Package Leaflet: Information for the User

Yasminelle 3mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

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 break 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 Yasminelle and what it is used for2

2.What you need to know before starting to take Yasminelle2

When not to use Yasminelle2

Warnings and precautions3

Blood clots5

Yasminelle and cancer9

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

Spotting between periods9

What to do if you do not have your period during the week of rest9

Other medicines and Yasminelle10

Taking Yasminelle with food and drink10

Laboratory tests10

Pregnancy11

Breastfeeding11

Driving and operating machines11

Yasminelle contains lactose11

3.How to take Yasminelle11

When can you start with the first pack?12

What to do if you take more Yasminelle than you should12

What to do if you forget to take Yasminelle13

What to do in case of severe vomiting or diarrhea14

Delayed menstrual period: what you should know14

Change in the first day of your menstrual period: what you should know14

What to do if you stop taking Yasminelle15

4.Possible side effects15

5.Storage of Yasminelle16

6. Contents of the pack and additional information………………………………………17

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

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

• Contraceptives that contain two hormones are known as combined contraceptives.

General Considerations

Before starting to use 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 starting to take 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 perform some other tests.

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

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

When not to 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 vein of the leg (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, deficiency of protein C, deficiency of protein S, deficiency of antithrombin III, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischaemic 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 hyperhomocysteinaemia.

• 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 properly (renal insufficiency).
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had), or are suspected of having breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, the cause of which is unknown.

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

You should 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 the 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.

Women of advanced age

Yasminelle is not indicated for useafter the menopause.

Women with liver insufficiency

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

Women with renal insufficiency

You should not take Yasminelle if you are suffering from a poor functioning of your kidneys 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 takeYasminelle.

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

In some situations, you should take special care while using Yasminelle or any other combined hormonal contraceptive, and you may need to have a periodic examination by your doctor. If the condition develops or worsens while you are using Yasminelle, you should also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
• If you have haemolytic uraemic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• If you have sickle cell anaemia (a genetic disorder of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of developing blood clots. You should ask your doctor when you can start taking Yasminelle after the birth.
• If you have superficial phlebitis (inflammation of the veins under the skin).
• 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 defence system).
• If you have a disease that may have appeared for the first time during pregnancy or during a previous use of sex hormones (for example, loss of hearing, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder in which involuntary movements occur (Sydenham’s chorea)).
• If you have or have had melasma (a skin discoloration, especially on the face and 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. Medicines containing oestrogens can induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

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

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

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

HOW TO RECOGNISE A BLOOD CLOT

Seek immediate 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 veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

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

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

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

What is the risk of developing a blood clot?

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

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Yasminelle 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 Yasminelle, 9-12women will develop a blood clot in a year.
• The risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

Your 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 (BMI) of 30kg/m2or more).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e. before the age of about 50years). You may have an inherited disorder of blood clotting.
• If you need an operation or spend a lot of time without standing up due to an injury or disease, or if you have your leg immobilised. You may need to stop taking Yasminelle for several weeks before the operation or while you have less mobility. If you need to stop taking Yasminelle, ask your doctor when you can start taking it again.
• With increasing age (especially above the age of about 35years).
• If you have given birth recently.

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

Long-distance flights (more than 4hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you should stop taking Yasminelle.

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

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to Yasminelle is very small, but it may increase:

• With age (above the age of about 35years).
• If you smoke.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (i.e. before the age of about 50years). You may also be at greater risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart 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, your risk of developing a blood clot may be increased even further.

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

Yasminelle and cancer

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

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

Mental health disorders

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

Spotting between periods

During the first few months of taking Yasminelle, you may experience unexpected bleeding (bleeding outside the pill-free interval). If these bleedings persist beyond a few months or start after a few months, your doctor will investigate what is wrong.

What to do if you do not have a period during the pill-free interval

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

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

Other medicines and Yasminelle

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

Some medicines

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

This may occur with:

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

Yasminellemay affect the effectof other medicines, for example:

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

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

Consult your doctor or pharmacist before using any medicine.

Taking Yasminelle with food and drink

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

Blood tests

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

Pregnancy, breastfeeding and fertility

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Yasminelle contains lactose

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

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

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

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

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

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

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

When can you start with the first package?

• If you have not used any hormonal contraceptives in the past month

Start taking Yasminelle on the first day of your cycle (i.e., the first day of your period). If you start taking 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 should use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking Yasminelle preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from theprogestin-only pillsany day (if it's an implant or IUS, on the same day of its removal; if it's an injection, on the corresponding next injection day), but in all cases, use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

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

If, after giving birth, you have already had sex before starting to take 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 giving birth

Read the section "Breastfeeding," page 11.

Ask your doctor if you are unsure when to start.

What to do if you take more Yasminelle than you should

No serious cases of harm have been reported due to the ingestion of an overdose of Yasminelle.

The symptoms that may appear if you take many tablets at once can be feeling unwell, 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 if 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.

What to do if you forget to take Yasminelle

• If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are latemore than 12 hourssin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

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

• Forgetting more than one tablet from the package

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 condoms, during the next 7 days. If you have had sex in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetting a tablet in week 2

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

• Forgetting a tablet in week 3

You can choose between two options:

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

You may experience bleeding during the second package, which may be light or similar to menstruation. After the usual rest week,startthe next package.

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 menstrual period during the first rest week, you may be pregnant. Contact your doctor before starting the next package.

What to do in case of severe vomiting or diarrhea

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

Delayed menstrual period: what you should know

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

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

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

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

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

What to do if you interrupt 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 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 Yasminelle, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to take Yasminelle”.

Severe side effects

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

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

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

• Mood changes
• Headache
• Abdominal pain (stomach pain)
• Acne
• Breast pain, breast enlargement, breast tenderness, painful or irregular periods
• Weight gain

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

• Candidiasis (a fungal infection)
• Herpes labialis (cold sore)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders
• Prickling sensation, dizziness
• Visual problems
• Irregular or unusually fast heart rate
• Clots (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• Sore throat
• Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
• Hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis
• Neck pain, limb pain, muscle cramps
• Urinary tract infection
• Breast lumps (benign and cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smears (Papanicolau or Papanicolau staining), decreased interest in sex
• Fluid retention, lack of energy, excessive thirst, increased sweating
• Weight loss

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

• Asthma
• Auditory problems
• Erythema nodosum (characterized by painful red nodules on the skin)
• Erythema multiforme (skin rash with red spots or ulcers)
• Detrimental 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 ischemic attack (TIA) or temporary symptoms similar to a stroke.
  • 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 through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special conditions for conservation.

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

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

Composition of Yasminelle

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

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

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

Appearance of the product and contents of the packaging

• Each blister of Yasminelle contains 21 coated tablets of pale pink color.
• Yasminelle contains coated tablets; the core of the tablet is coated. The tablets are pale pink, rounded, with convex surfaces, and one side bears the letters “DS” marked in a regular hexagon.
• Yasminelle is available in boxes of 1, 3, 6, and 13 packs (blisters), each containing 21 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí - Barcelona

Spain

Responsible 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 with 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

Last review date of this leaflet:May 2023

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