body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack

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, especially 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 moves 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 highest?

The risk of blood clots 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 medicine) 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 you stop using Yasmin, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Yasmin is small.

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

Factors that increase the risk of blood clots in veins

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

• if you are severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your 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, 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 using Yasmin for a few weeks before surgery or immobilization. If you need to stop using Yasmin, you should ask your doctor when you can resume using it.
• with age (especially over 35 years);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
You should 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 using Yasmin.
You should inform your doctor if any of the above conditions change while you are using Yasmin, e.g., if someone in your immediate 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 a blood clot forms in an artery?

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 associated with Yasmin is very small, but some factors can increase this risk:

• with age (over about 35 years);
• if you smoke.While using a hormonal contraceptive like Yasmin, 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 immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of heart attack or stroke;
• if you or a close relative have been diagnosed with 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, irregular heartbeat);
• if you have diabetes.

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

Yasmin and cancer

In women who take combined oral contraceptives, breast cancer is slightly more common, but it is not known if this is caused by the hormonal contraceptives. For example, it may be that more tumors are detected in women who use combined oral contraceptives because they are more frequently examined by doctors. The incidence of breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you feel any lumps.
Rarely, women who use combined oral contraceptives have been reported to have benign or, even more rarely, malignant liver tumors, which can cause life-threatening bleeding into the abdominal cavity. If you experience severe abdominal pain, you should contact your doctor as soon as possible.

Mental disorders

Some women who use hormonal contraceptives, including Yasmin, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Intermenstrual bleeding

During the first few months of taking Yasmin, 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 according to the schedule, have not vomited, or have not had severe diarrhea, and have not taken any other medicines, 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.

Yasmin and other medicines

Always inform your doctor which medicines or herbal products you are already taking. You should also tell any other doctor, including your dentist, or pharmacist who prescribes another medicine that you are using Yasmin. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long or if you need to change the use of another necessary medicine.
Some medicines may:

• affect the level of Yasmin in your blood,
• make Yasmin 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)

Yasmin 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).

You should not use Yasmin in patients with hepatitis C and taking medicinal products 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 resume using Yasmin about 2 weeks after stopping treatment. See section "When not to use Yasmin".
Before taking any medicine, you should consult your doctor or pharmacist.

Yasmin with food and drink

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

Lab tests

If you need to have a blood test, you should tell your doctor or laboratory staff that you are taking Yasmin, as oral contraceptives may affect the results of some tests.

Pregnancy

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

Breast-feeding

Yasmin is not recommended during breast-feeding. If you want to take Yasmin while breast-feeding, you should contact your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

There is no information to suggest that using Yasmin affects your ability to drive or use machines.

Yasmin contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Yasmin.

3. How to use Yasmin

You should take one Yasmin tablet every day, with or without food, but you should take it at the same time every day.
The blister pack contains 21 film-coated tablets. The day of the week is printed next to each tablet. If, for example, you start on a Wednesday, take the tablet with "ΤΕΤ" printed next to it (see: "Translation of day-of-the-week symbols on the packaging" at the end of the leaflet and on the blister pack). You should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, you should not take any tablets for 7 days. During this 7-day break (also known as the withdrawal week), you should start bleeding. This is known as "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the withdrawal week.
On the 8th day after taking the last Yasmin tablet (i.e., after the 7-day break), you should start the next blister pack, regardless of whether the bleeding has stopped or not. This means that you should start each blister pack on the same day of the week, and your withdrawal bleeding should occur on the same days of the week every month.
If you use Yasmin in this way, you are also protected against pregnancy during the 7 days when you are not taking tablets.

When can the first blister be started?

• If you have not used a hormonal contraceptive in the previous monthYou should start taking Yasmin on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Yasmin on the first day of your period, you are immediately protected against 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 patchYou can start taking Yasmin the next day after taking the last active tablet from your previous pack, but no later than the day after you finish the previous contraceptive's tablet-free period (or after removing the vaginal ring or patch). In the case of changing from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.

In the case of changing from a progestogen-only pill (mini-pill), an injectable, an implant, or an intrauterine system (IUS) that releases progestogen, you can switch on any day from the mini-pill (or on the day the implant or IUS is removed or on the day the next injectable is due), but you must use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Yasmin.

• After a miscarriageFollow your doctor's advice.
• After childbirthYou can start taking Yasmin between 21 and 28 days after giving birth. If you start later than 28 days, you should use a barrier method (e.g., condoms) for the first 7 days of taking Yasmin.

If you have had sex after giving birth and before restarting Yasmin, you should first make sure you are not pregnant or wait for your next menstrual period.

• If you are breast-feeding and want to start taking Yasmin (again) after childbirthYou should read the section on "Breast-feeding".

Taking more than the prescribed dose of Yasmin

There are no reports of serious harmful effects from taking too many Yasmin tablets at once.
If you take several tablets at the same time, you may experience 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 medicine by mistake.
If you take too many Yasmin tablets or if a child has taken some, you should consult your doctor or pharmacist.

Missing a dose of Yasmin

• If it has been less than 12 hourssince you missed a tablet, your contraceptive protection is not reduced. You should take the tablet as soon as possible and then take the next tablets at the usual time.
• If it has been more than 12 hourssince you missed a tablet, your contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

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

• More than one tablet missed in this blister packYou should consult your doctor.
• One tablet missed in the first weekYou should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next 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 you may be at risk of pregnancy. In this case, you should consult your doctor.
• One tablet missed in the second weekYou should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time. Your contraceptive protection is not reduced, and you do not need to use additional contraceptive methods.
• One tablet missed in the third weekThere are 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. Take the next tablets at the usual time. Instead of the tablet-free week, go directly to the next blister pack or
• 2. You can also stop taking tablets from the blister pack and go directly to the 7-day tablet-free period (do not take a break of more than 7 days, including the missed tablet). If you follow one of these recommendations, your contraceptive protection will be maintained.
• If you have missed a tablet and have not had withdrawal bleeding during the first tablet-free period, you may be pregnant. You should consult your doctor before starting the next blister pack.

Missed one or more tablets from the blister pack
Consult your doctor
yes
Did you have sex in the week before missing the tablet
in the week

• 1.

no

• Take the missed tablet
• Use a barrier method (e.g., condoms) for the next 7 days
• and finish the tablets in the blister pack

Only one tablet missed (taken more than 12 hours late)

• Take the missed tablet and
• finish the tablets in the blister pack
• 2.
• Take the missed tablet and
• finish the tablets in the blister pack
• Instead of the tablet-free week, go directly to the next blister pack or
• 3.
• Stop taking tablets from the blister pack
• Start the 7-day tablet-free period (do not take a break of more than 7 days, including the missed tablet)
• Start 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 you have severe diarrhea, there is a risk that the active substances from the tablet may not have been fully absorbed into your body.
The situation is similar to that of a missed tablet. After vomiting or diarrhea, you should take another tablet from the reserve blister pack as soon as possible. If possible, you should take it within 12 hoursafter the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the advice given in the section "Missing a dose of Yasmin".

Delaying the start of menstruation: what you need to know

Even though it is not recommended, it is possible to delay the start of menstruation by going directly to the next Yasmin blister pack, skipping the tablet-free period, until the end of the second pack. You may experience spotting or intermenstrual bleeding during the second pack.
You can ask your doctor for advice before deciding to delay your menstruation.
Menstruation

Changing the first day of menstruation: what you need to know

If you take the tablets according to the instructions, your withdrawal bleeding will start during the tablet-free week. If you want to change this day, you can do so by shortening ( but never lengthening - maximum 7 days!) the tablet-free period. For example, if your tablet-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start the next blister pack 3 days earlier than usual. If you shorten the tablet-free period very much (e.g., to 3 days or less), you may not have withdrawal bleeding during that period. You may experience spotting or intermenstrual bleeding.
If you are unsure what to do, you should consult your doctor.

Stopping Yasmin

You can stop using Yasmin whenever you want. If you do not want to become pregnant, you should consult your doctor about other effective contraceptive methods. If you want to become pregnant, you should stop using Yasmin and wait for your next menstrual period before trying to conceive. This way, it will be easier to calculate your expected delivery date.
In case of any doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible Adverse Reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any adverse reactions occur, especially severe and persistent ones or changes in
health status that the patient considers related to the use of Yasmin, a doctor should be consulted.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disease). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before taking Yasmin".

Severe Adverse Reactions

A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, which may cause difficulty breathing (see also the section "Warnings and precautions").
The following adverse reactions have been associated with the use of Yasmin:
Common Adverse Reactions(occurring in 1 to 10 out of every 100 patients):

• menstrual disorders, non-cyclic bleeding, breast pain, breast tenderness,
• headaches, depressive mood,
• migraine,
• nausea,
• thick, white vaginal discharge, candidiasis (fungal infection).

Uncommon Adverse Reactions(occurring in 1 to 10 out of every 1,000 patients):

• breast enlargement, changes in libido,
• high blood pressure, low blood pressure,
• vomiting, diarrhea,
• acne, rash, itching, hair loss,
• vaginitis,
• fluid retention, changes in body weight.

Rare Adverse Reactions(occurring in 1 to 10 out of every 10,000 patients):

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing impairment,
• erythema nodosum (a skin condition characterized by red, painful nodules) or 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 developing blood clots may be higher if the patient has any other risk factors that increase this risk (refer to section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting Adverse Reactions

If any adverse reactions occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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.
By reporting adverse reactions, more information can be gathered on the safety of the medicine.

5. How to Store Yasmin

The medicine should be stored out of sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package Contents and Other Information

What Yasmin Contains

• The active substances of Yasmin are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg of drospirenone and 0.030 mg of ethinylestradiol.
• The other ingredients (excipients) are: Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K 25, magnesium stearate; coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Yasmin Looks Like and What the Packaging Contains

• Each blister pack of Yasmin contains 21 light yellow coated tablets.
• Yasmin tablets are coated tablets; the tablet core is covered with a coating. The tablets are light yellow, round with convex surfaces, one side marked with the letters "DO" in a hexagonal shape.
• Yasmin is available in packs containing 1 or 3 blisters, each of 21 tablets. The packaging includes a cardboard wallet in which the blister should be placed.

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

Marketing Authorization Holder in Greece, the Country of Export:

Bayer Hellas ABEE
Agisilaou 6-8, 151 23 Marousi, Attica, Greece

Manufacturer:

Bayer AG
Müllerstrasse 178, 13353 Berlin, 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
Authorization number in Greece, the country of export: 4016/21-1-2016

Parallel Import Authorization Number: 42/25

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

• Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden: Yasmin
• France: Jasmine
• Czech Republic, Hungary, Slovakia: Yadine
• Estonia, Latvia, Lithuania, Slovenia: Yarina

Translation of the Day of the Week Symbols on the Packaging:

ΔΕΥ - Monday
ΤΡΙ - Tuesday
ΤΕΤ - Wednesday
ΠΕΜ - Thursday
ΠΑΡ - Friday
ΣΑΒ - Saturday
ΚΥΡ - Sunday

Date of Revision of the Leaflet: 30.01.2025

[Information about the trademark]