DROSPIRENONE/ETHINYLESTRADIOL EXELTIS 3 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Drospirenone/Ethinylestradiol Exeltis 3mg /0.02mg Film-Coated Tablets EFG

Drospirenone / Ethinylestradiol

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 any type of adverse effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Important Information about Combined Hormonal Contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
• Please be alert and consult your doctor if you think you are experiencing symptoms of a blood clot (see section 2, "Blood Clots")

Package Leaflet

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

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

• Drospirenone/Ethinylestradiol Exeltis is a contraceptive pill used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are also called placebo tablets.

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before you start taking Drospirenona/Etinilestradiol Exeltis

When you should not use Drospirenona/Etinilestradiol Exeltis

You should not use Drospirenona/Etinilestradiol Exeltis if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. Your doctor will tell you which alternative contraceptive method is most suitable for you.

Do not take Drospirenona/Etinilestradiol Exeltis:

• 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, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If you need surgery or are not going to be mobile for a long time (see section "Blood clots");
• If you have (or have had in the past) a heart attack or stroke;
• If you have (or have had in the past) angina pectoris (a condition that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke-like symptoms);
• If you have any of the following diseases, which may increase the risk of developing a blood clot in the arteries:
• • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a disease known as hyperhomocysteinemia
• If you have (or have had in the past) a type of migraine called "migraine with aura";
• If you have (or have had in the past) a liver disease and your liver function has not yet returned to normal;
• If your kidneys are not working well (renal insufficiency);
• If you have (or have had in the past) a liver tumor;
• If you have (or have had in the past) or are suspected to have breast cancer or cancer of the genital organs;
• If you have vaginal bleeding of unknown cause;
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.
• Do not take Drospirenona/Etinilestradiol Exeltis if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Taking Drospirenona/Etinilestradiol Exeltis with other medicines").

Additional information on special populations

Children and adolescents

Drospirenona/Etinilestradiol Exeltis is not indicated for use in women whose periods have not yet started.

Older women

Drospirenona/Etinilestradiol Exeltis is not indicated for use after menopause.

Women with liver insufficiency

Do not take Drospirenona/Etinilestradiol Exeltis if you have liver disease. See also sections "Do not take Drospirenona/Etinilestradiol Exeltis" and "Warnings and precautions".

Women with renal insufficiency

Do not take Drospirenona/Etinilestradiol Exeltis if you have kidney disease or acute renal failure. See also sections "Drospirenona/Etinilestradiol Exeltis" and "Warnings and precautions".

Warnings and precautions

Tell your doctor if you have any of these conditions.

If the condition appears or worsens while you are taking Drospirenona/Etinilestradiol Exeltis, you should also inform your doctor:

BLOOD CLOTS

Taking combined hormonal contraceptives like Drospirenona/Etinilestradiol Exeltis increases the risk of developing blood clots compared to not taking them. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

• in veins (known as "venous thrombosis", "venous thromboembolism" or VTE)
• in arteries (known as "arterial thrombosis", "arterial thromboembolism" or ATE).

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

It is important to note that the overall risk of a harmful blood clot caused by Drospirenona/Etinilestradiol Exeltis is low.

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?

• Taking combined hormonal contraceptives has been linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. More often, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.
• Very rarely, 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 highest during the first year after starting to take a combined hormonal contraceptive for the first time. The risk may also be higher after restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than when not using combined hormonal contraceptives.

When you stop using Drospirenona/Etinilestradiol Exeltis, the risk of having a blood clot decreases to normal levels 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 having a blood clot in the leg or lung (DVT or PE) with Drospirenona/Etinilestradiol Exeltis is low.

• Out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant, about 2 may have a blood clot in a year.
• Out of 10,000 women who take combined hormonal contraceptives that contain levonorgestrel, norethisterone, or norgestimate, between 5 and 7 may have a blood clot in a year.
• Out of 10,000 women who take combined hormonal contraceptives that contain drospirenone, such as Drospirenona/Etinilestradiol Exeltis, between 9 and 12 may have a blood clot in a year.
• The risk of blood clot varies depending on your personal medical history (see "Factors that increase the risk of blood clot" below).

Factors that increase the risk of blood clot in a vein

The risk of blood clot with Drospirenona/Etinilestradiol Exeltis is low, but some conditions increase the risk. The risk increases:

• 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 (e.g., before the age of 50). If so, you may have a hereditary clotting disorder;
• if you need surgery or are not going to be mobile for a long time due to injury or illness, or have your leg in a cast. You may need to stop taking Drospirenona/Etinilestradiol Exeltis for several weeks before surgery or while you are immobile. If you need to stop taking Drospirenona/Etinilestradiol Exeltis, ask your doctor when you can restart taking it.
• with increasing age (especially above 35 years);
• if you have recently given birth;

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

Long-distance flights (more than 4 hours) may temporarily increase the risk of blood clots, especially if you already have any of the above conditions.

It is important that you inform your doctor if you have any of these conditions, even if you are not sure. Your doctor may decide to stop you from taking Drospirenona/Etinilestradiol Exeltis.

If any of these conditions change while you are taking Drospirenona/Etinilestradiol Exeltis, e.g., if a close relative has a blood clot for unknown reasons or if 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 stroke.

Factors that increase the risk of blood clot in an artery

It is important to note that the risk of heart attack or stroke due to taking Drospirenona/Etinilestradiol Exeltis is very low, but it may increase:

• with age (above approximately 35 years);
• if you smoke.When taking a combined hormonal contraceptive like Drospirenona/Etinilestradiol Exeltis, you are advised to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraception;
• 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 (before the age of 50). In this case, you may also have a higher risk of 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 heart problems (valve disorders, heart rhythm disturbance known as 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 even higher.

If any of these conditions change while you are taking Drospirenona/Etinilestradiol Exeltis, e.g., if you start smoking, a close relative has a blood clot for unknown reasons, or if you gain a lot of weight, inform your doctor.

Drospirenona/Etinilestradiol Exeltis and cancer

There have been cases of breast cancer with a slightly higher frequency in women using combined pills, but it is not known if the cause is the treatment. For example,

3. How to take

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Each strip contains 24 active pink tablets and 4 white placebo tablets.

The two Drospirenona/Etinilestradiol Exeltis tablets of different colors are ordered. Each strip contains 28 tablets.

Take one Drospirenona/Etinilestradiol Exeltis tablet every day, with some water if necessary. You can take the tablets with or without food, but you must take them at approximately the same time every day.

Do not confuse the tablets: take one pink tablet every day for the first 24 days, followed by one white tablet for the last 4 days. Then you should start taking a new pack (24 pink tablets and 4 white tablets). This way, there is no break between two 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 blister

To help you follow the order of intake, each Drospirenona/Etinilestradiol Exeltis pack includes seven adhesive strips that have the 7 days of the week printed on them. Choose the strip of the week that starts with the day you take the first tablet. For example, if you start on Wednesday, stick the one that says "WED" as the initial tablet.

Stick the adhesive strip of the week on the top of the blister where it says "Place the strip here", so there is a day of the week indicated above each tablet and you can see if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

During the 4 days when you take the white placebo tablets (placebo days), you should have your period (also called withdrawal bleeding). Usually, the period starts on the 2nd or 3rd day after taking the last active pink tablet of Drospirenona/Etinilestradiol Exeltis. Once you have taken the last white tablet, you should start the next pack, even if you have not finished your period. This means that you should start each pack on the same day of the weekthat you started the previous one, and that your period should take place during the same days every month.

If you take Drospirenona/Etinilestradiol Exeltis as indicated, you will also be protected against pregnancy during the 4 days when you are taking the placebo tablets.

When can you start with the first strip?

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

Start taking Drospirenona/Etinilestradiol Exeltis on the first day of your cycle (i.e., the first day of your period). If you start Drospirenona/Etinilestradiol Exeltis on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but in that case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.

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

You can start taking Drospirenona/Etinilestradiol Exeltis preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, and at the latest the day after the tablet-free days (or after the last inactive tablet) of your previous contraceptive. When changing from a combined vaginal ring or patch, follow your doctor's recommendations.

• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system)

You can change from the progestogen-only pill at any time. If it is an implant or an intrauterine system, on the day of its removal; if it is an injectable, when the next injection is due. In all cases, it is recommended that you use additional contraceptive measures (e.g., condoms) during the first 7 days of tablet-taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

You can start taking Drospirenona/Etinilestradiol Exeltis between 21 and 28 days after giving birth. If you start more than 28 days after giving birth, you should use a barrier method (e.g., condoms) during the first 7 days of using Drospirenona/Etinilestradiol Exeltis.

If, after having a child, you have already had sexual intercourse, before starting to take Drospirenona/Etinilestradiol Exeltis, you should be sure that you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start takingDrospirenona/Etinilestradiol Exeltis again after having a baby

Read the section "Breastfeeding".

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

If you take moreDrospirenona/Etinilestradiol Exeltisthan you should

No cases have been reported where an overdose of Drospirenona/Etinilestradiol Exeltis has caused serious harm.

If you take several tablets at once, you may feel sick, vomit, or bleed from the vagina. Even girls who have not yet started menstruating but have accidentally taken this medication may experience this type of bleeding.

If you have taken too many Drospirenona/Etinilestradiol Exeltis tablets or discover that a child has taken them, consult your doctor or pharmacist.

If you forget to takeDrospirenona/Etinilestradiol Exeltis

The last 4 tablets of the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of Drospirenona/Etinilestradiol Exeltis. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet (tablets 1-24 of the strip), you should follow these steps:

• If less than 24 hourshave passed since you took a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets at the usual time.
• If more than 24 hourshave passed since you took a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a tablet at the beginning or end of the blister. The following recommendations should be followed in this situation (see also the diagram below):

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet during days 1-7

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional contraceptive precautionsfor the next 7 days, e.g., condoms. 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 during days 8-14

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Forgetting a tablet during days 15-24

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time until you finish the 24 tablets. Avoid the 4-day tablet-free interval and start a new blister (the start day will be different from the previous one).

You will probably have your period at the end of the second blister (during the 4-day tablet-free interval), although you may experience spotting or bleeding during the second blister.

1. You can also stop taking the tablets and go directly to the 4-day tablet-free interval (before starting this interval without tablets, note the day you forgot to take the tablet).If you want to start a new blister on the same day as usual, reduce the tablet-free interval to less than 4days.

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

• If you have forgotten to take a tablet from a strip and do not have your period during the placebo tablet days, this may mean that you are pregnant. You should go to your doctor before continuing with the next strip.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a tablet or if you have severe diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed by your body. It is similar to what happens when you forget to take a tablet. After vomiting or diarrhea, you should take a tablet from a reserve blister pack as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If it is not possible or more than 24 hours have passed, follow the advice in the section "If you forget to take Drospirenona/Etinilestradiol Exeltis".

Delayed menstrual period: what you need to know

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

Ask your doctor before deciding to delay your period.

Changing the first day of your period: what you need to know

If you take the tablets as instructed, your period will start during the placebo days. If you need to change this day, you can do so by reducing the placebo days (the days when you take the white tablets) (but never increase them - 4 maximum!). For example, if you start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. 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 withDrospirenona/Etinilestradiol Exeltis

You can stop taking Drospirenona/Etinilestradiol Exeltis whenever you want. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, it is recommended that you stop taking Drospirenona/Etinilestradiol Exeltis and wait until your next period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

If you have any other questions about the use of this product, 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 feel any change in health that you think may be caused by Drospirenona/Etinilestradiol Exeltis, consult your doctor.

Women who take combined hormonal contraceptives have a higher risk of 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 Drospirenona/Etinilestradiol Exeltis".

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 hives with possible difficulty breathing (see also the "Warnings and Precautions" section).

The following list of adverse effects has been associated with the use of Drospirenona/Etinilestradiol Exeltis:

• Frequent Adverse Effects(between 1 and 10 out of 100 users may be affected):
• • mood changes
  • headache
  • nausea
  • breast pain, menstrual problems such as irregular periods, absence of menstruation

• Uncommon Adverse Effects(between 1 and 10 out of 1,000 users may be affected):
• • depression, nervousness, drowsiness
  • dizziness, tingling
  • migraine, varicose veins, increased blood pressure
  • stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea
  • acne, itching, skin rash
  • discomfort and pain, such as back pain, pain in the limbs, muscle cramps
  • vaginal yeast infection, pain in the lower abdominal region (pelvic), breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful menstruation, shorter menstruation, heavy menstruation, vaginal dryness, abnormal vaginal cytology, loss of interest in sex
  • lack of energy, increased sweating, fluid retention
  • weight gain

Rare Adverse Effects(between 1 and 10 out of 10,000 users may be affected):

• candidiasis (a fungal infection)
• anemia, increased platelet count in the blood
• allergic reaction
• hormonal disorder (endocrine)
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood
• absence of orgasm, insomnia
• vertigo, tremors
• eye disorders, such as eyelid inflammation, dry eyes
• abnormally rapid heart rate
• inflammation of a vein, nosebleeds, fainting
• abdominal enlargement, intestinal disorder, feeling of flatulence, stomach hernia, oral thrush, constipation, dry mouth
• pain in the bile ducts or gallbladder, gallbladder inflammation
• yellow-brown spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, skin stretch marks, skin inflammation, photosensitivity skin inflammation, skin nodules
• difficult or painful sex, vaginal inflammation (vulvovaginitis), bleeding after sex, withdrawal metrorrhagia, breast cysts, increased breast cell count (hyperplasia), malignant breast lumps, abnormal growth of the cervical mucosa, shrinkage or loss of uterine lining, ovarian cysts, uterine enlargement
• general discomfort
• weight loss
• harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT)
  • In a lung (i.e., PE)
  • Heart attack
  • Stroke
  • Mild or temporary stroke-like symptoms, known as a transient ischemic attack (TIA)
  • Blood clots in the liver, stomach/intestine, kidneys, or eye

The risk 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).

• inflammation of a vein, nosebleeds, fainting
• abdominal enlargement, intestinal disorder, feeling of flatulence, stomach hernia, oral thrush, constipation, dry mouth
• pain in the bile ducts or gallbladder, gallbladder inflammation
• yellow-brown spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, skin stretch marks, skin inflammation, photosensitivity skin inflammation, skin nodules
• difficult or painful sex, vaginal inflammation (vulvovaginitis), bleeding after sex, withdrawal metrorrhagia, breast cysts, increased breast cell count (hyperplasia), malignant breast lumps, abnormal growth of the cervical mucosa, shrinkage or loss of uterine lining, ovarian cysts, uterine enlargement
• general discomfort
• weight loss

Also, the following adverse effects have been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with redness and blisters in a scarf-like shape).

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Drospirenona/Etinilestradiol Exeltis

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

Store below 30°C.

Do not use this medicine after the expiration date that appears on the strip and on the cardboard box after "EXP". The expiration 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 in the SIGRE Point of 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 Drospirenona/Etinilestradiol Exeltis

• The active ingredients are drospirenone and ethinylestradiol.

Each film-coated tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.

• The other components are:

Active film-coated pink tablets: lactose monohydrate, pregelatinized cornstarch, povidone K-30 (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Inactive film-coated white tablets: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Product Appearance and Package Contents

• Each strip of Drospirenona/Etinilestradiol Exeltis contains 24 active film-coated pink tablets in the 1st, 2nd, 3rd, and 4th rows and 4 inactive film-coated white tablets in the 4th row.
• The Drospirenona/Etinilestradiol Exeltis tablets, both pink and white, are film-coated tablets. The core of the tablets is coated
• Drospirenona/Etinilestradiol Exeltis is available in packages of 1, 3, 6, and 13 strips, each with 28 (24+4) tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare S.L.

Avda. de Miralcampo 7.

Miralcampo Industrial Estate.

19200 Azuqueca de Henares. (Guadalajara)

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n, Navatejera Industrial Estate.

24193 - Navatejera, León.

Spain

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

Netherlands: Chisylen 0.02 mg/3 mg film-coated tablets

Italy: Bravela

Date of the last revision of this prospectus: 11/2024

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.gob.es