Yira 3 mg/0.03 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Yira 3 mg/0.03 mg film-coated tablets

drospirenone/ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Important things you should know about combined hormonal contraceptives (CHCs):

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

Leaflet contents:

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

2. What you need to know before taking Yira 2

When not to use Yira 2

Warnings and precautions 4

Blood clots 5

Yira and cancer 9

Psychiatric disorders 10

Bleeding between periods 10

What to do if you do not have your period during the rest week 10

Other medicines and Yira 10

Taking Yira with food and drink 11

Laboratory tests 11

Pregnancy 11

Breast-feeding 11

Driving and using machines 11

Yira contains lactose 12

3. How to take Yira 12

When you can start with the first blister pack 12

If you take more Yira than you should 13

If you forget to take Yira 13

What to do in case of vomiting or severe diarrhoea 15

Delayed period: what you should know 15

Changing the first day of your period: what you should know 15

If you stop taking Yira 16

4. Possible side effects 16

5. How to store Yira 17

6. Contents of the pack and other information 17

1. What Yira is and what it is used for

• Yira is a contraceptive and is used to prevent pregnancy.

• Each film-coated tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

Contraceptives containing two hormones are called combined contraceptives.

2. What you need to know before starting Yira

General considerations

Before starting to use Yira, 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 starting Yira, 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 some additional tests.

This leaflet describes several situations in which you should stop using Yira, or in which the effect of Yira may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because Yira alters the monthly changes in body temperature and cervical mucus.

Yira, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to use Yira

Do not use Yira if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be most suitable.

Do not use Yira

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or if you are going to be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or a stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with blood vessel damage.

• Very high blood pressure.

• Very high levels of fat in the blood (cholesterol or triglycerides).

• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have (or have ever had) a liver disease and your liver function has not returned to normal.

• If your kidneys do not function properly (renal failure).

• If you have (or have ever had) a liver tumour.

• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the reproductive organs.

• If you have vaginal bleeding of unknown cause.

• If you are allergic to ethinylestradiol, drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.

Do not take Yira if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section “Other medicines and Yira”).

Additional information on special populations

Children and adolescents

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

Older women

Yira is not indicated for use after menopause.

Women with hepatic impairment

Do not take Yira if you have a liver disease. See sections “Do not use Yira” and “Warnings and precautions”.

Women with renal impairment

Do not take Yira if you have impaired kidney function or acute renal failure. See sections “Do not use Yira” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yira.

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Tell your doctor if you have any of the following conditions.

In certain situations, you should take special care when using Yira or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using Yira, you must also inform your doctor.

• If any close relative has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for long periods (see section 2, “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Yira after childbirth.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Other medicines and Yira”, page 10).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• If you have a condition that first occurred during pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham's chorea)).
• If you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as “pregnancy mask”). In such cases, 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, possibly with breathing difficulties, consult your doctor immediately. Medicines containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Yira increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

Recovery from blood clots is not always complete. Rarely, there may be long-lasting serious effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Yira is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis.
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, which may bring up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism.
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, heaviness. Feeling of tightness or fullness in the chest, arm, or beneath the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or 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, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision difficulty in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke.
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

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

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Yira, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and on 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 Yira is small.

• Among 10,000 women who do not use a 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 Yira, between about 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 in 10,000 women
Women who use Yira	About 9–12 in 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Yira is small, but certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you may have an inherited blood clotting disorder.
• If you require surgery or will be immobile for long periods due to injury, illness, or if your leg is in a cast. You may need to stop taking Yira several weeks before surgery or while you are less mobile. If you need to stop taking Yira, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other listed risk factors.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking Yira.

If any of the above conditions change while you are using Yira—for example, a close relative experiences a thrombosis without a known cause or you gain significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it may cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke while using Yira is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Yira, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have more than one of these conditions or if any of them is particularly severe, the risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Yira—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Yira and cancer

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

Benign liver tumors have rarely been reported in users of contraceptives, and even more rarely, malignant liver tumors. See your doctor if you experience unusual severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as Yira have reported depression or depressive mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Yira, you may experience unexpected bleeding (bleeding outside the week of the break). If this bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the break week

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

If you miss two consecutive periods, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and Yira

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal preparations. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Yira. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of any other medicine.

Some medicines:

• may affect the levels of Yira in the blood
• may make Yira less effective in preventing pregnancy
• may cause unexpected bleeding

This may occur with:

• medicines used to treat
  • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g. rifampicin)
  • HIV and Hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g. griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• St. John’s wort herbal preparations

Yira may affect the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (may lead to increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat pain and/or muscle spasms)

Do not take Yira if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in blood parameters measuring liver function (increase in liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Yira can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Yira.”

Consult your doctor or pharmacist before taking any medicine.

Taking Yira with Food and Drinks

Yira may be taken with or without food, and with some water if necessary.

Laboratory Tests

If you require a blood test, inform your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives may influence the results of certain tests.

Pregnancy and Breastfeeding

Pregnancy

If you are pregnant, you must not take Yira. If you become pregnant while taking Yira, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Yira at any time (see “If you stop taking Yira”, page 16).

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

Yira is generally not recommended during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and Using Machines

There is no information suggesting that the use of Yira affects the ability to drive or operate machinery.

Yira contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Yira

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take one Yira tablet every day, with some water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

The blister pack contains 21 film-coated tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on a Wednesday, take a tablet marked "WED" next to it. Follow the direction of the arrow on the blister until you have taken all 21 tablets.

Afterwards, do not take any tablets for 7 days. During these 7 days without tablets (called the "rest period"), menstruation should occur. The bleeding, also known as withdrawal bleeding, usually begins on the 2nd or 3rd day of the rest period.

On the 8th day after taking the last Yira tablet (i.e., after the 7-day rest period), you must start the next blister pack, even if bleeding has not yet stopped. This means you should start each new blister pack on the same day of the week, and your period should occur during the same days each month.

If you use Yira in this way, you are also protected against pregnancy during the 7 days when no tablets are taken.

When to start the first blister pack

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

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

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

You may preferably start taking Yira the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system IUS)

You may switch from the progestogen-only pill on any day (if it is an implant or IUS, on the same day of removal; if it is an injectable, at the time the next injection would be due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

You may start taking Yira between 21 and 28 days after giving birth. If you start later than day 28, use a barrier method (e.g., a condom) during the first 7 days of using Yira.

If, after giving birth, you have already had sexual intercourse before starting Yira (again), you must be sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and want to start (or restart) taking Yira after giving birth

Read the section “Breast-feeding”, page 11.

Ask your doctor if you are unsure about when to start.

If you take more Yira than you should

No cases have been reported in which overdose of Yira has caused serious harm.

Symptoms that may occur if you take several tablets at once include feeling unwell, vomiting, or vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine.

If you have taken too many Yira tablets, or if you find that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Yira

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and continue taking the following tablets at your usual time.

• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a tablet at the beginning or end of the pack. Therefore, follow the recommendations below (see the diagram on page 14):

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions, for example, a condom, during the next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant. In that case, consult your doctor.

• Missing one tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

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. Continue taking the tablets at your usual time. Instead of starting the rest period, begin the next blister pack immediately.

You will likely have your period at the end of the second pack, although you may also experience light bleeding or spotting similar to a period during the second pack.

2. You may also stop taking tablets and go directly into the 7-day rest period (noting the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period must last less than 7 days.

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

• If you have missed taking any tablets and do not have bleeding during the first rest period, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhea, there is a risk that the active ingredients of the contraceptive may not be fully absorbed by the body. This situation is almost equivalent to missing a tablet. After vomiting or severe diarrhea, take a tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual time of taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Yira”, page 13.

Delaying your period: what you should know

Although not recommended, you may delay your period by starting a new Yira blister pack instead of taking the usual 7-day rest period and completing it. During the second pack, you may experience light bleeding or spotting similar to a period. After the usual 7-day rest period, start the next pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

Changing the first day of your period: what you should know

If you take the tablets as instructed, your period will begin during the rest week. If you wish to change that day, reduce the number of rest days (but never increase them—maximum 7 days!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or fewer), you may not have bleeding during these days. In that case, you may experience light bleeding or spotting.

If you are unsure how to proceed, consult your doctor.

If you stop taking Yira

You may stop taking Yira whenever you wish. If you do not want to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking Yira and wait until your period before trying to conceive. This will make it easier to calculate your estimated due date.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think could be due to Yira, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in 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 starting to take Yira”.

Serious adverse effects

Contact 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 with possible difficulty breathing (see also section “Warnings and precautions”).

The following list of adverse effects has been associated with the use of Yira:

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

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness

• headache, depressed mood

• migraine

• nausea

• thick, whitish vaginal discharge and fungal vaginal infection

Uncommon adverse effects (may affect up to 1 in 100 patients):

• increased breast size, changes in sex drive

• high blood pressure, low blood pressure

• vomiting, diarrhoea

• acne, skin rash, intense itching, hair loss (alopecia)

• vaginal infection

• fluid retention and changes in body weight

Rare adverse effects (may affect up to 1 in 1,000 patients):

• allergic reactions (hypersensitivity), asthma

• breast discharge

• hearing problems

• skin disorders such as erythema nodosum (characterised by painful, reddish skin nodules) or erythema multiforme (characterised by skin rash with target-like red spots or ulcers)

• harmful blood clots in a vein or artery, for example:

  • in a leg or foot (i.e., DVT).

  • in a lung (i.e., PE).

  • heart attack.

  • stroke.

  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).

  • blood clots in the liver, stomach/intestine, 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).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Yira

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

Do not store above 30°C. Keep in the original blister pack to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yira

• The active substances are drospirenone and ethinylestradiol.

Each active tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.

• The other components (excipients) are:

Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, povidone 25,000, magnesium stearate (E-470b).

Tablet coating: hypromellose (E-464), macrogol 6000, talc (E-553b), titanium dioxide (E-171) and yellow iron oxide (E-172), see section 2 “Yira contains lactose”.

Presentation of the product and contents of the pack

• Each Yira blister contains 21 pale yellow film-coated tablets.

• Yira tablets are film-coated tablets, with the tablet core coated. The tablets are pale yellow, rounded, with convex surfaces, and one side is marked with the letters “DO” within a regular hexagon.

• Yira is available in packs of 1, 3, 6 and 13 blisters, each containing 21 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí - Barcelona

Spain

Manufacturer

Bayer AG, 13342 Berlin, Germany

Bayer Weimar GmbH und Co. KG

Döbereinerstraße 20

99427 Weimar, Germany

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

• Netherlands: Ethinylestradiol / Drospirenon 0,03 / 3 mg Berlipharm
• Spain: Yira
• Austria: Yirala
• France: Convuline
• Germany: Petibelle

Date of the most recent review of this leaflet: November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)