Iasmin

Leaflet accompanying the packaging: information for the user

Yasmin,0.03 mg + 3.00 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
• 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
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots")

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

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 as yours.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

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 Yasmin and other medicines Pregnancy Breastfeeding Driving and using machines Yasmin contains lactose
• 3. How to take Yasmin When can the first blister be started If you have taken another combined hormonal contraceptive If you have taken only progestogens After childbirth After miscarriage or abortion If you have taken more than the recommended dose of Yasmin If you stop taking Yasmin If you forget to take 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 combined oral contraceptive. Each film-coated tablet contains two different hormones. These are: ethinylestradiol (estrogen) and drospirenone (progestogen).
When taking Yasmin according to the instructions in this leaflet, the likelihood of becoming pregnant is very low.
Remember that Yasmin, like other combined oral contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Indications for use

Prevention of pregnancy.

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").
About 1 in 100 women who take combined oral contraceptives become pregnant every year. This number may increase if pills are missed or not taken correctly.

When not to take Yasmin

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

• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of Yasmin (listed in section 6). May cause: itching, rash or swelling.
• 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 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 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 start taking it again.
• 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 (temporary stroke symptoms);
• if you have had a heart attack or stroke;
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have had) 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) severe liver disease until liver function tests have returned to normal;
• if you have severe or acute kidney failure;
• if you have had (or have) benign or malignant liver tumors;
• if you have (or have had) a hormone-dependent cancer (breast or genital cancer);
• if you have unexplained vaginal bleeding;
• if you are pregnant or think you may be pregnant.

If any of the conditions listed above occur for the first time while taking Yasmin, you should stop taking the medicine and consult a doctor immediately. In this case, non-hormonal methods of contraception should be used (see also "General notes").
Do not take Yasmin if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir (see also "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
Do not take Yasmin if you have liver disease. See also "When not to take Yasmin" and "Warnings and precautions".
Women with kidney disease
Do not take Yasmin if you have kidney failure or acute kidney failure. See also "When not to take Yasmin" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor
You should contact a doctor immediately

• -if you notice any of the symptoms 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 (thrombosis)"). To find a description 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.

If you are taking oral contraceptives in any of the following situations, you will need regular medical check-ups. If these symptoms occur or worsen while taking Yasmin, you should also tell your doctor.

• if you smoke,
• if you have diabetes,
• if you are overweight,
• if you have high blood pressure,
• if you have heart valve problems or heart rhythm disorders,
• if you have superficial thrombophlebitis (inflammation of the veins under the skin),
• if you have varicose veins,
• if there have been cases of blood clots, heart attack, or stroke in close relatives,
• if you have migraines,
• if you have epilepsy (see "Yasmin and other medicines"),
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or 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 are immediately after childbirth, in which case you are at increased risk of blood clots. You should consult a doctor to find out how soon you can start taking Yasmin after childbirth,
• if you or a close relative have had breast cancer,
• if you have liver or gallbladder disease,
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system),
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure),
• if you have sickle cell anemia (a genetic disease of red blood cells),
• if you have a disease that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g., hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea),
• if you have skin discoloration (yellow-brown pigmentation, so-called chloasma), you should avoid excessive exposure to the sun or ultraviolet radiation. If any of the above symptoms occur for the first time, recur, or worsen while taking Yasmin, you should contact a doctor.

BLOOD CLOTS

Thrombosis is the formation of blood clots that can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis).
In the event of a clot breaking loose from the site where it is formed, it can block the arteries in the lungs and cause pulmonary embolism. Deep vein thrombosis is rare; it can occur even when not taking the medicine, e.g., during pregnancy.
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 veins (also called "venous thromboembolism" or "venous thromboembolic disease")
• in arteries (also called "arterial thromboembolism" or "arterial thromboembolic disease"). Not all patients who have had 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 Yasmin is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact a 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 the legs and (or) swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• 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 cyanosis
• sudden onset of unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden onset of coughing without an obvious cause, 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 a 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).
Symptoms usually occur in one eye:
Retinal vein thrombosis
(blood clot in the eye)

• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision
• chest pain, discomfort, or

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur most often in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause 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.

• -In one year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• -In one year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• -In 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 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 overweight (body mass index (BMI) over 30 kg/m);
• 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). 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 start taking it again.
• 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. Traveling by air (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor. You should tell your doctor if any of the risk factors are present, even if you are not sure. The doctor may decide to stop Yasmin. You should inform your doctor if any of the above conditions change while taking 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.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery

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

Factors that increase the risk of blood clots in arteries

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

• 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 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). In this case, you may also be at increased 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, heart rhythm disorder called atrial fibrillation)
• if you have diabetes. If you have more than one of the above 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 the above conditions change while taking 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.
In the event of symptoms suggesting a blood clot, you should stop taking the pills and consult a doctor immediately (see also "When to contact a doctor").

Yasmin and cancer

Women who take oral contraceptives have a slightly higher incidence of breast cancer than women of the same age who do not take them. It is not known whether this difference is caused solely by oral contraceptives. The reason may also be that women who take hormonal contraceptives are examined more frequently and breast cancer is detected earlier in them. The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping oral contraceptives.
Rarely, cases of benign or, even more rarely, malignant liver tumors have been reported in women taking combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should contact a doctor as soon as possible.
There are reports of a higher incidence of cervical cancer in women who have taken oral contraceptives for a long time. This association may not be related to taking the pills but to sexual behavior or other factors.

Psychiatric disorders

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

Yasmin and other medicines

Some medicines may:

• affect the level of Yasmin in the 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), rheumatoid arthritis, osteoarthritis (etoricoxib) pulmonary hypertension (bosentan)
• herbal products containing St. John's wort (Hypericum perforatum)
• Yasmin may affect the action of other medicines, e.g., 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 Yasmin if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, as this may cause elevated liver function test results (elevated 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 the treatment. See "When not to take Yasmin".
Before taking any medicine, you should consult a doctor or pharmacist.
Always inform your doctor about any 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, if so, for how long.

Pregnancy

Before taking any medicine, you should consult a doctor or pharmacist.
Yasmin is not recommended during pregnancy or if pregnancy is suspected. If pregnancy is suspected, you should consult a doctor as soon as possible.

Breastfeeding

Before taking any medicine, you should consult a doctor or pharmacist.
Yasmin is not recommended during breastfeeding.

Driving and using machines

No effects of Yasmin on the ability to drive and use machines have been observed.

When to contact a doctor

You should contact a doctor immediately if:

• you notice any worrying changes in your health, especially any of the symptoms listed above as requiring special caution;
• there have been cases of blood clots, heart attack, or stroke in close relatives;
• a breast lump has been detected;
• you plan to take other medicines (see also "Yasmin and other medicines");
• you may be immobilized or are scheduled to have surgery (you should inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding;
• you missed pills in the first week of the cycle (every first week of the month) and had sex during the previous 7 days;
• you experience severe diarrhea;
• you have not had bleeding for 2 consecutive months (do not start the next pack without your doctor's decision).

The situations and symptoms listed above are described in more detail in other parts of this leaflet.

Yasmin contains lactose.

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

3. How to take Yasmin

Yasmin should always be taken as directed by your doctor. If you are unsure, you should contact your doctor again.
Yasmin, like other oral contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

When to start the first blister

• If Yasmin is taken for the first time or after a break in taking it, the first tablet should be taken on the first day of the menstrual cycle, i.e., on the day of menstrual bleeding.
• In other cases, you should follow the instructions in the sections "If you have taken another combined hormonal contraceptive" or "If you have taken only progestogens", or "After childbirth", or "After miscarriage or abortion".
• The first tablet should be taken on the day of the week indicated on the tablet. If, for example, menstruation starts on a Wednesday, the first tablet to be taken is the one marked "Wed". The following tablets should be taken according to the instructions on the blister pack.

Taking Yasmin for the first time

• After taking the first tablet, you should continue taking the tablets, one per day, for the next 21 days. The tablets should be taken according to the direction of the arrows on the packaging.
• The tablets should be taken every day at the same time.
• The tablets should be swallowed whole, with water if necessary.

7-day break in taking Yasmin

After taking the entire package (21 tablets), you should not take tablets for the next 7 days.
During this break, withdrawal bleeding will start. It usually occurs on the 2nd or 3rd day after taking the last tablet of Yasmin. You should start taking tablets from the next package after the 7-day break.
During the 7-day break in taking tablets, you do not need to use additional contraceptive methods, provided that the tablets were taken according to the recommended schedule and the next package is started after 7 days.

Next package of Yasmin

You should start taking tablets from the next package after the 7-day break. Each new package will be started on the same day of the week as the previous one, so it is easy to remember when to start the next package. You should start taking tablets from the next package after the 7-day break, even if withdrawal bleeding is still occurring.

If you have taken another combined hormonal contraceptive

If you have taken another combined hormonal contraceptive for 21 days
After taking all the tablets from the package of another combined hormonal contraceptive for 21 days, there is a 7-day break, after which you should start taking Yasmin.
The first tablet of Yasmin should be taken on the day of the week indicated on the tablet, and then follow the instructions in the section "Taking Yasmin for the first time".
If you start taking Yasmin in this way, its contraceptive effect will be maintained.
Withdrawal bleeding may not occur before finishing the first package of Yasmin, but this is not a cause for concern. During the days of taking the tablets, minor bleeding may occur, but this is also not a cause for concern.
If you have taken another combined hormonal contraceptive for 28 days
If you have taken another combined hormonal contraceptive for 28 days, you should start taking Yasmin the next day after taking the last tablet of the previous contraceptive. The first tablet of Yasmin should be taken on the day of the week indicated on the tablet, and then follow the instructions in the section "Taking Yasmin for the first time".
If you follow the above instructions, you will not need to use additional contraceptive methods. Withdrawal bleeding may not occur before finishing the first package of Yasmin, but this is not a cause for concern. During the days of taking the tablets, minor bleeding may occur, but this is also not a cause for concern.
In the case of a vaginal ring or transdermal patch, you should start taking Yasmin on the day the ring or patch is removed, but no later than the day a new ring or patch would be applied.

If you have taken only progestogens

If you have taken a progestogen-only pill (minipill)
You can stop taking the minipill at any time and start taking Yasmin instead, at the same time. If you have sex during the first 7 days of taking Yasmin, you should use additional contraceptive methods (barrier methods).
If you have taken progestogen injections, an implant, or an intrauterine system releasing progestogen
You should start taking Yasmin on the day the next injection would be due or on the day the implant or intrauterine system would be removed. If you have sex during the first 7 days of taking Yasmin, you should use additional contraceptive methods (barrier methods).

After childbirth, miscarriage, or abortion

After a miscarriage in the first trimester of pregnancy
You can start taking Yasmin immediately. In this case, you do not need to use additional contraceptive methods.
After childbirth or miscarriage in the second trimester of pregnancy
You should start taking tablets between 21 and 28 days after childbirth or miscarriage in the second trimester of pregnancy. If you start taking Yasmin later, you should use additional mechanical contraception for the first 7 days of taking the tablets. If you have had sex before starting to take a combined oral contraceptive, you should make sure you are not pregnant or wait for your first menstrual period.

Taking more than the recommended dose of Yasmin

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not yet started their menstrual cycle, but have taken the medicine by mistake. There are no reports of serious side effects after taking multiple tablets of Yasmin at the same time. If you have taken more than the recommended dose of Yasmin, you should inform your doctor.

Stopping Yasmin

The medicine can be stopped at any time. Your doctor will recommend other contraceptive methods.
If you stop taking Yasmin because you want to become pregnant, you should wait until you have had a natural menstrual period. This will help determine the expected date of delivery.

Missing a dose of Yasmin

If it has been less than 12 hourssince you missed a tablet, the contraceptive effect of Yasmin is maintained. You should take the missed tablet as soon as possible and take the next one at the usual time.
If it has been more than 12 hourssince you missed a tablet or if you have missed more than one tablet, the contraceptive effect of Yasmin may be reduced. Therefore, you should use additional contraceptive methods. The more tablets you have missed, the higher the risk of reduced contraceptive effectiveness.

Missing more than one tablet from the current package

You should consult your doctor.

Missing one tablet in the first week of taking Yasmin from the current package

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. For the next 7 days, you should use additional contraceptive methods (barrier methods).
If you had sex during the week before missing the tablet, it is possible that you may become pregnant. You should contact your doctor as soon as possible.

Missing one tablet in the second week of taking Yasmin from the current package

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. The contraceptive effect of Yasmin is maintained, and you do not need to use additional contraceptive methods.
However, if you made a mistake in taking the tablets earlier or if you missed more than one tablet, you should use an additional (mechanical) contraceptive method for 7 days.

Missing one tablet in the third week of taking Yasmin from the current package

You can choose one of the following options without the need for additional contraceptive methods, provided that you have taken the tablets correctly for 7 days before missing the dose. If not, you should use the first of the two options below and use an additional contraceptive method for 7 days.

• 1. Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. Start taking tablets from the next package immediately after finishing the current one, i.e., without a 7-day break. Withdrawal bleeding will occur after finishing the second package, but during the days of taking the tablets, spotting or bleeding may occur.
• 2. You can also not take the remaining tablets from the current package, take a break of 7 days or less (including the day you missed the tablet), and then continue taking tablets from the next package.

If you forget to take tablets and do not have the expected withdrawal bleeding during the first break, it is possible that you are pregnant. Before starting the next package of Yasmin, you should consult a doctor.

Procedure in case of a missed tablet

Consult a doctor
had sex in the week before missing the tablet
did not have sex

• take the missed tablet
• use an additional contraceptive method for 7 days
• finish the package

Missed only
1 tablet (delay of more than 12 hours,
but less than
24 hours)
Week 1.

• take the missed tablet
• finish the package

• take the missed tablet
• finish the package
• do not take a 7-day break
• continue with the next package

or
Week 2

• take the missed tablet
• finish the package

Week 3

• stop taking the remaining tablets from the package
• take a break (not more than 7 days, counting from the day the tablet was missed)
• continue with the next package

4. Possible side effects

Like any drug, Yasmin can cause side effects, although they do not occur in everyone.
If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of the Yasmin drug, you should consult a doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). To obtain detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should read point 2 "Important information before using the Yasmin drug”.

Severe side effects

Severe side effects related to the use of the Yasmin drug and their symptoms have been described in the following sections of the leaflet: "Blood clots" and "Yasmin drug and cancer". You should read these sections to obtain additional information and, if necessary, immediately consult a doctor.

Other possible side effects

Below are the symptoms reported by patients taking the Yasmin drug, although they may not have been caused by the drug's action.
Common (in more than 1 in 100 people and less than 1 in 10 people):

• nausea,
• abdominal pain,
• migraine,
• weight gain,
• headache, mood changes, depressive mood,
• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness.
• vaginal discharge, candidiasis (fungal infection),

Uncommon (in more than 1 in 1000 people and less than 1 in 100 people):

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

Rare (in less than 1 in 1000 people):

• hypersensitivity reactions, asthma,
• intolerance to contact lenses,
• hearing impairment,
• weight loss,
• increased libido,
• leucorrhea,
• breast discharge,
• erythema nodosum, erythema multiforme.
• 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 symptoms, known as a transient ischemic attack

o blood clots in the liver, stomach, and intestine, kidneys, or eye
The likelihood of blood clots may be higher if the patient has any other risk factors (see point 2 for more information on risk factors for blood clots and symptoms of blood clots).
In women with hereditary angioedema, exogenous estrogens may cause the occurrence or worsening of its symptoms.
In some people, during the use of the Yasmin drug, other side effects may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist about them. Side effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the drug.

5. How to store the Yasmin drug

The drug should be stored out of sight and reach of children.
Store at a temperature below 30°C. Store in the original packaging.
Do not use after the expiration date stated on the packaging.
The expiration date means the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. Package contents and other information

Each coated tablet contains 0.03 mg of ethinylestradiol and 3.00 mg of drospirenone.
Excipients:
tablet core:
lactose monohydrate
corn starch
modified starch
povidone 25 000
magnesium stearate
coating:
talc
macrogol 6000
hypromellose
titanium dioxide (E 171)
yellow iron oxide (E 172)

What the Yasmin drug looks like and what the package contains

The package contains 1 or 3 blisters of 21 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer

Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
To obtain more detailed information, you should contact a doctor or a representative of the marketing authorization holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
phone: (0-22) 572 35 00
Date of leaflet approval: March 2021