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

Introduction

Package Leaflet: Information for the User

Ethinylestradiol/Drospirenone Daily Cinfalab 0.02 mg/3 mg Film-Coated Tablets EFG

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

Contents of the pack and other information

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

Ethinylestradiol/Drospirenone Daily Cinfalab is a contraceptive and is used to prevent pregnancy.

Each of the 21 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” pills.

2. What you need to know before starting to take etinilestradiol/drospirenona daily cinfalab

General considerations

Before starting to use etinilestradiol/drospirenona daily cinfalab, 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 etinilestradiol/drospirenona daily cinfalab, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your state of health, may perform other tests.

In this prospectus, several situations are described in which you should interrupt the use of etinilestradiol/drospirenona daily cinfalab, or in which the effect of etinilestradiol/drospirenona daily cinfalab may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable since etinilestradiol/drospirenona daily cinfalab alters the monthly changes in body temperature and cervical mucus.

etinilestradiol/drospirenona daily cinfalab, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take etinilestradiol/drospirenona daily cinfalab

You should not take etinilestradiol/drospirenona daily cinfalab 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 had in the past) a liver disease and your liver function has not yet normalized.
• If your kidneys do not work well (renal failure).
• If you have (or have had) a tumor in the liver.
• If you have (or have 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 etinilestradiol or drospirenona, or to any of the other components of etinilestradiol/drospirenona daily cinfalab (see section 6). This may manifest with itching, rash or inflammation.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section Other medicines and etinilestradiol/drospirenona daily cinfalab).

Additional information on special populations

Children and adolescents

etinilestradiol/drospirenona daily is not indicated for use in women who have not yet had their first menstrual period.

Older women

etinilestradiol/drospirenona daily is not indicated for use after menopause.

Women with liver failure

Do not take etinilestradiol/drospirenona daily if you suffer from liver disease (see sections "Do not take etinilestradiol/drospirenona daily cinfalab" and "Warnings and precautions").

Women with kidney failure

Do not take etinilestradiol/drospirenona daily if you are suffering from kidney malfunction or acute renal failure (see sections "Do not take etinilestradiol/drospirenona daily cinfalab" and "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to take etinilestradiol/drospirenona daily cinfalab.

When you should be particularly careful with etinilestradiol/drospirenona daily cinfalab

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

If the condition develops or worsens while you are using etinilestradiol/drospirenona daily cinfalab, you should also inform your doctor. In some situations, you will need to be particularly careful while using etinilestradiol/drospirenona daily cinfalab or any other combined hormonal contraceptive, and your doctor may need to perform regular checks.

• 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. Some women who use hormonal contraceptives like etinilestradiol/drospirenona daily cinfalab have reported depression or a depressed mood. Depression can be serious 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.
• 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 (an inherited disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking etinilestradiol/drospirenona daily cinfalab after delivery.
• 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 etinilestradiol/drospirenona daily cinfalab").
• If you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones; for example, loss of hearing, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease in which involuntary movements appear).
• If you have or have ever had chloasma (a discoloration of the skin, especially on the face and neck, known as "pregnancy spots"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• • If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like etinilestradiol/drospirenona daily cinfalab increases your risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

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

It is important to remember that the overall risk of a harmful blood clot due to etinilestradiol/drospirenona daily cinfalab is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).

• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.

• In very rare cases, a clot can form in a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of 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 etinilestradiol/drospirenona daily cinfalab, 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 etinilestradiol/drospirenona daily cinfalab is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimate, about 5-7 will develop a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenona like etinilestradiol/drospirenona daily cinfalab, between about 9 and 12 women will develop 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 a blood clot with etinilestradiol/drospirenona daily cinfalab 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 if you 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 stop using etinilestradiol/drospirenona daily cinfalab several weeks before the operation or while you have less mobility. If you need to stop using etinilestradiol/drospirenona daily cinfalab, ask your doctor when you can start using it again.

• As you get older (especially above about 35 years).

• If you have given birth less than a few weeks ago.

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

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

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

If any of the above conditions change while you are using etinilestradiol/drospirenona daily cinfalab, 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 important to note that the risk of a heart attack or stroke due to etinilestradiol/drospirenona daily cinfalab is very small, but it can increase:

• With age (above about 35 years).

• If you smoke. When using a combined hormonal contraceptive like etinilestradiol/drospirenona daily cinfalab, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.

• If you are overweight.

• If you have high blood pressure.

• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.

• If you have a high level of fat in the blood (cholesterol or triglycerides).
• If you suffer from 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 one or more of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using etinilestradiol/drospirenona daily cinfalab, 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.

etinilestradiol/drospirenona daily cinfalaband cancer

Women who use combined contraceptives have a slightly higher rate of breast cancer, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by the doctor more frequently. The incidence of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to undergo regular breast exams, and you should see your doctor if you notice any lump.

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

Bleeding between periods

During the first few months of using etinilestradiol/drospirenona daily cinfalab, unexpected bleeding (bleeding outside of the week when you are taking the white tablets) may occur. If you experience such bleeding for more than a few months, or if it starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

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

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

Other medications and etinilestradiol/drospirenona daily cinfalab

Tell your doctor about the medications or herbal preparations you are taking, have recently taken, or may need to take. Also, inform any other doctor or dentist who prescribes you another medication (or your pharmacist) that you are taking etinilestradiol/drospirenona daily cinfalab. They may indicate that you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or if you should modify the use of another medication you need.

Some medications may influence the levels of etinilestradiol/drospirenona daily cinfalab in the blood and make it less effective in preventing pregnancy or may cause unexpected bleeding. This applies to:

• medications used to treat
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
  • tuberculosis (e.g., rifampicin),
  • HIV and Hepatitis C infection (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin, ketoconazole)
  • arthritis, arthrosis (etoricoxib)
  • high blood pressure in the blood vessels in the lungs (bosentan).
  • the herbal medicine St. John's Wort.

etinilestradiol/drospirenona daily cinfalab may influence the effect of other medications, e.g.,

• medications containing cyclosporine,
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures),
• theophylline (used to treat respiratory problems),
• tizanidine (used to treat muscle pain and/or cramps).

Do not take etinilestradiol/drospirenona daily cinfalab if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results in the blood (increase in the liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medications. etinilestradiol/drospirenona daily cinfalab can be taken again approximately 2 weeks after the end of this treatment. See the section "Do not take etinilestradiol/drospirenona daily cinfalab".

Consult your doctor or pharmacist before taking any medication.

Taking etinilestradiol/drospirenona daily cinfalab with food and drinks

etinilestradiol/drospirenona daily can be taken with or without food and with some water if necessary.

Laboratory tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as hormonal contraceptives can influence the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should not take etinilestradiol/drospirenona daily cinfalab. If you become pregnant during treatment with etinilestradiol/drospirenona daily cinfalab, you should stop treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking etinilestradiol/drospirenona daily cinfalab at any time (see also: "If you stop treatment with etinilestradiol/drospirenona daily cinfalab").

Consult your doctor or pharmacist before taking any medication.

Breastfeeding

In general, it is not recommended to take etinilestradiol/drospirenona daily cinfalab during the breastfeeding period. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

There is no information to suggest that the use of etinilestradiol/drospirenona daily cinfalab has any effect on the ability to drive or use machinery.

etinilestradiol/drospirenona daily cinfalab contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to Take Ethinylestradiol/Drospirenone Daily Cinfalab

Follow the administration instructions for this medication exactly as 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 ethinylestradiol/drospirenone daily cinfalab are placed in order. One package contains 28 tablets.

Take one tablet of ethinylestradiol/drospirenone daily cinfalab every day with a glass of water if necessary. You can take the tablets with or without food, but every day at approximately the same time.

Do not get confused about the tablet: take a pink tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you should start taking a new package (21 pink tablets and 7 white tablets). This way, there is no break between two packages.

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

Preparing the package

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

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

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

If you take ethinylestradiol/drospirenone daily cinfalab 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 package?

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

Start taking ethinylestradiol/drospirenone daily cinfalab on the first day of your cycle (i.e., the first day of your menstruation). If you start ethinylestradiol/drospirenone daily cinfalab on the first day of your menstruation, you will be protected immediately 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, combined vaginal ring, or patch.

You should start taking ethinylestradiol/drospirenone daily cinfalab 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 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 recommendations.

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

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

• After an abortion or termination of pregnancy.

Follow your doctor's recommendations.

• After having a child.

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

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

• If you are breastfeeding and want to start taking ethinylestradiol/drospirenone daily cinfalab (again) after having a child.

Read the "Breastfeeding" section.

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

If you take more ethinylestradiol/drospirenone daily cinfalab than you should

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

If you take several tablets at once, you may experience overdose symptoms such as nausea and vomiting. Young girls may experience vaginal bleeding. This bleeding can occur even in young girls who have not yet had their first menstrual period, if they have accidentally taken this medication.

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

If you forget to take ethinylestradiol/drospirenone daily cinfalab

The tablets in the 4throw of the package are placebo tablets. If you forget to take one of these tablets, the effect of ethinylestradiol/drospirenone daily cinfalab will not be affected. 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 will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk that the protection against pregnancy will decrease.

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

• Forgetfulness of more than one tablet in the package:

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 once. Continue taking the 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 contact your doctor because there is a possibility that you may be pregnant.

• Forgetfulness of a tablet in week 2:

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time. The contraceptive protection will not decrease, 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 once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this package, discard them and start the next package.

You will likely have your menstrual period at the end of the second package, during the intake of white placebo tablets, although you may experience spotting or bleeding during the intake of the second package.

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 on which you forgot to take the tablet). If you want to start a new package on your fixed start day, 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 your menstrual period during the placebo days, this may mean that you are pregnant. In this case, you should consult your doctor before continuing with the next package.

The following diagram describes how to proceed if you forget to take the tablets:

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 will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take a tablet from a reserve package as soon as possible. If possible, take it before 12 hourshave passed since the usual time you take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the "If you forget to take ethinylestradiol/drospirenone daily cinfalab" section.

Delayed menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period if you do not take the white placebo tablets from the fourth row and start taking a new package of ethinylestradiol/drospirenone daily cinfalab. You may experience spotting or bleeding during the use of the second package. Finish this second package by taking the 7 white tablets from the 4th row. Start the next package.

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

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

If you take the tablets as instructed, your menstrual period will begin during the placebo period. If you need to change that day, reduce the number of days with placebo - when you take the white placebo tablets - (but never increase them - 7 at most!). For example, if your placebo period starts on Friday and you want to change it to Tuesday (3 days earlier), you should start a new package 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), you may not have menstruation during this period. Then, you may experience light bleeding or spotting.

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

If you interrupt treatment with ethinylestradiol/drospirenone daily cinfalab

You can stop taking ethinylestradiol/drospirenone daily cinfalab 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 ethinylestradiol/drospirenone daily cinfalab and wait for a period before trying to become pregnant. You will be able to calculate the probable date of delivery more easily.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to ethinylestradiol/drospirenone daily cinfalab, 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 starting to take ethinylestradiol/drospirenone daily cinfalab".

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

The following is a list of side effects related to the use of ethinylestradiol/drospirenone daily cinfalab.

Common side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

• Candida (vaginal infection),
• cold sore (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling and numbness, dizziness,
• vision problems,
• irregular or unusually fast heartbeat
• blood clot (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 with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, rash, dry skin, seborrheic dermatitis,
• neck pain, limb pain, muscle cramps,
• bladder infection,
• breast lumps (benign and cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic), abnormal cervical smears (Pap smear or Pap staining), decreased libido
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare side effects(may affect up to 1 in 1,000 people):

• asthma,
• hearing problems,
• erythema nodosum (characterized by painful nodules on the skin with a reddish color),
• erythema multiforme (skin rash with target-like redness or ulcers).
• Harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT)
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mini-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 possibilities of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ethinylestradiol/drospirenone daily cinfalab

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not take this medication after the expiration date that appears on the blister/package after "EXP:". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Ethinylestradiol/Drospirenone Daily Cinfalab

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

Active Tablets:

The active ingredients are 0.02 mg of Ethinylestradiol and 3 mg of Drospirenone.

The other 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: lactose, povidone, magnesium stearate.

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

Product Appearance and Packaging Content

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

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

• Ethinylestradiol/Drospirenone Daily Cinfalab is available in boxes of 1, 2, 3, 6, and 13 packages (blister packs), each with 28 tablets (21 active tablets and 7 placebo tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

C/ La Vallina s/n;

24008-Villaquilambre, León

Spain

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

Date of Last Revision of this Leaflet:April 2023

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