Information for the user: package insert

Yira 3 mg/0.03 mg film-coated tablets

drospirenone/ethinylestradiol

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a break of 4weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section2 “Blood clots”).

1.What Yira is and for what it is used2

2.What you need to know before starting to take Yira2

When not to use Yira2

Warnings and precautions4

Blood clots5

Yira and cancer9

Mental health disorders10

Intermenstrual bleeding10

What to do if you do not have your period during the week of rest10

Other medicines and Yira10

Yira with food and drinks11

Laboratory tests11

Pregnancy11

Breastfeeding11

Driving and operating machinery11

Yira contains lactose12

3.How to take Yira12

When to start with the first pack12

What to do if you take more Yira than you should13

What to do if you forget to take Yira13

What to do in case of severe vomiting or diarrhea15

Delayed period: what you should know15

Change in the first day of your period: what you should know15

What to do if you interrupt the treatment with Yira16

4.Possible side effects16

5.Storage of Yira17

6.Contents of the pack and additional information17

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

• Each coated tablet contains a small amount of two different female hormones, known as drospirenona and ethinylestradiol.

Contraceptives that contain two hormones are known as combined contraceptives.

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 perform some other tests.

In this prospectus, several situations are described in which you should interrupt the use of Yira, or in which the effect of Yira may decrease. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm or 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) or any other sexually transmitted disease.

When not to use Yira

You should 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 vein of the leg (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that 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 surgery or if you spend a lot of time without standing up (see section 2 “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, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular 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 normalized yet.
• If your kidneys do not function well (renal insufficiency).
• If you have (or have ever had) a tumor in the liver.
• If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive 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 medication (including in section 6). This may cause itching, rash or inflammation.

You should not take Yira if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section “Other medications 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 useafter menopause.

Women with liver insufficiency

You should not take Yira if you suffer from liver disease. See sections “Do not use Yira” and “Warnings and precautions”.

Women with renal insufficiency

You should not take Yira if you are suffering from kidney dysfunction or acute renal insufficiency. See sections “Do not use Yira” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yira.

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

In some situations, you should take special care while using Yira or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor. If the condition develops or worsens while you are using Yira, you should also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a genetic disorder 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 surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you are at increased risk of blood clots after giving birth. You should ask your doctor when you can start taking Yira after delivery.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have epilepsy (see “Other medications 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 appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)).
• If you have or have had melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). In that case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medications containing estrogens can induce or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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 immediate medical attentionif 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 veins (venous thrombosis). However, these adverse 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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood 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 start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4weeks 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 in 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 who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimato, 5-7will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Yira, 9-12will 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

Your risk of developing a blood clot is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30kg/m2or higher).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50years). You may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or disease, or if you have your leg immobilized. You may need to stop using Yira for several weeks before the surgery or while you have less mobility. If you need to stop using Yira, ask your doctor when you can start using it again.
• With increasing age (especially above about 35years).
• If you have given birth recently.

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

Long flights (more than 4hours) may temporarily increase your 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Yira.

If any of the conditions listed above change while you are using Yira, for example, a close relative experiences a blood clot without a 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 blood 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 may increase:

• With age (above about 35years).
• If you smoke.When using a combined hormonal contraceptive like Yira, you are advised to quit smoking. If you are unable to quit smoking and are over 35years, 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 (less than about 50years). You may also be at increased risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation).
• If you have diabetes.

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

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

Yira and cancer

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

In rare cases, benign tumors in the liver and, more rarely, malignant tumors have been reported in users of combined hormonal contraceptives. You should consult your doctor if you experience severe abdominal pain.

Mental health disorders

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

Spotting between periods

During the first few months of taking Yira, you may experience unexpected bleeding (bleeding outside of the menstrual period). If these bleeding persist beyond a few months or start after a few months, your doctor should examine what is wrong.

What to do if you do not have your period during the menstrual period

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

If your expected period does not come in two consecutive occasions, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medications and Yira

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription or prepared from plants. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Yira. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or if you need to modify the use of another medication that you need.

Some medications

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

This may occur with:

• medications used in the treatment of
• • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g. rifampicin)
  • infections with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapina, efavirenz)
  • fungal infections (e.g. griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations of St. John's Wort

Yira mayinfluence the effectof other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or cramps)

You should not take Yira if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medications. Yira can be taken again approximately 2 weeks after the end of this treatment. See section “Do not use Yira”.

Consult your doctor or pharmacist before taking any medication.

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, inform your doctor or the laboratory staff that you are taking a contraceptive, as hormonal contraceptives can affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should not take Yira. If you become pregnant while taking Yira, you should stop taking it immediately and consult your doctor. If you want to become pregnant, you can stop taking Yira at any time (see “If you stop taking 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 breastfeeding). 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 operating machinery

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

Yira contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated 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 can take the tablets with or without food, but approximately at the same time every day.

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

Do not take any tablets for 7 days afterwards. During these 7 days when no tablets are taken (called the rest week), menstruation should take place. Menstruation, also known as withdrawal bleeding, usually starts on the 2nd or 3rd day of the rest week.

By the 8th day of taking the last Yira tablet (i.e. after the 7-day rest period), you should start with the next blister, even if the bleeding has not stopped yet. This means that you should start each blister on the same day of the week and menstruation should take place on the same days every month.

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

When can you start with the first blister

• If you have not used any hormonal contraceptives 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 immediately protected 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, vaginal combined contraceptive ring or patch

You can start taking Yira preferably 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 week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from progestin-only pills at any time (if it is an implant or an SLI, on the day of its removal; if it is an injectable, on the day of the next injection), but in all cases use additional contraceptive methods (e.g. a condom) during the first 7 days of taking tablets.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

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

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

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

See the section "Breastfeeding", page 11.

Ask your doctor if you are unsure when to start.

If you take more Yira than you should

No serious damage has been reported in cases of overdose of Yira.

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

If you have taken too many Yira tablets, or if 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 lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.

• If you are latemore than 12 hourssin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a tablet at the beginning or end of the blister. Therefore, you should follow the following recommendations (see the diagram on page 14):

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, for example, a condom, during the next 7 days. If you have had sex in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetting a tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy does not decrease and you do not need to take additional precautions.

• Forgetting a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of starting the rest period, start the next blister.

You may experience light bleeding or bleeding similar to menstruation during the use of the second blister. After the usual 7-day rest period,startthe next blister.

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

• If you have forgotten to take a tablet and do not have bleeding during the first rest period, you may be pregnant. Contact your doctor before starting the next blister.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3-4 hours after taking a tablet or have intense 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 forgetting a tablet. After the vomiting or diarrhea, take a tablet from a reserve blister as soon as possible. If possible, take itwithin 12 hoursafter the usual time when you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forgot to take Yira", page 13.

Delay of your period: what you should know

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

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

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

If you take the tablets according to the instructions, your period will start during the rest week. If you have to change that day, reduce the number of rest days(but never increase – 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 3 days earlier than usual. If you make the rest period very short (e.g. 3 days or less), you may not have bleeding during these days. Then you may experience light bleeding or bleeding similar to menstruation.

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

If you interrupt the 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 calculate your estimated due date more easily.

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

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

All women taking 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 section2 “What you need to know before starting to take Yira”.

Severe side effects

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

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

Frequent 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

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

• breast enlargement, changes in sex drive
• 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
• auditory problems
• skin disorders such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by skin rash with red rings 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.
  • mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA).
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section2 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 86°F (30°C). Store in the original blister pack to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after “CAD:”.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Yira

• The active principles aredrospirenone 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, cornstarch, pregelatinized cornstarch, 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”.

Appearance of the product and contents of the package

• Each blister pack of Yira contains 21 coated tablets.

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí - Barcelona

Spain

Responsible for manufacturing

Bayer AG, 13342 Berlin, Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Date of the last review of this leaflet:November 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)