ETHINYL ESTRADIOL/DROSPIRENONE DAILY CINFALAB 0.03 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Etinilestradiol/Drospirenone Daily Cinfalab 0.03 mg/3 mg Film-Coated Tablets EFG

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

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

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

Each of the 21 yellow tablets contains a small amount of two different female hormones, called etinilestradiol 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. Your doctor will also measure your blood pressure and, depending on your state of health, may perform other tests.

This prospectus describes several situations in which you should interrupt the use of 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 the use of 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. If you have any of the conditions listed below, you must inform your doctor. 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 symptoms of stroke).

• 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 had liver disease in the past and your liver function has not yet normalized.
• If your kidneys do not work well (renal failure).
• If you have or have had a liver tumor.
• If you have (or have 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 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.

Do not take etinilestradiol/drospirenona daily cinfalab 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 medications 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 kidney 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 on you.

• 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 (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 etinilestradiol/drospirenona daily cinfalab 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 "Use of other medications").
• If you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones; for example, hearing loss, 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 (brownish spots, also called "pregnancy spots", especially on the face). 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 or pharynx, 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.

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.

BLOOD CLOTS

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

Blood clots can form:

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

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

It is 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 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 of another organ such as the eye (retinal vein thrombosis)

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

The risk of having a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking etinilestradiol/drospirenona daily cinfalab, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of having a blood clot in the leg or lung (DVT or PE) with 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 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 drospirenona like etinilestradiol/drospirenona daily cinfalab, between 9 and 12 women will have a blood clot in a year.

The risk of having a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below)

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

The risk of having a blood clot with 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 50 approximately). 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 interrupt the use of etinilestradiol/drospirenona daily cinfalab several weeks before surgery or while you have less mobility. If you need to interrupt the use of etinilestradiol/drospirenona daily cinfalab, ask your doctor when you can start using it again.

• As you get older (especially over 35 years).

• If you have given birth in the last few weeks.

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

Long-distance 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 interrupt the use of 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 (over 35 years).

• If you smoke. When using a combined hormonal contraceptive like etinilestradiol/drospirenona daily cinfalab, 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 method of contraception.

Advise her to use a different type of contraceptive.

• If she is overweight.
• If she has high blood pressure.
• If a close relative has suffered a heart attack or stroke at a young age (less than 50 years). In this case, she may also be at higher risk of having a heart attack or stroke.
• If she or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If she suffers from migraines, especially migraines with aura.
• If she has a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If she has diabetes.

If she has 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 she is using etinilestradiol/drospirenona daily cinfalab, for example, she starts smoking, a close relative experiences a thrombosis without a known cause, or she gains a lot of weight, she should inform her doctor.

etinilestradiol/drospirenona daily cinfalab and cancer

Women who use combined contraceptives have a slightly higher rate of breast cancer, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by 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 she should see her doctor if she notices any lump.

In rare cases, benign tumors in the liver and, even more rarely, malignant tumors have been reported in users of contraceptives. She should see her doctor if she suffers from sudden severe abdominal pain.

Bleeding between menstrual periods

During the first few months of using etinilestradiol/drospirenona daily cinfalab, unexpected bleeding (bleeding outside the placebo period) may occur. If she experiences such bleeding for more than a few months or if it starts after a few months, her doctor should investigate the cause.

What should she do if she does not have her period during the placebo phase?

If she has taken all the yellow tablets correctly, has not vomited, or suffered from severe diarrhea, and has not taken any other medication, it is very unlikely that she is pregnant.

If she does not have two consecutive menstrual periods, she may be pregnant. In this case, she should see her doctor immediately. She should not start the next pack until she is sure she is not pregnant.

Other medications and etinilestradiol/drospirenona daily cinfalab

She should inform the doctor who prescribed etinilestradiol/drospirenona daily cinfalab about the medications or herbal preparations she is taking, has taken recently, or may need to take. She should also inform any other doctor or dentist who prescribes her another medication (or her pharmacist) that she is taking etinilestradiol/drospirenona daily cinfalab. They may advise her to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or if she should change the use of another medication.

• 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 virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
  • fungal infections (griseofulvin, ketoconazole),
  • arthritis, arthrosis (etoricoxib),
  • high blood pressure in the blood vessels in the lungs (bosentan).

• the herbal remedy 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 (for treating respiratory problems),
• tizanidine (for treating muscle pain and/or muscle cramps).

She should not take etinilestradiol/drospirenona daily cinfalab if she has Hepatitis C and is taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in the liver enzyme ALT).

Her doctor will prescribe another type of contraceptive before starting treatment with these medications.

etinilestradiol/drospirenona daily cinfalab can be used again approximately 2 weeks after the end of this treatment. See the section "Do not take etinilestradiol/drospirenona daily cinfalab".

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 she needs a blood test, she should inform her doctor or the laboratory staff that she is taking a contraceptive, as oral contraceptives can influence the results of some tests.

Pregnancy and breastfeeding

If she is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medication.

Pregnancy

If she is pregnant, she should not take etinilestradiol/drospirenona daily cinfalab. If she becomes pregnant during treatment with etinilestradiol/drospirenona daily cinfalab, she should stop the treatment immediately and contact her doctor. If she wants to become pregnant, she can stop taking etinilestradiol/drospirenona daily cinfalab at any time (see also: "Stopping treatment with etinilestradiol/drospirenona daily cinfalab").

Breastfeeding

In general, it is not recommended to take etinilestradiol/drospirenona daily cinfalab during breastfeeding. If she wants to take the contraceptive while breastfeeding, she should consult her doctor.

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

If her doctor has told her that she has an intolerance to certain sugars, she should consult him before taking this medication.

3. How to take etinilestradiol/drospirenona daily cinfalab

Follow the administration instructions of 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 yellow tablets and 7 white tablets that contain a placebo.

The two different types of colored etinilestradiol/drospirenona daily cinfalab tablets are placed in order. A pack contains 28 tablets.

Take one etinilestradiol/drospirenona daily cinfalab tablet 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 with the tablet: take a yellow tablet for the first 21 days and then a white tablet for the last 7 days. Then, you should start taking a new pack (21 yellow 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 that you 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 pack.

Preparation of the pack

To keep track of the daily intake of the contraceptive, each pack (blister) of etinilestradiol/drospirenona daily cinfalab includes seven adhesive strips that have 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 pack, in the "Start" position. This way, there is a day of the week indicated above each tablet and you can visually check if you have taken a 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 (also called withdrawal bleeding) usually begins. Menstruation usually starts on the second or third day after taking the last active yellow etinilestradiol/drospirenona tablet. Once you have taken the last white tablet, you should start the next pack, even if you have not finished bleeding. This means that you should start the next pack on the same day of the weekthat you started the previous one, and that menstruation should take place during the same days every month.

If you take etinilestradiol/drospirenona 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 pack?

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

Start taking etinilestradiol/drospirenona daily cinfalab on the first day of your cycle (i.e., the first day of your menstruation). If you start etinilestradiol/drospirenona daily cinfalab on the first day of your menstruation, you will be immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but you 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 etinilestradiol/drospirenona daily cinfalab preferably on the day after the rest week of your previous contraceptive (or after taking the last inactive tablet). When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

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

You can switch from a progestin-only pill at any time; however, (if it is an implant or IUD, you should 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 etinilestradiol/drospirenona 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 etinilestradiol/drospirenona daily cinfalab.

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

• If you are breastfeeding and want to start taking etinilestradiol/drospirenona 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 etinilestradiol/drospirenona daily cinfalab than you should

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

If you take several tablets at once, you may feel unwell or have 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 etinilestradiol/drospirenona 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 used.

If you forget to take etinilestradiol/drospirenona daily cinfalab

The tablets in the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, the effect of etinilestradiol/drospirenona daily cinfalab will not be affected. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the efficacy of the etinilestradiol/drospirenona daily cinfalab tablets.

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

• If you are less than 12 hourslate in taking an active tablet, protection against pregnancy will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking an active tablet, protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk that protection against pregnancy will decrease.

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

• Forgetfulness of more than one tablet from 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 once. Continue taking the following tablets at the usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should 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 following tablets at the usual time. 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 following tablets at the usual time. Instead of taking the 7 white placebo tablets, start taking the next pack.

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

1. You can also stop taking the active yellow tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, note the day you forgot the tablet). If you want to start a new pack on your fixed start day, take the placebo tablets for 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 period during the placebo week (rest period), this may mean that you are pregnant. In this case, you should consult your doctor before continuing with the next pack.

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

What to do in case of nausea or severe diarrhea

If you vomit within 3-4 hours after taking an active yellow tablet or have severe diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take a tablet from a reserve pack as soon as possible. If possible, take it before 12 hourshave passed since the usual time you take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the "If you forgot to take Etinilestradiol/drospirenona daily cinfalab" section.

Delay of 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 go directly to a new pack of etinilestradiol/drospirenona daily cinfalab and finish it.

You may experience light bleeding or similar to menstruation while using this second pack. Finish this second pack by taking the 7 white tablets from the 4th row. Then, start the next pack.

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

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

If you take the tablets as instructed, your menstrual period (withdrawal bleeding) will begin during the placebo period. If you need to change that day, you can do so by shortening ( but never lengthening - 7 is the maximum) the placebo period. 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 pack 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), you may not have menstruation (withdrawal bleeding) during this period. Then, you may experience spotting (drops or spots of blood) or bleeding.

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

If you interrupt treatment with etinilestradiol/drospirenona daily cinfalab

You can stop taking etinilestradiol/drospirenona 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 etinilestradiol/drospirenona 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 medicines, etinilestradiol/drospirenona daily cinfalab can cause side effects, although not everyone gets 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 etinilestradiol/drospirenona 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 taking etinilestradiol/drospirenona 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 etinilestradiol/drospirenona daily cinfalab.

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

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness

• headache, depression,
• migraine,
• nausea,
• lethargy, white vaginal discharge, and vaginal yeast infection.

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

• changes in libido (sex drive), breast enlargement

• high blood pressure, low blood pressure,

• vomiting, diarrhea

• acne, skin rash, intense itching, hair loss (alopecia)

• vaginal infection,
• fluid retention and changes in body weight.

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

• allergic reactions (hypersensitivity), asthma,
• breast secretion,
• hearing problems,
• skin conditions such as erythema nodosum (characterized by painful nodules on the skin of a reddish color) or erythema multiforme (characterized by a skin rash with a target-like appearance or sores).
• 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 possibility of having a blood clot can 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 of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side 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 side effects, you can help provide more information on the safety of this medication.

5. Storage of etinilestradiol/drospirenona 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 pack/container after "Do not use after:" or "EXP:". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This 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 yellow 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 0.03 mg of Ethinylestradiol and 3 mg of Drospirenone.

The other components are:

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

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, and yellow iron oxide (E-172).

Placebo Tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of Ethinylestradiol/Drospirenone Daily Cinfalab and Packaging Content

The active tablets are film-coated, round, yellow 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 packs (blisters), each containing 28 tablets (21 active tablets and 7 placebo tablets).

Only some pack 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 thisLeaflet:April 2022

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