DROSPIL 0.02 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Drospil 0.02 mg/3 mg film-coated tablets EFG

ethinylestradiol/drospirenone

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

1. What is Drospil and what is it used for

• Drospil is a contraceptive used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.
• The 4 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 taking Drospil

General considerations

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

Before starting to take Drospil, 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 carry out some other tests.

This prospectus describes several situations in which you should interrupt the use of Drospil, or in which the reliability of Drospil may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as the use of a condom or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since Drospil alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drospil

You should not use Drospil 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 of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in 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 without getting up (see section "Blood clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a 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 normalized.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have ever had) a tumor in the liver.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the sex 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 (included in section 6). This may manifest with itching, rash or inflammation.

Do not take Drospil 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 Drospil").

Additional information on special populations

Children and adolescents

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

Older women

Drospil is not indicated for use after menopause.

Women with liver insufficiency

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

Women with renal insufficiency

Do not take Drospil if you are suffering from kidney malfunction or acute kidney failure. See sections "Do not take Drospil" 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 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" 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 Drospil or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using Drospil, 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 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 lot of time without getting up (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 Drospil after childbirth.
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• if you have varicose veins.
• if you have epilepsy (see "Other medicines and Drospil").
• if you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy [herpes gestationalis], a nervous disease in which involuntary movements appear [Sydenham's chorea]).
• if you have or have had brownish discoloration (chloasma), also known as "pregnancy spots", especially on the face. In this case, avoid direct exposure to the sunor to ultraviolet rays.
• Consult your doctor immediately if you experience symptoms of angioedema, such as inflammation of the face, tongue and/or throat, difficulty swallowing or urticaria potentially with difficulty breathing. Medicines that contain estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

Consult your doctor before taking Drospil.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drospil increases your risk of having a blood clotcompared 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 Drospil 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 clot can form in a vein of 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 again (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 Drospil, 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 Drospil 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 like Drospil, between about 9 and 12 women will have a blood clot in a year.
• The risk of 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 Drospil 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).
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to interrupt the use of Drospil several weeks before surgery or while you have reduced mobility. If you need to interrupt the use of Drospil, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years).
• If you have recently given birth.

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

Long-distance air travel (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 interrupt the use of Drospil.

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

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Drospil, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If 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 a high level 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 disorder 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 a blood clot may be further increased.

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

Drospil and cancer

It has been observed that breast cancer occurs slightly more frequently 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 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 unusually severe abdominal pain.

Psychiatric disorders

Some women who use hormonal contraceptives like Drospil 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.

3. How to take Drospil

Each blister pack contains 24 active pink tablets and 4 white placebo tablets.

The two different types of colored tablets of Drospil are placed in order. A blister pack contains 28 tablets.

Take one Drospil tablet every day, with some water if necessary. You can take the tablets with or without food, but always 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, start another pack immediately (24 pink tablets and 4 white tablets). Therefore, there is no gap between two packs.

Since the composition of the tablets is different, you must start the pack from the tablet in the upper left corner and take the tablets every day. Follow the direction of the arrows on the pack to take the tablets in the correct order.

Preparing the blister pack

To help you follow the order of intake, each Drospil blister pack includes 7 adhesive strips with the 7 days of the week. Choose the 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 adhesive strip on the top of the blister pack where it says "Place the adhesive strip here", so that the first day is placed above the tablet marked with "1". Now you will have a day marked above each tablet and you can visually check if you have taken your tablet. The arrows indicate the order of intake of the tablets.

During the 4 days when you take the white placebo tablets (placebo days), you should have your period (the so-called withdrawal bleeding). It usually starts on the 2nd or 3rd day after taking the last active pink tablet of Drospil. After taking the last white tablet, start the next pack, even if your period has not finished. This means that you must start the next pack on the same day of the weekthat you started the previous one, and that the withdrawal bleeding must occur during the same days every month.

If you take Drospil in this way, you are also protected against pregnancy during the 4 days when you take 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 Drospil on the first day of your cycle (i.e., the first day of your period). If you start Drospil 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 must use additional contraceptive methods (e.g., a condom) for the first 7 days.

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

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

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

You can switch 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., a condom) for the first 7 days of tablet intake.

• After an abortion

Follow your doctor's recommendations.

• After having a baby

You can start taking Drospil between 21 and 28 days after having a baby. If you start later, you must use a barrier method (e.g., a condom) for the first 7 days of Drospil use.

If, after having a baby, you have already had sexual intercourse, before starting Drospil, you must be sure that you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start taking Drospil

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take more Drospil than you should

No cases have been reported in which an overdose of Drospil has caused serious harm.

If you take many tablets at the same time, you may feel unwell or have 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 Drospil tablets, or discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Drospil

The last 4 tablets of the 4throw of the pack are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of Drospil. Discard the forgotten placebo tablet.

If you forgot to take an active pink tablet (tablets 1-24 of the blister pack), follow these tips:

• If you are less than 24 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 24 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. The following recommendations should be followed in this situation (see the diagram below):

• Forgetfulness of more than one pink tablet from the pack

Consult your doctor.

• Forgetfulness of a tablet during days 1-7 (first row)

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 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 know that there is a risk of pregnancy. In this case, consult your doctor.

• Forgetfulness of a tablet during days 8-14 (second row)

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.

• Forgetfulness of a tablet between days 15-24 (third or fourth row)

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. Instead of continuing with the white placebo tablets, discard them and start a new pack (the day you take the first tablet will be different).

You will likely have your period at the end of the second pack – during the intake of the white placebo tablets – although you may experience spotting or bleeding similar to menstruation during the intake of the second pack.

1. You can also stop taking the active pink tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day you forgot to take the tablet). If you want to start a new pack on the scheduled start day, take the placebo tablets for less than 4 days.

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

• If you have forgotten to take a tablet from a pack and do not have your period during the placebo days, this may mean that you are pregnant. You must consult your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active pink 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. This is similar to forgetting a tablet. After vomiting or diarrhea, you must take a pink tablet from a reserve pack as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If this is not possible or more than 24 hours have passed, follow the tips in the section "If you forget to take Drospil".

Delayed menstrual period: what you should 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 the tablets from a new pack of Drospil and finish it. You may experience spotting or bleeding similar to menstruation during the intake of the second pack. Finish this second pack by taking the 4 white tablets from the 4th row. Then, start the next pack.

Ask your doctor before deciding to delay your menstrual period.

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

If you take the tablets according to the instructions, your menstrual period will begin during the placebo days. If you need to change this day, you can do so by reducing the placebo days (the days you take the white tablets) (but never increase them - 4 days is the maximum!). For example, if you start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), you must start a new pack 3 days earlier than usual. You may not have bleeding during these placebo days. Afterward, you may experience light bleeding or bleeding similar to your period.

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

If you stop treatment with Drospil

You can stop taking Drospil 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, stop taking Drospil 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 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 Drospil, 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 Drospil".

Severe Adverse Effects

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 section "Warnings and Precautions").

The following adverse effects have been associated with the use of Drospil.

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

• mood changes,
• headache,
• nausea,
• breast pain, menstrual problems such as irregular periods, absence of periods.

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

• depression, nervousness, drowsiness,
• dizziness, tingling, and numbness,
• 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 periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex,
• lack of energy, increased sweating, fluid retention,
• weight gain.

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

• 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,
• vein inflammation, nosebleeds, fainting,
• abdominal enlargement, intestinal disorder, feeling of flatulence, gastric hernia, oral thrush, constipation, dry mouth,
• pain in the bile ducts or gallbladder, gallbladder inflammation,
• brownish-yellow spots on the skin, eczema, hair loss, skin inflammation with acne-like appearance, skin inflammation with swelling, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, skin inflammation due to photosensitivity, skin nodules,
• difficult or painful sex, vaginal inflammation (vulvovaginitis), bleeding after sex, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucous membrane of the cervix, shrinkage or loss of uterine lining, ovarian cysts, uterine enlargement,
• 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 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 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).

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with target-like redness or ulcers).

Reporting Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. 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 Drospil

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use 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 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 Drospil

• The active ingredients are ethinylestradiol and drospirenone. Each active pink film-coated tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone. The white film-coated tablets do not contain active ingredients.
• The other components are:

Active pink tablets:

Tablet core: lactose monohydrate, pregelatinized corn starch, povidone (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572).

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

White placebo tablets:

Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).

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

Appearance of the Product and Package Contents

• Each Drospil blister pack contains 24 active pink film-coated tablets, in the 1st, 2nd, 3rd, and 4th row of the blister pack, and 4 white film-coated placebo tablets, in the 4th row.
• The Drospil tablets (pink and white) are film-coated tablets; the tablet core is coated.
• Drospil is available in boxes containing 1, 3, 6, and 13 blister packs, each with 28 (24+4) tablets.

Only some pack 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

24193 Villaquilambre, León

Spain

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

Belgium: Droseffik 0,02 mg/3 mg filmomhulde tabletten

Spain: Drospil 0,02 mg/3 mg comprimidos recubiertos con película EFG

Italy: Drospil 0,02 mg/3 mg compresse rivestite con film

Luxembourg: Droseffik 0.02 mg/3 mg comprimés pelliculés

Portugal: Droseffik 3 mg/0,02 mg comprimidos revestidos por película

Date of the last revision of this leaflet: 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/.