Yasmin Diario 3 mg / 0.03 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Yasmin Daily 3 mg/0.03 mg film-coated tablets

drospirenone/ethinylestradiol

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

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

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

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

Leaflet contents:

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

2. What you need to know before taking Yasmin Diario 2

When not to use Yasmin Diario 2

Warnings and precautions 4

Blood clots 5

Yasmin Diario and cancer 9

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

Bleeding between periods 10

What to do if you do not have your period during the placebo days 10

Other medicines and Yasmin Diario 10

Taking Yasmin Diario with food and drinks 11

Laboratory tests 11

Pregnancy 11

Breast-feeding 11

Driving and using machines 11

Yasmin Diario contains lactose 12

3. How to take Yasmin Diario 12

Preparing the blister 12

When to start the first pack 13

If you take more Yasmin Diario than you should 13

If you forget to take Yasmin Diario 14

What to do in case of vomiting or severe diarrhoea 15

Delayed period: what you should know 16

Change in the first day of your period: what you should know 16

If you stop treatment with Yasmin Diario 16

4. Possible side effects 16

5. How to store Yasmin Diario 17

6. Contents of the pack and other information ………………………………………18

1. What Yasmin Diario is and what it is used for

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

Each of the 21 film-coated pale yellow tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

The 7 film-coated white tablets do not contain any active substances and are referred to as placebo tablets.

Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting Yasmin Diario

General considerations

Before starting to use Yasmin Diario, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before starting Yasmin Diario, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.

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

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

When not to use Yasmin Diario

Do 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 which alternative contraceptive method would be most suitable.

Do not use Yasmin Diario

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

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

• If you require surgery or will be immobile for a long time (see section “Blood clots”).

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

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

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

• Severe diabetes with blood vessel damage.

• Very high blood pressure.

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

• A condition called hyperhomocysteinemia.

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

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

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

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

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

• If you have vaginal bleeding of unknown cause.

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

Do not use Yasmin Diario if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines 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.

Older women

Yasmin Diario is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

Do not take Yasmin Diario if you have impaired kidney function or acute renal failure. 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.

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

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

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

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

BLOOD CLOTS

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

Blood clots may form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

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

BLOOD CLOTS IN A VEIN

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

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

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

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

After the first year, the risk decreases, but it is always somewhat 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 within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE (venous thromboembolism) 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.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.

• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.

• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Yasmin Diario, between about 9 and 12 women will develop a blood clot in one year.

• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

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

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

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

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

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

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

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

If any of the above conditions change while you are using Yasmin Diario, for example, a close relative experiences thrombosis 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 clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

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

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

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

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

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

Yasmin Diario and cancer

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

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

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Yasmin Diario, you may experience unexpected bleeding (bleeding outside the week when you are taking the white tablets). If this bleeding persists beyond a few months or starts after several months, your doctor should investigate the cause.

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

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

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

Other medicines and Yasmin Diario

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine or herbal preparation. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Yasmin Diario. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of another medicine you require.

Some medicines:

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

This may occur with:

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

Yasmin Diario may influence the effect of other medicines, for example:

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

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

Consult your doctor or pharmacist before taking any medicine.

Taking Yasmin Daily with food and drink

Yasmin Daily may be taken with or without food, and with some water if needed.

Laboratory tests

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

Pregnancy and breastfeeding

Pregnancy

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

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

In general, Yasmin Daily is not recommended during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

There is no information suggesting that the use of Yasmin Daily has any effect on the ability to drive or operate machinery.

Yasmin Daily contains lactose

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

3. How to take Yasmin Diario

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

Each blister contains 21 pale yellow film-coated active tablets and 7 white film-coated placebo tablets.

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

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

Do not confuse the tablets: take a pale yellow tablet for the first 21 days, followed by a white tablet for the last 7 days. Then start a new blister (21 pale yellow tablets and 7 white tablets). In this way, there is no break week between two blisters.

Due to the different composition of the tablets, you must start with the first tablet located at the top left corner and then take one tablet each day. To maintain the correct order, follow the direction of the arrows on the blister.

Preparing the blister

To help you keep track of the dosing schedule, each Yasmin Diario pack contains 7 self-adhesive strips labeled with the days of the week. Choose the strip that starts with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with “WED”.

Attach the weekly adhesive strip to the top of the Yasmin Diario blister, where indicated “Place the adhesive strip here!”, so that the first day is positioned above the tablet marked “Start”.

This way, each tablet will have a day of the week indicated above it, allowing you to see whether 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 the white placebo tablets (the placebo days), your period usually begins (also called withdrawal bleeding). Your period usually starts on the second or third day after taking the last active pale yellow tablet of Yasmin Diario. After taking the last white tablet, you should start the next blister, even if bleeding has not yet finished. This means you should start each new blister on the same day of the week as you started the previous one, and your menstruation should occur on the same days each month.

If you take Yasmin Diario as directed, you will also be protected against pregnancy during the 7 days when you are taking the placebo tablets.

When to start 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 may also start on days 2–5 of the cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You may start taking Yasmin 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 period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal ring or patch, follow your doctor’s recommendations.

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

You may switch from a progestogen-only pill on any day (if switching from an implant or IUS, on the same day of removal; if switching from an injectable, at the time the next injection would have been due), but in all cases you must use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Yasmin Diario tablets.

• After an abortion

Follow your doctor’s recommendations.

• After giving birth

You may start taking Yasmin Diario between 21 and 28 days after giving birth. If you start later than day 28, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Yasmin Diario.

If, after giving birth, you have already had sexual intercourse 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 wish to start taking Yasmin Diario (again) after giving birth

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

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

If you take more Yasmin Diario than you should

No serious harmful effects have been reported from overdosing on Yasmin Diario.

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

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

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

If you forget to take Yasmin Diario

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

If you forget to take an active pale yellow tablet from row 1st, 2nd or 3rd, do the following:

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

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

The risk of incomplete protection against pregnancy is greatest if you forget a pale yellow tablet at the beginning or end of the blister. Therefore, follow the recommendations below (see the diagram on page 15):

• Forgetting more than one tablet in the blister

Consult your doctor.

• Forgetting one tablet in week 1

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

• Forgetting one tablet in week 2

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

• Forgetting one tablet in week 3

You have two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the white placebo tablets of this blister, discard them and start the next blister immediately.

You will likely have your period at the end of the second blister, while taking the white placebo tablets, although you may experience light bleeding or spotting during the second blister.

2. You may also stop taking the active pale yellow tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day on which you forgot the tablet). If you wish to start a new blister on the day you usually start, take the placebo tablets for fewer than 7 days.

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

• If you have forgotten to take any tablets 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 severe diarrhoea

If you vomit within 3–4 hours after taking an active pale yellow tablet, or if you have severe diarrhoea, there is a risk that the active ingredients of the contraceptive may not be fully absorbed by your body. This situation is almost equivalent to missing a tablet. After vomiting or severe diarrhoea, take another pale yellow tablet from a spare blister as soon as possible. If possible, take it within 12 hours of your usual time of taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Yasmin Diario”, page 14.

Delaying your period: what you should know

Although not recommended, you may delay your period by not taking the white placebo tablets in the fourth row and instead starting a new Yasmin Diario blister and completing it. During the second blister, you may experience light bleeding or spotting. After completing this second blister, take the 7 white tablets in the 4th row. Then start a new blister.

You should consult your doctor before deciding to delay your menstrual period.

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

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

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

If you stop taking Yasmin Diario

You may stop taking Yasmin Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Yasmin Diario and wait until your next period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

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

4. Possible adverse effects

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

All women who take combined hormonal contraceptives have an increased 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 associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Yasmin Diario”.

Serious adverse effects

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

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

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

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depressed mood
• migraine
• nausea
• thick, whitish vaginal discharge and fungal vaginal infection

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

• breast enlargement, changes in sex drive
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• vaginal infection
• fluid retention and changes in body weight

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

• allergic reactions (hypersensitivity), asthma
• breast discharge
• hearing problems
• skin disorders such as erythema nodosum (characterized by painful, reddish skin nodules) or erythema multiforme (characterized by target-shaped skin rashes 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.
  • transient ischaemic attack (TIA) or minor stroke with temporary stroke-like symptoms.
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects:

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

5. Storage of Yasmin Diario

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

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

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

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

6. Package contents and other information

Composition of Yasmin Diario

• The active ingredients are drospirenone and ethinylestradiol. Each active, pale yellow film-coated tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.

• The white film-coated tablets do not contain any active ingredients.

• Other components are:

Active pale yellow film-coated tablets:

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

Film coating: hypromellose (E-464), macrogol 6,000, talc (E-553b), titanium dioxide (E-171) and yellow iron oxide (E-172).

Inactive white film-coated tablets:

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

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

See section 2 “Yasmin Diario contains lactose”.

Appearance of the product and contents of the pack

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

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

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

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

• Yasmin Diario is available in packs of 1, 3, 6 and 13 blisters, each containing 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí - Barcelona

Spain

Manufacturer

Bayer AG

13342 Berlin, Germany

Bayer Weimar GmbH und Co. KG

Döbereinerstraße 20

99427 Weimar, Germany

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

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

• Spain: Yasmin Diario

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

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