DROSURELLE DAILY 0.02 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Drosurelle Daily 0.02 mg/3 mg film-coated tablets EFG

ethinylestradiol/drospirenone

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

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

Contents of the package leaflet

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

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

• Drosurelle Daily is a contraceptive and is used to prevent pregnancy.
• Each of the 21 active pink tablets 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 contraceptives.

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

General considerations

Before you start using Drosurelle Daily, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before you start taking Drosurelle 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 leaflet describes several situations in which you should stop using Drosurelle Daily, or in which the effect of Drosurelle Daily may be reduced. In these situations, you should not have sex or should take additional non-hormonal contraceptive precautions, for example, using a condom or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since Drosurelle Daily alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drosurelle Daily

You should not use Drosurelle 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.

• 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 long time sitting or lying down (see section 2 "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 if you suspect you have breast cancer or cancer of the genitals.
• 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 cause itching, rash, or inflammation.
• Do not take Drosurelle Daily if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medicines and Drosurelle Daily").

Additional information on special populations

Children and adolescents

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

Older women

Drosurelle Daily is not indicated for use after menopause.

Women with liver insufficiency

Do not take Drosurelle Daily if you suffer from liver disease. See sections "Do not take Drosurelle Daily" and "Warnings and precautions".

Women with renal insufficiency

Do not take Drosurelle Daily if you are suffering from kidney malfunction or acute kidney failure. See sections "Do not take Drosurelle Daily" and "Warnings and precautions".

Warnings and precautions

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

In some situations, you should be particularly careful while using Drosurelle Daily or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using Drosurelle Daily, you should also inform your doctor.

• If a close relative has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression. Some women who use hormonal contraceptives like Drosurelle Daily have reported depression or depressed mood. Depression can be serious 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.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• 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 pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time sitting or lying down (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Drosurelle Daily 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 Drosurelle Daily").
• If you have any disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (a discoloration of the skin, especially on the face and neck, known as "pregnancy patches"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• Consult your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, difficulty swallowing, or urticaria potentially with difficulty breathing. Medicines containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drosurelle Daily increases your risk of blood clots 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 may be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Drosurelle 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 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 in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

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

What is the risk of 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 a blood clot in the leg or lung (DVT or PE) with Drosurelle 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 Drosurelle Daily, between 9 and 12 women will have a blood clot in a year.
• The risk of 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 a blood clot with Drosurelle Daily 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 long time sitting or lying down due to an injury or illness, or if you have your leg in a cast. You may need to stop using Drosurelle Daily several weeks before surgery or while you have reduced mobility. If you need to stop using Drosurelle Daily, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have given birth within the past few weeks.

The risk of 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 Drosurelle Daily.

If any of the above conditions change while you are using Drosurelle Daily, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain much 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 essential to note that the risk of a heart attack or stroke due to Drosurelle Daily is very small, but it may increase:

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

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

If any of the above conditions change while you are using Drosurelle Daily, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain much weight, inform your doctor.

Drosurelle Daily and cancer

Breast cancer has been 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 have your breasts checked regularly, and you should see your doctor if you notice any lump.

In rare cases, liver tumors have been reported in women who use hormonal contraceptives. These tumors are sometimes benign, and in rare cases, they can be malignant.

3. How to take Drosurelle Daily

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

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

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

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

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

Due to the different composition of the tablets, it is necessary to 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 pack.

Preparing the pack

To help you follow the order of intake, each Drosurelle Daily pack includes seven adhesive strips with the 7 days of the week.

Choose the adhesive strip that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with "WED".

Stick the weekly strip on the top left of the pack, in the "Start" position.

This way, there is a day of the week indicated above each tablet, and you can see if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

During the 7 days when you take the white placebo tablets (the placebo days), you will usually start your period (also called withdrawal bleeding). Normally, your period will start on the second or third day after taking the last active pink tablet of Drosurelle Daily. 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 menstruation should take place during the same days every month.

If you take Drosurelle Daily 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 used any hormonal contraceptive in the previous month.

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

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

You can start taking Drosurelle Daily preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest days of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal ring or patch, follow your doctor's advice.

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

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

• After an abortion or miscarriage.

Follow your doctor's advice.

• After having a baby.

You can start taking Drosurelle Daily between 21 and 28 days after giving birth. If you start later, use a barrier method (e.g., a condom) during the first 7 days of taking Drosurelle Daily.

If, after having a baby, you have had sexual intercourse before starting to take Drosurelle Daily again, you should be sure that you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and want to start taking Drosurelle Daily again after having a baby.

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take more Drosurelle Daily than you should

No cases have been reported where an overdose of Drosurelle Daily has caused serious harm.

The symptoms that may appear if you take many tablets may include feeling unwell or vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication.

If you have taken too many Drosurelle Daily tablets, or a child has taken them, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Drosurelle Daily

The tablets in the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, it will have no effect on the effect of Drosurelle Daily. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet from rows 1, 2, or 3, do the following:

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you forget to take a pink tablet at the beginning or end of the pack. Therefore, you should follow these recommendations (see the diagram below):

• Forgetfulness of more than one tablet in the pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you may be pregnant. In this case, consult your doctor.

• Forgetfulness of a tablet in week 2

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

• Forgetfulness of a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this pack, discard them and start the next pack.

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

1. You can also stop taking the active pink tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new pack on the day you always start, take the placebo tablets less than 7 days.

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

• If you have forgotten to take a tablet and do not have a period during the placebo days, you may be pregnant. Contact your doctor before starting the next pack.

The following diagram shows you what to do if you forget to take a tablet

What to do in case of vomiting 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 of the contraceptive will not be fully absorbed by the body, in which case you may need to use extra protection (such as a condom). The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take another pink tablet from a reserve pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Drosurelle Daily".

Delayed menstruation: what you should know

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

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

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

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

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

If you stop taking Drosurelle Daily

You can stop taking Drosurelle Daily whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Drosurelle Daily and wait until your menstrual period before trying to become pregnant. This way, you can more easily calculate the expected date of delivery.

If you have any doubts 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 Drosurelle Daily, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Drosurelle Daily".

The following list of adverse effects has been associated with the use of Drosurelle Daily.

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

• mood changes,
• headache,
• abdominal pain (stomach pain),
• acne,
• breast pain, breast enlargement, breast tenderness, painful or irregular periods,
• weight gain.

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

• Candida (a fungal infection),
• cold sore (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling and numbness, dizziness,
• vision problems,
• irregular or unusually rapid heart rate,
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, decreased 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, along with difficulty breathing (angioedema),
• hair loss (alopecia), eczema, itching, skin rash, dry skin, seborrheic dermatitis,
• neck pain, limb pain, muscle cramps,
• bladder infection,
• breast lumps (benign or cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal infection or inflammation, vaginal dryness, pain in the lower abdominal region (pelvic), abnormal cervical smears (Pap or Pap staining), decreased libido
• fluid retention, lack of energy, feeling of thirst, increased sweating,
• weight loss,
• generalized pain.

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

• asthma,
• hearing problems,
• erythema nodosum (characterized by painful nodules on the skin, reddish in color)
• erythema multiforme (skin rash with target-like lesions or ulcers)
• harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild or temporary stroke-like symptoms, called 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).

Contact your 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 potentially with difficulty breathing (see also the "Warnings and Precautions" section).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Drosurelle Daily

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

Store below 30°C.

Do not take this medicine after the expiration date that appears on the packaging after "CAD". 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 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Drosurelle Daily

The Drosurelle Daily blister pack contains 21 active pink tablets in the 1st, 2nd, and 3rd rows, and 7 white placebo tablets in the 4th row.

Active Tablets

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

The other components are:

Tablet core: lactose monohydrate, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Placebo Tablets

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the Product and Package Contents

The active tablets are film-coated, round, pink tablets with a diameter of approximately 5.7 mm.

The placebo tablets are film-coated, round, white tablets with a diameter of approximately 5.7 mm.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24008-Villaquilambre, León

Spain

O

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

Oddzial Produkcyjny W Nowej Debie, Ul. Metalowca 2

39-460 Nowa Deba

Poland

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

Date of the Last Revision of this Prospectus: November 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.gob.es.