Iasmin

Leaflet accompanying the packaging: information for the user

Warning!

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

Yasmin

0.03 mg + 3 mg, film-coated tablets

Ethinylestradiol+ Drospirenone

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Important information about combined hormonal contraceptives:

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

Table of contents of the leaflet:

• 1. What is Yasmin and what is it used for
• 2. Important information before using Yasmin When not to use Yasmin Warnings and precautions BLOOD CLOTS Yasmin and cancer Mental disorders Intermenstrual bleeding What to do if bleeding does not occur during the break week Yasmin and other medicines Yasmin with food and drink Laboratory tests Pregnancy Breastfeeding Driving and using machines Yasmin contains lactose monohydrate
• 3. How to use Yasmin When can the first blister be started? Taking a higher dose of Yasmin than recommended 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 packaging 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 containing two hormones are called "combined" pills.

2. Important information before using Yasmin

General notes

Before starting to take Yasmin, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use Yasmin, the doctor will ask a few questions about your health and the health of your close relatives. The doctor will also measure your blood pressure and, if necessary, perform other examinations.
This leaflet describes several situations in which you should stop using Yasmin or in which the effectiveness of Yasmin may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Yasmin modifies the monthly changes in body temperature and cervical mucus.

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

When not to use Yasmin

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

Do not use Yasmin:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have 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 "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 transient ischemic attack (transient 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 had (or currently have) severe liver disease, and liver function is still impaired;
• if you have kidney problems (kidney failure);
• if you have had (or currently have) liver cancer;
• if you have had 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 use Yasmin in patients with hepatitis C and taking medicinal products containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (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 cycles.
Women of advanced age
Yasmin is not intended for use after menopause.
Women with liver function disorders
You should not take Yasmin if you have liver disease. See also "When not to use Yasmin" and "Warnings and precautions".
Women with kidney function disorders
You should not take Yasmin if you have kidney failure or acute kidney failure. See also "When not to use Yasmin" and "Warnings and precautions".

Warnings and precautions

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

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

To find a description of 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 to use Yasmin, you should discuss this with your doctor. In certain situations, you should be particularly careful when using Yasmin or any other combined hormonal contraceptive, and you may also need to be regularly examined by your doctor. If these symptoms occur or worsen during the use of 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 "Blood clots"),
• if you are immediately after childbirth, then you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Yasmin after childbirth,
• if you have superficial thrombophlebitis (blood clots in the veins under the skin),
• if you have varicose veins,
• if you have epilepsy (see "Yasmin and other medicines"),
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system),
• if you have a disease that first appeared during pregnancy or while using sex hormones [e.g., hearing loss, porphyria (a blood disease), herpes during pregnancy (a skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disease in which there are sudden body movements)],
• if you have skin discoloration (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 swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Yasmin, is associated with an increased risk of blood clots, compared to not using the therapy.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

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

Not all people recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or very rarely fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN VEINS

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

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

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

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

What 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.

• Within a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• Within a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• Within a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Yasmin, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots in veins", below).

Factors that increase the risk of blood clots in veins

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

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has had blood clots in their legs, lungs, or other organs at a young age (e.g., under 50). In this case, you may have hereditary blood coagulation disorders.
• if you need to have surgery or will be immobilized for a long time (see "Blood clots"). It may be necessary to stop using Yasmin for a few weeks before surgery or immobilization. If you need to stop using Yasmin, you should ask your doctor when you can resume using it.
• with age (especially over 35);
• 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-distance air travel (>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 using Yasmin.
You should inform your doctor if any of the above conditions change while using Yasmin, e.g., if someone in your immediate family is diagnosed with thrombosis 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?

Like 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 using a hormonal contraceptive like Yasmin, it is recommended to quit smoking. If you cannot quit smoking and are over 35, your doctor may recommend using 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, arrhythmia called atrial fibrillation);
• if you have diabetes.

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

Yasmin and cancer

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

Mental disorders

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

Intermenstrual bleeding

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

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

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

Yasmin and other medicines

You should 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 using Yasmin. They may tell you that you need to use additional contraceptive products (e.g., condoms) and for how long or whether you need to change the use of another necessary medicine.
Some medicines may:

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

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g., griseofulvin, ketoconazole)
• arthritis or degenerative joint disease (etoricoxib)
• pulmonary hypertension (bosentan)

Yasmin may affect the actionof other medicines, such as:

• those containing cyclosporin
• antiepileptic drugs - lamotrigine (may lead to an increased frequency of seizures)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and/or muscle spasms).

You should not use Yasmin in patients with hepatitis C and taking medicinal products containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause elevated liver function test results (increased levels of the liver enzyme ALT).
Your doctor will recommend another type of contraception before starting these medicines.
You can resume using Yasmin about 2 weeks after completing treatment. See "When not to use Yasmin".
Before using any medicine, you should consult your doctor or pharmacist.

Yasmin with food and drink

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

Lab tests

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

Driving and using machines

There is no information suggesting that the use of Yasmin affects the ability to drive or operate machines.

Yasmin contains lactose monohydrate

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

3. How to use Yasmin

You should take one Yasmin tablet every day, if necessary with a small amount of water. You can take the tablets with or without food, but you should take them every day at about the same time.
The blister pack contains 21 film-coated tablets. The day of the week is printed next to each tablet. If, for example, you start on a Wednesday, 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 called 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 a new 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 the withdrawal bleeding should occur on the same days of the week each month.
If you use Yasmin in this way, you are also protected against pregnancy during the 7 days when you are not taking tablets.

When can the first blister be started?

• If you have not used a hormonal contraceptive in the previous monthYou should start taking Yasmin on the first day of your menstrual cycle (i.e., 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 on days 2-5 of your cycle,

but then you should 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's tablet-free period (or after the last inactive tablet). In the case of 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 is 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 childbirthAfter childbirth, you can start taking Yasmin from the 21st to the 28th day after giving birth. If you start later than 28 days, you should use a so-called mechanical method (e.g., condoms) for the first 7 days of taking Yasmin.

If you have had sexual intercourse after childbirth and before resuming Yasmin, you should first make sure you are not pregnant or wait for your next menstrual period.

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

Taking a higher dose of Yasmin than recommended

There are no reports of serious harmful effects from taking too many Yasmin tablets at once.
If you take several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their menstrual cycles, but have taken the medicine by mistake.
If you take too many Yasmin tablets or if a child swallows 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 then take the next 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 a tablet at the beginning or end of the blister pack. Therefore, you should follow the rules below (see also the diagram below):

• More than 1 tablet missed in this blister packYou should consult your doctor.
• 1 tablet missed in the 1st weekYou should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time and use additional contraceptive methods, such as 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 consult your doctor.
• 1 tablet missed in the 2nd weekYou should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time. Your protection against pregnancy is not reduced, and you do not need to use additional contraceptive methods.
• 1 tablet missed in the 3rd weekThere are two options to choose from:
• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time. 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 it may also occur as 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 recommendations, your protection against pregnancy will be maintained.

• If you miss a tablet from the blister pack and do not experience withdrawal bleeding during the first tablet-free period, it may mean that you are pregnant. You should consult your doctor before starting the next blister pack.

Missed several tablets
from one blister pack
Consult a doctor
yes
Did you have sexual intercourse in the week before missing the tablet
in the week

• 1.

no

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days
• and finish taking the tablets from the blister pack

Only 1 tablet missed (taken more than 12 hours late)

• Take the missed tablet and
• finish taking the tablets from the blister pack
• 2.
• Take the missed tablet and
• finish taking the tablets from the blister pack
• Instead of the tablet-free week, start taking tablets from the next blister pack immediately or
• 3.
• Stop taking tablets from the blister pack immediately
• Start the tablet-free week (no longer than 7 days, including the missed tablet)
• Start taking tablets from the next blister pack

What to do if vomiting or severe diarrhea occurs

If vomiting occurs within 3-4 hours after taking a tablet or if you experience severe diarrhea, there is a risk that the active substances from the tablet may not have been fully absorbed into your body.
The situation is similar to that of missing a tablet. After vomiting or diarrhea, you should take another tablet from the reserve blister pack as soon as possible. If possible, you should take it within 12 hoursafter the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the advice given in the section "Missing a dose of Yasmin".

Delaying the 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 a new 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 according to the instructions, withdrawal bleeding will start during the tablet-free week. If you need to change this day, you 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 Tuesday (3 days earlier), you should start the new 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 experience withdrawal bleeding during the tablet-free period. You may experience spotting or intermenstrual bleeding instead.
If you are unsure what to do, you should consult your doctor.

4. Possible side effects

Like all medicines, Yasmin can cause side effects, although not everybody gets them.
If side effects occur, especially severe or persistent ones, or changes in health that the patient considers related to the use of Yasmin, consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before taking Yasmin".

Severe side effects

Seek medical attention immediately if any of the following symptoms of angioedema occur: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which may cause difficulty breathing (see also section "Warnings and precautions").
The following side effects have been associated with the use of Yasmin:
Common side effects(occurring in 1 to 10 out of every 100 patients):

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

Uncommon side effects(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 side effects(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 characterized by redness or ulceration),
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis)
• in the lungs (e.g., pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, tell a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicinal product.

5. How to store Yasmin

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C. Store in the original package.
Do not use 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. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Yasmin contains

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

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

For further information, consult the marketing authorization holder or parallel importer:

Marketing authorization holder in the Netherlands, country of export:

Bayer B.V., Siriusdreef 36, 2132 WT Hoofddorp, Netherlands

Manufacturer:

Bayer AG, Müllerstrasse 178, 13353 Berlin, Germany

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands, country of export, authorization number: RVG 23827

Parallel import authorization number: 385/21

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:

MA - Monday
DI

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

Date of revision of the leaflet: 13.06.2024

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