Information for the user: package insert

YAZ 3 mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Important things you should 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

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

2.What you need to know before starting to take YAZ2

When not to use YAZ2

Warnings and precautions3

Blood clots5

YAZ and cancer9

Trastornos psiquiátricos………………………………………………………………….9

Intermenstrual bleeding10

What to do if you do not have your period during the placebo days10

Other medicines and YAZ10

Taking YAZ with food and drinks11

Laboratory tests11

Pregnancy11

Lactation11

Driving and operating machinery11

YAZ contains lactose12

3.How to take YAZ12

Preparing the blister pack12

When to start with the first blister pack13

What to do if you take more YAZ than you should14

What to do if you forget to take YAZ14

What to do in case of severe vomiting or diarrhea16

Delayed menstrual period: what you should know17

Change in the first day of your menstrual period: what you should know17

What to do if you interrupt the treatment with YAZ17

4.Possible adverse effects17

5.Storage of YAZ19

6.Contents of the package and additional information…………………………………………20

• YAZ is a contraceptive used to prevent pregnancy.
• Each of the 24 film-coated tablets contains a small amount of two different female hormones, known as drospirenone and ethinyl estradiol.

• The 4 film-coated tablets without active ingredients are also called placebo tablets.
• Contraceptives that contain two hormones are called combined contraceptives.

When Not to Use YAZ

You should 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 leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that 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 surgery or if you spend a lot of time without getting up (see section 2 “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, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Diabetes with severe vascular 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 function well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or are suspected of having breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding of unknown cause.
• 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.

You should 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 for Special Populations

Children and Adolescents

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

Women of Advanced Age

YAZ is not indicated for useafter menopause.

Women with Liver Insufficiency

You should not take YAZ if you suffer from liver disease. See sections “Do Not Use YAZ” and “Warnings and Precautions”.

Women with Renal Insufficiency

You should not take YAZ if you are suffering from kidney dysfunction or acute renal failure. See sections “Do Not Use YAZ” and “Warnings and Precautions”.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take YAZ.

Inform Your Doctor If You Suffer From Any of the Following Conditions.

In some situations, you should take special care while using YAZ or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor. If the condition develops or worsens while you are using YAZ, you should also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic-uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency).
• If you have sickle cell anemia (a genetic disorder 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 surgery or spend a lot of time without getting up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking YAZ after delivery.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• 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 (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)). If you have or have had any brownish-yellow patches (chloasma), also known as “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 facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medications containing estrogens can induce or worsen 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 developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (known as “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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 Emergency Medical Assistanceif 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 veins (venous thrombosis). However, these adverse 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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In rare cases, a blood 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 of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different one) after a break 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 in 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.

• Of every 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.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like YAZ, about 9-12 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 developing a blood clot with YAZ is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without getting up due to an injury or illness or if you have your leg immobilized. You may need to stop taking YAZ for several weeks before the operation or while you have limited mobility. If you need to stop taking YAZ, ask your doctor when you can start taking it again.
• With increasing age (especially above about 35 years old).
• If you have given birth recently.

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

Long flights (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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking YAZ.

If any of the conditions listed above change while you are using YAZ, for example, a close relative experiences a blood clot 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 blood 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 about 35 years old).
• If you smoke.When using a combined hormonal contraceptive like YAZ, you are advised to quit smoking. If you are unable to quit 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 a close relative has had a heart attack or stroke at a young age (less than about 50 years old). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, abnormal heart rhythm 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 even higher.

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

YAZ and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women using combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have regular breast examinations, and you should consult your doctor if you notice any lump.

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

Mental Health Disorders

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

Spotting Between Periods

During the first few months of taking YAZ, you may experience unexpected bleeding (bleeding outside of the days of active pill use). If this bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.

What to Do If You Do Not Have a Period During the Placebo Days

If you have taken all the active pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other Medications and YAZ

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication or herbal preparations. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking YAZ. They may advise you to take additional contraceptive precautions and, if so, for how long, or to modify the use of another medication that you need.

Some medications

• may affect the levels of YAZ in the blood
• may makeYAZ less effective in preventing pregnancy
• may cause unexpected bleeding

This may occur with

• medications used in the treatment of:
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapina, efavirenz)
  • fungal infections (e.g., griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations containing St. John's Wort

YAZ mayinfluence the effectof other medications, for example:

You should not take YAZ if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated ALT levels). Your doctor will prescribe another type of contraceptive before starting treatment with these medications. YAZ can be taken again approximately 2 weeks after the completion of this treatment. See the section “Do Not Use YAZ”.

Consult your doctor or pharmacist before using any medication.

YAZ with Food and Beverages

YAZ can be taken with or without food, and with some water if necessary.

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as contraceptives can affect the results of some tests.

Pregnancy, Lactation, and Fertility

Pregnancy

If you are pregnant, you should not take YAZ. If you become pregnant while taking YAZ, you should stop taking it immediately and consult your doctor. If you want to become pregnant, you can stop taking YAZ at any time (see “If You Interrupt Treatment with YAZ”, page 17).

Consult your doctor or pharmacist before using any medication.

Lactation

Generally, it is not recommended to take YAZ during lactation. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

There is no information to suggest that the use of YAZ has any effect on your ability to drive or operate machines.

YAZ Contains Lactose

If your doctor has told you that you have a certain sugar intolerance, consult them before taking this medication.

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 contains 24 active film-coated tablets of pale pink color, and 4 white placebo film-coated tablets.

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

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

Do not confuse the tablets:take a pale pink tablet for the first 24 days and then a white tablet for the last 4 days. After that, you must start another blister immediately (24 pale pink tablets and then 4 white tablets). Therefore, there is no interval between two blisters.

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

Preparation of the blister

To help you follow the taking order, each YAZ package contains 7 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 adhesive strip of the week on the top of the YAZ blister, where it is indicated “Stick the adhesive 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 will be able to check visually if you have taken your tablet. The arrows indicate the taking order of the tablets.

Throughout the 4 days when you take the placebo tablets (the placebo days), you should have menstruation (the so-called withdrawal bleeding). Usually it starts on the 2nd or 3rd day after taking the last active tablet of pale pink color of YAZ. After taking the last white tablet, start the next blister, even if menstruation has not finished. This means that you must start the next blister on the same day of the week that you started the previous one and menstruation by withdrawal should take place during the same days every month.

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

By following this way, you will also be protected against pregnancy during the 4 days when you take the placebo tablets.

When can you start with the first blister

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

Start taking YAZ on the first day of the cycle (i.e., the first day of your menstruation). If you start YAZ on the first day of your menstruation, you will be immediately protected against pregnancy. You can also start on days 2–5 of the cycle, but in that case you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking YAZ preferably on the day after taking the last active tablet (the last tablet that contains active principles) of your previous contraceptive, but no later than the day after the days without tablets (or after the last inactive tablet) of your previous contraceptive. When changing from a combined vaginal ring or patch, follow your doctor's recommendations.

• Change from a progestin-only method (progestin-only pills, injection, implant, or intrauterine system (IUS))

You can change from progestin-only pills on any day. If it is an implant or an IUS, on the same day of its removal; if it is an injectable, on the day of the next injection. In all cases, it is recommended that you use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

After giving birth, you can start taking YAZ between 21 and 28 days. If you start later than day 28, you must use one of the barrier methods (e.g., a condom) during the first 7 days of taking YAZ.

If, after giving birth, you have already had sexual intercourse, before starting to take YAZ again, you must be sure that you are not pregnant or wait for your next menstrual 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 serious cases of overdose of YAZ have been reported.

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

If you have taken too many YAZ tablets, or if you 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 forgot to take YAZ

The last 4 tablets of the 4th row of the blister are placebo tablets. If you forgot one of these tablets, you will not lose the contraceptive effect of YAZ. You must discard the forgotten placebo tablet.

If you forgot an active pale pink tablet (tablets 1–24 of the blister), follow these instructions:

• If you are lateless than 24 hoursin taking some tablets, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are latemore than 24 hoursin taking some tablets, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of pregnancy.

The risk of incomplete protection against pregnancy is maximum if you forget to take a pale pink tablet at the beginning or end of the blister. The following recommendations are given in this situation (see also the diagram on page 16):

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting one tablet during days 1–7 (first row)

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time and use additional precautions (e.g., condoms) for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you must know that there is a risk of pregnancy. In that case, consult your doctor.

• Forgetting one tablet during days 8–14 (second row)

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time. The protection against pregnancy is not reduced and you do not need to take additional precautions.

• Forgetting one 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, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time. Instead of continuing with the white placebo tablets, discard them and start taking the next blister (the day you take the first tablet will be different).

Probably, you will have bleeding at the end of the second blister – during the taking of the white placebo tablets – although you may experience spotting or bleeding similar to menstruation during the taking of the second blister.

1. You can also interrupt the taking of active pale pink tablets and pass 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 on your scheduled start day, take the placebo tablets forless than 4 days.

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

• If you have forgotten to take some tablets from a blister and you do not have menstruation during the placebo days, this may mean that you are pregnant. In this case, you must go to your doctor before continuing with the next blister.

Forgetting several tabletsAsk your doctor for advice

of the same

blister

Yes

Days 1–7Did you have sexual intercourse the

week before forgetting?

No

-Take the forgotten tablet

-Use additional precautions

(condoms) during the next 7 days

-Finish the blister

Forgetting 1 only tablet

of pale pink color (takenDays 8–14-Take the forgotten tablet and

more than 24 hours late)-Finish the blister

-Take the forgotten tablet and

-Finish the taking of the

active pale pink tablets

-Discard the 4 white placebo

-Start immediately with the

next blister

Days 15–24or

-Stop taking the active pale

pink tablets immediately

-Pass directly to the 4 white

placebo tablets

-After that, continue with the

next blister

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3–4 hours after taking an active pale pink tablet, or if you have intense diarrhea, there is a risk that the active principles of the tablet will not be fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take a pale 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 instructions in the section “If you forgot to take YAZ”, page 14.

Delay of menstrual period: what you should know

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

Before deciding to delay your menstrual period, ask your doctor.

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

If you take the tablets according to the instructions, your menstrual period will startduring the placebo days. If you have to change this day, you can do it by reducing theplacebo days(the days when you take the white placebo tablets) – 4 days is the maximum! For example, if you start the placebo days on a Friday and want to change it to a Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. It is possible that you will 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 interrupt the treatment with YAZ

You can stop taking YAZ whenever you want. If you do not want to get pregnant, consult your doctor about other effective methods of birth control. If you want to get pregnant, stop taking YAZ and wait until your menstrual period before trying to get pregnant. This way you will be able to calculate the estimated date of delivery more easily.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to YAZ, consult your doctor.

All women taking 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 section2 “What you need to know before starting to take YAZ”.

Severe side effects

Contact your 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 section “Warnings and precautions”).

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

Frequent side effects (may affect up to 1 in 10 patients)

Infrequent side effects (may affect up to 1 in 100 patients)

Rare side effects (may affect up to 1 in 1000 patients)

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with circular red patches or ulcers).

Reporting of side effects:

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

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of YAZ

• The active ingredients aredrospirenone and ethinylestradiol (as betadex clathrate). Each film-coated 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:

- Film-coated active tablets of pale pink color:

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

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

- Film-coated inactive white tablets:

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

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

Appearance of the product and contents of the package

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

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

• The active tablet is pale 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 package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí - Barcelona

Spain

Responsible manufacturer

Bayer Weimar GmbH und Co. KG

Döbereinerstr. 20, 99427 Weimar, Germany

or

Bayer AG

13342 Berlin, Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

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

Date of the last review of this leaflet:May 2023

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).