Information for the user: package insert

Yasmin Diario 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 even if they 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 use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

1.What is Yasmin Diario and how it is used.2

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

When not to use Yasmin Diario2

Warnings and precautions4

Blood clots5

Yasmin Diario and cancer9

Psychiatric disorders…………………………………………………………………… 10

Spotting between periods10

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

Other medicines and Yasmin Diario10

Taking Yasmin Diario with food and drinks11

Laboratory tests11

Pregnancy11

Breastfeeding11

Driving and operating machinery11

Yasmin Diario contains lactose12

3.How to take Yasmin Diario12

Preparing the blister pack12

When to start with the first blister pack13

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

What to do if you forget to take Yasmin Diario14

What to do in case of severe vomiting or diarrhea15

Delayed period: what you should know16

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

What to do if you interrupt treatment with Yasmin Diario16

4.Possible side effects16

5.Storage of Yasmin Diario17

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

Yasmin Diario is a contraceptive and is used to prevent pregnancy.

Each of the 21 yellowish film-coated tablets contains a small amount of two different female hormones, known as drospirenone and ethinyl estradiol.

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

Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

Before starting to use Yasmin 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 Yasmin 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 prospectus, several situations are described in which you should interrupt the use of Yasmin Diario, or in which the effect of Yasmin 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 another barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable because Yasmin Diario alters the monthly changes in body temperature and cervical mucus.

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

When not to use Yasmin Diario

You should not use Yasmin 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 Yasmin Diario

• If you have (or have ever had) a blood clot in a leg vein (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 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 if you suspect that you have 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 any of the other components of this medication (including in section 6). This may cause itching, rash, or inflammation.

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

Additional information on special populations

Children and adolescents

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

Women of advanced age

Yasmin Diario is not indicated for useafter menopause.

Women with liver insufficiency

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

Women with renal insufficiency

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yasmin Diario.

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

In some situations, you should take special care while using Yasmin Diario 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 Yasmin 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 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 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 recently gave birth, you are at higher risk of developing blood clots. Ask your doctor when you can start taking Yasmin Diario after childbirth.
• 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 Yasmin Diario”, 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 this 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 the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Clots can form in:

• Veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• 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 serious blood clot due to Yasmin 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 in 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 in 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 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 Yasmin 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 Yasmin 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, such as Yasmin Diario, 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 Yasmin Diario is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) greater than 30kg/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 about 50years). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to interrupt the use of Yasmin Diario for several weeks before the operation or while you have less mobility. If you need to interrupt the use of Yasmin Diario, ask your doctor when you can start taking it again.
• As you get older (especially over about 35years).
• If you have given birth recently.

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

Long flights (over 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 Yasmin Diario.

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

• With age (over 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 (less than about 50years). 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 high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (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 Yasmin 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.

Yasmin 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 tumors are detected in women taking combined hormonal contraceptives because they are examined by their 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. Consult your doctor if you experience severe abdominal pain.

Mental health disorders

Some women who use combined hormonal contraceptives like Yasmin Diario have reported depression or a depressive mood. Depression can be severe and may sometimes 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 Yasmin Diario, you may experience unexpected bleeding (bleeding outside the week when you take the white pills). If this bleeding persists beyond a few months or starts after a few months, your doctor should examine what is wrong.

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

If you have taken all the active 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 Yasmin Diario

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication or herbal preparation. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Yasmin 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 medication that you need.

Some medications

• may affect the levels of Yasmin Diario in the blood
• may make itless 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, 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

Yasmin Diariomay affect 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 Yasmin Diario 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 this treatment. Yasmin Diario can be taken again approximately 2 weeks after the end of this treatment. See the section “Do not use Yasmin Diario”.

Consult your doctor or pharmacist before taking any medication.

Yasmin Diario with food and drinks

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

Lab 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 Yasmin Diario. If you become pregnant during treatment with Yasmin Diario, stop the treatment immediately and consult your doctor. If you want to become pregnant, you can stop taking Yasmin Diario at any time (see “If you interrupt treatment with Yasmin Diario”, page 16).

Consult your doctor or pharmacist before taking any medication.

Breastfeeding

Generally, it is not recommended to take Yasmin Diario during the breastfeeding period (when you are breastfeeding). If you want to take the contraceptive during the breastfeeding period, 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 Yasmin Diario has any effect on your ability to drive or operate machinery.

Yasmin Diario contains lactose

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

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 yellow color and 7 white film-coated placebo tablets.

The two different colored tablets of Yasmin Diario are arranged in order. A blister contains 28 tablets.

Take one Yasmin 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 a pale yellow tablet for the first 21 days, and then a white tablet for the last 7 days. You should then start taking a new blister (21 pale yellow tablets and 7 white tablets). In this way, there is no week of rest between two blisters.

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 blister.

Preparation of the blister

To help you follow the taking order, each package of Yasmin 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 Yasmin 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 should take the tablets.

During the 7 days when you take white placebo tablets (the placebo days), you usually start your period (also called withdrawal bleeding). Normally, your period starts the second or third day after taking the last active tablet, of pale yellow color, of Yasmin Diario. Once you have taken the last white tablet, you should start the next blister, even if you have not finished bleeding yet. This means that you should start each blisteron 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 Yasmin Diario as indicated, you will also be protected against pregnancy during the 7 days when you are taking the placebo tablets.

When can you start with the first blister

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

Start taking Yasmin Diario on the first day of your cycle (i.e., the first day of your period). If you start Yasmin Diario 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, vaginal combined contraceptive ring, or patch

You can start taking Yasmin Diario preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the rest days 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 on any day (if it is an implant or an SLI, 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 Yasmin 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 Yasmin Diario.

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

• If you are breastfeeding and want to start taking Yasmin Diario again after giving birth

See the section “Breastfeeding”, page 11.

Ask your doctor if you are unsure when to start.

If you take more Yasmin Diario than you should

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

The symptoms that may appear if you take many tablets can be feeling unwell or vomiting or vaginal bleeding. This bleeding can 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 Yasmin Diario tablets, or if a child has taken them, consult your doctor or pharmacist.

For 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 Yasmin Diario

The tablets in thefourthrow of the blister are the placebo tablets. If you forget to take one of these tablets, it will have no effect on the reliability of Yasmin Diario. Discard the forgotten placebo tablet.

If you forget to take an active tablet of pale yellow 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 hourssin taking some tablets, the protection against pregnancy may be reduced. 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 pale yellow tablet at the beginning or end of the blister. Therefore, you should follow the following recommendations (see the diagram on page 15):

• 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, such as a condom, for 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 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, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this blister, discard them and start the next blister.

You may experience bleeding during the use of the second blister, which may be light or similar to menstruation. Finish this second blisterby taking the 7 white placebo tablets from the 4th row. Then start the new blister.

1. You can also interrupt the taking of active tablets, of pale yellow 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 blisteron 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 bleeding during the placebo days, 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 an active 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 vomiting or diarrhea, take another active tablet from a reserve blister 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 Yasmin Diario”, page 14.

Delayed period: what you should know

Although not recommended, you can delay your period if you do not take the placebo tablets and start taking a new blisterof Yasmin Diario and finish it. You may experience bleeding during the use of the second blister, which may be light or similar to menstruation. Finish this second blisterby taking the 7 white placebo tablets from the 4th row. Then start the new blister.

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

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

If you take the tablets as indicated, your period will start during the placebo week. If you need to change that day, reduce the number of days of placebo - when you take the white placebo tablets -(but never increase – 7 at most!). For example, if you usually start taking the placebo tablets on Fridays, and you want to change it to Tuesdays (3 days earlier), start a blister 3 days earlier than usual. If you make the interval between taking placebo tablets very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience light or similar to menstrual bleeding.

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

If you interrupt the treatment with Yasmin Diario

You can stop taking Yasmin 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 Yasmin Diario 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 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 change that you think may be due to Yasmin 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 Yasmin Diario”.

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 (see also “Warnings and precautions”).

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

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 Vigilance 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 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 Yasmin Daily

• The active principles aredrospirenone and ethinylestradiol. Each coated tablet with active film of pale yellow color contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.

• The white-coated tablets do not contain active principles.

• The other components are:

Coated tablets with active film of pale yellow color:

Tablet core:lactose monohydrate, cornstarch, pregelatinized cornstarch, povidone K25, magnesium stearate (E-470b),

Coating film of the tablet:hypromellose (E-464), macrogol 6.000, talc (E-553b), titanium dioxide (E-171) and yellow iron oxide (E-172).

Coated tablets with inactive film of white color:

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

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

see section 2 “Yasmin daily contains lactose”.

Appearance of the product and contents of the package

• Each blister of Yasmin Daily contains 21 coated tablets with active film of pale yellow color in the 1st, 2nd and 3rd row of the blister and 7 coated placebo tablets of white color in the 4th row.

• Both the pale yellow and white tablets of Yasmin Daily are coated tablets; the tablet core is coated.

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

• The white tablets are rounded, with convex surfaces, and one side bears the letters “DP” marked in a regular hexagon.

• Yasmin Daily is available in boxes of 1, 3, 6 and 13 blisters, each with 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

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

• Denmark, Iceland, Netherlands, Norway, Sweden: Yasmin 28

• Spain:Yasmin Daily

Date of the last review of this leaflet:November 2023

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