YAZ 3 mg / 0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

YAZ 3 mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and talk to your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the pack

1. What is YAZ and what is it used for .2

1. What you need to know before you start taking YAZ 2

When not to use YAZ 2

Warnings and precautions 3

Blood clots 5

YAZ and cancer 9

Psychiatric disorders………………………………………………………………….9

Bleeding between periods 10

What to do if you do not have your period during the placebo days 10

Other medicines and YAZ 10

Taking YAZ with food and drink 11

Laboratory tests 11

Pregnancy 11

Breast-feeding 11

Driving and using machines 11

YAZ contains lactose 12

1. How to take YAZ 12

Preparation of the blister pack 12

When you can start with the first blister pack 13

If you take more YAZ than you should 14

If you forget to take YAZ 14

What to do in case of vomiting or severe diarrhea 16

Delay of menstrual period: what you should know 17

Change of the first day of your menstrual period: what you should know 17

If you stop taking YAZ 17

1. Possible side effects 17

1. Storage of YAZ 19

1. Contents of the pack and further information…………………………………………20

1. What is YAZ and what is it used for

• YAZ is a contraceptive that is used to prevent pregnancy.
• Each of the 24 film-coated pink tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

• The 4 film-coated white tablets do not contain active ingredients and are also called placebo tablets.
• Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking YAZ

General considerations

Before using YAZ, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before taking YAZ, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure, and depending on your personal situation, may perform some other tests.

This prospectus describes several situations in which you should interrupt the use of YAZ, or in which the reliability of YAZ may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable since YAZ alters the monthly changes in body temperature and cervical mucus.

YAZ, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When not to use YAZ

Do not use YAZ if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not use YAZ:

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) a liver disease and your liver function has not yet normalized.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have ever had) a tumor in the liver.
• If you have (or have ever had), or are suspected to have breast cancer or cancer of the sex organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol, drospirenone, or any of the other components of this medication (including those listed in section 6). This may manifest as itching, rash, or inflammation.

Do not take YAZ if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and YAZ").

Additional information on special populations

Children and adolescents

YAZ is not indicated for use in women who have not yet had their first menstrual period.

Older women

YAZ is not indicated for use after menopause.

Women with liver insufficiency

Do not take YAZ if you suffer from liver disease. See sections "Do not use YAZ" and "Warnings and precautions".

Women with renal insufficiency

Do not take YAZ if you are suffering from kidney malfunction or acute kidney failure. See sections "Do not use YAZ" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take YAZ.

Tell your doctor if you suffer from any of the following conditions.

In some situations, you will need to be particularly careful while using YAZ or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using YAZ, you should also inform your doctor.

• If a close relative has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking YAZ after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Other medications and YAZ", page 10).
• If you have some diseases that appeared for the first time during pregnancy or in a previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea)). If you have or have ever had brownish patches (chloasma), also called "pregnancy patches", especially on the face. In this case, avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medications that contain estrogens may induce or worsen the symptoms of hereditary and acquired angioedema.

Consult your doctor before taking YAZ.

BLOOD CLOTS

The use of a combined hormonal contraceptive like YAZ increases your risk of having a blood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to YAZ is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking YAZ, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with YAZ is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as YAZ, between 9 and 12 women will develop a blood clot in a year.
• The risk of developing a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with YAZ is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50).
• If you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using YAZ several weeks before surgery or while you have reduced mobility. If you need to stop using YAZ, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

The risk of developing a blood clot increases with the number of conditions you have.

Long-distance air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using YAZ.

If any of the above conditions change while you are using YAZ, for example, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to YAZ is very small, but it may increase:

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like YAZ, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased further.

If any of the above conditions change while you are using YAZ, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

YAZ and cancer

There have been reports of breast cancer slightly more often in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who use combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts examined regularly, and you should see your doctor if you notice any lump.

In rare cases, benign liver tumors, and more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

Some women who use hormonal contraceptives like YAZ have reported depression or a depressive mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible.

Vaginal bleeding

3. How to take YAZ

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each blister pack contains 24 active pink film-coated tablets and 4 white placebo film-coated tablets.

The YAZ tablets of different colors are ordered. A blister pack contains 28 tablets.

Take one YAZ tablet every day, with some water if necessary. You can take the tablets with or without food, but always at approximately the same time every day.

Do not confuse the tablets: take a pink tablet for the first 24 days and then a white tablet for the last 4 days. Then you should start another blister pack immediately (24 pink tablets and then 4 white tablets). Therefore, there is no interval between two blister packs.

Since the composition of the tablets is different, you must start the blister pack with the tablet from the upper left corner and take the tablets every day. Follow the direction of the arrows on the blister pack to take the tablets in the correct order.

Preparing the blister pack

To help you follow the order of intake, each YAZ package contains 7 self-adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with "WED".

Stick the self-adhesive strip on the top of the YAZ blister pack, where it says "Place the strip here!", so that the first day is placed above the tablet marked with "1".

Now you will have a day marked above each tablet and you can visually check if you have taken your tablet. The arrows indicate the order of intake of the tablets.

During the 4 days when you take the placebo tablets (the placebo days), you should have your period (the so-called withdrawal bleeding). It usually starts on the 2nd or 3rd day after taking the last active pink YAZ tablet. After taking the last white tablet, start the next blister pack, even if your period has not finished. This means that you must start the next blister pack on the same day of the week that you started the previous one, and your withdrawal bleeding should occur during the same days every month.

If you use YAZ in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablet.

When can you start with the first blister pack

• If you have not used any hormonal contraceptive in the previous month

Start taking YAZ on the first day of your cycle (i.e., the first day of your period). If you start YAZ 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 in this case, you must use additional contraceptive methods (e.g., condoms) for the first 7 days.

• Changing from a combined hormonal contraceptive, vaginal ring, or patch

You can start taking YAZ preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the pill-free days (or after the last inactive tablet) of your previous contraceptive. When changing from a vaginal ring or patch, follow your doctor's recommendations.

• Changing from a progestogen-only method (mini-pill, injection, implant, or intrauterine system)

You can change from the mini-pill at any time. If it's an implant or intrauterine system, on the day of its removal; if it's an injectable, when the next injection is due. In all cases, it is recommended that you use additional contraceptive measures (e.g., condoms) for the first 7 days of tablet-taking.

• After an abortion

Follow your doctor's recommendations.

• After having a baby

After having a baby, you can start taking YAZ between 21 and 28 days later. If you start later than day 28, you must use a barrier method (e.g., condoms) for the first 7 days of YAZ use.

If, after having a baby, you have already had sexual intercourse, before starting to take YAZ again, you must be sure you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start taking YAZ

Read the section "Breastfeeding", page 12.

Consult your doctor if you have doubts about when to start.

If you take more YAZ than you should

No cases have been reported where an overdose of YAZ has caused serious harm.

If you take many tablets at the same time, you may feel unwell or have vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first period, if they have accidentally taken this medication.

If you have taken too many YAZ tablets, or discover that a child has taken them, consult your doctor or pharmacist. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take YAZ

The last 4 tablets of the 4th row of the blister pack are placebo tablets. If you forget one of these tablets, you do not lose the contraceptive effect of YAZ. You should discard the forgotten placebo tablet.

If you forget an active pink tablet (tablets 1-24 of the blister pack), you should follow these tips:

• If you are less than 24 hourslate in taking a tablet, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 24 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget a pink tablet at the beginning or end of the blister pack. The following recommendations should be followed in this situation (see also the diagram on page 16):

• Forgetfulness of more than one tablet from the blister pack

Consult your doctor.

• Forgetfulness of a tablet during days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time and use additional precautions, for example, condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In this case, consult your doctor.

• Forgetfulness of a tablet during days 8-14 (second row)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. The protection against pregnancy does not decrease and you do not need to take additional precautions.

• Forgetfulness of a tablet between days 15 and 24 (third or fourth row)

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. Instead of continuing with the white placebo tablets, discard them and start the next blister pack (the day you take the first tablet will be different).

You will probably have your period at the end of the second blister pack - during the intake of the white placebo tablets - although you may experience spotting or bleeding similar to menstruation during the intake of the second blister pack.

1. You can also stop taking the active pink tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day you forgot to take your tablet). If you want to start a new blister pack on your fixed start day, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten to take a tablet from a blister pack and do not have your period during the placebo days, this may mean that you are pregnant. In this case, you should see your doctor before continuing with the next blister pack.

Forgetfulness of several pink tablets. Ask your doctor for advice

from the same blister pack

Yes

Day 1-7 Did you have sexual intercourse the week before forgetting the tablet?

No

- Take the forgotten tablet

- Use a barrier method (condom) for the next 7 days and

- Finish the blister pack

Forgetfulness of only one pink tablet (taken more than 24 hours late) Day 8-14 - Take the forgotten tablet and

- Finish the blister pack

- Take the forgotten tablet and

- Finish taking the pink tablets

- Discard the 4 white placebo tablets

- Start the next blister pack immediately

Day 15-24 or

- Stop taking the pink tablets immediately

- Go directly to the 4 white placebo tablets

- Then continue with the next blister pack

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active pink tablet or if you have severe diarrhea, there is a risk that the active ingredients of the tablet may not be fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take a pink tablet from a reserve package as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If it is not possible or more than 24 hours have passed, follow the advice in the section "If you forget to take YAZ", page 14.

Delayed period: what you should know

Although it is not recommended, it is possible to delay your period if you do not take the white placebo tablets from the 4th row and start directly with the tablets from a new YAZ blister pack until you finish this new blister pack. You may experience spotting (drops or spots of blood) or bleeding similar to menstruation during the use of the second blister pack. After finishing this second blister pack, taking the 4 white tablets from the 4th row, you start the next blister pack.

Before deciding to delay your period, ask your doctor.

Changing the first day of your period: what you should know

If you take the tablets according to the instructions, your period will start during the placebo days. If you need to change this day, you can do so by reducing the placebo days (the days you take the white tablets), but never extending them - 4 days is the maximum! For example, if you start the placebo days on a Friday and want to change it to Tuesday (3 days earlier), you must start a new blister pack 3 days earlier than usual. You may not have bleeding during these placebo days. Then you may experience spotting or bleeding similar to menstruation.

If you are not sure how to proceed, consult your doctor.

If you stop treatment with YAZ

You can stop taking YAZ at any time. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, stop taking YAZ and wait until your period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to YAZ, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking YAZ".

Severe Adverse Effects

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also the "Warnings and Precautions" section).

The following adverse effects are related to the use of YAZ:

Frequent Adverse Effects (may affect up to 1 in 10 patients)

• mood changes
• headache
• nausea
• breast pain, menstrual problems such as irregular periods, absence of periods

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• depression, nervousness, drowsiness
• dizziness, tingling sensation
• migraine, varicose veins, increased blood pressure
• stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea
• acne, itching, skin rash
• discomfort and pain, such as back pain, pain in the limbs, muscle cramps
• vaginal yeast infection, pain in the lower abdominal region (pelvic), breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex
• lack of energy, increased sweating, fluid retention
• weight gain

Rare Adverse Effects (may affect up to 1 in 1000 patients)

• candida (a fungal infection)
• anemia, increased platelet count in the blood
• allergic reaction
• hormonal disorder (endocrine)
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood
• absence of orgasm, insomnia
• vertigo, tremors
• eye disorders, such as eyelid inflammation, dry eyes
• abnormally rapid heart rate
• vein inflammation, nosebleeds, fainting
• abdominal enlargement, intestinal disorder, feeling of bloating, gastric hernia, oral thrush, constipation, dry mouth
• pain in the bile ducts or gallbladder, gallbladder inflammation
• yellow-brown spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, skin inflammation due to photosensitivity, skin nodules
• difficult or painful intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased breast cell growth (hyperplasia), malignant breast lumps, abnormal growth of the cervical mucous membrane, shrinkage or loss of uterine lining, fluid-filled sacs in an ovary, uterine enlargement
• discomfort
• weight loss
• harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild or temporary stroke-like symptoms, known as a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with target-like redness or ulcers).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of YAZ

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after "EXP:". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of YAZ

• The active ingredients are drospirenone and ethinylestradiol (as betadex clathrate). Each active film-coated pink tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol (as betadex clathrate).

• The white film-coated tablets do not contain active ingredients.

• The other components are:

• Active film-coated pink tablets:

Tablet core: lactose monohydrate, cornstarch, magnesium stearate (E470b).

Tablet film coating: hypromellose (E464), talc (E553b), titanium dioxide (E171), and red iron oxide (E172).

• Inactive white film-coated tablets:

Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate (E470b).

Tablet film coating: hypromellose (E464), talc (E553b), and titanium dioxide (E171). See section 2 "Yaz contains lactose".

Product Appearance and Package Contents

• Each YAZ blister pack contains 24 active film-coated pink tablets in the 1st, 2nd, 3rd, and 4th rows of the blister pack, and 4 white film-coated placebo tablets in the 4th row.

• YAZ tablets, both pink and white, are film-coated tablets; the tablet core is coated.

• The active tablet is pink, round with convex faces, marked on one side with the letters "DS" included in a regular hexagon.

• The placebo tablet is white, round with convex faces, marked on one side with the letters "DP" included in a regular hexagon.

• YAZ is available in packs of 1, 3, 6, and 13 blister packs, each containing 28 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí - Barcelona

Spain

Manufacturer

Bayer Weimar GmbH und Co. KG

Döbereinerstr. 20, 99427 Weimar, Germany

or

Bayer AG

13342 Berlin, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

• Bulgaria, Czech Republic, Estonia, France, Germany, Ireland, Italy, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia, Spain: YAZ
• Austria, Belgium, Croatia, Finland, Luxembourg, Norway, Portugal, Sweden: Yaz
• Netherlands: YAZ 24+4

Date of the last revision of this prospectus:May 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).