DROSPIRENONE/ETHINYL ESTRADIOL DAILY 3 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Drosbelalle Daily 3mg/0.02mg Film-Coated Tablets EFG

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 the use of a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

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.

Contents of the Package Leaflet

1. What Drosbelalle Daily is and what it is used for
2. What you need to know before starting to take Drosbelalle Daily
3. How to take Drosbelalle Daily
4. Possible side effects
5. Storage of Drosbelalle Daily
6. Package contents and additional information

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

Drosbelalle Daily is a contraceptive and is used to prevent pregnancy.

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

The 7 white tablets do not contain active ingredients and are called placebo tablets.

Contraceptives that contain two hormones are called “combined” tablets

2. What you need to know before starting to take Drosbelalle Daily

General considerations

Before starting to use Drosbelalle Daily, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take Drosbelalle Daily, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your state of health, may perform other tests.

This prospectus describes several situations in which you should interrupt the use of Drosbelalle Daily, or in which the effect of Drosbelalle Daily may decrease.

In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

Do not use the rhythm or temperature method. These methods may not be reliable since Drosbelalle Daily alters the monthly changes in body temperature and cervical mucus.

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

Do not use Drosbelalle Daily

You should not use Drosbelalle 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.

• 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.

When you should be careful with Drosbelalle Daily

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot that may mean you are suffering from

a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see section

"Blood clot (thrombosis)" below).

To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

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

If the condition develops or worsens while you are using Drosbelalle Daily, you should also inform your doctor.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drosbelalle Daily increases your risk of suffering from 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 lasting effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Drosbelalle 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 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 of 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 having a blood clot in a vein higher?

The risk of having 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 medication 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 Drosbelalle Daily, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with Drosbelalle Daily is small.

Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have 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 have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Drosbelalle Daily, between 9 and 12 women will have a blood clot in a year.
• The risk of having a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below)

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

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

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

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

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

If any of the above conditions change while you are using Drosbelalle Daily, for example, 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 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 Drosbelalle Daily is very small, but it can increase:

with age (above about 35 years).

• . When using a combined hormonal contraceptive like Drosbelalle 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 have one or more of these conditions or if any of them are particularly severe, the risk of having a blood clot may be increased further.

If any of the above conditions change while you are using Drosbelalle Daily, 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.

Drosbelalle Daily and cancer

Women who use combined contraceptives have a slightly higher rate of breast cancer, 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 have your breasts examined regularly, and you should see your doctor if you notice any lump.

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

Psychiatric disorders:

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

Bleeding between menstrual periods

During the first few months of using Drosbelalle Daily, unexpected bleeding (bleeding outside the placebo period) may occur. If you experience such bleeding for more than a few months, or if it starts after a few months, your doctor should investigate the cause.

What should you do if you do not have your period during the placebo phase?

If you have taken all the pink tablets correctly, have not vomited, or had severe diarrhea, and have not taken any other medication, it is unlikely that you are pregnant.

If you do not have two consecutive menstrual periods, you may be pregnant. In this case, see your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Drosbelalle Daily with other medications

Always inform the doctor who prescribed Drosbelalle Daily about the medications or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes you another medication (or your pharmacist) that you are taking Drosbelalle Daily. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

Some medications may affect the blood levels of Drosbelalle Daily and may make it less effective in preventing pregnancy or may cause unexpected bleeding. This applies to:

• medications used to treat
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g., rifampicin)
  • viral infections such as HIV and hepatitis C (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz).
  • medications for the treatment of high blood pressure in the blood and lungs (bosentan)
  • fungal infections (e.g., griseofulvina, ketoconazol)
  • arthritis (etoricoxib)

• the herbal remedy St. John's Wort.

3. How to take Drosbelalle Diario

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

The two different types of colored tablets in Drosbelalle Diario are arranged in order. A pack contains 28 tablets.

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

Do not get confused about the tablet: take a pink tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you should start taking a new pack (21 pink tablets and 7 white tablets). Therefore, there is no tablet-free period between packs.

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

Preparing the pack

To keep track of daily intake of the contraceptive, each Drosbelalle Diario pack (blister pack) includes seven adhesive strips with the days of the week printed on them. You should know the day of the week you will take the first tablet.

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

During the 7 days when you take placebo tablets (placebo week), menstruation usually begins (also called withdrawal bleeding). Usually, menstruation starts on the second or third day after taking the last active pink tablet of ethinylestradiol/drospirenone. Once you have taken the last white tablet, you should start the next pack, even if you have not finished bleeding. This means that you should start the next pack on the same day of the week you started the previous one, and that menstruation should occur during the same days every month.

If you take Drosbelalle Diario as indicated, you will also be protected against pregnancy during the 7 days when you are taking the placebo tablets.

When can you start with the first pack?

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

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

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

You can start taking Drosbelalle Diario the day after the tablet-free week of your previous contraceptive (or after taking the last inactive tablet). When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

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

You can switch from a progestin-only pill at any time (if it's an implant or IUD, on the day of its removal; if it's 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 tablet intake.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Drosbelalle Diario between 21 and 28 days later. If you start later, you should use a barrier method (e.g., a condom) during the first 7 days of Drosbelalle Diario use.

If, after having a child, you have had sexual intercourse before starting to take Drosbelalle Diario again, you should first make sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Drosbelalle Diario again after having a child.

Read the section "Breastfeeding".

Let your doctor advise you if you are unsure when to start.

If you take more Drosbelalle Diario than you should

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

The symptoms that may appear if you take many tablets at once are nausea and vomiting. Adolescent girls may experience vaginal bleeding.

If you have taken too many Drosbelalle Diario tablets, or 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 Drosbelalle Diario

The tablets in the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, the effect of Drosbelalle Diario 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 efficacy of the Drosbelalle Diario tablets.

If you forget to take a tablet from the 1st, 2nd, or 3rdrow, you should follow these recommendations:

• If you are less than 12 hourslate in taking an active tablet, the protection against pregnancy will not decrease. 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 an active tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk that the protection against pregnancy will decrease.

The risk of incomplete protection against pregnancy is highest if you forget to take a tablet at the beginning of the pack (1st row) or at the end of the 3rd week (3rd row of the pack). Therefore, you should take the following measures (see also the diagram below):

• Forgetting more than one tablet from the pack

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should be aware that there is a risk of pregnancy. In that case, consult your doctor.

• Forgetting a tablet in week 2

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

• Forgetting a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time. Instead of taking the 7 white placebo tablets (tablet-free period), start taking the next pack.

You will likely have menstruation (withdrawal bleeding) at the end of the second pack, during the placebo tablet week, although you may experience spotting or bleeding during the second pack.

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 week, this may mean that you are pregnant. In that case, you should consult your doctor before continuing with the next pack.

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

If you vomit within 3-4 hours after taking an active pink tablet or experience severe diarrhea, there is a risk that the active ingredients 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 pack as soon as possible. If possible, take it before 12 hourshave passed since 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 Drosbelalle Diario".

Delayed menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you do not take the white placebo tablets from the fourth row and start taking a second pack of Drosbelalle Diario. You may experience spotting (drops or spots of blood) or bleeding during the second pack. After the usual placebo week, during which you take the 7 white tablets, start the next pack.

You should consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your menstrual period (withdrawal bleeding) will begin during the placebo week. If you need to change this day, you can do so by shortening ( but never lengthening - 7 is the maximum) the placebo week. For example, if your placebo week starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. If you make the placebo week very short (e.g., 3 days or less), you may not experience menstruation (withdrawal bleeding) during this period. Then, you may experience spotting (drops or spots of blood) or bleeding.

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

If you stop treatment with Drosbelalle Diario

You can stop taking Drosbelalle Diario 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 Drosbelalle Diario and wait for a period before trying to become pregnant. You will be able to calculate the probable date of delivery more easily.

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

4. Possible Adverse Effects

Like all medicines, Drosbelalle Dailycan 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 Drosbelalle Daily, 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 you start using Drosbelalle Daily".

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, which is 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).

The following is a list of adverse effects related to the use of Drosbelalle Daily.

Common Adverse Effects(may affect up to 1 in 10 women):

• Emotional instability
• Headache
• Abdominal pain (stomach pain)
• Acne
• Breast pain, breast enlargement, painful or irregular menstrual periods, weight gain.

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

• Candidiasis (vaginal infection)
• Herpes simplex (on the lips)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders, loss of interest in sex
• Numbness and tingling, dizziness
• Vision problems
• Irregular or unusually fast heartbeat
• Blood clots (thrombosis) in a blood vessel in the legs or lungs (pulmonary embolism), high blood pressure, migraine, varicose veins
• Sore throat
• Nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
• Sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat), and/or difficulty swallowing or urticaria with possible difficulty breathing (angioedema), hair loss (alopecia), itching, skin rash, dry skin, seborrheic dermatitis
• Neck pain, pain in the limbs, muscle cramps
• Bladder infection
• Breast lumps (benign and cancerous), production of a milky liquid in the nipples (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstrual bleeding, vaginal discharge, vaginal dryness, abdominal pain (pelvic), abnormal cervical smears
• Fluid retention, lack of energy, excessive thirst, increased sweating
• Weight loss.

Rare Adverse Effects(may affect between 1 in 1,000 women):

• Asthma
• Hearing problems
• Blockage of a blood vessel by a clot formed in some part of the body
• Erythema nodosum (characterized by painful red nodules on the skin)
• Erythema multiforme (characterized by a skin rash with a target-like appearance or blisters).

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 "Warnings and Precautions" section).

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 Drosbelalle Daily

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

This medicine does not require special storage conditions.

Do not take Drosbelalle Daily after the expiration date stated on the packaging after the phrase "Do not use after:" or "EXP:"

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

6. Package Contents and Additional Information

Composition of Drosbelalle Daily

A blister pack of Drosbelalle Daily contains 21 active pink tablets in rows 1, 2, and 3 of the blister pack and 7 white placebo tablets in row 4.

Active Tablets:

The active ingredients are 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other ingredients are:

Tablet core: lactose monohydrate, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 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 Drosbelalle Daily and Package Contents

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

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

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

Only some package sizes may be marketed.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare S.L.

Avda. de Miralcampo 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. (Guadalajara).

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24193-Villaquilambre, León

Spain

Date of the Last Revision of this Prospectus:September 2022

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