Iasmin

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! 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 or pharmacist. See section 4.

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 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 taking Yasmin When not to take 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 Breastfeeding Driving and using machines Yasmin contains lactose monohydrate
• 3. How to take Yasmin When can the first blister be started? Taking more than the recommended dose of Yasmin Missing a dose of Yasmin 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 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 taking 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 taking 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 taking 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 can be unreliable because Yasmin modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Yasmin

You should not take 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 take Yasmin:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood coagulation disorders - such as 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 2, "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 impaired;
• 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;
• 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). May cause: itching, rash, or swelling.

You should not take 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 childbearing 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 take 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 take Yasmin" and "Warnings and precautions".

Warnings and precautions

When to 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), a blood clot in your lung (pulmonary embolism), a heart attack, or a stroke [see below "Blood clots (thrombosis)"].

To find out about the symptoms of these serious side effects, see "How to recognize a blood clot".

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

Before starting Yasmin, you should discuss this with your doctor. In some situations, you should be extra careful when taking Yasmin 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 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 a higher risk of blood clots. You should ask your doctor 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 section 2, "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 previous use of 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 characterized by sudden movements of the body)],
• if you have skin discolorations (yellow-brown pigment spots, 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

Taking combined hormonal contraceptives, such as Yasmin, 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").

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

Remember that the overall risk of harmful blood clots caused by taking 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
this symptom?

• 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 only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color in the affected leg, such as pallor, redness, or cyanosis;

venous thromboembolism (blood clot in a vein)

• 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 stomach pain;

If you are unsure, you should contact your doctor,
as some of these symptoms, such as coughing or shortness of breath, can 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, pressure, tightness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the upper 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;

myocardial infarction (heart attack)

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, difficulty speaking, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden severe or prolonged headache without a known cause;
• loss of consciousness or fainting with or without seizures;

stroke
In some cases, stroke symptoms may be temporary with almost immediate and complete recovery, however, you should contact your doctor immediately, as you may be at risk of having another stroke.

BLOOD CLOTS IN VEINS

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

• 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.
• If blood clots form in the veins in the leg or foot, it can lead to 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 taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming 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 taking combined hormonal contraceptives.
If you stop taking Yasmin, 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 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.

• During one year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• During one year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During one year, about 9-12 out of 10,000 women who take combined hormonal contraceptives containing drospirenone, such as Yasmin, will develop blood clots.
• The risk of blood clots depends on the individual medical history of the patient (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 overweight (body mass index (BMI) over 30 kg/m^2);
• 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). 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 Yasmin for a few weeks before surgery or immobilization. If you need to stop taking Yasmin, you should ask your doctor when you can resume taking it;
• with age (especially over 35);
• if you have given birth in the last few weeks.

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 taking Yasmin.
You should inform your doctor if any of these conditions change while taking Yasmin, e.g., 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 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. The risk is higher:

• with age (over about 35 years);
• if you smoke. While taking a hormonal contraceptive like Yasmin, you are advised to stop smoking. If you are unable to stop smoking and are over 35, your doctor may advise you to use 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). In this case, you may also be at higher risk of heart attack or stroke;
• if you or a close relative have 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 these conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of these conditions change while taking Yasmin, 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.

Yasmin and cancer

Women taking combined oral contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the hormonal contraceptives. For example, it may be that more breast cancers are detected in women taking combined oral contraceptives because they are more frequently examined by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly check your breasts and contact your doctor if you feel any lumps.
Women taking combined oral contraceptives have rarely reported cases of 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 taking hormonal contraceptives, including Yasmin, have reported depression or low mood. Depression can be severe and, in some cases, 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 continues for more 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 and have not vomited or 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 taking 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, or
• cause unexpected bleeding.

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),

tuberculosis (e.g., rifampicin),

• HIV or hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),

fungal infections (e.g., griseofulvin),

• rheumatoid arthritis or osteoarthritis (etoricoxib),

pulmonary hypertension (bosentan),

• herbal products containing St. John's Wort (Hypericum perforatum).

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 take 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 test results (elevated levels of the liver enzyme ALT). Your doctor will recommend a different type of contraception before starting these medicines.
You can resume taking Yasmin about 2 weeks after finishing treatment. See section 2, "When not to take 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, can be taken with a small amount of water.

Lab tests

If a blood test is necessary, 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 taking Yasmin, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Yasmin at any time (see also section 3, "Stopping Yasmin").
Before taking any medicine, you should consult your doctor or pharmacist.

Breastfeeding

Yasmin is not recommended during breastfeeding. If you want to take Yasmin while breastfeeding, 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 taking 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 take Yasmin

You should take one Yasmin tablet every day, with or without food, but you should take them at the same time every day. The blister pack contains 21 film-coated tablets. Next to each tablet, the day of the week is printed on which it should be taken. If, for example, you start taking the tablets on a Wednesday, you should take the tablet with "WED" printed next to it (see "Translation of day of the week symbols on the packaging" at the end of the leaflet and on the sachet).
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 called "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 that the withdrawal bleeding should occur on the same days of the week every month.
If you take 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 taken a hormonal contraceptive in the previous monthYou should start taking Yasmin on the first day of your menstrual cycle (i.e., on 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 taking it 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 the previous pack, but no later than the day after the end of the previous contraceptive-free period (or after the last inactive tablet from the previous pack). When changing from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)You can switch on any day from a progestogen-only pill (from an implant or intrauterine system on the day it is removed, or from an injection when the next injection would be due), but in all cases, you should 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 from 21 to 28 days after giving birth. If you start later than 28 days, you should use a non-hormonal method of contraception (e.g., condoms) for the first 7 days of taking Yasmin.

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

• If you are breastfeeding and want to start taking Yasmin again after childbirthYou should read the section on "Breastfeeding".

Taking more than the recommended dose of Yasmin

There are no reports of serious harmful effects from taking too many Yasmin tablets at once.
If you have taken several tablets at once, 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 have taken 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 protection against pregnancy is not reduced. You should 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 you missed a tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of reduced protection against pregnancy 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):

Missed more than 1 tablet in this blister pack

You should contact your doctor.

Missed 1 tablet in the 1st week

You should take the missed tablet as soon as possible, even if it means taking two tablets at once. Take 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 sexual intercourse 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 1 tablet in the 2nd week

You should take the missed tablet as soon as possible, even if it means taking two tablets at once. Take the rest of the tablets at the usual time.
Your protection against pregnancy is not reduced, and you do not need to use additional contraceptive methods.

Missed 1 tablet in the 3rd week

There are two options to choose from:

• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at once. Take the rest of the tablets at the usual time. Do not take a break from taking tablets, 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 you may experience spotting or intermenstrual bleeding during the second blister pack.

• 2. You 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 you missed the tablet). If you want to start the next blister pack on your usual start day, you can shorten the tablet-free period to less than 7 days.

If you follow one of these rules, your protection against pregnancy will be maintained.

• If you have missed any of the tablets in the blister pack and have not had withdrawal bleeding during the first tablet-free period, you may be pregnant. You should contact your doctor before starting the next blister pack.

What to do if vomiting or severe diarrhea occurs

If you vomit within 3-4 hours of taking a tablet or have severe diarrhea, there is a risk that the active ingredients of the tablet may not have been fully absorbed into your body.
The situation is similar to that of missing a tablet. After vomiting or diarrhea, you should take another tablet from a spare blister pack as soon as possible. If possible, you should take it within 12 hoursof 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 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 the next Yasmin blister pack, skipping the tablet-free period, until the end of the second blister pack. You may experience spotting or intermenstrual bleeding during the second blister pack.
After the usual 7-day tablet-free period, you should starttaking tablets from the next blister pack.
You can ask your doctor for advice before deciding to delay the onset of withdrawal bleeding.
Do not do this without consulting your doctor first.

Changing the first day of withdrawal bleeding: what to know

If you take the tablets as directed, withdrawal bleeding will start during the tablet-free week. If you need to change this day, you can 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 you want to change the day to a Tuesday (3 days earlier), you should start the next blister pack 3 days earlier than usual. If you significantly shorten the tablet-free period (e.g., to 3 days or less), you may not have withdrawal bleeding during the tablet-free period. You may experience spotting or intermenstrual bleeding.
If you are unsure what to do, you should contact your doctor.

Stopping Yasmin

You can stop taking Yasmin whenever you want. If you do not want to become pregnant, you should consult your doctor about other effective methods of birth control. If you want to become pregnant, you should stop taking Yasmin and wait until you have had a menstrual period before trying to become pregnant. This will make it easier to calculate the expected date of delivery.
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 veins (venous thromboembolism) or blood clots in arteries (arterial thromboembolism). 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 hives, which may cause difficulty breathing (see also section 2, "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: o in the leg or foot (e.g., deep vein thrombosis), o in the lungs (e.g., pulmonary embolism), o heart attack, o stroke, o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack, o 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 or pharmacist 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.
Reporting adverse reactions can help gather more information 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.
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. The pharmacist should be asked 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 Yasmin Contains

• The active substances of Yasmin are ethinylestradiol and drospirenone. Each coated tablet contains 0.030 mg of ethinylestradiol and 3 mg of drospirenone.
• The other ingredients (excipients) are: lactose monohydrate, cornstarch, pregelatinized cornstarch, povidone K 25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), see section 2, "Yasmin contains lactose monohydrate".

What Yasmin Looks Like and Contents of the Pack

• Each blister of Yasmin contains 21 light yellow coated tablets.
• Yasmin tablets are film-coated; the core of the tablet 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 pack includes a cardboard wallet in which the blister should be placed.

For more detailed information, the marketing authorization holder or parallel importer should be contacted.

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
13342 Berlin
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
Irish Authorization Number:PA1410/023/001
Parallel Import Authorization Number:413/21

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:
MON– Monday
TUE– Tuesday
WED– Wednesday
THU– Thursday
FRI– Friday
SAT– Saturday
SUN– Sunday

Date of Revision of the Leaflet: 20.03.2024

[Information about the trademark]