YAZ

Patient Information Leaflet: Information for the User

YAZ 0.02 mg / 3 mg Film-Coated Tablets

ethinylestradiol/drospirenone
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others; it may be harmful if used by someone else.
• If you get any side effects, talk to your doctor or pharmacist (see section 4).

Important information about combined hormonal contraceptives (CHCs):

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

Contents of this leaflet

1. What YAZ is and what it is used for
2. What you need to know before you use YAZ
   ➢ When you must not use YAZ
   ➢ Warnings and precautions
   ➢ Blood clots
   ➢ YAZ and cancer
   ➢ Psychiatric disorders
   ➢ Intermenstrual bleeding
   ➢ What to do if you do not have a period during the placebo days
   ➢ Other medicines and YAZ
   ➢ YAZ with food and drink
   ➢ Laboratory tests
   ➢ Pregnancy
   ➢ Breast-feeding
   ➢ Driving and using machines
   ➢ YAZ contains lactose
3. How to take YAZ
   ➢ Preparation of the blister pack
   ➢ When can you start the first pack?
   ➢ If you take more YAZ than you should
   ➢ If you forget to take YAZ
   ➢ What to do in case of vomiting or severe diarrhoea
   ➢ Delayed menstruation: what you need to know
   ➢ Changing the day of onset of menstruation: what you need to know
   ➢ If you stop taking 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 pill used to prevent pregnancy.
• Each of the 24 light pink film-coated tablets contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
• The 4 white film-coated tablets do not contain any active ingredients and are also called placebo tablets.
• Contraceptive pills that contain two hormones are called combined pills.

2. What you need to know before taking YAZ

General information
Before starting to take YAZ, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before taking YAZ, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes various situations in which you should stop taking YAZ or in which the safety of YAZ may be reduced. In such cases, you must abstain from sexual intercourse or use additional non-hormonal contraceptive measures, such as a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because YAZ alters the monthly changes in body temperature and cervical mucus.
YAZ, like all hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

When you must not use YAZ
Do not use YAZ if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for you.
Do not use YAZ:

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are about to undergo surgery or will be bedridden for a long time (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which could increase the risk of forming clots in the arteries:
  o severe diabetes with blood vessel damage
  o very high blood pressure
  o very high levels of fats (cholesterol or triglycerides) in the blood
  o a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) liver disease and liver function is still abnormal;
• if your kidneys do not work properly (renal failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or if it is suspected that you have cancer of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or any of the excipients of this medicine (listed in section 6). This condition may manifest as itching, skin rash, or swelling.
  Do not use YAZ if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section “Other medicines and YAZ”).

Additional information on special populations
Children and adolescents
YAZ is not indicated in women whose menstrual cycle has not yet started.
Elderly patients
YAZ is not indicated after menopause.
Patients with liver impairment
Do not take YAZ if you suffer from liver disease. See also sections “Do not take YAZ” and “Warnings and precautions”.
Patients with renal impairment
Do not take YAZ if you suffer from renal failure or acute renal failure. See also sections “Do not take YAZ” and “Warnings and precautions”.

Warnings and precautions
When should you contact a doctor?
Contact a doctor immediately

• if you notice signs suggesting a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”).
  For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In some situations, you need to be particularly careful when using YAZ or any other combined oral contraceptive, and your doctor may need to examine you regularly. If any of these conditions develop or worsen while you are taking YAZ, you must inform your doctor.

• if a close relative has or has ever had 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 disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (a hereditary red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are about to undergo surgery or will be bedridden for a long time (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking YAZ;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you suffer from epilepsy (see “Other medicines and YAZ”);
• if you have a disease that first occurred during pregnancy or during previous use of sex steroids (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden body movements (Sydenham’s chorea));
• if you have or have ever had patchy brown pigmentation (chloasma), also known as “pregnancy mask”, especially on the face. In this case, 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 with possible breathing difficulties, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Contact your doctor before taking YAZ.

Blood clots
Using a combined hormonal contraceptive such as YAZ increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).
  Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with YAZ is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have one of these signs? What are you likely suffering from?

• Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
  Deep vein thrombosis

  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as paleness, redness, or bluish discoloration

• Sudden and unexplained shortness of breath or rapid breathing
  Pulmonary embolism

  • sudden cough without an obvious cause, possibly with coughing up blood
  • sharp chest pain that may worsen when breathing deeply
  • severe dizziness or lightheadedness
  • rapid or irregular heartbeat
  • severe stomach pain

If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a “common cold”).

Symptoms occurring more frequently in one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision

• painless blurring of vision that may progress to vision loss

• pain, discomfort, pressure, or heaviness in the chest
  Heart attack

  • squeezing or fullness sensation in the chest, arm, or under the breastbone

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

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

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking YAZ, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your underlying risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with YAZ is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as YAZ, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with YAZ is low, but certain conditions can increase this risk.
Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking YAZ several weeks before surgery or during periods of reduced mobility. If you need to stop taking YAZ, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago. The risk of developing a blood clot increases when you have more than one of these conditions.

Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking YAZ.
If any of the above conditions change while you are using YAZ—for example, if a close relative develops thrombosis without a known cause or if you gain a significant amount of weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
As with blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of YAZ is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as YAZ, it is advisable to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an 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 suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.
  If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
  If any of the above conditions change while you are using Yaz—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain a significant amount of weight—contact your doctor.

YAZ and cancer
Breast cancer is observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, women using the pill may have more tumors diagnosed simply because they undergo more frequent medical check-ups.
The occurrence of breast cancer gradually decreases after stopping combined hormonal contraception. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been observed in women using the pill. Contact your doctor if you experience unusual and severe abdominal pain.

Psychiatric disorders
Some women using hormonal contraceptives, including Yaz, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking YAZ, unexpected bleeding (bleeding outside the placebo days) may occur. If this bleeding continues for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the placebo days
If you have taken all the light pink active tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Begin the next pack only if you are certain you are not pregnant.

Other medicines and YAZ
Always inform your doctor if you are taking any medicines or herbal products. Inform any other doctor or dentist (or pharmacist) who prescribes you another medicine that you are taking YAZ. They will advise you whether you need to use additional contraceptive measures (e.g., condoms), and for how long, or whether the use of another medicine you may need should be adjusted.
Some medicines:

• affect the levels of YAZ in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding. These include:
• medicines for treating epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g., rifampicin), HIV infection and Hepatitis C virus (ritonavir, nevirapine, efavirenz—known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), high blood pressure in the pulmonary arteries (bosentan), or St. John’s wort (Hypericum perforatum), a herbal remedy.

YAZ may affect the action of other medicines, for example:

• medicines containing cyclosporine,
• the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures),
• Theophylline (used to treat respiratory problems),
• Tizanidine (used to treat muscle pain and/or muscle cramps).
  Do not use Yaz if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in blood test results for liver function (elevated liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines. Yaz may be resumed approximately 2 weeks after completing this treatment. See section “Do not use Yaz”.
  Ask your doctor or pharmacist for advice before taking any medicine.

YAZ with food and drink
YAZ may be taken with or without food, if necessary with a little water.

Laboratory tests
If you need a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.

Pregnancy
You must not use YAZ if you are pregnant. If you become pregnant while taking YAZ, you must stop taking the pill immediately and contact your doctor. If you wish to become pregnant, you may stop taking YAZ at any time (see also “If you stop taking YAZ”).
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
The use of YAZ is generally not recommended during breast-feeding. If you wish to take the pill while breast-feeding, you should consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
There is no evidence to suggest that YAZ affects the ability to drive or use machinery.

YAZ contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking YAZ.

3. How to take YAZ

Each blister contains 24 light pink film-coated active tablets and 4 white film-coated placebo tablets.
The two different-coloured tablets in YAZ are arranged in sequence. One blister contains 28 tablets.
Take one tablet of YAZ every day, if necessary with a small amount of water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
Do not confuse the tablets: take one light pink tablet for the first 24 days, then one white tablet for the last 4 days. You must then immediately start a new blister (24 light pink tablets and 4 white tablets). There is therefore no break between blisters.
Because the composition of the tablets differs, you must start with the first tablet in the top left corner and take one tablet each day. To ensure correct order, follow the direction of the arrows on the blister.

Blister preparation
To help you keep track of your daily tablet intake, each YAZ blister contains 7 adhesive labels with the 7 days of the week, each starting with a different day.
Choose the label that starts with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the adhesive label starting with "WED".
Apply the weekly adhesive label along the top edge of the YAZ blister where it says "Apply label here", so that the first day appears above the tablet marked "Start".
Now each tablet has a day marked above it, allowing you to visually check whether you have taken a particular tablet. The arrows indicate the order in which the tablets should be taken.

During the 4 days when you take the white placebo tablets (the placebo days), you should experience menstruation (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last active light pink tablet of YAZ. After taking the last white tablet, you must immediately start the next blister, even if menstruation is still ongoing. This means you will start each blister on the same day of the week, and your periods will occur on the same days each month.
When taking YAZ as described above, you are protected against pregnancy even during the 4 days when you take the placebo tablet.

When can you start the first blister?

• If you have not used a hormonal contraceptive in the previous month Start taking YAZ on the first day of your cycle (i.e. the first day of menstruation). If you start on the first day of your period, contraceptive protection is immediate. You may also start taking YAZ between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive measures (e.g. a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive, a combined vaginal ring, or a contraceptive patch Start taking YAZ preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the tablet-free interval (or after the last inactive tablet of your previous pill). When switching from a combined vaginal ring or contraceptive patch, follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system (IUS))
  You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of its removal, from an injectable when the next injection is due), but in all these cases you must use additional contraceptive measures (e.g. a condom) for the first 7 days of tablet intake.

• After an abortion Follow your doctor's advice.

• After childbirth You may start taking YAZ between day 21 and day 28 after childbirth. If you start later than day 28, you must use a so-called barrier method (e.g. a condom) during the first 7 days of taking YAZ. If, after childbirth, you have had sexual intercourse before starting (or restarting) YAZ, you must first ensure that you are not pregnant or wait for your menstruation.

• If you are breastfeeding and wish to start (or restart) taking YAZ Read the section “Breast-feeding”. Consult your doctor if you are unsure about when to start.

If you take more YAZ than you should
There have been no reports of serious harmful effects following overdose with YAZ tablets.
If you take several tablets at once, you may experience nausea or vomiting or vaginal bleeding.
Girls who have not yet had their periods but have accidentally taken this medicine may also experience such bleeding.
If you have taken too many YAZ tablets, or if you find that a child has taken any tablets, contact your doctor or pharmacist.

If you forget to take YAZ
The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget one of these tablets, this will not affect the reliability of YAZ. You should discard the forgotten placebo tablet.
If you forget an active light pink tablet (tablets 1 to 24 in the blister pack), follow the instructions below:

• If the delay in taking a tablet is less than 24 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, then continue taking the tablets at your usual time.
• If the delay in taking a tablet is more than 24 hours, contraceptive protection may be reduced. The greater the number of tablets missed, the higher the risk of pregnancy. This risk is greatest if you miss a light pink tablet at the beginning or end of the blister. Therefore, follow the instructions below (see also the diagram below):
• More than one tablet missed in this pack Consult your doctor.
• One tablet missed during days 1-7 (first row) Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive measures for the next 7 days, e.g. a condom. If you had sexual intercourse in the week before the missed tablet, pregnancy may have occurred. In this case, consult your doctor.
• One tablet missed during days 8-14 (second row) Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets as scheduled. Contraceptive protection remains effective and no additional precautions are necessary.
• One tablet missed during days 15-24 (third or fourth row)

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets as scheduled. Instead of taking the placebo tablets in the current blister, discard them and start the new blister immediately (your starting day will be different). Your menstruation will most likely occur at the end of the second blister, during the intake of the white placebo tablets, but you may experience spotting or breakthrough bleeding during the second blister.
2. You may also stop taking the current cycle's active light pink tablets and switch directly to the 4 white placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start the next blister on your usual day, take the placebo tablets for fewer than 4 days.

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

• If you have missed any tablet in the blister and do not have a withdrawal bleed during the placebo days, you may be pregnant. Consult your doctor before starting a new blister.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after taking an active light pink tablet or have severe diarrhoea, the active ingredients of the tablet may not be completely absorbed by your body. This situation is comparable to missing a tablet. After vomiting or diarrhoea, take a new active light pink tablet from a spare pack 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 instructions in the section “If you forget to take YAZ”.

Delaying menstruation: what you need to know
Although not recommended, it is possible to delay menstruation by not taking the white placebo tablets from the fourth row and continuing directly with a new blister of YAZ. During use of this second blister, you may experience light bleeding or menstrual-like spotting. Complete this second blister, including the 4 white tablets in the fourth row. Then start the next blister.
You may consult your doctor before deciding to delay your menstrual period.

Changing the day your menstruation starts: what you need to know
If you take the tablets as instructed, your periods will start during the placebo days. If you wish to change the day your period starts, you may shorten (but never lengthen – 4 days is the maximum!) the placebo days when taking the white placebo tablets. For example, if your placebo period starts on Friday and you wish to shift it to Tuesday (3 days earlier), you should start the next blister 3 days earlier. You may not have a period during this time. You may subsequently experience light bleeding or menstrual-like spotting.
Consult your doctor if you are unsure what to do.

If you stop taking YAZ
You may stop taking YAZ at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control. If you wish to have a baby, stop taking YAZ and wait for your period before trying to become pregnant. This will allow you to calculate the expected date of delivery more accurately.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to YAZ, tell your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking YAZ”.

Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

The following side effects have been associated with the use of YAZ:

Common side effects (may affect between 1 and 10 in 100 women)

• Mood swings
• Headache
• Nausea
• Breast pain, menstrual problems such as irregular periods, absence of periods

Uncommon side effects (may affect between 1 and 10 in 1,000 women)

• Depression, nervousness, drowsiness
• Dizziness, tingling
• Migraine, varicose veins, increased blood pressure
• Stomach ache, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea
• Acne, itching, skin rashes
• Pain, such as back pain, limb pain, muscle cramps
• Vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually decreases with continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual problems, painful periods, light periods, heavy periods, vaginal dryness, abnormal Pap test, decreased interest in sex
• Lack of energy, increased sweating, fluid retention
• Weight gain

Rare side effects (may affect between 1 and 10 in 10,000 women)

• Candidiasis (fungal infection)
• Anaemia, increased platelet count in blood
• Allergic reaction
• Hormonal disorders (endocrine)
• Increased appetite, loss of appetite, excessively high potassium levels in blood, abnormally low sodium levels in blood
• Inability to achieve orgasm, insomnia
• Dizziness, tremor
• Eye disorders, such as eyelid inflammation, dry eyes
• Rapid heartbeat
• Vein inflammation, nosebleeds, fainting
• Abdominal swelling, intestinal disorders, bloated feeling, hiatus hernia, fungal infection of the mouth, constipation, dry mouth
• Pain in the bile ducts or gallbladder, gallbladder inflammation
• Brownish-yellow skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, granulomatous skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitivity-related skin inflammation, skin nodules
• Painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast nodules, abnormal growth of the cervical mucosa, reduction or thinning of the uterine lining, ovarian cysts, uterine enlargement
• General feeling of malaise
• Weight loss
• Harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, stroke, mini-stroke or temporary stroke-like symptoms known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestines, kidneys or eye.

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

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with red, inflamed target-shaped lesions).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store YAZ

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Do not use after:” or “EXP.:”. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What YAZ contains
➢ The active substances are ethinylestradiol (as beta-cyclodextrin clathrate) and drospirenone. Each active pinkish film-coated tablet contains 0.020 milligrams of ethinylestradiol (as beta-cyclodextrin clathrate) and 3 milligrams of drospirenone.
➢ The white film-coated tablets do not contain any active substances.
➢ The excipients are:

• in the active light pink film-coated tablets:
• In the tablet core: monohydrate lactose, corn starch, magnesium stearate (E470b).
• In the tablet film coating: hypromellose (E464), talc (E553b), titanium dioxide (E171) and red iron oxide (E172).
• in the inactive white film-coated tablets:
• In the tablet core: monohydrate lactose, microcrystalline cellulose, magnesium stearate (E470b).
• In the tablet film coating: hypromellose (E464), talc (E553b), titanium dioxide (E171).
• See section 2 “YAZ contains lactose”

Description of the appearance of YAZ and package contents
➢ Each YAZ pack contains 24 active pinkish film-coated tablets in rows 1, 2, 3 and 4 of the blister, and 4 white placebo film-coated tablets in row 4.
➢ YAZ tablets, both the light pink and the white ones, are film-coated tablets; the tablet core is covered with a coating layer.
➢ The active tablet is light pink, round, with convex faces, and bears the letters “DS” within a regular hexagon on one side.
➢ The placebo tablet is white, round, with convex faces, and bears the letters “DP” within a regular hexagon on one side.
➢ YAZ is available in packs containing 1, 3, 6 or 13 blisters, each blister containing 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156, Milan, Italy
Manufacturer
Bayer AG
13342 Berlin - Germany
Bayer Weimar GmbH und Co. KG
Döbereinerstr. 20, 99427 Weimar - Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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