Iasmin

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Yasmin

0.03 mg + 3 mg, 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
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see point 2 "Blood clots")

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

• One should keep this leaflet, so that it can be read again if necessary.
• One should consult a doctor or pharmacist if there are any further doubts.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, one should tell the doctor or pharmacist about it. See point 4.

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 Yasmin and other medicines Pregnancy Breast-feeding Driving and using machines Yasmin contains lactose
• 3. How to use Yasmin When can the first blister be started If the first tablet is missed If more than one tablet is missed After childbirth, after a miscarriage or abortion Overdose Contraindications
• 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 coated tablet contains two different hormones. These are: ethinylestradiol (estrogen) and drospirenone (progestogen). When using Yasmin according to the recommendations in this leaflet, the likelihood of becoming pregnant is very low. One should remember that Yasmin, like other combined oral contraceptives, does not protect against HIV infection (AIDS) and sexually transmitted diseases.

Indications for use

Prevention of pregnancy.

2. Important information before using Yasmin

General notes

Before starting to use Yasmin, one should read the information about blood clots (thrombosis) in point 2. It is especially important to read about the symptoms of blood clots (see point 2 "Blood clots"). Every year, about 1 in 100 women who use combined oral contraceptives correctly become pregnant. This number may increase if tablets are missed or not taken correctly.

When not to use Yasmin

Yasmin should not be used if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to ethinylestradiol or drospirenone or any of the other ingredients of Yasmin (listed in point 6). May cause: itching, rash or swelling;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows that they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see point "Blood clots");
• if the patient has (or has 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 (transient stroke symptoms);
• if the patient has had a heart attack or stroke;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has any of the diseases listed below, which may increase the risk of a blood clot in an artery;
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia;
• if the patient has had severe liver disease (until liver function tests return to normal);
• if the patient has severe or acute kidney failure;
• if the patient has had or currently has benign or malignant liver tumors;
• if the patient has been diagnosed with a hormone-dependent tumor (breast or genital cancer);
• if the patient has unexplained vaginal bleeding;
• if the patient is pregnant or suspects they are pregnant.

If any of the symptoms listed above occur for the first time while taking Yasmin, the medicine should be stopped immediately and a doctor consulted. In the meantime, non-hormonal methods of contraception should be used (see also "General notes"). Yasmin should not be used if the patient has hepatitis C and is 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 advanced age
Yasmin is not intended for use after menopause.
Women with liver function disorders
Yasmin should not be taken if the patient has liver disease. See also "When not to use Yasmin" and "Warnings and precautions".
Women with kidney function disorders
Yasmin should not be taken if the patient has kidney failure or acute kidney failure. See also "When not to use Yasmin" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor
One should contact a doctor immediately

• -if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see point below "Blood clots (thrombosis)").

In order to get a description of the serious side effects listed, see "How to recognize the occurrence of blood clots".

One should tell the doctor if the patient has any of the following conditions.

If combined oral contraceptives are used in any of the situations listed below, close medical supervision is necessary. If these symptoms appear or worsen while taking Yasmin, one should also tell the doctor.

• if the patient smokes;
• if the patient has diabetes;
• if the patient is obese;
• if the patient has high blood pressure;
• if the patient has heart valve defects or heart rhythm disorders;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if there have been cases of blood clots, heart attack, or stroke in close relatives;
• if the patient has migraines;
• if the patient has epilepsy (see "Yasmin and other medicines");
• if the patient has 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 the patient needs to have surgery or will be immobilized for a long time (see point 2 "Blood clots");
• if the patient has just given birth, as they are at increased risk of blood clots. One should consult a doctor to find out how soon they can start taking Yasmin after giving birth;
• if the patient or a close relative has had breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient has a disease that first appeared or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, porphyria, herpes during pregnancy, Sydenham's chorea);
• if the patient has or has ever had skin discolorations (yellow-brown pigment spots, so-called chloasma), one 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, one 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). If a blood clot breaks loose from 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. 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 form:

• in the veins (also called "venous thrombosis" or "venous thromboembolism")
• in the arteries (also called "arterial thrombosis" or "arterial thromboembolism").
• Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

One should remember that the total risk of harmful blood clots caused by Yasmin is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS

One should contact a doctor immediately if they notice any of the following symptoms. Is the patient experiencing any of these symptoms? Why is the patient likely to be suffering from it?

• swelling of the legs and (or) swelling along the vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt while standing or walking;
• increased temperature in the affected leg
• change in skin color of the leg, e.g. pallor, redness, or cyanosis Deep vein thrombosis

Pulmonary embolism

• 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 the patient is unsure, they should contact a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold). 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)

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thrombosis). Although these side effects are rare, they can occur most often 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 pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

The risk of 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 the patient stops using Yasmin, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

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

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

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

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 approximately 35 years old);
• if the patient smokes.While using a hormonal contraceptive like Yasmin, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or someone in their immediate family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation)
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher. One should inform their doctor if any of the above conditions change while using Yasmin, e.g. if they start smoking, if someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight. If symptoms suggesting a blood clot occur, one should stop taking the tablets and consult a doctor immediately (see also "When to contact a doctor").

Yasmin and cancer

In women who use combined oral contraceptives, breast cancer is slightly more common than in women of the same age who do not use them. It is not known whether this difference is caused solely by the use of hormonal contraceptives. The reason may also be that women who use hormonal contraceptives are more often examined 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 the use of combined oral contraceptives. In women who use combined oral contraceptives, benign or, even more rarely, malignant liver tumors have been rarely reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, one should inform their doctor as soon as possible. There are reports of a more common occurrence of cervical cancer in women who use combined oral contraceptives for a long time. However, this relationship may not be related to the use of the tablets, but to sexual behavior or other factors.

Psychiatric 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 mood changes and symptoms of depression occur, one should contact a doctor as soon as possible to receive 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) arthritis, degenerative joint disease (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)

Yasmin should not be used if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, as this may cause elevated liver function test results (increased level of the liver enzyme ALT). The doctor will propose a different type of contraception before starting these medicines. One can resume using Yasmin about 2 weeks after finishing the treatment. See point "When not to use Yasmin". Before using any medicine, one should consult a doctor or pharmacist. One should always inform their doctor about any medicines or herbal products they are already taking. One should also tell any other doctor, including a dentist or pharmacist, who prescribes another medicine, that they are using Yasmin. They may say that additional contraceptive measures should be used (e.g. condoms), and if so, for how long.

Pregnancy

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

Breast-feeding

Before using any medicine, one should consult a doctor or pharmacist. Yasmin is not recommended during breast-feeding.

Driving and using machines

No influence of Yasmin on the ability to drive and use machines has been observed.

When to contact a doctor

One should contact a doctor immediately if:

• they notice worrying changes in their health, especially any of the symptoms listed above that require special caution;
• there have been cases of blood clots, heart attack, or stroke in close relatives;
• a breast lump has been detected;
• they plan to use other medicines (see also "Yasmin and other medicines");
• they may be immobilized or are planning to have surgery (one should inform their doctor at least 4 weeks in advance);
• they experience heavy vaginal bleeding;
• they missed tablets in the first week of the cycle (every first week of the following months of using Yasmin), and they had sexual intercourse during the previous 7 days;
• they experience severe diarrhea;
• they do not have bleeding for 2 consecutive months or suspect they are pregnant (one should not start the next pack without their doctor's decision).

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

Yasmin contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to use Yasmin

Yasmin should always be used according to the doctor's recommendations. In case of doubts, one should contact their doctor again. Yasmin, like other oral contraceptives, does not protect against HIV infection (AIDS) and sexually transmitted diseases.

When can the first blister be started

• If Yasmin is used for the first time or after a break in use, the first tablet should be taken on the first day of the cycle, i.e. on the day of menstrual bleeding.
• In other cases, one should follow the recommendations in the points: "If a different combined oral contraceptive was used earlier" or "If only progestogens were used earlier", or "After childbirth", or "After a miscarriage or abortion".
• The first tablet to be taken is the one marked with the current day of the week. If the menstrual period starts, for example, on a Wednesday, the first tablet to be taken is the one marked "Wed." The following tablets should be taken according to the marking on the blister.

Taking Yasmin for the first time

• After taking the first tablet, one 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 using Yasmin

After taking the entire package (21 tablets), one does not take tablets for the next 7 days. During this time, withdrawal bleeding occurs. It usually starts on the 2nd or 3rd day after taking the last tablet of Yasmin. One starts taking tablets from the next package after a 7-day break. During the 7-day break in taking tablets, there is no need to use additional methods of contraception, provided that the tablets were taken according to the recommended schedule, and the next package is started after 7 days.

Next package of Yasmin

One starts taking tablets from the next package after a 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 new package. One starts taking tablets from the next package after a 7-day break, even if the withdrawal bleeding is still ongoing.

If a different combined oral contraceptive was used earlier

If a different combined oral contraceptive was used for 21 days
After taking all the tablets from the package of a different combined oral contraceptive for 21 days, there is a 7-day break, after which Yasmin is started. The first tablet of Yasmin should be taken on the day of the week marked on the tablet, and then one should follow the instructions described in the point "Taking Yasmin for the first time". If one starts using 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 a different combined oral contraceptive was used for 28 days
If a different combined oral contraceptive was used for 28 days, one should start taking Yasmin the day after taking the last tablet of the previous contraceptive. The first tablet of Yasmin should be taken on the day of the week marked on the tablet, and then one should follow the instructions described in the point "Taking Yasmin for the first time". If one follows the above recommendations, there is no need to use additional methods of contraception. 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 a vaginal ring or transdermal patch is used, one 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 only progestogens were used earlier

If a progestogen-only pill (minipill) was used earlier
One can stop taking the minipill on any day and instead, at the same time, start taking Yasmin. If sexual intercourse is maintained during the first 7 days of taking Yasmin, one should use additional methods of contraception (barrier methods).
If progestogen injections, an implant, or an intrauterine system were used earlier
One should start taking Yasmin on the day the next injection would be due or on the day the implant or intrauterine system is removed. If sexual intercourse is maintained during the first 7 days of taking the tablets, one should use additional methods of contraception (barrier methods).

After childbirth, after a miscarriage or abortion

After a miscarriage in the first trimester of pregnancy
One can start taking Yasmin immediately. In this case, there is no need to use additional methods of contraception.
After childbirth or a miscarriage in the second trimester of pregnancy
One should start taking tablets between the 21st and 28th day after childbirth or miscarriage in the second trimester of pregnancy. If one starts using the tablets later, one should use additional mechanical contraception for the first 7 days of taking the tablets. If sexual intercourse has occurred before starting to use a combined oral contraceptive, one should make sure they are not pregnant or wait for the first menstrual period.

Overdose 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 a higher dose of Yasmin than recommended has been taken, or if someone else has taken it, one should inform their doctor.

Stopping the use of Yasmin

The medicine can be stopped at any time. The doctor will propose other methods of contraception. If one stops taking Yasmin because they want to become pregnant, they should wait until they have a natural menstrual period. This will help determine the expected date of birth of the child.

Missing a dose of Yasmin

If less than 12 hourshave passed since missing a tablet, the contraceptive effect of Yasmin is maintained. One should take the missed tablet as soon as possible and take the next one at the usual time.
If more than 12 hourshave passed since missing a tablet or if more than one tablet has been missed, the contraceptive effect of Yasmin may be reduced. Therefore, the patient must use additional methods of contraception. The more consecutive tablets are missed, the higher the risk of reduced contraceptive effectiveness.

Missing more than 1 tablet from the package

One should consult their doctor.

Missing 1 tablet in the 1st week of taking Yasmin from the current package

One 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, one should use additional methods of contraception (barrier methods). If sexual intercourse was maintained during the week preceding the missed tablet, it is possible to become pregnant. One should contact their doctor as soon as possible.

Missing 1 tablet in the 2nd week of taking Yasmin from the current package

One 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 there is no need to use additional methods of contraception. However, if errors were made in dosing earlier or if more than one tablet was missed, one should use additional mechanical contraception for 7 days.

Missing 1 tablet in the 3rd week of taking Yasmin from the current package

One can choose one of the following options, without the need to use additional methods of contraception, provided that the correct dosing was followed for 7 days preceding the missed dose. If not, one should use the first of the two options below and use additional mechanical contraception 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 the 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.

One can also stop taking the tablets from the current package, take a 7-day or shorter break (including the day the tablet was missed), and then continue taking the tablets from the next package. If a tablet is missed and during the first break in taking the tablets, withdrawal bleeding does not occur, it is possible that one is pregnant. Before starting the next package of Yasmin, one should consult their doctor.

Procedure in case of missing a tablet

4. Possible side effects

Like any drug, Yasmin can cause side effects, although not everyone will experience them.
If any side effects occur, especially severe and persistent ones, or changes in health that you consider 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 section 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 are 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.
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, weight changes. 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, such as: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism)

o myocardial infarction
o stroke
o mini-stroke or transient stroke-like 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 you have any other risk factors (see section 2 for more information about 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store the Yasmin drug

The drug should be stored in a place invisible and inaccessible to 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 thrown into the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

Each coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone.
Excipients:
Core:
lactose monohydrate
corn starch
corn starch, pregelatinized
povidone K 25
magnesium stearate
Coating:
hypromellose
macrogol 6000
talc
titanium dioxide (E 171)
yellow iron oxide (E 172)

What the Yasmin drug looks like and what the package contains

The package contains blisters of PVC/Al foil with 21 or 63 coated tablets in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands

Manufacturer

Bayer AG
Müllerstrasse 178
13353 Berlin
Germany

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28 Street
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Marketing authorization number in the Netherlands, the country of export: RVG 23827

Parallel import authorization number: 431/22

Translation of day of the week symbols on the immediate packaging:

MA

• Monday DI
• Tuesday WO
• Wednesday DO
• Thursday VR
• Friday ZA
• Saturday ZO
• Sunday

Date of leaflet approval: 13.12.2022
[Information about the reserved trademark]