Package Leaflet: Information for the User

Yasminelle Diario 3 mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

Important information about combined hormonal contraceptives (CHCs):

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

1.What is Yasminelle Diario and for what it is used.2

2.What you need to know before starting to take Yasminelle Diario2

When not to use Yasminelle Diario2

Warnings and precautions4

Blood clots5

Yasminelle Diario and cancer9

Mental disorders……………………………………………………………………...9

Spotting between periods9

What to do if you do not have your period during the placebo days10

Other medicines and Yasminelle Diario10

Taking Yasminelle Diario with food and drink11

Laboratory tests11

Pregnancy11

Breast-feeding11

Driving and operating machinery11

Yasminelle Diario contains lactose11

3.How to take Yasminelle Diario11

Preparing the package12

When to start with the first package12

What to do if you take more Yasminelle Diario than you should13

What to do if you forget to take Yasminelle Diario13

What to do in case of severe vomiting or diarrhea15

Delayed menstrual period: what you should know15

Change in the first day of your menstrual period: what you should know16

What to do if you interrupt the treatment with Yasminelle Diario16

4.Possible side effects16

5.Storage of Yasminelle Diario18

6.Contents of the package and additional information………………………………………18

• Yasminelle Diario is a contraceptive and is used to prevent pregnancy.

• Each of the 21 film-coated active tablets, pale pink in color, contains a small amount of two different female hormones, known as drospirenone and ethinyl estradiol.

• The 7 film-coated white tablets that do not contain active ingredients are called placebo tablets.

• Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

Before starting to use Yasminelle Diario, 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 Yasminelle Diario, 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 leaflet, several situations are described in which you should interrupt the use of Yasminelle Diario, or in which the effect of Yasminelle Diario may be reduced. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use of a condom or other barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable since Yasminelle Diario alters the monthly changes in body temperature and cervical mucus.

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

When not to use Yasminelle Diario

You should not use Yasminelle Diario 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 Yasminelle Diario

• 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, deficiency of protein C, deficiency of protein S, deficiency of antithrombin III, factor V Leiden or antiphospholipid antibodies.
• If you need an operation 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 yet normalized.
• If your kidneys do not function well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had) or are suspected of having breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, the cause of which is unknown.

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

You should not take Yasminelle Diario if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other medicines and Yasminelle Diario”).

Additional information on special populations

Children and adolescents

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

Older women

Yasminelle Diario is not indicated for useafter menopause.

Women with liver insufficiency

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

Women with renal insufficiency

You should not take Yasminelle Diario if you are suffering from a poor functioning of your kidneys or acute renal insufficiency. See sections “Do not use Yasminelle Diario” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeYasminelle Diario.

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

In some situations, you should take special care while using Yasminelle Diario or any other combined hormonal contraceptive, and your doctor may need to examine you periodically. If the condition develops or worsens while you are using Yasminelle Diario, 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 haemolytic uraemic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• If you have sickle cell anaemia (a hereditary 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 an operation or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of developing blood clots. You should ask your doctor when you can start taking Yasminelle Diario after the birth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have epilepsy (see “Other medicines and Yasminelle Diario”, page 10).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defence system).
• If you have a disease that may have appeared for the first time during pregnancy or during a previous use of sex hormones (for example, loss of hearing, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder in which involuntary movements occur (Sydenham’s chorea)).
• If you have or have ever had melasma (a skin discoloration, especially on the face and 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. Medicines containing oestrogens can induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Yasminelle Diario increases your risk of developing ablood clotcompared with 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 ATE).

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 Yasminelle Diario 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 thromboembolism). 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 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 in which you take a combined hormonal contraceptive for the first time. The risk may be higher also if you restart taking a combined hormonal contraceptive (the same medicine or a different medicine) 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 Yasminelle Diario, 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 Yasminelle Diario 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 Yasminelle Diario, 9-12women 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 Yasminelle Diario is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30kg/m2or more).
• 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 about 50years). In this case, you may have an inherited disorder of blood clotting.
• If you need an operation 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 interrupt the use of Yasminelle Diario for several weeks before the operation or while you have less mobility. If you need to interrupt the use of Yasminelle Diario, ask your doctor when you can start using it again.
• With increasing age (especially above about 35years).
• If you have given birth recently.

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

Long flights (more than 4hours) 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 conditions above, even if you are unsure. Your doctor may decide that you should interrupt the use of Yasminelle Diario.

If any of the conditions above change while you are using Yasminelle Diario, 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 Yasminelle Diario is very small, but it may increase:

• With age (above about 35years).
• If you smoke.
• 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 (i.e. before about 50years). In this case, you may also be at greater risk of having a heart attack or stroke.
• If you or any of your close relatives have 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, abnormal heart rhythm 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 even higher.

If any of the conditions above change while you are using Yasminelle Diario, 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.

Yasminelle Diario 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 tumours are detected in women taking combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumours 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 tumours in the liver and, more rarely, malignant tumours have been reported in users of combined hormonal contraceptives. Consult your doctor if you have an unusual severe abdominal pain.

Mental disorders

Some women who use combined hormonal contraceptives like Yasminelle Diario 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

During the first few months of taking Yasminelle Diario, you may experience unexpected bleeding (bleeding outside the week in which you take the white tablets). If this bleeding persists beyond a few months or starts after a few months, your doctor will investigate what is wrong.

What to do if you do not have your period during the placebo days

If you have taken all the active tablets correctly, have not had severe vomiting or diarrhoea, and have not taken other medicines, 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 medicines and Yasminelle Diario

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine or herbal preparation. You should also inform any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking Yasminelle Diario. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or to modify the use of another medicine that you need.

Some medicines:

• may affect the levels of Yasminelle Diario in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding

This may occur with:

• medicines 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, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations containing St. John’s Wort.

Yasminelle Diario mayinfluence the effectof other medicines, for example:

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

Consult your doctor or pharmacist before using any medicine.

Yasminelle Diario with food and drinks

Yasminelle Diario 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 may affect the results of some tests.

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant, you should not take Yasminelle Diario. If you become pregnant during treatment with Yasminelle Diario, you should stop treatment immediately and consult your doctor. If you want to become pregnant, you can stop taking Yasminelle Diario at any time (see “If you interrupt treatment with Yasminelle Diario”, page 17).

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

In general, it is not recommended to take Yasminelle Diario during breastfeeding. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Yasminelle Diario contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Each blister contains 21 active film-coated tablets of pale pink color and 7 white film-coated placebo tablets.

The two different colored tablets of Yasminelle Diario are arranged in order. A pack contains 28 tablets.

Take one Yasminelle Diario tablet every day, with water if necessary. You can take the tablets with or without food, but at approximately the same time every day.

Do not confuse the tablets: take one pale pink tablet every day for the first 21 days, followed by one white tablet for the last 7 days. Then you must start taking a new pack (21 pale pink tablets and 7 white tablets). In this way, there is no break between two packs.

Due to the different composition of the tablets, you must start with the first tablet located in the upper left corner and then take one tablet every day. To maintain the order, follow the direction of the arrows on the pack.

Preparation of the pack

To help you follow the taking order, each pack of Yasminelle Diario contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with “WED”.

Stick the adhesive strip of the week on the top of the Yasminelle Diario blister, where it is indicated “Stick the adhesive strip here!”, so that the first day is placed above the tablet marked with “Start”.

In this way, there is a day of the week indicated above each tablet and you can see if you have taken a specific tablet. The arrows show the order in which you must take the tablets.

During the 7 days when you take white placebo tablets (the placebo days), your period (also called withdrawal bleeding) usually starts. Normally, your period starts the second or third day after you have taken the last active tablet, of pale pink color, of Yasminelle Diario. Once you have taken the last white tablet, you must start the next pack, even if you have not finished your period. This means that you should start each packon the same day of the weekthat you started the previous one, and your period should occur during the same days every month.

If you take Yasminelle Diario as indicated, you are also protected against pregnancy during the 7 days when you are taking placebo tablets.

When can you start with the first pack

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

Start taking Yasminelle Diario on the first day of your cycle (i.e., the first day of your period). If you start Yasminelle Diario on the first day of your period, you are 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 Yasminelle Diario 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 break 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 pill, injection, implant, or intrauterine system (IUS))

You can switch from theprogestin-only pillany day (if it is an implant or an IUS, on the day of its removal; if it is an injection, 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 Yasminelle Diario 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 Yasminelle Diario.

If, after giving birth, you have already had sex before starting to take Yasminelle Diario (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 Yasminelle Diario again after giving birth

Read the section “Breastfeeding”, page 11.

Ask your doctor if you are unsure when to start.

If you take more Yasminelle Diario than you should

No serious cases of overdose of Yasminelle Diario have been reported.

The symptoms that may appear if you take many tablets at once may be feeling unwell, 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 Yasminelle Diario tablets, or if you discover that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or callthe Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount taken.

If you forget to take Yasminelle Diario

The tablets in thefourthrow of the pack are the placebo tablets. If you forget to take one of these tablets, it will have no effect on the effect of Yasminelle Diario. Dispose of the forgotten placebo tablet. If you forget to take an active tablet of pale pink color from the1st, 2nd, or 3rdrow, do the following:

• If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.

• If you are latemore than 12 hoursin taking some tablets, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a pale pink tablet at the beginning or end of the pack. Therefore, you must follow the following recommendations (see the diagram on page 16):

• Forgetting more than one tablet from the pack

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, such as condoms, 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, although this may mean taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced 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, although this may mean taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this pack, dispose of them and start the next pack.

You may experience bleeding during the use of the second pack, which may be similar to your period. Finish this second pack by taking the 7 white placebo tablets from the 4th row. Then start the new pack.

1. Alternatively, you can interrupt the taking of active tablets, of pale pink color, and pass directly to the 7 white placebo tablets(before taking the placebo tablets, you must note the day on which you forgot to take the tablet). If you want to start a new pack on the day you always start, take the placebo tablets forless than 7 days.

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 your period during the placebo days, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3-4 hours after taking an active tablet, of pale pink color, 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 vomiting or diarrhea, take another active tablet of pale pink color from a reserve pack as soon as possible. If possible, take itwithin 12 hoursafter the usual time for taking 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 Yasminelle Diario”, page 14.

Delay of your menstrual period: what you should know

Although not recommended, you can delay your menstrual period if you do not take the placebo tablets, of white color, from the 4th row and start taking a new pack of Yasminelle Diario and finish it. You may experience bleeding during the use of the second pack, which may be similar to your period. Finish this second pack by taking the 7 white placebo tablets from the 4th row. Then start the new pack.

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

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

If you take the tablets as instructed, your period will start during theweek of placebo. If you want to change that day, reduce the number of days with placebo –when you take the white placebo tablets-(but never increase it - 7 at most!. For example, if you normally start taking the placebo tablets on Friday, and you want to change it to Tuesday (3 days earlier) start a new pack 3 days earlier than usual. If you make the interval of taking placebo tablets very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience bleeding similar to your period.

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

If you interrupt the treatment with Yasminelle Diario

You can stop taking Yasminelle Diario when 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 Yasminelle Diario and wait until your menstrual 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 can 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 changes that you think may be related to Yasminelle Diario, 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 Yasminelle Diario”.

Severe side effects

Contact your doctor immediately if you experience any of the following angioedema symptoms: 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 Yasminelle Diario.

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

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

Rare side effects(may affect up to 1 in 1000 patients):

• Asthma
• Auditory problems
• Eructation nodosa (characterized by painful red nodules on the skin)
• Eructation multiforme (skin rash with rosy spots or ulcers)
• Deleterious blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., TVP).
  • In a lung (i.e., EP).
  • Myocardial infarction.
  • Stroke.
  • Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
  • 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 section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of 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 through the Spanish System for the Pharmacovigilance of Medicines 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.

This medication does not require any special conditions for conservation.

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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Yasminelle Diario

• The active principles aredrospirenone and ethinylestradiol (as betadex clathrate).

Each film-coated tablet of pale pink color contains 3 milligrams of drospirenone and 0.020 milligrams of ethinylestradiol (as betadex clathrate).

• The white film-coated tablets do not contain active principles.
• The other components are

Film-coated active tablets of pale pink color:

Tablet core:lactose monohydrate, cornstarch, magnesium stearate (E-470b),

Film coating of the tablet:hypromellose (E-464), talc (E-553b), titanium dioxide (E-171) and iron oxide red (E-172).

Film-coated inactive tablets of white color:

Tablet core:lactose monohydrate, microcrystalline cellulose, magnesium stearate (E-470b),

Film coating of the tablet:hypromellose (E-464), talc (E-553b) and titanium dioxide (E-171).

See section 2 “Yasminelle Diario contains lactose”.

Appearance of the product and contents of the package

• Each blister of Yasminelle Diario contains 21 film-coated active tablets of pale pink color in the 1st, 2nd and 3rd row of the blister and 7 film-coated placebo tablets of white color in the 4th row.
• Both the pale pink and white tablets of Yasminelle Diario are referred to as film-coated tablets; the tablet core is coated.
• The active tablet is pale pink, rounded, with convex surfaces, and one side bears the letters “DS” marked in a regular hexagon.
• The placebo tablet is white, rounded, with convex surfaces, and one side bears the letters “DP” marked in a regular hexagon.
• Yasminelle Diario is available in boxes of 1, 3, 6 and 13 packs (blister packs), each containing 28 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

or

Bayer Weimar GmbH und Co. KG, Döbereinerstr.20 99427 Weimar, Germany

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

• Denmark, Netherlands, Norway, Sweden: Yasminelle 28

• France:Jasminellecontinu

• Spain:Yasminelle Diario

Date of the last review of this leaflet:May 2023

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)