Iaz

Leaflet attached to the packaging: information for the user

Yaz, 0.02 mg + 3.0 mg, film-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 when resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Yaz and what is it used for? ................................................................... 2
• 2. Important information before using Yaz ............................................................... 2 When not to use Yaz: ............................................................................................. 2 BLOOD CLOTS ........................................................................................................... 4 Yaz and cancer ............................................................................................................ 8 Irregular bleeding.................................................................................................. 8 What to do if bleeding does not occur during the placebo period ...................................................................................................................... 8 Yaz and other medicines ............................................................................................ 9 Laboratory tests ............................................................................................................ 9 Pregnancy ...................................................................................................................... 10 Breastfeeding ............................................................................................................. 10 Driving and using machines ....................................................................................... 10 Yaz contains lactose .................................................................................................. 10
• 3. How to use Yaz ....................................................................................................... 10 Preparing the blister ....................................................................................................... 10 When can you start the first blister ................................................................................ 11 Using more than the recommended dose of Yaz ......................................................... 11 Missing a dose of Yaz ........................................................................................... 12 What to do if you vomit or have severe diarrhea............................................ 13

Delaying the onset of bleeding: what you need to know................................................... 14
Changing the first day of bleeding: what you need to know .................................................. 14
Stopping Yaz ............................................................................................................... 14

• 4. Possible side effects ........................................................................................ 14
• 5. How to store Yaz............................................................................................... 16
• 6. Contents of the pack and other information .................................................................. 16

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 film-coated tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 4 white film-coated tablets, like the placebo tablets, do not contain active substances.
• Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before using Yaz

General notes

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

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

Do not use Yaz:

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

You should not use Yaz if you have hepatitis C and are taking medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "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
You should not take Yaz if you have liver disease. See also "When not to use Yaz" and "Warnings and precautions".
Women with kidney disease
You should not take Yaz if you have kidney failure or acute kidney failure. See also "When not to use Yaz" and "Warnings and precautions".

Warnings and precautions

When to contact your doctor
You should see your doctor immediately

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

In order to describe the symptoms of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

In some situations, you should be careful when using Yaz or any other combined hormonal contraceptive. If any of the following conditions occur or worsen while using Yaz, you should consult your doctor.

• if you or a close relative have had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this disease. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you are immediately after childbirth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Yaz after childbirth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Yaz and other medicines");
• if you have a disease that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, porphyria - a blood disease), herpes during pregnancy (a skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disease in which there are involuntary movements of the body);
• if you have chloasma (brownish spots, so-called pregnancy spots, especially on the face). If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications may cause or worsen the symptoms of both hereditary and acquired angioedema.

You should consult your doctor before starting to use Yaz.

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 occur:

• in the veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in the arteries (also known as "arterial thromboembolism" or "arterial thrombosis"). Not all patients recover fully after a blood clot. In rare cases, the effects of a blood clot can be permanent or very rarely fatal.

It should be remembered that the overall risk of harmful blood clots caused by Yaz is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should see your doctor immediately if you notice any of the following symptoms.
Do you experience any of these symptoms?
Why is the patient likely to suffer
from these symptoms?

• 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;
• change in the color of the leg skin, such as pallor, redness, or discoloration; Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• severe chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain;

If you are unsure, you should see your doctor, because some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• immediate loss of vision or
• painless vision disturbances that may lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, tightness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the lower part of the body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;

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 the veins (venous thromboembolism). Although these side effects are rare, they can occur, most often in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in 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 you stop using Yaz, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

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

• if you are significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• with age (especially over 35);
• if you gave birth recently. The risk of blood clots increases with the number of risk factors present in you. Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor. You should tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Yaz. You should inform your doctor if any of these conditions change while using Yaz, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries

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

Factors that increase the risk of blood clots in arteries

It should be emphasized that the risk of heart attack or stroke associated with Yaz is very small, but it may increase:

• with age (over about 35);
• if you smoke.When using a hormonal contraceptive like Yaz, it is recommended to quit smoking. If you are unable to quit smoking and are over 35, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50). In this case, you may also be at increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes. If you have more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher. You should inform your doctor if any of these conditions change while using Yaz, e.g., if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Yaz and cancer

In women using 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 using combined contraceptives because they are examined by doctors more often. The frequency of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to examine your breasts regularly and contact your doctor if you feel any lump.
In rare cases, women using the pill have been reported to have benign liver tumors, and even more rarely, malignant liver tumors. If you experience severe abdominal pain, you should contact your doctor.

Mental disorders

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

Irregular bleeding

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

What to do if bleeding does not occur during the 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 you are pregnant.
If the expected bleeding does not occur within two consecutive menstrual cycles, it may mean that you are pregnant. You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Yaz and other medicines

Always inform your doctor which medicines or herbal products you are already taking. You should also tell any other doctor or dentist or pharmacist who prescribes another medicine that you are taking Yaz. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and if so, for how long.
Some medicines may:

• affect the level of Yaz in your 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 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).

Yaz may affect the actionof other medicines, such as:

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

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

Yaz with food and drink

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

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking Yaz, as oral contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not use Yaz. If you become pregnant while taking Yaz, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Yaz at any time (see also page 14 "Stopping Yaz").
Before taking any medicine, consult your doctor or pharmacist.

Breastfeeding

Yaz is not recommended for use during breastfeeding. If you want to use Yaz while breastfeeding, you should contact your doctor.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

Yaz contains lactose

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

3. How to use Yaz

Each pack contains 24 light pink film-coated tablets containing active substances and 4 white film-coated placebo tablets.
The two types of tablets are arranged in sequence. One blister pack contains 28 tablets.
You 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 you should take them every day at about the same time.
Do not confuse the tablets:the light pink tablets are taken for the first 24 days, and then the white tablets are taken for the last 4 days. You should start a new blister pack immediately (24 light pink, then 4 white tablets) without a break between the two packs.
Due to the differences in the composition of the tablets, it is essential to start taking them from the first tablet on the top left and then take them every day in the direction of the arrows on the blister pack.

Preparing the blister pack

To check that you are taking your tablets daily, each Yaz blister pack comes with 7 self-adhesive strips with the days of the week printed on them. You should choose a strip that starts with the first day of your menstrual cycle. For example, if your first day of taking Yaz was on a Wednesday, you should attach the strip that starts with "Wednesday".
You should attach the strip to the top of the Yaz blister pack, where it says "Attach the strip with the days of the week here". This way, the first day will be above the tablet marked "Start". Each tablet is marked above it, and you can check that you have taken the correct tablets. The arrows show the order in which the tablets should be taken.
During the 4 days when you take the white placebo tablets (placebo period), you should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last light pink tablet containing the active substance of Yaz. After taking the last white tablet, you 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 occur at about the same time every month.
If you use Yaz in this way, you will be protected against pregnancy, including during the 4 days when you take the placebo tablets.

When can you start the first blister pack

• If you are not using a hormonal contraceptive in the previous month.You should start taking Yaz on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Yaz on the first day of your period, you will be protected against pregnancy immediately. You can also start taking Yaz on days 2-5 of your menstrual cycle, but in that case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Changing from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal system or transdermal system.You can start taking Yaz the next day after taking the last active tablet from your previous pack, but no later than the next day after the end of the break in taking tablets from your previous contraceptive (or after the last inactive tablet from your previous contraceptive). When changing from a combined hormonal contraceptive vaginal system or transdermal system, you should follow your doctor's advice.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system).You can switch on any day from a progestogen-only pill (from an implant or intrauterine system on the day it is removed, or from injections when the next injection would be due), but in all cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking tablets.
• After a miscarriage.Follow your doctor's advice.
• After childbirth.After childbirth, you can start taking Yaz from the 21st to the 28th day after giving birth. If you start later than 28 days, you should use a barrier method (e.g., condoms) for the first 7 days of taking Yaz. If you have had sex since giving birth and before starting Yaz again, you should first make sure you are not pregnant or wait for a period.
• If you are breastfeeding and want to start taking Yaz again after childbirth.You should read the section on "Breastfeeding".

If you are unsure when to start taking Yaz, you should consult your doctor.

Using more than the recommended dose of Yaz

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

4. Possible Side Effects

Like all medicines, Yaz can cause side effects, although not everybody gets them.
If you experience any side effects, especially serious or persistent ones, or changes in your health that you think may be related to the use of Yaz, consult a doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important Information Before Taking Yaz".

Severe Side Effects

Consult 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 hives that may cause difficulty breathing (see also section "Warnings and Precautions").
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 periods, absence of periods
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, gas, gastritis, diarrhea
˗ acne, itching, rash
˗ pain, such as back pain, limb pain, muscle cramps
˗ fungal infections of the vagina, pelvic pain, breast enlargement, benign breast tumor, uterine/vaginal bleeding (which usually disappears during continued treatment), discharge, hot flashes, vaginal inflammation, menstrual disorders, painful periods, scanty periods, very heavy periods, vaginal dryness, abnormal Pap 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
˗ endocrine disorders (hormonal disorders)
˗ increased appetite, loss of appetite, significantly increased potassium levels in the blood, significantly decreased sodium levels in the blood
˗ anorgasmia, insomnia
˗ dizziness, chills
˗ eye disorders, such as conjunctivitis, dry eyes
˗ rapid heartbeat
˗ vein inflammation, nosebleeds, fainting
˗ abdominal distension, intestinal disease, 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, excessive hair growth, skin disorders, striae, skin inflammation, skin sensitivity to light, skin nodules
˗ difficult or painful intercourse, vaginal inflammation, postcoital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, malignant breast tumor, significant cervical erosion, cervical atrophy, ovarian cyst, uterine enlargement
˗ malaise
˗ weight loss
harmful blood clots in a vein or artery, for example:
o in the leg or foot (e.g., deep vein thrombosis)
o in the lungs (e.g., pulmonary embolism)
o heart attack
o stroke
o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
o blood clots in the liver, stomach/intestine, kidneys, or eye
The risk of blood clots may be higher if you have other risk factors (see section 2 for more information on risk factors for blood clots 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 estimate their frequency.

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Yaz

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging after "Expiry Date:" or "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 clathrate) and drospirenone. Each light pink film-coated tablet contains 0.02 mg of ethinylestradiol (in the form of ethinylestradiol betadex clathrate) and 3.0 mg of drospirenone.
• The white film-coated tablets do not contain active substances.

Other ingredients are:
Light pink tablets:

• Core: lactose, cornstarch, magnesium stearate
• Coating: hypromellose, talc, titanium dioxide (E171), iron oxide red (E172).

White tablets:

• Core: lactose, microcrystalline cellulose, magnesium stearate
• Coating: hypromellose, talc, titanium dioxide (E171).

See section 2 "Yaz contains lactose".

What Yaz Looks Like and Contents of the Pack

• Each blister pack 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 tablet core is covered with a coating.
• The active substance tablet is light pink, round with convex surfaces, one side marked with the letters "DS" in a regular hexagon.
• The placebo tablet is white, round with convex surfaces, one side marked with the letters "DP" in a regular hexagon.
• Yaz is available in packs containing 1 or 3 blister packs, each with 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:

Bayer Weimar GmbH und Co. KG
Bayer AG
Doebereinerstrasse 20
Muellerstrasse 178
99427 Weimar
13353 Berlin
Germany
Germany
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Bayer Sp. z o.o.
Jerozolimskie Avenue 158
02-326 Warsaw, Poland
phone (0-22) 572-35-00
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

Date of Last Revision of the Leaflet: May 2023