YIRA 3 mg / 0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Yira 3 mg/0.03 mg film-coated tablets

drospirenone/ethinylestradiol

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to 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 having a blood clot in the veins and arteries, especially in the first year or when you start using a combined hormonal contraceptive again after a break of 4 weeks or more.
• Be alert and see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

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

1. What you need to know before you start taking Yira 2

When not to use Yira 2

Warnings and precautions 4

Blood clots 5

Yira and cancer 9

Psychiatric disorders 10

Irregular bleeding 10

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

1. How to take Yira 12

When you can start with the first blister 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 diarrhea 15

Delayed period: what you should know 15

Change of your first day of period: what you should know 15

If you stop taking Yira 16

1. Possible side effects 16

1. Storage of Yira 17

1. Package contents and further information 17

1. What is Yira and what is it 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 that contain two hormones are called combined contraceptives.

2. What you need to know before taking Yira

General considerations

Before starting to use Yira, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take Yira, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may carry out some other tests.

This prospectus describes several situations in which you should interrupt the use of Yira, or in which the effect of Yira may decrease. In such situations, you should not have sexual intercourse or should take 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 since Yira alters the monthly changes in body temperature and cervical mucus.

Yira, like other hormonal contraceptives, does not protect against HIV infection (AIDS) 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 what other form of contraception would be more suitable.

Do not use Yira

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (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 that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a 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 yet normalized.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the sex organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol, drospirenone or any of the other components of this medicine (including those listed in section 6). This can cause itching, rash or inflammation.

Do not take Yira if you have hepatitis C and are taking medicines that contain 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 liver insufficiency

Do not take Yira if you suffer from liver disease. See sections "Do not use Yira" and "Warnings and precautions".

Women with renal insufficiency

Do not take Yira if you are suffering from kidney malfunction 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.

Tell your doctor if you suffer from any of the following conditions.

In some situations, you will need to be particularly careful while using Yira or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using Yira, you should also inform your doctor.

• If a 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 (a hereditary disease of red blood cells).
• 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 need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Yira after childbirth.
• If you have inflammation of the veins that are under 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 that affects your natural defense system).
• If you have a disease that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (a skin discoloration, especially on the face or neck, known as "pregnancy spots"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medicines that contain estrogens can induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Yira increases your risk of having a blood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential 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.

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 the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of 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 moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can 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 in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption 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 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 Yira is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Yira, between 9 and 12 women will develop a blood clot in a year.
• The risk of developing a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung or other organ at a young age (i.e., before the age of about 50).
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have your leg in a cast. You may need to interrupt the use of Yira several weeks before surgery or while you have reduced mobility. If you need to interrupt the use of Yira, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

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

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

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should interrupt the use of Yira.

If any of the above conditions change while you are using Yira, for example, a close relative experiences a thrombosis without known cause or you gain a lot of 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 can cause a heart attack or a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to Yira is very small, but it can increase:

• With age (above 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have a high level of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

Yira and cancer

There have been reports of slightly more frequent breast cancer in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have regular breast exams, and you should see your doctor if you notice any lump.

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

Psychiatric disorders

Some women who use hormonal contraceptives like Yira have reported depression or a depressive mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Bleeding

Taking Yira with food and drinks

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

Laboratory tests

If you need a blood test, tell your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives can influence the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should not take Yira. If you become pregnant during treatment with Yira, you should stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Yira at any time (see "If you stop treatment with Yira", page 16).

Consult your doctor or pharmacist before taking any medication.

Breastfeeding

In general, it is not recommended to take Yira during the breastfeeding period (when you are giving breast milk). If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

There is no information to suggest that the use of Yira has any effect on the ability to drive or use machinery.

Yira contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Yira

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take one Yira pill every day, with some water if necessary. You can take the pills with or without food, but all days approximately at the same time.

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

After that, you should not take any pills for 7 days. During these 7 days when you do not take pills (called the rest week), you should have your period. The period, which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the rest week.

On the 8th day after taking the last Yira pill (i.e., after the 7-day rest period), you should start with the next blister pack, even if you have not yet finished bleeding. This means that you should start each blister pack on the same day of the week, and your period should take place during the same days each month.

If you use Yira in this way, you are also protected against pregnancy during the 7 days when you do not take any pills.

When can you start with 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 immediately against pregnancy. You can also start on days 2-5 of your 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 ring, or patch

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

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

You can switch from the progestin-only pill at any time (if it's an implant or intrauterine system, on the same day it is removed; if it's an injectable, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of pill taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

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

If, after having a child, you have had sexual intercourse before starting to take Yira again, you should be sure you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start taking Yira again after having a child

Read the section "Breastfeeding", page 11.

Ask your doctor if you are not sure when to start.

If you take more Yira than you should

No cases have been reported where an overdose of Yira has caused serious harm.

The symptoms that may appear if you take many pills at once may include feeling unwell or vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first period, if they accidentally take this medication.

If you have taken too many Yira pills, or discover that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Yira

• If you are less than 12 hourslate in taking a pill, protection against pregnancy is not reduced. Take the pill as soon as you remember and the following pills at the usual time.

• If you are more than 12 hourslate in taking a pill, protection against pregnancy may be reduced. The more pills you have missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you miss a pill at the beginning or end of the blister pack. Therefore, you should follow the following recommendations (see the diagram on page 14):

• Missing more than one pill from the blister pack

Consult your doctor.

• Missing a pill in week 1

Take the missed pill as soon as you remember, even if it means taking two pills at once. Continue taking the pills at the usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the week before missing the pill, you may be pregnant. In this case, consult your doctor.

• Missing a pill in week 2

Take the missed pill as soon as you remember, even if it means taking two pills at once. Continue taking the pills at the usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing a pill in week 3

You can choose between two options:

1. Take the missed pill as soon as you remember, even if it means taking two pills at once. Continue taking the pills at the usual time. Instead of starting the rest week, start the next blister pack.

You will probably have your period at the end of the second blister pack, although you may also experience light bleeding or spotting during the second blister pack.

1. You can also stop taking pills and go directly to the 7-day rest week (noting the day you missed the pill). If you want to start a new blister pack on the day you usually start, your rest week should last less than7 days.

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

• If you have missed a pill and do not have bleeding during the first rest week, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a pill or have severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to missing a pill. After vomiting or diarrhea, take a pill from a reserve blister pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your 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.

Delayed period: what you should know

Although it is not recommended, you can delay your period if you start taking a new Yira blister pack instead of continuing with the rest week and finish it. You may experience light bleeding or spotting during the use of the second blister pack. After the usual 7-day rest week, startthe next blister pack.

You should ask your doctor for advice before deciding to delay your menstrual period.

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

If you take the pills according to the instructions, your period will start during the rest week. If you need to change that day, reduce the number of rest days (but never increase them - 7 at most!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the rest week very short (e.g., 3 days or less), you may not have bleeding during those days. Then you may experience light bleeding or spotting.

If you are not sure how to proceed, consult your doctor.

If you stop treatment with Yira

You can stop taking Yira whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Yira and wait until your period before trying to become pregnant. This way, you can more easily calculate the estimated delivery date.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. If you experience any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to Yira, consult your doctor.

All women who take combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section 2 "What you need to know before starting to take Yira".

Serious side 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 urticaria with possible difficulty breathing (see also section "Warnings and precautions").

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

Common side effects(may affect up to 1 in 10 patients):

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depressive mood
• migraine
• nausea
• thick white vaginal discharge and vaginal yeast infection

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

• breast enlargement, changes in libido
• high blood pressure, low blood pressure
• vomiting, diarrhea
• acne, skin rash, intense itching, hair loss (alopecia)
• vaginal infection
• fluid retention and changes in body weight

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

• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing problems
• skin disorders such as erythema nodosum (characterized by painful nodules on the skin) or erythema multiforme (characterized by a skin rash with target-like lesions 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 symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having 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 side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Yira

Keep this medication out of sight and reach of children.

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

Do not use this medication after the expiration date shown on the packaging after "EXP:". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Yira Composition

• The active ingredients 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: lactose monohydrate, 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".

Product Appearance and Packaging Content

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

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

• Yira is available in boxes of 1, 3, 6, and 13 blister packs, 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

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

• Netherlands: Ethinylestradiol / Drospirenone 0.03 / 3 mg Berlipharm
• Spain: Yira
• Austria: Yirala
• France: Convuline
• Germany: Petibelle

Date of the last revision of this leaflet:November 2023

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