Label: Information for the User

Drospirenone/Ethinyl Estradiol Daily Exeltis 3 mg/0.02 mg Film-Coated Tablets

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

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

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

6. Contents of the package and additional information

Drospirenona/Ethinylestradiol is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are known as combined contraceptives.

General Considerations

Before starting to take drospirenone/etinilestradiol, 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 drospirenone/etinilestradiol, 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 health status, perform other tests.

This leaflet describes several situations in which you should interrupt the use of drospirenone/etinilestradiol, or in which the effect of drospirenone/etinilestradiol may be reduced.

In these situations, you should not have sexual intercourse or take additional 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 drospirenone/etinilestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drospirenone/Etinilestradiol Diario Exeltis

You should not take drospirenone/etinilestradiol 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 other forms of contraception that would be more suitable.

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

• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary 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:

• Diabetes with severe vascular damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

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

• If you have (or have ever had) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or are suspected to have breast cancer or cancer of the reproductive organs.
• If you have unexplained vaginal bleeding.
• If you are allergic to etinilestradiol, or drospirenone, or to any of the other components of this medication (including in section 6). This may manifest as itching, rash or inflammation.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section “Other Medications and Drospirenone/Etinilestradiol Diario Exeltis”).

Additional Information on Special Populations

Children and Adolescents

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

Women of Advanced Age

Drospirenone/Etinilestradiol is not indicated for use after menopause.

Women with Liver Insufficiency

Do not take Drospirenone/Etinilestradiol if you suffer from liver disease. See sections “Do not take Drospirenone/Etinilestradiol Diario Exeltis” and “Warnings and Precautions”.

Women with Renal Insufficiency

Do not take Drospirenone/Etinilestradiol if you are suffering from kidney dysfunction or acute renal insufficiency. See sections “Do not take Drospirenone/Etinilestradiol Diario Exeltis” and “Warnings and Precautions”.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Drospirenone/Etinilestradiol.

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

In some situations, you should take special care while taking drospirenone/etinilestradiol or any other combined hormonal contraceptive, and you may need to have regular check-ups. If the condition develops or worsens while you are taking drospirenone/etinilestradiol, you should also inform your doctor.

• If a close relative has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• • If you have sickle cell anemia (a genetic disorder of red blood cells).
  • If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
  • If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
  • If you recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking drospirenone/etinilestradiol after delivery.
  • If you have superficial vein inflammation under the skin (superficial thrombophlebitis).
  • If you have varicose veins.
• If you have epilepsy (see “Other Medications and Drospirenone/Etinilestradiol Diario Exeltis”).
• 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 a previous use of sex hormones (for example, hearing loss, porphyria (a blood disorder), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disorder with involuntary movements).
• 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 angioedema symptoms such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria, along with difficulty breathing,consult your doctor immediately. Medications containing estrogens can induce or worsen symptoms of hereditary and acquired angioedema

BLOOD CLOTS

The use of a combined hormonal contraceptive like drospirenone/etinilestradiol increases your risk of developing a blood clot compared to 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 long-lasting or, very rarely, fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• 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 start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 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 drospirenone/etinilestradiol, 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 drospirenone/etinilestradiol 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 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as drospirenone/etinilestradiol, 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 developing a blood clot is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking drospirenone/etinilestradiol for several weeks before the operation or while you have less mobility. If you need to stop taking drospirenone/etinilestradiol, ask your doctor when you can start taking it again.
• With increasing age (especially above the age of about 35).
• If you have given birth recently.

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

Long flights (more than 4 hours) 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking drospirenone/etinilestradiol.

If any of the conditions listed above change while you are using drospirenone/etinilestradiol, for example, a close relative experiences a blood clot without a known cause or gains 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 drospirenone/etinilestradiol is very small, but it may increase:

• With age (above the age of about 35).
• If you smoke. When using a combined hormonal contraceptive like drospirenone/etinilestradiol, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia 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 listed above change while you are using drospirenone/etinilestradiol, 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.

Drospirenone/Etinilestradiol Diario Exeltis and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.

It is essential to have regular breast examinations and to consult your doctor if you notice any lump.

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

Mental Disorders

Some women who use hormonal contraceptives like drospirenone/etinilestradiol 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, contact your doctor for additional medical advice as soon as possible.

Spotting

During the first few months of taking drospirenone/etinilestradiol, you may experience unexpected bleeding (bleeding outside of the pill-free week). If these bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the pill-free week

If you have taken all the pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is highly 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 Medications and Drospirenone/Etinilestradiol Diario Exeltis

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication or herbal preparation. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking drospirenone/etinilestradiol. They may advise you to take additional contraceptive precautions and, if so, for how long, or to modify the use of another medication that you need.

Some medications

• may affect the levels of drospirenone/etinilestradiol in the blood
• may make itless effective inpreventing pregnancy
• may cause unexpected bleeding.

This may occur with:

• Medications used to treat:
• • Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • Tuberculosis (e.g., rifampicin)
  • Infection with HIV or 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)
  • Pulmonary hypertension in the blood vessels (bosentan)
  • Herbal preparations containing St. John's Wort.

Drospirenone/etinilestradiolmay affect the effectof other medications, for example:

• Medications containing ciclosporin
• The antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• Theophylline (used to treat respiratory problems)
• Tizanidine (used to treat muscle pain and/or cramps)

Do not take drospirenone/etinilestradiol if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Drospirenone/etinilestradiol can be restarted approximately 2 weeks after the completion of this treatment. See section “Do not take Drospirenone/Etinilestradiol Diario Exeltis”.

Consult your doctor or pharmacist before taking any medication.

Taking Drospirenone/Etinilestradiol Diario Exeltis with Food and Drinks

Drospirenone/Etinilestradiol can be taken with or without food, and with a little water if necessary.

Laboratory 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 and Breastfeeding

Pregnancy

If you are pregnant, you should not take drospirenone/etinilestradiol. If you become pregnant while taking drospirenone/etinilestradiol, stop taking it immediately and consult your doctor.If you wantto become pregnant,you can stop takingdrospirenone/etinilestradiolat any time (see “If you interrupt treatment with Drospirenone/EthinylestradiolDiarioExeltis”).

Consult your doctor or pharmacist before taking any medication.

In general, it is not recommended to take drospirenone/etinilestradiol during breastfeeding. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and Operating Machinery

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

Drospirenone/Etinilestradiol Diario Exeltis contains lactose

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

Drospirenone/Etinilestradiol Diario Exeltis containssodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Each blister contains 21 active pink tablets and 7 white tablets containing placebo.

The two different types of colored tablets of drospirenone/etinilestradiol are placed in order. A pack contains 28 tablets.

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 tablet of drospirenone/etinilestradiol every day, with some water if necessary. You can take the tablets with or without food, but every day approximately at the same time.

Do not confuse the tablets:take a pink tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you must start taking a new blister (21 pink tablets and 7 white tablets). Therefore, there is no break without tablets between blisters.

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

Preparation of the blister

To control the daily intake of the contraceptive, each blister of drospirenone/etinilestradiol includes seven adhesive strips that have the days of the week printed on them. You must know the day of the week on which you will take the first tablet.

According to the day of the week on which you will start taking the tablets, you should choose the corresponding adhesive strip, for example, if you start on Wednesday, stick the one that indicates "WED" as the initial tablet. Then, you must stick the corresponding strip on the top left of the blister, in the "Start" position. In this way, there is a day of the week indicated above each tablet and you can check visually if you have taken a specific tablet. The arrows show the order in which the tablets should be taken.

During the 7 days in which you take placebo tablets (placebo week), menstruation (also called withdrawal bleeding) usually begins. Normally, menstruation begins the second or third day after taking the last active tablet, which is pink, of drospirenone/etinilestradiol. Once you have taken the last white tablet, you must start a new blister, even if you have not finished bleeding. This means that you should start the new blister on the same day of the week as the previous one, and menstruation should occur during the same daysevery month.

If you take drospirenone/etinilestradiol as indicated, you will also be protected against pregnancy during the 7 days in which you are taking placebo tablets.

When can you start with the first blister?

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

Start taking drospirenone/etinilestradiol on the first day of the cycle (i.e., the first day of your menstruation). If you start drospirenone/etinilestradiol on the first day of your menstruation, you will be protected immediately against pregnancy. You can also start on days 2-5 of the cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Change from another combined hormonal contraceptive, vaginal combined contraceptive ring, or patch.

You can start taking drospirenone/etinilestradiol preferably the day after taking the last active tablet of your previous contraceptive, but no later than the day after the break of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When changing from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can change from the progestin-only pill on any day (if it is an implant or an IUD, on the same day of its extraction; if it is an injectable, on the next scheduled injection), but in all cases, it is recommended that you 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 having a child.

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

If, after having a child, you have already had sex before starting to take drospirenone/etinilestradiol (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 drospirenone/etinilestradiol (again) after having a child.

Read the section "Breastfeeding".

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

If you take more Drospirenone/Etinilestradiol Diario Exeltis than you should

No serious cases of overdose of drospirenone/etinilestradiol have been reported.

The symptoms that may appear if you take many tablets at once may 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 tablets of drospirenone/etinilestradiol, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Drospirenone/Etinilestradiol Diario Exeltis

The tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these tablets, the effect of drospirenone/etinilestradiol will not be affected. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the effectiveness of the drospirenone/etinilestradiol tablets.

If you forget to take a tablet from the 1st, 2nd, or 3rd row:

• If you are delayedless than 12 hoursin taking any active tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are delayedmore than 12 hoursin taking any active 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 maximum if you forget to take the tablet at the beginning of the blister (1st row) or at the end of week 3 (3rd row of the blister). Therefore, you should take the following measures (see also the diagram below):

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time and useadditional precautions, such as a condom, 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 subsequent tablets at the usual time. The protection against pregnancy is not reduced and you do not need to take additional precautions.

• Forgetting a tablet in week 3

You can choose between two options:

Probably, you will have menstruation (withdrawal bleeding) at the end of the second blister, although you may experience light bleeding or similar to menstrual cramps during the use of the second blister.

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

• If you have forgotten to take a tablet and you do not have your period during the placebo week, you may be pregnant. In that case, you should consult your doctor before continuing with the next blister.

What should you do in case of vomiting or intense diarrhea?

If you have vomiting in the 3-4 hours following the intake of an active pink tablet or have intense diarrhea, there is a risk that the active principles of the contraceptive will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take a tablet from a reserve blister as soon as possible. If possible,within 12 hoursafter the usual time when you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the instructions in the section "If you forgot to take Drospirenone/Etinilestradiol Diario Exeltis".

Delay of menstrual period: what should you know?

Although it is not recommended, you can delay your menstrual period (withdrawal bleeding) if you start taking a new blister of drospirenone/etinilestradiol instead of continuing with the break and finish it. You may experience light bleeding or similar to menstrual cramps during the use of the second blister.

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

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

If you take the tablets as instructed, your menstrual period will begin during the placebo week. If you need to change the day, you can do so by shortening(but never extending! – 7 is the maximum) the placebo week. For example, if your placebo week begins on Friday and you want to change to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. If you make the placebo week too short (e.g., 3 days or less), you may not experience bleeding during these days. Then, you may experience light bleeding or similar to menstrual cramps.

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

If you interrupt the treatment with Drospirenone/Etinilestradiol Diario Exeltis

You can stop taking drospirenone/etinilestradiol when you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods.If you want to become pregnant, stop takingdrospirenone/etinilestradioland waituntil your menstrual periodbefore trying to become pregnant.This way, you can calculate your estimated due datemore easily.

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

Like all medicines, this medicine may 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 drospirenona/etinilestradiol, 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 section 2 “What you need to know before starting to take Drospirenona/Etinilestradiol Diario Exeltis”.

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 (also see section “Warnings and precautions”).

The following list ofside effects has been associatedwith the useof drospirenona/etinilestradiol.

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.
• 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, amenorrhea, heavy periods, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic), 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 1,000 patients):

• Asthma.
• Auditory problems.
• Erythema nodosum (characterized by painful nodules on the skin of a reddish color).
• Erythema multiforme (characterized by skin rash with rosy patches 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 section 2 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 Medicines 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 special conditions for conservation.

Do not take this medication after the expiration date that appears on the packaging after CAD or EXP. The 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 point at 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 Drospirenona/Ethinylestradiol Daily Exeltis

A blister pack contains21active pink tablets in rows1,2, and3of the blister pack and7white placebo tablets in row4.

Active tablets:

The active principles are 0.02 mg of ethinylestradiol and 3 mg of drospirenona.

The other components are:

Tablet core: lactose monohydrate, pregelatinized cornstarch, povidone, croscarmellose sodium, polisorbate 80, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance of Drospirenona/Ethinylestradiol Daily Exeltis and contents of the packaging

The active tablets are film-coated, round, pink tablets.

The placebo tablets are film-coated, round, white tablets.

• It is available in boxes of 1, 2, 3, 6, and 13 blister packs, each containing 28 tablets (21 active tablets plus 7 placebo tablets).

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Exeltis Healthcare, S.L.

Pol. Ind.Miralcampo, Avda. de Miralcampo 7, 19200

Azuqueca de Henares,

Guadalajara, Spain

Responsible manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera, C/ La Vallina s/n

24193 - Villaquilambre, León

Spain

Last review date of this leaflet:November 2023

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