Iaz

Leaflet attached to the packaging: user information

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

Yaz

0.02 mg + 3 mg, coated tablets
Ethinylestradiol + Drospirenone

Important information about combined hormonal contraceptives:

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

You should read the leaflet before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What is Yaz and what is it used for
• 2. Important information before taking Yaz When not to take Yaz BLOOD CLOTS Yaz and cancer Vaginal bleeding What to do if bleeding does not occur during the placebo period Yaz and other medicines Laboratory tests Pregnancy Breast-feeding Driving and using machines Yaz contains lactose monohydrate
• 3. How to take Yaz Preparing the blister When to start the first blister Taking more than the recommended dose of Yaz Forgetting to take Yaz What to do if vomiting or severe diarrhea occurs Delaying the onset of bleeding: what to know Changing the first day of bleeding: what to know Stopping Yaz
• 4. Possible side effects
• 5. How to store Yaz
• 6. Package contents and other information

1. What is Yaz and what is it used for

• Yaz is a contraceptive pill used to prevent pregnancy.
• Each of the 24 light pink coated tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 4 white coated tablets, like the placebo tablets, do not contain active substances.
• Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before taking Yaz

General notes

Before starting to take Yaz, one 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 Yaz can be started, the doctor will ask the patient some questions about her health and that of her close relatives. The doctor will also measure the patient's blood pressure and, if necessary, perform other examinations.
This leaflet describes several situations in which one should stop taking Yaz or in which the effectiveness of Yaz may be reduced. In such situations, one should not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. One should not use the calendar method or the temperature measurement method. These methods may be unreliable because Yaz modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Yaz

One should not take Yaz if any of the following conditions are present. If any of the following conditions are present, one should inform the doctor. The doctor will discuss with the patient which other method of contraception will be more suitable.

Do not take Yaz:

• if the patient is allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). May cause: itching, rash, or swelling;
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if the patient knows that she has a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• if the patient has had a heart attack or stroke;
• if the patient has (or has 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 the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) liver disease, and liver function is still abnormal;
• if the patient has kidney problems (kidney failure);
• if the patient has (or has ever had) a liver tumor;
• if the patient has (or has ever had) or is suspected to have breast or genital cancer;
• if the patient has any vaginal bleeding of unknown cause.

Do not take Yaz if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir (see also section "Yaz and other medicines").
Additional information for special populations
Children and adolescents
Yaz is not intended for use in girls who have not yet started their menstrual cycles.
Elderly women
Yaz is not intended for use after menopause.
Women with liver disease
Yaz should not be taken if the patient has liver disease. See also sections "When not to take Yaz" and "Warnings and precautions".
Women with kidney disease
Yaz should not be taken if the patient has kidney failure or acute kidney failure. See also sections "When not to take Yaz" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor
One should immediately contact a doctor

• if the patient notices any of the following symptoms that may indicate the formation of blood clots, which may mean that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS").

To find a description of the symptoms of these serious side effects, see "HOW TO RECOGNIZE BLOOD CLOTS".

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

In certain situations, one should be particularly careful when taking Yaz or any other combined hormonal contraceptive. If any of the following conditions occur or worsen while taking Yaz, one should consult a doctor.

• if the patient or a close relative has ever had breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient has an increased level of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• if the patient is immediately after childbirth, she is at increased risk of blood clots. One should consult a doctor to find out how soon after childbirth one can start taking Yaz;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient has epilepsy (see "Yaz and other medicines");
• if the patient has 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 characterized by involuntary movements of the body);
• if the patient has or has ever had chloasma (golden brown pigment spots, so-called "pregnancy spots", especially on the face). If so, one should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient has hereditary angioedema, estrogen-containing medications may cause or worsen its symptoms. One should immediately contact a doctor if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives with difficulty breathing.

Before starting to take Yaz, one should consult a doctor.

BLOOD CLOTS

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

• in veins (also called "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also called "arterial thromboembolism" or "arterial thrombosis"). Not all people who have a blood clot will recover fully after it. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

One should remember that the overall risk of harmful blood clots caused by taking Yaz is small.

HOW TO RECOGNIZE BLOOD CLOTS

One should immediately contact a doctor if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
this symptom?

• swelling of the 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,

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur.

Most often, they occur in the first year of using combined hormonal contraceptives.

• If blood clots form in the veins of the leg or foot, it can lead to the development of 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 veins highest

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

What affects the risk of blood clots

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots associated with Yaz is small.

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

Factors that increase the risk of blood clots in veins

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

• if the patient is overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's 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, the patient may have a genetic blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS");
• with age (especially over 35 years);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-distance air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
One should tell the doctor if any of these risk factors are present, even if one is not sure. The doctor may decide to stop Yaz.
One should inform the doctor if any of the above conditions change while taking Yaz, e.g., if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, 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 associated with Yaz is very small, but it may increase:

• with age (over about 35 years);
• if the patient smokes. While taking a hormonal contraceptive like Yaz, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, irregular heartbeat);
• if the patient has diabetes. If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.

One should inform the doctor if any of the above conditions change while taking Yaz, e.g., if the patient starts smoking, if someone in the patient's close family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.

Yaz and cancer

In women taking combined contraceptives, breast cancer is slightly more common, but it is not known if this is caused by the pills. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by doctors more often. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if a lump is found.
In rare cases, women taking the pill have been reported to have benign liver tumors, and even more rarely, malignant liver tumors. If one experiences severe abdominal pain, one should contact a doctor.

Psychiatric disorders

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

Vaginal bleeding

During the first few months of taking Yaz, one may experience unexpected bleeding (bleeding outside the placebo period). If such bleeding continues for longer than a few months or starts after a few months, the doctor should investigate the cause.

What to do if bleeding does not occur during the placebo period

If all the light pink tablets were taken correctly, no vomiting or severe diarrhea occurred, and no other medicines were taken, it is very unlikely that the patient is pregnant.
If the expected bleeding does not occur within two consecutive menstrual cycles, it may mean that the patient is pregnant. One should contact a doctor immediately. Do not start the next blister until it is certain that the patient is not pregnant.

Yaz and other medicines

Always inform the doctor about any medicines or herbal products already being taken.
One should also tell any other doctor, including dentists or pharmacists, who may prescribe another medicine, that Yaz is being taken. They may say whether additional contraceptive methods should be used (e.g., condoms) and for how long.
Some medicines may:

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

This applies to medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (etoricoxib);
• pulmonary hypertension (bosentan);
• herbal products containing St. John's Wort ( Hypericum perforatum).

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

Do not take Yaz if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, as this may cause elevated liver function test results (increased levels of the liver enzyme ALT). The doctor will recommend a different type of contraception before starting these medicines. One can resume taking Yaz about 2 weeks after finishing the treatment. See section "When not to take Yaz".
Before taking any medicine, one should consult a doctor or pharmacist.

Yaz with food and drink

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

Laboratory tests

If a blood test is necessary, one should tell the doctor or laboratory staff that Yaz is being taken, as oral contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not take Yaz. If the patient becomes pregnant while taking Yaz, she should stop taking it immediately and contact a doctor. If the patient wants to become pregnant, she can stop taking Yaz at any time (see also section "Stopping Yaz").
Before taking any medicine, one should consult a doctor or pharmacist.

Breast-feeding

Yaz is not recommended for use during breast-feeding. If the patient wants to take Yaz while breast-feeding, she should contact her doctor.
Before taking any medicine, one should consult a doctor or pharmacist.

Driving and using machines

There is no information suggesting that taking Yaz affects the ability to drive or use machines.

Yaz contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, she should contact her doctor before taking Yaz.

3. How to take Yaz

Each pack contains 24 light pink coated tablets containing active substances and 4 white coated placebo tablets.
The two types of tablets are arranged in sequence. One blister pack contains 28 tablets.
One should take one Yaz tablet every day, if necessary, with a small amount of water.
The tablets can be taken with or without food, but one should take them every day at about the same time.
Do not confuse the tablets:the light pink tablets should be taken for the first 24 days, followed by the white tablets for the last 4 days. A new blister pack should be started immediately (24 light pink, followed by 4 white tablets) without a break between the two packs.
Due to the differences in tablet composition, one must start taking the tablets from the first tablet at the top left and then take the tablets every day in the direction of the arrows on the blister pack.

Preparing the blister pack

To check that the tablets are taken daily, each Yaz blister pack has 7 self-adhesive strips with the days of the week printed on them. One should choose a strip that starts with the day of the week when the pack is started. For example, if the first day of taking the tablets was on a Wednesday, one should use the strip that starts with "WED".
The strip should be stuck to the top of the Yaz blister pack where it says "Plaats hier de weeksticker" (which means "Place the day sticker here", see section 5. "Translation of some information on the immediate packaging"). In this way, the first day of the week will be above the tablet marked with an orange triangle.
Each tablet has been marked above, and one can check that the correct tablets have been taken. The arrows show the order in which the tablets should be taken.
During the 4 days when the white placebo tablets are taken (the placebo period), bleeding should occur (so-called "withdrawal bleeding"). This bleeding usually starts on the 2nd or 3rd day after taking the last light pink tablet containing the active substances of Yaz. After taking the last white tablet, one should start a new blister pack, regardless of whether the bleeding has stopped. This means that new packs will be started on the same day of the week, and the bleeding will also occur at about the same time every month.
If one is taking Yaz in this way, one is protected against pregnancy, including during the 4 days when the placebo tablets are taken.

When to start the first blister pack

• •If no hormonal contraceptive has been used in the previous month.One should start taking Yaz on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts taking Yaz on the first day of menstruation, she will be immediately protected against pregnancy. One can also start taking Yaz on days 2-5 of the menstrual cycle, but in this case, additional contraceptive methods (e.g., condoms) should be used for the first 7 days.
• One can start taking Yaz on days 2-5 of the menstrual cycle, but in this case, additional contraceptive methods (e.g., condoms) should be used for the first 7 days.
• •Changing from a combined hormonal contraceptive or a combined contraceptive patch or vaginal ring.One can start taking Yaz the next day after taking the last active tablet from the previous pack, but no later than the day after the usual break in taking the previous contraceptive. If changing from a combined contraceptive patch or vaginal ring, one should follow the doctor's advice.
• •Changing from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen IUS).One can switch on any day from the mini-pill (from an implant or intrauterine system on the day it is removed, or from injections when the next injection is scheduled), but in all cases, one should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Yaz.
• •After a miscarriage.One should follow the doctor's advice.
• •After childbirth.After childbirth, one can start taking Yaz from the 21st to the 28th day after giving birth. If one starts later than 28 days, one should use a mechanical method (e.g., condoms) for the first 7 days of taking Yaz. If the patient has had sexual intercourse after giving birth before starting to take Yaz again, she should first make sure that she is not pregnant or wait for a menstrual period.
• •If the patient is breast-feeding and wants to start taking Yaz again after childbirth.One should read the section on "Breast-feeding".

If the patient is unsure when to start taking Yaz, she should consult a doctor.

Taking more than the recommended dose of Yaz

There are no reports of serious harmful effects from taking too many Yaz tablets at once.
If several tablets are taken at the same time, symptoms may occur, such as nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their menstrual cycles but have taken the medicine by mistake.
If too many Yaz tablets are taken or if a child has swallowed some tablets, one should consult a doctor or pharmacist.

Forgetting to take Yaz

The last 4 tablets in the 4th rowof the blister pack are placebo tablets. If one forgets to take one of them, the contraceptive effectiveness of Yaz is maintained. One should discard the missed placebo tablet.
If a light pink tablet containing active substances is missed (1 out of 24 tablets), one should follow these instructions:

• If it has been less than 24 hourssince the tablet was missed, the contraceptive effectiveness is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If it has been more than 24 hourssince the tablet was missed, the contraceptive effectiveness may be reduced. The more tablets the patient misses, the higher the risk of becoming pregnant.

The risk of reduced contraceptive effectiveness is highest if the patient misses a tablet at the beginning or end of the blister pack. Therefore, one should follow these rules (see also the scheme below):

• •Missing more than one tablet from the blister packOne should contact a doctor.
• •Missing one tablet in days 1-7 (first row)One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and additional precautionsshould be used, such as condoms, for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet or missed taking the next blister pack, she should be aware that she may be pregnant. In this case, one should contact a doctor.
• •Missing one tablet in days 8-14 (second row)One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. The contraceptive effectiveness is not reduced, and no additional precautions are needed.
• •Missing one tablet in days 15-24 (third or fourth row)There are two options to choose from:
• 1. One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Instead of taking the white placebo tablets, one should discard them and start the next blister pack immediately (the first day of taking will be different from before).

It is likely that withdrawal bleeding will occur at the end of the second blister pack, but it may also occur as spotting or breakthrough bleeding during the second blister pack.

• 2. One can also stop taking the light pink tablets from the blister pack and go directly to the 4 white placebo tablets (before starting the placebo period, one should note the day on which the tablet was missed). If one wants to start the new blister pack on the scheduled day for starting the placebo period, one can shorten the placebo period to less than 4 days.

If one follows one of these instructions, the contraceptive effectiveness will be maintained.
If the patient misses any of the tablets from the blister pack and does not experience bleeding during the first placebo period, it may mean that she is pregnant. One should contact a doctor before starting the next blister pack.
Missing more than 1 light pink tablet from one blister pack
One should consult a doctor
yes
Did the patient have sexual intercourse in the week before missing the tablet?
Day 1-7
no

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish taking the tablets from the blister pack Missing only 1 light pink tablet (taking more than 24 hours late)
• Take the missed tablet and
• Finish taking the tablets from the blister pack Day 8-14
• Take the missed tablet
• Finish taking the tablets from the blister pack
• Discard the 4 white placebo tablets
• Start the next blister pack Day 15-24 or
• Stop taking the light pink tablets from the blister pack immediately
• Go directly to the 4 white placebo tablets
• Start the next blister pack

What to do if vomiting or severe diarrhea occurs

If vomiting occurs within 3-4 hours after taking a light pink tablet containing active substances or if severe diarrhea occurs, there is a risk that the active substances from the tablet may not have been fully absorbed into the body. The situation is similar to missing a tablet.
After vomiting or diarrhea, one should take another light pink tablet from a reserve blister pack as soon as possible. If possible, one should take it within 24 hours of the usual time of taking the tablet. If this is not possible or more than 24 hours have passed, one should follow the advice given in the section "Forgetting to take Yaz".

4. Possible side effects

Like all medicines, Yaz can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Yaz, you should consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using Yaz".
The following side effects have been associated with the use of Yaz:
Common side effects(occurring in 1 to 10 out of every 100 people):

• mood changes;
• headache;
• nausea;
• breast pain, menstrual disorders, such as irregular menstruation, absence of menstruation.

Uncommon side effects(occurring in 1 to 10 out of every 1000 people):

• depression, nervousness, drowsiness;
• fainting, tingling, and numbness;
• migraine, varicose veins, increased blood pressure;
• abdominal pain, vomiting, indigestion, intestinal gas, gastritis, diarrhea;
• acne, itching, rash;
• pain, e.g. back pain, limb pain, muscle cramps;
• fungal infections of the vagina, pelvic pain, breast enlargement, benign breast tumor, uterine/vaginal bleeding (which usually subsides during continued treatment), discharge, hot flashes, vaginitis, menstrual disorders, painful menstruation, scanty menstruation, very heavy menstruation, vaginal dryness, abnormal cervical smear, decreased libido;
• lack of energy, increased sweating, fluid retention;
• weight gain.

Rare side effects(occurring in 1 to 10 out of every 10,000 people):

• candidiasis (fungal infection);
• anemia, increased platelet count;
• allergic reaction;
• hormonal disorders (endocrine);
• increased appetite, loss of appetite, significantly increased potassium levels in the blood, significantly decreased sodium levels in the blood;
• orgasmic dysfunction, insomnia;
• dizziness, chills;
• eye disorders, e.g. conjunctivitis, dry eyes;
• rapid heartbeat;
• phlebitis, nosebleeds, fainting;
• abdominal distension, gastrointestinal disease, feeling of bloating, hiatal hernia, oral thrush, constipation, dry mouth;
• biliary colic or cholecystitis;
• chloasma, rash, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, hirsutism, skin disorders, striae, skin inflammation, skin sensitivity to light, skin tumors;
• difficult or painful intercourse, vaginitis, postcoital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, malignant breast tumor, significant cervical ectropy, cervical or endometrial atrophy, ovarian cyst, uterine enlargement;
• malaise;
• weight loss;
• 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 blood clots may be higher if the patient has any other risk-increasing factors (see section 2 for more information on risk-increasing factors and symptoms of blood clots).

The following side effects have also been reported: hypersensitivity, erythema multiforme (rash and redness or ulcers) but based on available data, it is not possible to determine their frequency.

Reporting side effects

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

5. How to store Yaz

The medicine should be stored out of sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Translation of some information on the immediate packaging:

Plaats hier de weeksticker– "Place the day sticker here".
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. Contents of the pack and other information

What Yaz contains

• The active substances of Yaz are: ethinylestradiol (in the form of ethinylestradiol betadex chloride) and drospirenone. Each light pink film-coated tablet contains 0.02 mg of ethinylestradiol (in the form of ethinylestradiol betadex chloride) and 3 mg of drospirenone.
• The white film-coated tablets do not contain active substances.

Other ingredients are:
Light pink tablets:

• Core: lactose monohydrate, corn starch, magnesium stearate (E 470b).
• Coating: hypromellose (E 464), talc (E 553b), titanium dioxide (E 171), iron oxide red (E 172).

White tablets:

• Core: lactose monohydrate, microcrystalline cellulose, magnesium stearate (E 470b).
• Coating: hypromellose (E 464), talc (E 553b), titanium dioxide (E 171).

What Yaz looks like and what the pack contains

• Each blister of Yaz contains 24 light pink film-coated tablets containing active substances in rows 1, 2, 3, and 4, and 4 white film-coated placebo tablets in row 4.
• Yaz tablets, both light pink and white, are film-coated; the core of the tablet is covered with a coating.
• The active substance tablet is light pink, round with convex surfaces, one side with the letters "DS" embossed in a regular hexagon.
• The placebo tablet is white, round with convex surfaces, one side with the letters "DP" embossed in a regular hexagon.
• Yaz is available in packs containing 1 blister, containing 28 tablets.
• A day sticker is attached to the packaging - see: section 3 "Preparing the blister".

For more detailed information, you should contact the marketing authorization holder or the parallel importer.

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

Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands

Manufacturer:

Bayer Weimar GmbH und Co. KG
Döbereinerstrasse 20
99427 Weimar
Germany

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands export license number: RVG 33842

Parallel import license number: 54/17

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

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

Date of leaflet approval: 17.02.2022
[Information about the trademark]