YASMINELLE 3 mg / 0.02 mg FILM-COATED TABLETS

2. What you need to know before you start taking Yasminelle

General considerations

Before you start using Yasminelle, 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 you start taking Yasminelle, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may carry out some other tests.

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

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

When you should not use Yasminelle

You should not use Yasminelle 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

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a long time immobile (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood 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 yet returned to normal.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or are suspected to have breast cancer or cancer of the genitals.
• If you have vaginal bleeding, whose cause is unknown.

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

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

Additional information on special populations

Children and adolescents

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

Older women

Yasminelle is not indicated for use after menopause.

Women with liver insufficiency

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

Women with renal insufficiency

Do not take Yasminelle if you are suffering from kidney malfunction or acute renal insufficiency. See sections "Do not use Yasminelle" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yasminelle.

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

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

• If a close relative has had or has breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time immobile (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Yasminelle after giving birth.
• If you have inflammation of the veins just under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Other medicines and Yasminelle", page 10).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have a disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., loss of hearing, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (a discoloration of the skin, especially on the face and neck, known as "pregnancy spots"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medicines that contain estrogens may induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a 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 also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Yasminelle, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Yasminelle is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Yasminelle, 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 Yasminelle is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50).
• If you need an operation or spend a long time immobile due to injury or illness or if you have your leg in a cast. You may need to stop using Yasminelle several weeks before the operation or while you are less mobile. If you need to stop using Yasminelle, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

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

Long-distance flights (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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Yasminelle.

If any of the above conditions change while you are using Yasminelle, for example, a close relative experiences a thrombosis without a known cause or you gain much 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 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 due to Yasminelle is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When you use a combined hormonal contraceptive like Yasminelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have 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, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

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

Yasminelle and cancer

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

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

Psychiatric disorders

Some women who use hormonal contraceptives like Yasminelle have reported depression or a depressed mood. Depression

Taking Yasminelle with food and drinks

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

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you should not take Yasminelle. If you become pregnant during treatment with Yasminelle, you must stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Yasminelle at any time (see "If you stop treatment with Yasminelle", page 15).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Yasminelle contains lactose

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

3. How to take Yasminelle

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

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

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

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

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

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

When can you start with the first pack?

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

Start taking Yasminelle on the first day of your cycle (i.e., the first day of your period). If you start Yasminelle 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 ring, or patch

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

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

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

• After an abortion

Follow your doctor's recommendations.

• After having a child

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

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

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

Read the section "Breastfeeding", page 11.

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

If you take more Yasminelle than you should

No cases have been reported in which an overdose of Yasminelle has caused serious harm.

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

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

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

If you forget to take Yasminelle

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, 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 highest if you forget to take a tablet at the beginning or end of the pack. Therefore, you should follow these recommendations (see the diagram on page 14):

• Forgetfulness of more than one tablet in the pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetfulness of a tablet in week 2

Take the forgotten tablet as soon as you remember, even if it 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.

• Forgetfulness of a tablet in week 3

You can choose between two options:

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

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

1. You can also stop taking tablets and go directly to the rest week (noting the day you forgot to take the tablet). If you want to start a new pack on the day you always start, your rest week should last less 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 a period during the first rest week, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take a tablet from a reserve pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Yasminelle", page 14.

Delaying your menstrual period: what you should know

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

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

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

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

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

If you stop treatment with Yasminelle

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Yasminelle, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Yasminelle".

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 urticaria with possible difficulty breathing (see also the "Warnings and Precautions" section).

The following list of adverse effects has been associated with the use of Yasminelle.

Frequent Adverse Effects(may affect up to 1 in 10 patients):

• mood changes
• headache
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tension, painful or irregular periods
• weight gain

Uncommon Adverse Effects(may affect up to 1 in 100 patients):

• Candida (a fungal infection)
• cold sore (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling sensation, dizziness
• vision problems
• irregular or unusually rapid heart rate
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins
• throat pain
• nausea, vomiting, stomach and/or intestinal inflammation, diarrhea, constipation
• hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lumps (benign and cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, pain in the lower abdominal region (pelvic), abnormal cervical smears (Pap smear or Pap staining), decreased libido
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

Rare Adverse Effects(may affect up to 1 in 1000 patients):

• asthma
• hearing problems
• erythema nodosum (characterized by painful red nodules on the skin)
• erythema multiforme (skin rash with target-like redness 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 or temporary stroke-like symptoms, known as a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

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

Reporting Adverse Effects:

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

5. Storage of Yasminelle

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after "CAD:". The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Yasminelle

• The active ingredients are drospirenone and ethinylestradiol (as betadex clathrate).

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

• The other ingredients (excipients) are lactose monohydrate, cornstarch, magnesium stearate (E-470b), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), and red iron oxide (E-172), see section 2 "Yasminelle contains lactose".

Appearance of the Product and Package Contents

• Each Yasminelle blister pack contains 21 film-coated tablets of pale pink color.
• Yasminelle contains film-coated tablets; the core of the tablet is coated. The tablets are pale pink, round, with convex surfaces, and one side has the letters "DS" marked in a regular hexagon.
• Yasminelle is available in boxes of 1, 3, 6, and 13 packages (blister packs), each containing 21 tablets.

Only some package 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

or

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

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

• Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden: Yasminelle

• France: Jasminelle

Date of the Last Revision of this Leaflet:May 2023

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