DROSPIRENONE/ETHINYLESTRADIOL EXELTIS 3mg/0.03mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Drospirenone/Ethinylestradiol Exeltis 3 mg/0.03 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Important Things You Should Know About Combined Hormonal Contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of blood clots in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a pause 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").

Package Leaflet Contents

1. What is Drospirenone/Ethinylestradiol Exeltis and what it is used for
2. What you need to know before taking Drospirenone/Ethinylestradiol Exeltis
3. How to take Drospirenone/Ethinylestradiol Exeltis
4. Possible side effects
5. Storage of Drospirenone/Ethinylestradiol Exeltis

1. Package Contents and Additional Information

1. What is Drospirenone/Ethinylestradiol Exeltis and what it is used for

Drospirenone/ethinylestradiol is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Drospirenone/Ethinylestradiol Exeltis

General considerations

Before taking drospirenone/ethinylestradiol, 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 taking drospirenone/ethinylestradiol, 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 state of health, may perform other tests.

This leaflet describes several situations in which you should stop using drospirenone/ethinylestradiol or in which the effect of drospirenone/ethinylestradiol may be reduced.

In such situations, you should not have sex or should 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 since drospirenone/ethinylestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drospirenone/Ethinylestradiol Exeltis

You should not take drospirenone/ethinylestradiol 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 for you.

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

• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time immobile (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

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

• If you have (or have ever had) a liver disease and your liver function has not yet returned to normal.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or are suspected to have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (listed in section 6). This may be manifested by itching, rash, or inflammation.
• If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section "Other medicines and Drospirenone/Ethinylestradiol Exeltis").

Additional information on special populations

Children and adolescents

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

Older women

Drospirenone/Ethinylestradiol is not indicated for use after menopause.

Women with liver insufficiency

Do not take Drospirenone/Ethinylestradiol if you suffer from liver disease. See sections "Do not take Drospirenone/Ethinylestradiol Exeltis" and "Warnings and precautions".

Women with renal insufficiency

Do not take Drospirenone/Ethinylestradiol if you are suffering from kidney malfunction or acute renal insufficiency. See sections "Do not take Drospirenone/Ethinylestradiol Exeltis" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take drospirenone/ethinylestradiol.

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

In some situations, you will need to be particularly careful while taking drospirenone/ethinylestradiol or any other combined contraceptive, and your doctor may need to perform regular check-ups. If the condition develops or worsens while you are taking drospirenone/ethinylestradiol, 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 Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• • If you have sickle cell anemia (a hereditary disease of red blood cells).
  • If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
  • If you need an operation or spend a lot of time immobile (see section 2 "Blood clots").
  • If you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking drospirenone/ethinylestradiol after delivery.
  • 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 Drospirenone/Ethinylestradiol 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 previous use of sex hormones (e.g., hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease in which involuntary movements appear)).
• If you have or have ever had chloasma (a skin discoloration, especially on the face or neck, known as "pregnancy patches"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria along with difficulty breathing.

BLOOD CLOTS

The use of a combined hormonal contraceptive like drospirenone/ethinylestradiol 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 the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

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

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

When you stop taking drospirenone/ethinylestradiol, 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 drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol, about 9-12 will develop a blood clot in a year.
• The risk of developing a blood clot depends on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

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

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

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

It is important to inform your doctor if you suffer from any of the conditions above, even if you are not sure. Your doctor may decide that you should stop using drospirenone/ethinylestradiol.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

It is important to note that the risk of a heart attack or stroke due to drospirenone/ethinylestradiol is very small, but it can increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like drospirenone/ethinylestradiol, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

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

Drospirenone/Ethinylestradiol Exeltis and cancer

It has been observed that breast cancer is slightly more common in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.

It is essential to undergo regular breast examinations.

3. How to take Drospirenone/Ethinylestradiol Exeltis

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

Take one drospirenone/ethinylestradiol pill every day, with some water if necessary. You can take the pills with or without food, but every day at approximately the same time.

The blister pack contains 21 film-coated pills. The day of the week on which you should take the pill is printed next to each pill. For example, if you start on a Wednesday, you should take a pill with "WED" next to it. Follow the direction of the arrow on the blister pack until you have taken all 21 pills.

After that, you should not take any pills for 7 days. During these 7 days in which you do not take pills (called the rest week), you should have your period. Usually, the period, which can also be called withdrawal bleeding, starts on the second or third day of the rest week.

On the eighth day after taking the last drospirenone/ethinylestradiol pill (i.e., after the 7-day rest period), you should start with the next blister pack, even if you have not yet finished your period. This means that you should start each blister pack on the same day of the week that you started the previous one, and your period should take place during the same days each month.

If you take drospirenone/ethinylestradiol in this way, you are also protected against pregnancy during the 7 days in which you do not take any pills.

When can you start with the first blister pack?

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

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

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

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

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

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

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

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

If, after having a child, you have had sexual intercourse before starting to take drospirenone/ethinylestradiol again, you must be sure that you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start taking drospirenone/ethinylestradiol 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/Ethinylestradiol Exeltis than you should

No cases have been reported in which an overdose of drospirenone/ethinylestradiol has caused serious harm.

The symptoms that may appear if you take many pills at the same time may be feeling unwell or having vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first period, if they have accidentally taken this medication.

If you have taken too many drospirenone/ethinylestradiol pills, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount used.

If you forget to take Drospirenone/Ethinylestradiol Exeltis

• If you are less than 12 hourslate in taking a pill, your protection against pregnancy will not decrease. Take the pill as soon as you remember and the following pills at the usual time.
• If you are more than 12 hourslate in taking a pill, your protection against pregnancy may be reduced. The more pills 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 pill at the beginning of the blister pack (1st row) or at the end of the 3rd week (3rd row of the blister pack). Therefore, you should take the following measures (see also the diagram below):

• Forgetfulness of more than one pill from the blister pack

Consult your doctor.

• Forgetfulness of a pill in week 1

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time and use additional precautions, for example, a condom, during the next 7 days. If you have had sexual intercourse in the week before forgetting the pill, you may be pregnant. In that case, consult your doctor.

• Forgetfulness of a pill in week 2

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time. Your protection against pregnancy will not decrease, and you do not need to take additional precautions.

• Forgetfulness of a pill in week 3

You can choose between two options:

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time. Instead of starting the rest week, start the next blister pack.

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

1. You can also stop taking pills and go directly to the rest week (noting the day you forgot to take the pill). If you want to start a new blister pack on the day you always start, your rest week should last lessthan 7 days.

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

• If you have forgotten to take a pill and do not have your period during the first rest week, you may be pregnant. In that case, you must go to your doctor before continuing with the next blister pack.

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

If you vomit within 3-4 hours after taking a pill or have severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. This is similar to what happens when you forget a pill. After vomiting or diarrhea, you should take a pill from a reserve blister pack as soon as possible. If possible, within 12 hoursafter the usual time you take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Drospirenone/Ethinylestradiol Exeltis".

Delayed period: what should you know?

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

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

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

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

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

If you stop treatment with Drospirenone/Ethinylestradiol Exeltis

You can stop taking drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol and wait until your period before trying to become pregnant. This way, you will be able to calculate the estimated date of delivery more easily.

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 have any change in health that you think may be due to drospirenone/ethinylestradiol, 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 Drospirenone/Ethinylestradiol Exeltis".

Serious Adverse Effects

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

The following list of adverse effects has been associated with the use of drospirenone/ethinylestradiol.

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

• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness.
• Headache, emotional instability.
• Migraine.
• Nausea.
• Thick white vaginal discharge and vaginal fungal infection.

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

• Increased breast size, changes in sexual interest.
• High blood pressure, low blood pressure.
• Vomiting, diarrhea.
• Acne, skin rash, intense itching, hair loss (alopecia).
• Vaginal infection.
• Fluid retention and changes in body weight.

Rare Adverse Effects(may affect up to 1 in 1,000 patients):

• Allergic reactions (hypersensitivity), asthma.
• Breast secretion.
• Hearing problems.
• Skin disorders such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by a skin rash with target-like redness or ulcers).
• Harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• 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 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Drospirenone/Ethinylestradiol Exeltis

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

This medicine does not require special storage conditions.

Do not take this medicine after the expiration date that appears on the packaging after CAD or EXP. The date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Drospirenone/Ethinylestradiol Exeltis

The active ingredients are 0.03 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

Core of the tablet: lactose monohydrate, corn starch, pregelatinized corn starch, crospovidone, povidone, polysorbate 80, magnesium stearate.

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

Appearance of Drospirenone/Ethinylestradiol Exeltis and Package Contents

It is presented in the form of film-coated tablets, round, yellow in color.

It is available in boxes of 1, 2, 3, 6, and 13 blisters, each with 21 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L.

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

Azuqueca de Henares,

Guadalajara, Spain

Manufacturer

Laboratorios León Farma, S.A.

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

24193 - Villaquilambre, León

Spain

Date of the Last Revision of this Prospectus:November 2023

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