YASMINELLE DAILY 3 mg / 0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Yasminelle Daily 3 mg/0.02 mg Film-Coated Tablets

drospirenone/ethinylestradiol

Important things to 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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be aware and consult your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood Clots”).

Contents of the Package Leaflet:

1. What is Yasminelle Daily and what is it used for .2
2. What you need to know before you start taking Yasminelle Daily 2

When not to use Yasminelle Daily 2

Warnings and precautions 4

Blood Clots 5

Yasminelle Daily and cancer 9

Psychiatric disorders……………………………………………………………………...9

Intermenstrual bleeding 9

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

Other medicines and Yasminelle Daily 10

Taking Yasminelle Daily with food and drink 11

Laboratory tests 11

Pregnancy 11

Breast-feeding 11

Driving and using machines 11

Yasminelle Daily contains lactose 11

1. How to take Yasminelle Daily 11

Preparation of the pack 12

When you can start with the first pack 12

If you take more Yasminelle Daily than you should 13

If you forget to take Yasminelle Daily 13

What to do in case of vomiting or severe diarrhea 15

Delay of your menstrual period: what you should know 15

Change of your menstrual period's first day: what you should know 16

If you stop taking Yasminelle Daily 16

1. Possible side effects 16
2. Storage of Yasminelle Daily 18
3. Contents of the pack and further information ………………………………………18

1. What is Yasminelle Daily and what is it used for

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

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

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

• Contraceptives that contain two hormones are called combined contraceptives.

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

General considerations

Before you start using Yasminelle Daily, 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 Daily, 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 Daily, or in which the effect of Yasminelle Daily may be reduced. In such situations, you should not have sex or should take extra 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 as Yasminelle Daily alters the monthly changes in body temperature and cervical mucus.

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

When you should not use Yasminelle Daily

You should not use Yasminelle Daily 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 Daily

• 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 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 are going to 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 that causes severe chest pain and may be a sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following diseases that may increase your risk of developing 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 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 returned to normal.
• If your kidneys are not working well (renal insufficiency).
• If you have (or have ever had) a tumour in the liver.
• If you have (or have ever had) or are suspected to have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, the cause of which is unknown.

• 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 inflammation.

Do not take Yasminelle Daily 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 Daily").

Additional information on special populations

Children and adolescents

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

Older women

Yasminelle Daily is not indicated for use after menopause.

Women with liver insufficiency

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

Women with renal insufficiency

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yasminelle Daily.

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

In some situations, you will need to take special care while using Yasminelle Daily or any other combined contraceptive, and your doctor may need to examine you more closely. If the condition develops or worsens while you are using Yasminelle Daily, you should also tell 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 haemolytic uraemic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anaemia (an inherited disease of the 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 developing pancreatitis (inflammation of the pancreas).
• If you need an operation or are going to be immobile for a long time (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 Daily after childbirth.
• 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 Daily", 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 previous use of sex hormones (e.g. hearing loss, a blood disease called porphyria, blistering rash during pregnancy (gestational herpes), 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 patches"). In this case, you should avoid direct exposure to the sun or ultraviolet radiation.
• 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 containing oestrogens may induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Yasminelle Daily 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 lasting 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 Daily 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 linked to 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 clot can 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 that 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 a break 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 Daily, 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 Daily 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 Daily, between about 9 and 12 women will develop a blood clot in a year.
• The risk of developing a blood clot will depend on your individual circumstances (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 Daily is small, but some conditions will 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. below the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or if you are going to be immobile for a long time due to injury or illness, or if you have your leg in a plaster cast. You may need to stop using Yasminelle Daily several weeks before the operation or while you are less mobile. If you need to stop using Yasminelle Daily, ask your doctor when you can start using it again.
• As you get older (especially above the age of about 35).
• If you have just given birth.

The risk of developing a blood clot increases with the number of risk factors 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 tell your doctor if you suffer from any of these conditions, even if you are not sure. Your doctor may decide that you should stop using Yasminelle Daily.

If any of these conditions change while you are using Yasminelle Daily, for example, if you start smoking, a close relative experiences a clot without obvious cause, or you gain a lot of weight, tell 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 a 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 Daily 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 Daily, 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 have a 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 problem (valvular heart disease, a heart rhythm disorder 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 these conditions change while you are using Yasminelle Daily, for example, if you start smoking, a close relative experiences a clot without obvious cause, or you gain a lot of weight, tell your doctor.

Yasminelle Daily and cancer

Breast cancer has been found slightly more often in women who use combined 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 who take combined contraceptives because they are examined by a doctor more often. The incidence of breast tumours 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 tumours, and even more rarely, malignant liver tumours, have been reported in users of hormonal contraceptives. See your doctor if you have any symptoms.

Taking Yasminelle Daily with food and drinks

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

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you should not take Yasminelle Daily. If you become pregnant during treatment with Yasminelle Daily, stop treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking Yasminelle Daily at any time (see "If you stop treatment with Yasminelle Daily", page 17).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to take Yasminelle Daily during breastfeeding. 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 suggesting that the use of Yasminelle Daily has any effect on the ability to drive or use machinery.

Yasminelle Daily contains lactose

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

3. How to take Yasminelle Daily

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

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

The two different types of colored tablets of Yasminelle Daily are arranged in order. One pack contains 28 tablets.

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

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

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

Preparing the pack

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

Stick the weekly strip on the top of the Yasminelle Daily blister pack, where it says "Place the strip here!", so that the first day is placed above the tablet marked with "Start".

This way, there is a day of the week indicated above each tablet, and you can see if you have taken a particular 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), you usually start your period (also called withdrawal bleeding). Normally, your period starts on the second or third day after taking the last active, pale pink Yasminelle Daily tablet. Once you have taken the last white tablet, start the next pack, even if you have not finished your period. This means that you should start each pack on the same day of the weekthat you started the previous one, and that your menstruation should take place during the same days every month.

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

When to start with the first pack

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

Start taking Yasminelle Daily on the first day of your cycle (i.e., the first day of your period). If you start Yasminelle Daily 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., condoms) during the first 7 days.

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

You can start taking Yasminelle Daily 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 days 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 progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system)

You can switch from the progestogen-only pill at any time (if it is an implant or intrauterine system, on the day of its removal; if it is an injectable, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., condoms) 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 Daily between 21 and 28 days after giving birth. If you start later than day 28, use a barrier method (e.g., condoms) during the first 7 days of Yasminelle Daily use.

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

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

Read the section "Breastfeeding", page 11.

Ask your doctor if you are unsure when to start.

If you take more Yasminelle Daily than you should

No cases have been reported where an overdose of Yasminelle Daily 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 may occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication.

If you have taken too many Yasminelle Daily 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 Daily

The tablets in the fourthrow of the pack are the placebo tablets. If you forget to take one of these tablets, it will have no effect on the effect of Yasminelle Daily. Discard the forgotten placebo tablet. If you forget to take an active, pale pink tablet from the 1st, 2nd, or 3rdrow, do the following:

• 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 pale pink tablet at the beginning or end of the pack. Therefore, you should follow these recommendations (see the diagram on page 16):

• 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 the same time. 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 this 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 the same time. 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 the same time. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this pack, discard them and start the next pack.

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

1. You can also stop taking the active, pale pink tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new pack on the day you always start, take the placebo tablets for 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 your period during the placebo days, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active, pale pink tablet, or suffer from 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 another pale pink 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 Daily", page 14.

Delaying your menstrual period: what you should know

Although it is not recommended, you can delay your menstrual period if you do not take the white placebo tablets from the fourth row and start a new Yasminelle Daily pack and finish it. You may experience light bleeding or spotting during the use of the second pack. Finish this second pack by taking the 7 white tablets from the 4th row. Then, start a new pack.

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

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

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

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

If you stop treatment with Yasminelle Daily

You can stop taking Yasminelle Daily 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 Daily 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 Daily, 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 Daily".

Severe 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 Daily.

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

1. changes in mood
2. headache
3. abdominal pain (stomach pain)
4. acne
5. pain in the breasts, increased breast size, breast tension, painful or irregular periods
6. weight gain

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

1. Candida (a fungal infection)
2. cold sore (herpes simplex)
3. allergic reactions
4. increased appetite
5. depression, nervousness, sleep disorders
6. tingling sensation, dizziness
7. vision problems
8. irregular or unusually rapid heart rate
9. blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins
10. sore throat
11. nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
12. hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis
13. neck pain, pain in the limbs, muscle cramps
14. bladder infection
15. breast lumps (benign or 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 Papanicolaou staining), decreased libido
16. fluid retention, lack of energy, excessive thirst, increased sweating
17. 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-shaped 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 Medicines and Healthcare Products Agency's (AEMPS) online system: 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 Daily

Keep this medicine out of 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 "EXP:". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicines at the pharmacy's SIGRE collection point. If in 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 Daily

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

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

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

Active pinkish-white film-coated tablets:

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

Tablet film coating: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), and red iron oxide (E-172).

Inactive white film-coated tablets:

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

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

See section 2 "Yasminelle Daily contains lactose".

Appearance and Package Contents

• Each Yasminelle Daily blister pack contains 21 active pinkish-white film-coated tablets in the 1st, 2nd, and 3rd rows of the blister pack and 7 white film-coated placebo tablets in the 4th row.
• Both the pinkish-white and white tablets of Yasminelle Daily are called film-coated tablets; the tablet core is coated.
• The active tablet is pinkish-white, round, with convex surfaces, and one side has the letters "DS" marked in a regular hexagon.
• The placebo tablet is white, round, with convex surfaces, and one side has the letters "DP" marked in a regular hexagon.
• Yasminelle Daily is available in packs of 1, 3, 6, and 13 (blister packs), each containing 28 tablets.

Not all 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

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:

• Denmark, Netherlands, Norway, Sweden: Yasminelle 28

• France: Jasminellecontinu

• Spain: Yasminelle Daily

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 Healthcare Products (AEMPS) (http://www.aemps.gob.es)