Yaz

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Yaz
0,02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Important information about combined hormonal contraceptives:

• When 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 during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "BLOOD CLOTS").

Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If any side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Yaz is and what it is used for
2. What you need to know before taking Yaz
   When not to take Yaz
   BLOOD CLOTS
   Yaz and cancer
   Breakthrough bleeding
   What to do if no bleeding occurs during the placebo tablet period
   Yaz and other medicines
   Laboratory tests
   Pregnancy
   Breast-feeding
   Driving and using machines
   Yaz contains monohydrate lactose
3. How to take Yaz
   Preparing the blister
   When to start the first blister pack
   Taking more Yaz than you should
   If you forget to take Yaz
   What to do if you vomit or have severe diarrhoea
   Delayed bleeding: what you should know
   Change in the first day of bleeding: what you should know
   Stopping Yaz
4. Possible side effects
5. How to store Yaz
6. Contents of the pack and other information

1. What Yaz is and what it is used for

• Yaz is a contraceptive tablet 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 are placebo tablets and do not contain any active substances.
• Contraceptive tablets containing two hormones are known as "combined" pills.

2. Important information before using Yaz

General information
Before starting to take Yaz, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "BLOOD CLOTS").
Before you can start taking Yaz, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, if necessary, carry out other examinations.
This leaflet describes several situations in which you should stop taking Yaz or in which the effectiveness of Yaz may be reduced. In such situations, you should either abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the rhythm method or temperature-based methods. These methods may be unreliable because Yaz alters the monthly changes in body temperature and cervical mucus.
Yaz, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to use Yaz
Do not use Yaz if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other method of contraception may be more suitable.
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). Symptoms may include itching, rash, or swelling;
• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a long time (see section "BLOOD CLOTS");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial clot:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia;
• if you currently have or have previously had a type of migraine called "migraine with aura";
• if you currently have (or have previously had) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you have previously had or currently have liver tumour;
• if you have previously had, currently have, or are suspected of having breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding.

Do not use Yaz if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir (see also section "Yaz and other medicines").

Additional information for specific populations
Children and adolescents
Yaz is not intended for use in girls who have not yet started menstruating.
Women of advanced age
Yaz is not intended for use after menopause.
Women with liver function disorders
Do not take Yaz if you have liver disease. See also sections "When not to use Yaz" and "Warnings and precautions".
Women with kidney function disorders
Do not take Yaz if you have kidney failure or acute kidney failure. See also sections "When not to use Yaz" and "Warnings and precautions".

Warnings and precautions
When to contact your doctor
Seek immediate medical advice

• if you notice possible symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or stroke (see section below "BLOOD CLOTS").

For a description of symptoms of these serious adverse effects, see "HOW TO RECOGNIZE BLOOD CLOTS".

Tell your doctor if you have any of the following conditions.
Special caution is required when using Yaz or any other combined hormonal contraceptive in certain situations. If any of the following conditions occur or worsen while taking Yaz, consult your doctor.

• if you have a family history of breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have hypertriglyceridaemia (elevated blood fat levels) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• if you require surgery or will be immobile for a long time (see section 2 "BLOOD CLOTS");
• if you have recently given birth, as you are in a high-risk group for blood clots. Consult your doctor for advice on how soon after delivery you can start taking Yaz;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Yaz and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria—a blood disorder, herpes gestationis—skin rash with blisters during pregnancy, Sydenham's chorea—a nervous system disorder with involuntary body movements);
• if you have melasma (chloasma), brownish pigmentation patches, especially on the face, or have had them in the past. If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary angioedema, estrogen-containing medicines may trigger or worsen symptoms. Seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives with difficulty breathing.

Consult your doctor before starting to take Yaz.

BLOOD CLOTS
Using combined hormonal contraceptives such as Yaz is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in the veins (referred to below as "venous thrombosis" or "venous thromboembolic disease")
• in the arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events"). Full recovery from a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots caused by using Yaz is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

Do you experience any of these symptoms? What is the likely reason you may be suffering?

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking,
• increased warmth 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 developing blood clots in veins (venous thromboembolism). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.

• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.

• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.

• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of venous blood clots is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Yaz, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of blood clots in the legs or lungs associated with using Yaz is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of 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 individual woman's medical history (see "Factors that increase the risk of venous blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Yaz is low, but certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have an inherited tendency to form blood clots;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Yaz several weeks before surgery or during immobilization. If the patient must stop taking Yaz, ask the doctor when it is safe to restart;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of blood clots increases with the number of risk factors present.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
Inform the doctor if any of the above factors apply to the patient, even if uncertain. The doctor may decide to discontinue Yaz.
Inform the doctor if any of the above conditions change during treatment with Yaz, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It should be emphasized that the risk of heart attack or stroke associated with the use of Yaz is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Yaz, smoking should be stopped. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes. If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.

Inform the doctor if any of the above conditions change during treatment with Yaz, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Yaz and cancer
Women using combined hormonal contraceptives have a slightly increased incidence of breast cancer, but it is not known whether this is caused by the use of the pill. For example, it may be that more cancers are detected in women using combined hormonal contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and to contact the doctor if any lump is felt.
Benign liver tumors have been reported in women using oral contraceptives, and in even rarer cases, malignant liver tumors. If unusual, severe abdominal pain occurs, contact the doctor immediately.

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

Breakthrough bleeding
During the first few months of taking Yaz, unexpected bleeding (bleeding outside the placebo tablet period) may occur. If this bleeding persists for longer than a few months or starts after several months of use, the doctor should investigate the cause.

What to do if no withdrawal bleeding occurs during the placebo tablet period
If all light pink tablets have been taken correctly, without vomiting or severe diarrhea, and no other medications have been taken, the likelihood of pregnancy is very low.
If withdrawal bleeding does not occur in two consecutive menstrual cycles, this may indicate pregnancy. Contact the doctor immediately. Do not start the next blister pack until it is confirmed that the patient is not pregnant.

Yaz and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking.
Also inform any other doctor, including a dentist or pharmacist, who prescribes another medicine that you are using Yaz. They may advise whether you should use additional contraceptive methods (e.g., condoms), and if so, for how long.
Some medicines may:

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

These include medicines used to treat:

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

Yaz may also affect the action of other medicines, for example:

• those containing cyclosporine;
• antiepileptic 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 use 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 tests (increased levels of liver enzyme ALT). The doctor will recommend another type of contraception before starting these medicines. Yaz may be restarted approximately 2 weeks after stopping treatment. See section “When not to use Yaz”.
Before taking any medicine, consult a doctor or pharmacist.

Yaz with food and drink
Yaz may be taken independently of meals. If necessary, it can be taken with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that you are taking Yaz, as oral contraceptives may affect the results of certain tests.

Pregnancy
Yaz must not be used during pregnancy. If the patient becomes pregnant while taking Yaz, she should stop immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Yaz at any time (see also section “Discontinuation of Yaz”).

Breast-feeding
Yaz is generally not recommended during breast-feeding. If the patient wishes to use Yaz while breast-feeding, she should consult her doctor.

Driving and using machines
There is no information suggesting that Yaz affects the ability to drive or operate machinery.

Yaz contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should contact her doctor before taking this medicine.

3. How to use 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 a specific order. One blister contains 28 tablets.
Take one tablet of Yaz daily, with a small amount of water if needed.
The tablets may be taken regardless of meals, but they must be taken every day at approximately the same time.
Do not confuse the tablets: take the light pink tablets for the first 24 days, followed by the white placebo tablets for the last 4 days. Start a new blister immediately (24 light pink tablets, then 4 white tablets) without any break between blisters.
Due to differences in tablet composition, it is essential to start from the first tablet at the top left corner and take the tablets each day in the direction indicated by the arrows on the blister.

Preparing the blister
To help track daily tablet intake, each Yaz blister pack includes 7 self-adhesive strips printed with symbols for the days of the week. Choose the strip where the first day symbol corresponds to the day you start the pack. For example, if the first day of use is Wednesday, apply the strip starting with "WED".
Attach the sticker to the top of the Yaz blister, in the area marked "Plaats hier de weeksticker" (meaning "Place the weekly sticker here", see section 5. "Translation of certain information on the immediate packaging"). In this way, the first day symbol will be above the tablet marked with an orange triangle.
Each tablet is labeled above, allowing you to verify that the correct tablets have been taken. Arrows indicate the order for taking the tablets.

During the 4 days of taking the white placebo tablets (placebo period), withdrawal bleeding should occur (so-called "withdrawal bleeding"). This bleeding usually begins on the 2nd or 3rd day after taking the last active light pink tablet. After taking the last white tablet, start the next blister immediately, regardless of whether bleeding is still occurring. This means that new packs will always be started on the same day of the week, and bleeding will occur approximately on the same days each month.
When Yaz is taken as directed, contraceptive protection is maintained even during the 4 days when placebo tablets are taken.

When to start the first blister

• If no hormonal contraceptive has been used in the previous month: Begin taking Yaz on the first day of the menstrual cycle (i.e., the first day of menstruation). Starting Yaz on the first day of the period provides immediate protection against pregnancy. It is also possible to start between days 2 and 5 of the cycle, but in this case, additional contraceptive methods (e.g., condoms) must be used for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined vaginal contraceptive system or transdermal system: Start Yaz the day after taking the last active tablet of the previous contraceptive pack, but no later than the day after the usual tablet-free interval ends (or after the last inactive tablet of the previous contraceptive). When switching from a combined vaginal contraceptive system or transdermal patch, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only minipill, injection, implant, or intrauterine system releasing progestogen - IUS): You may switch at any time from the progestogen-only pill (from an implant or intrauterine system on the day of removal, or from an injectable method on the scheduled day of the next injection), but in all cases, additional contraceptive methods (e.g., condoms) must be used for the first 7 days of tablet use.
• After miscarriage: Follow your doctor's advice.
• After childbirth: You may start taking Yaz between days 21 and 28 after delivery. If starting later than day 28, use a mechanical method (e.g., condoms) for the first 7 days of taking Yaz. If sexual intercourse occurred before starting (or restarting) Yaz after childbirth, ensure you are not pregnant or wait until withdrawal bleeding occurs.
• If breastfeeding and wishing to start (or restart) Yaz after childbirth: Read the section "Breastfeeding".

If you are unsure when to start taking the medicine, consult your doctor.

Taking more Yaz tablets than recommended
There are no reports of serious harmful effects from taking too many Yaz tablets.
If several tablets are taken at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took the medicine.
If too many Yaz tablets are taken or if a child swallows any tablets, consult your doctor or pharmacist immediately.

Missed dose of Yaz
The last 4 tablets in the 4th row of the blister are placebo tablets. If one of these is missed, the contraceptive effectiveness of Yaz remains unchanged. Discard the missed placebo tablet.

If a light pink active tablet (1 of 24) is missed, follow the instructions below:

• If less than 24 hours have passed since the missed tablet, contraceptive effectiveness is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.
• If more than 24 hours have passed since the missed tablet, contraceptive effectiveness may be reduced. The more tablets missed, the higher the risk of pregnancy.

The risk of reduced contraceptive effectiveness is greatest if a light pink tablet is missed at the beginning or end of the pack. Therefore, follow the rules below (see also the chart below):

• Missing more than one tablet from the blister: Contact your doctor.
• Missing one tablet in days 1–7 (first row): Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet or forgot to start the next blister, be aware that you may be pregnant. In such a case, contact your doctor.
• Missing one tablet in days 8–14 (second row): Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Contraceptive effectiveness is not reduced, and additional protection is not needed.
• Missing one tablet in days 15–24 (third or fourth row): Two options are available:
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Discard the white placebo tablets and immediately start the next blister (the first day of use will be different than usual).
     Withdrawal bleeding will most likely occur at the end of the second blister, but spotting or breakthrough bleeding may also occur during use of the second blister.
  2. Alternatively, stop taking the light pink tablets and immediately proceed to the 4 white placebo tablets (before starting the placebo period, note the day on which the tablet was missed). If you wish to start the next blister on the originally scheduled day, you may shorten the placebo period to fewer than 4 days.

If you follow either of these recommendations, contraceptive effectiveness will be maintained.
If you missed any tablet from the blister and no bleeding occurs during the first placebo period, this may indicate pregnancy. Contact your doctor before starting the next blister.

Missed more than 1 light pink tablet from one blister?
→ Yes: Consult your doctor
→ No:
Did sexual intercourse occur in the week before missing the tablet?
→ Yes:
* Take the missed tablet
* Use mechanical contraception (condoms) for the next 7 days
* Finish the tablets in the blister
→ No:
* Take the missed tablet
* Finish the tablets in the blister

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking a light pink active tablet, or if severe diarrhoea occurs, there is a risk that the active substances have not been completely absorbed. This situation is similar to missing a tablet.
After vomiting or diarrhoea, take another light pink active tablet from a spare blister as soon as possible. If possible, take it within 24 hours of your usual tablet-taking time. If this is not possible or if more than 24 hours have passed, follow the advice given in the section "Missed dose of Yaz".

Delaying withdrawal bleeding: what you should know
Although not recommended, withdrawal bleeding can be delayed by skipping the white placebo tablets in the 4th row and immediately starting the second Yaz blister, continuing until its end. Spotting or breakthrough bleeding may occur during use of the second blister. Complete the second pack by taking the 4 white placebo tablets from the 4th row of the second pack. Then start the next blister.
You may consult your doctor before deciding to delay withdrawal bleeding.

Changing the first day of bleeding: what you should know
If you take the tablets as instructed, withdrawal bleeding will occur during the placebo tablet period. If you wish to change this day, you may shorten (but never extend – maximum 4 days!) the placebo period. For example, if the placebo period normally starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. In this case, bleeding may not occur at that time, but spotting or breakthrough bleeding may occur.

If you are unsure what to do, contact your doctor.

Stopping Yaz
You may stop taking Yaz at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Yaz and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Yaz may cause adverse effects, although not everyone experiences them.
If any adverse effects occur, particularly if they are severe and persistent, or if there are changes in
health which the patient considers to be related to the use of Yaz, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of blood clots in the
veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic
disorders). For detailed information on various risk factors associated with the use of combined
hormonal contraceptives, please refer to section 2, "Important information before taking Yaz".
The following adverse effects have been associated with the use of Yaz:
Common adverse effects (occur in 1 to 10 out of every 100 people):

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

Uncommon adverse effects (occur in 1 to 10 out of every 1,000 people):

• depression, nervousness, drowsiness;
• fainting, tingling and numbness;
• migraine, varicose veins, increased blood pressure;
• abdominal pain, vomiting, indigestion, flatulence, gastritis, diarrhoea;
• acne, itching, rash;
• pain, e.g. back pain, limb pain, muscle cramps;
• fungal vaginal infections, pelvic pain, breast enlargement, benign breast tumour, uterine/vaginal bleeding (which usually resolves during continued treatment), vaginal discharge, hot flushes, vaginal inflammation, menstrual disorders, painful periods, scanty periods, very heavy periods, vaginal dryness, abnormal cervical smear, decreased sexual desire.

Rare adverse effects (occur in 1 to 10 out of every 10,000 people):

• candidiasis (fungal infection);
• anaemia, increased platelet count;
• allergic reaction;
• endocrine disorders (hormonal disorders);
• increased appetite, loss of appetite, markedly increased blood potassium levels, markedly decreased blood sodium levels;
• anorgasmia, insomnia;
• dizziness, chills;
• eye disorders, e.g. blepharitis, dry eyes;
• rapid heartbeat;
• phlebitis, nosebleeds, fainting;
• abdominal distension, intestinal disease, bloating, gastric hernia, fungal infection of the mouth, constipation, dry mouth;
• biliary or gallbladder pain, cholecystitis;
• brownish skin patches, rash, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, hirsutism, skin disorders, skin striae, dermatitis, photosensitivity, skin nodules;
• painful or difficult sexual intercourse, vaginal inflammation, post-coital bleeding, withdrawal bleeding, breast cyst, increased breast cells (hyperplasia), malignant breast tumour, significant endocervical hyperplasia, endometrial atrophy or shrinkage, 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 ischaemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

The following adverse effects have also been reported: hypersensitivity, erythema multiforme (rash, redness or ulceration), but based on available data, the frequency of occurrence cannot be determined.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store the medicine Yaz

Keep this medicine out of the sight and reach of children.
There are no special storage instructions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Plaats hier de weeksticker – "Place the weekly sticker here."
Medicines must 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 packaging and other information

What Yaz contains

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

Other ingredients are:
Light pink tablets:

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

White tablets:

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

What Yaz looks like and contents of the pack

• Each Yaz blister pack 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 tablet containing active substances is light pink, round, with convex surfaces, one side embossed with the letters "DS" within a regular hexagon.
• The placebo tablet is white, round, with convex surfaces, one side embossed with the letters "DP" within a regular hexagon.
• Yaz is available in packs containing 1 blister with 28 tablets.
• A label with days of the week is included in the package – see section 3 "Preparing the blister".

For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in the Netherlands, country of export:
Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
The 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Netherlands, country of export: RVG 33842
Parallel import authorization number: 54/17
This medicinal product is authorized for sale in the European Economic Area countries 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
• The Netherlands: YAZ 24+4