Iasmin

Leaflet accompanying the packaging: information for the user

Yasmin, 0.03 mg + 3 mg, film-coated tablets

(ethinylestradiol+ drospirenone)

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

Important information about combined hormonal contraceptives:

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after restarting use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if you suspect that you have symptoms of blood clots (see section 2 "Blood clots").

Table of contents of the leaflet:

• 1. What is Yasmin and what is it used for? ........................................................................... 2
• 2. Important information before taking Yasmin ....................................................................... 2 When not to take Yasmin ...................................................................................................... 2 Warnings and precautions ....................................................................................................... 3 BLOOD CLOTS .......................................................................................................................... 5 Yasmin and cancer ...................................................................................................................... 9 Mental disorders...................................................................................................................... 9 Intermenstrual bleeding ................................................................................................... 9 What to do if bleeding does not occur during the break week ............................................. 9 Yasmin and other medicines ..................................................................................................... 9 Yasmin with food and drink .................................................................................................. 10 Laboratory tests ......................................................................................................................... 10 Pregnancy ……………...…………………………………………………………………10 Breast-feeding ............................................................................................................................ 10 Driving and using machines .............................................................................................. 10 Yasmin contains lactose ........................................................................................................... 11
• 3. How to take Yasmin ................................................................................................................. 11 When can the first blister be started? ........................................................................................... 11 What to do if you take more Yasmin than you should ................................................................ 12 What to do if you forget to take Yasmin .................................................................................... 12 What to do if you vomit or have severe diarrhea ................................................................. 15 Delaying the start of withdrawal bleeding: what you need to know ....................................... 15

Changing the first day of withdrawal bleeding: what you need to know ...................................... 15
Stopping Yasmin .............................................................................................. 15

• 4. Possible side effects ....................................................................................................... 15
• 5. How to store Yasmin ........................................................................................................ 17
• 6. Contents of the pack and other information ......................................................................... 17

1. What is Yasmin and what is it used for?

• Yasmin is a contraceptive pill and is used to prevent pregnancy.
• Each film-coated tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called "combined" pills.

2. Important information before taking Yasmin

General notes
Before starting to take Yasmin, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start taking Yasmin, your doctor will ask you some questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, if necessary, perform other tests.
This leaflet describes several situations in which you should stop taking Yasmin or in which the effectiveness of Yasmin may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods 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 take Yasmin

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

Do not take Yasmin:

• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know that you have a disorder that affects blood clotting - for example, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have ever 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 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 ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) severe liver disease, and liver function is still not normal;
• if you have kidney problems (kidney failure);
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) breast cancer or cancer of the genital organs, or if cancer is suspected;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). May cause: itching, rash, or swelling.

You should not take Yasmin if you have hepatitis C and are taking medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Yasmin and other medicines").

Additional information for special populations

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

Warnings and precautions

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

• -if you notice any of the following symptoms, 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 out about the symptoms of these serious side effects, see "How to recognize a blood clot".

Tell your doctor if you have any of the following conditions.

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

• if you or a close relative have (or have ever 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 genetic disorder of red blood cells),
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of pancreatitis,
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots"),
• if you have just given birth, as you are at increased risk of blood clots. You should ask your doctor how soon you can start taking Yasmin after giving birth,
• if you have superficial thrombophlebitis (blood clots in the veins under the skin),
• if you have varicose veins,
• if you have epilepsy (see page 9 "Yasmin and other medicines"),
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system),
• if you have a disease that first appeared during pregnancy or previous use of sex hormones [e.g., hearing loss, porphyria (a blood disorder), herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a nervous system disorder that causes sudden movements of the body)],
• if you have skin discolorations (yellow-brown pigment spots, so-called chloasma), you should avoid excessive sun exposure 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, which may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medicines may cause or worsen the symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives like Yasmin is associated with an increased risk of blood clots, compared to not taking them.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form:

• in the veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in the arteries (also known as "arterial thromboembolism"). Not everyone who has a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of a blood clot due to 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
probably suffering
from this?
Deep vein thrombosis

• swelling of one leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pale, red, or purple,
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain; If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for less serious conditions, such as a respiratory infection (e.g., a cold).

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. They are most likely to occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, this can lead to deep vein thrombosis.
• If a blood clot moves from the leg to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

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

What factors increase the risk of blood clots in veins?

The risk of blood clots due to Yasmin is small, but some factors may increase this risk. The risk is higher:

• if you are severely overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). 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. You may need to stop taking Yasmin for a few weeks before surgery or immobilization. If you need to stop taking Yasmin, ask your doctor when you can restart taking it;
• with increasing age (especially over 35 years);
• if you gave birth recently. The risk of blood clots increases as the number of risk factors increases. 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 your Yasmin. You should inform your doctor if any of these conditions change while taking Yasmin, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

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

Factors that increase the risk of blood clots in arteries

It should be noted that the risk of heart attack or stroke due to Yasmin is very small, but it may increase:

• with age (over approximately 35 years);
• if you smoke. If you are taking a hormonal contraceptive like Yasmin, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years). 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, irregular heartbeat);
• if you have diabetes.

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

Yasmin and cancer

Women taking combined oral contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the hormonal contraceptives. For example, more breast cancers may be detected in women taking combined oral contraceptives because they are more likely to have regular check-ups with their doctor. The frequency of breast cancer decreases gradually after stopping combined hormonal contraceptives. It is important to check your breasts regularly and contact your doctor if you feel any lumps.
Women taking combined oral contraceptives have rarely reported cases of benign or, even more rarely, malignant liver tumors, which can cause life-threatening bleeding into the abdominal cavity. If you experience severe stomach pain, you should contact your doctor immediately.

Mental disorders

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

Intermenstrual bleeding

During the first few months of taking Yasmin, you may experience unexpected bleeding (bleeding outside of the break 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 break week

If you have taken all the tablets as directed and have not vomited or had severe diarrhea and have not taken any other medicines, it is very unlikely that you are pregnant.
If your 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 which medicines or herbal products you are already taking. You should also tell any other doctor, dentist, or pharmacist who prescribes another medicine that you are taking Yasmin. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long or if you need to change how you take another medicine that you need.
Some medicines may:

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

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) tuberculosis (e.g., rifampicin) HIV 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 actionof other medicines, such as:

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

You should not take Yasmin if you have hepatitis C and are taking medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause elevated liver function tests (increased levels of the liver enzyme ALT). Your doctor will recommend a different type of contraception before starting these medicines. You can restart taking Yasmin about 2 weeks after finishing treatment. See section "When not to take Yasmin".
Before taking any medicine, you should consult your doctor or pharmacist.

Yasmin with food and drink

Yasmin can be taken with or without food, but you should take it with a small amount of water if necessary.

Lab tests

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

Pregnancy

Pregnant women should not take Yasmin. If you become pregnant while taking Yasmin, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Yasmin at any time (see also page 15 "Stopping Yasmin").
Before taking any medicine, you should consult your doctor or pharmacist.

Breast-feeding

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

Driving and using machines

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

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

You should take one Yasmin tablet every day, with a small amount of water if necessary. You can take the tablets with or without food, but you should take them at the same time every day.
The blister pack contains 21 film-coated tablets. The day of the week is printed next to each tablet. If, for example, you start on a Wednesday, take the tablet marked "Wed". You should move in the direction of the arrows 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 break week), you should start bleeding. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the break 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 bleeding has stopped or not. This means that you should start each blister pack on the same day of the week and that withdrawal bleeding should occur on the same days of the week every month.
If you take Yasmin in this way, you will also be protected from pregnancy during the 7 days when you are not taking tablets.

• When can the first blister be started?
• If you are not taking a hormonal contraceptive in the previous monthYou should start taking Yasmin on the first day of your cycle (i.e., the first day of your period). If you start taking Yasmin on the first day of your period, you are immediately protected from pregnancy. You can also start between days 2-5 of your cycle, but you will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patchYou can start taking Yasmin the next day after taking the last active tablet from your previous pack, but no later than the next day after taking the last inactive tablet from your previous pack (or after removing the vaginal ring or patch). If you are changing from a progestogen-only contraceptive pill (mini-pill), you can start taking Yasmin on the day after taking the last mini-pill, on the day of removal of an implant, or on the day of removal of an intrauterine device.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system)You can switch from a progestogen-only pill on any day, from an implant or intrauterine system on the day of removal, or from an injection when the next injection would be due. In all cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Yasmin.
• After a miscarriageFollow your doctor's advice.
• After childbirthYou can start taking Yasmin between 21-28 days after giving birth. If you start later than 28 days, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Yasmin.

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

• If you are breast-feeding and want to restart Yasmin after childbirthYou should read the section "Breast-feeding" on page 10.

What to do if you take more Yasmin than you should

There are no reports of serious harmful effects from taking too many Yasmin tablets at once.
If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their periods, but have taken the medicine by mistake.

What to do if you forget to take Yasmin

• If it has been less than 12 hourssince you missed a tablet, your protection from pregnancy is not reduced. Take the tablet as soon as possible and take the next tablets at the usual time.
• If it has been more than 12 hourssince you missed a tablet, your protection from pregnancy may be reduced. The more tablets you miss, the greater the risk of pregnancy.

The risk of reduced protection is highest if you miss tablets at the beginning or end of a blister pack. Therefore, you should follow these rules (see also the diagram on page 14):

• Missed more than 1 tablet in this blister packYou should contact your doctor.
• Missed 1 tablet in the 1st weekTake the missed tablet as soon as possible, even if it means taking two tablets at the same time. Take the next tablets at the usual time and use additional contraceptive methods(e.g., condoms) for the next 7 days. If you had sex in the week before missing the tablet, you should be aware that you may be at risk of pregnancy. In this case, you should contact your doctor.
• Missed 1 tablet in the 2nd weekTake 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 from pregnancy is not reduced, and you do not need to use additional contraceptive methods.
• Missed 1 tablet in the 3rd weekYou have 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, just go on to the next blister pack. You may not have withdrawal bleeding until the end of the second blister pack, but you may have spotting or breakthrough bleeding during the second blister pack.
• 2. You can also stop taking tablets from the blister pack and have a break of up to 7 days (including the missed tablet). If you want to start your next blister pack on the same day as usual, you can make the break shorter than 7 days. If you follow one of these rules, your protection from pregnancy will be maintained.
• If you have missed a tablet and have not had withdrawal bleeding, you may be pregnant. You should contact your doctor before starting the next blister pack.

Missed several tablets
from one blister pack
Contact your doctor
yes
in week 1.
Did you have sex in the
week before missing
the tablet?
no

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

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

• Take the missed tablet and
• finish the tablets in the blister pack
• Take the missed tablet and
• finish the tablets in the blister pack
• Instead of the break week, start the next blister pack immediately

or
in week 3.

• Stop taking tablets from the blister pack immediately
• Have a break week (no longer than 7 days, including the missed tablet)
• Start the next blister pack in week 2.

4. Possible side effects

Like all medicines, Yasmin can cause side effects, although not everybody gets them. If you experience any side effects, especially serious or persistent ones, or changes in your health that you think may be related to the use of Yasmin, you should consult your doctor.
All women taking 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 various risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before taking Yasmin".

Severe side effects

You should immediately contact your doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives, which may cause difficulty breathing (see also section "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, intermenstrual 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 in the form of redness or ulcers),
• 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 likelihood of developing blood clots may be higher if you have 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Yasmin

The medicine should be stored out of sight and reach of children.
Do not store above 30°C. Store in the original blister to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging, after "Expiry date:". The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Yasmin contains

• The active substances of Yasmin are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg of drospirenone and 0.030 mg of ethinylestradiol.
• The other ingredients (excipients) are: lactose monohydrate, corn starch, corn starch paste, povidone K25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172), see section 2 "Yasmin contains lactose".

What Yasmin looks like and what the pack contains

• Each Yasmin blister 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, 3, 6, or 13 blisters, each of 21 tablets. Not all pack sizes may be marketed.

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 your doctor or the representative of the marketing authorization holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
phone (0-22) 572 35 00

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

Date of last revision of the leaflet: November 2023