DROSPIRENONE/ETHINYLESTRADIOL CINFALAB 3mg/0.03mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

drospirenone/ethinylestradiol cinfalab 3 mg/0.03 mg film-coated tablets EFG

drospirenone/ethinylestradiol

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

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get 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 methods of contraception 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 see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the pack

1. What is drospirenone/ethinylestradiol cinfalab and what it is used for
2. What you need to know before you start taking drospirenone/ethinylestradiol cinfalab
3. How to take drospirenone/ethinylestradiol cinfalab
4. Possible side effects
5. Storage of drospirenone/ethinylestradiol cinfalab
6. Contents of the pack and other information

1. What is drospirenone/ethinylestradiol cinfalab and what it is used for

drospirenone/ethinylestradiol cinfalab is a contraceptive. It is used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before you start taking drospirenone/ethinylestradiol cinfalab

General considerations

Before you start using drospirenone/ethinylestradiol 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 you start taking drospirenone/ethinylestradiol cinfalab, your doctor will ask you about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health, may perform other tests.

This leaflet describes several situations in which you should stop using drospirenone/ethinylestradiol cinfalab, or in which the effect of drospirenone/ethinylestradiol cinfalab may be reduced. In such situations, you should not have sex or should take extra non-hormonal contraceptive precautions, such as using a condom or another barrier method.

Do not use the rhythm or temperature methods. These methods may not be reliable because drospirenone/ethinylestradiol cinfalab alters the monthly changes in body temperature and cervical mucus.

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

When you should not use drospirenone/ethinylestradiol cinfalab

Do not take drospirenone/ethinylestradiol cinfalab if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking drospirenone/ethinylestradiol cinfalab with other medicines”).

You should not use drospirenone/ethinylestradiol 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.

Do not take drospirenone/ethinylestradiol cinfalab:

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolus, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you are to be immobile for a long time (see section “Blood clots”).
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of an impending heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following diseases that may increase your risk of 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 known as hyperhomocysteinaemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have had) an inflammation of the pancreas (pancreatitis).
• If you have or have had liver disease and your liver function has not returned to normal yet.
• If your kidneys are not working well (renal failure).
• If you have or have had a liver tumor.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding that has not been explained.
• If you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of drospirenone/ethinylestradiol cinfalab. This may cause itching, rash, or inflammation.

Warnings and precautions

Consult your doctor or pharmacist before you start taking drospirenone/ethinylestradiol cinfalab.

When you need to be especially careful with drospirenone/ethinylestradiol cinfalab

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

In some situations, you should be extra careful while using drospirenone/ethinylestradiol cinfalab or any other combined hormonal contraceptive, and your doctor may need to perform regular check-ups. If the condition develops or worsens while you are using drospirenone/ethinylestradiol cinfalab, 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 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 systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• 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 surgery 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 drospirenone/ethinylestradiol 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 first appeared 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 had chloasma (brownish spots, also called "pregnancy spots", especially on the face). In that 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.

Psychiatric disorders:

Some women who use hormonal contraceptives like drospirenone/ethinylestradiol cinfalab 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.

BLOOD CLOTS

The use of a combined hormonal contraceptive like drospirenone/ethinylestradiol 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 (called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (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 drospirenone/ethinylestradiol 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 adverse 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 having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year 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 drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol 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 containing 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 containing drospirenone, such as drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol 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).
• If you need to have surgery or spend a lot of time without getting up due to an injury or illness or if you have your leg in a cast. You may need to stop using drospirenone/ethinylestradiol cinfalab several weeks before surgery or while you have less mobility. If you need to stop using drospirenone/ethinylestradiol cinfalab, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

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

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

It is essential to inform your doctor if you have any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using drospirenone/ethinylestradiol cinfalab.

If any of the above conditions change while you are using drospirenone/ethinylestradiol cinfalab, for example, a close relative experiences a thrombosis without a known cause or you gain much weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a 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 drospirenone/ethinylestradiol cinfalab is very small, but it can increase:

• With age (above about 35 years).
• If yousmoke. When you use a combined hormonal contraceptive like drospirenone/ethinylestradiol 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 or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using drospirenone/ethinylestradiol cinfalab, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain much weight, inform your doctor.

Drospirenone/ethinylestradiol 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 a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.

It is essential to have your breasts checked regularly, and you should see your doctor if you notice any lump.

Rarely, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you experience severe abdominal pain.

Bleeding between menstrual periods

During the first few months of using drospirenone/ethinylestradiol cinfalab, you may experience unexpected bleeding (bleeding outside of the placebo period). 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 should you do if you do not have your period during the rest phase?

If you have taken all the yellow tablets correctly, have not vomited, or had severe diarrhea, and have not taken any other medication, it is 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.

Taking other medications

Always inform the doctor who prescribed drospirenone/ethinylestradiol cinfalab about the medications or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes you another medication (or your pharmacist) that you are taking drospirenone/ethinylestradiol cinfalab. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

Do not take drospirenone/ethinylestradiol cinfalab if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver test results (increase in liver enzyme ALT).

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

Drospirenone/ethinylestradiol cinfalab can be used again approximately 2 weeks after the end of this treatment. See the section "Do not use drospirenone/ethinylestradiol cinfalab".

• Some medications may cause drospirenone/ethinylestradiol cinfalab to lose its contraceptive effect or may cause unexpected bleeding. This applies to medications used to treat:

• epilepsy (primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• HIV infection (ritonavir, nevirapine) or other infectious diseases (griseofulvina, penicillin, tetracycline)
• St. John's Wort herbal remedy.

• Drospirenone/ethinylestradiol cinfalab may affect the effect of other medications, e.g.,

• medications containing cyclosporin
• antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

Consult your doctor or pharmacist before using any medication.

Taking drospirenone/ethinylestradiol cinfalab with food, drinks, and alcohol

You can take the tablets with or without food, with a glass of water if necessary.

Lab tests

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, you should not take drospirenone/ethinylestradiol cinfalab. If you become pregnant during treatment with drospirenone/ethinylestradiol cinfalab, you should stop treatment immediately and see your doctor.

3. How to take drospirenone/ethinylestradiol cinfalab

Take one drospirenone/ethinylestradiol 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.

A pack (blister) contains 21 tablets. The day of the week on which you should take the tablet is printed next to each tablet. For example, if you start on a Wednesday, you should take a tablet with "WED" on the side. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Then, you should not take any tablets for 7 days. During those 7 days when you should not take tablets (called the tablet-free period), menstruation should occur. Usually, menstruation, which can also be called withdrawal bleeding, begins on the second or third day of the tablet-free period.

On the eighth day after taking the last drospirenone/ethinylestradiol cinfalab tablet (i.e., after the 7-day tablet-free period), start the next pack, even if you have not yet finished menstruating. This means that you should start the next pack on the same day of the week that you started the previous one, and that menstruation should occur during the same days every month.

If you use drospirenone/ethinylestradiol cinfalab in this way, you will also be protected against pregnancy during the 7 days when you do not take any tablets.

When can you start with the first pack?

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

Start taking drospirenone/ethinylestradiol cinfalab on the first day of your cycle (i.e., the first day of your menstruation). If you start drospirenone/ethinylestradiol 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.

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

You can start taking drospirenone/ethinylestradiol cinfalab the day after the week of rest from your previous contraceptive (or after taking the last inactive tablet). When changing from a combined vaginal ring or patch, follow your doctor's recommendations.

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

You can change from the progestin-only pill at any time (if it is an implant or an IUD, on the same 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 taking.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

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

If, after having a child, you have already had sexual intercourse before starting to take drospirenone/ethinylestradiol cinfalab again, 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 drospirenone/ethinylestradiol cinfalab again after having a child.

Read the "Breastfeeding" section.

Let your doctor advise you in case you are not sure when to start.

If you take more drospirenone/ethinylestradiol cinfalab than you should

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

The symptoms that may appear if you take many tablets at once are nausea and vomiting. Adolescent girls may experience vaginal bleeding.

If you have taken too many drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol cinfalab

• If you are late less than 12 hoursin taking a 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 late more than 12 hoursin taking a 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):

?

Consult your doctor.

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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, during 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 that case, consult your doctor.

?

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. Contraceptive protection will not decrease, and you do not need to take additional precautions.

?

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 starting the tablet-free period, start the next pack.

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

1. You can also stop taking tablets. You must start a 7-day tablet-free period (noting the day you forgot to take thetablet). If you want to start a new pack on your fixed start day, the tablet-free period must be 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 tablet-free period, this may mean that you are pregnant. In that case, you must consult your doctor before continuing with the next pack.

What should you do in case of vomiting or severe diarrhea?

If you vomit within 3-4 hours after taking a yellow tablet or suffer from 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 forget to take drospirenone/ethinylestradiol cinfalab" section.

Delayed menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you continue taking a second pack of drospirenone/ethinylestradiol cinfalab instead of starting the tablet-free period. You may experience spotting (drops or spots of blood) or bleeding during the use of the second pack. After the usual 7-day tablet-free period, continuewith the next pack.

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

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

If you take the tablets according to the instructions, your menstrual period (withdrawal bleeding) will begin during the tablet-free period. If you need to change that day, you can do so by shortening ( but never lengthening!- 7 is the maximum) the tablet-free period. For example, if your tablet-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you must start a new pack 3 days earlier than usual. If you make the tablet-free period very short (e.g., 3 days or less), you may not experience 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 drospirenone/ethinylestradiol cinfalab

You can stop taking drospirenone/ethinylestradiol cinfalab 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 drospirenone/ethinylestradiol 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol cinfalab, consult your doctor.

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 section "Warnings and precautions").

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 you start using drospirenone/ethinylestradiol cinfalab".

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

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

• menstrual disorders, intermenstrual bleeding, breast pain
• headache, depression
• migraine
• nausea
• lethargy, white vaginal discharge, and vaginal yeast infection.

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

• changes in libido (interest in sex)
• high blood pressure, low blood pressure
• vomiting
• acne, skin rash (eczema), intense itching
• vaginal infection
• fluid retention and changes in body weight.

Rare side effects (may affect up to 1 in 10,000 women):

• allergic reactions (hypersensitivity),
• asthma
• breast secretion
• hearing problems
• 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, which is called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

• 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).

The possibilities of having a blood clot may be greater 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 medicine.

5. Storage of drospirenone/ethinylestradiol cinfalab

Keep this medicine out of the sight and reach of children. This medicine does not require special storage conditions.

Do not take drospirenone/ethinylestradiol cinfalab after the expiration date that appears on the packaging after the phrase "Do not use after:" or "CAD:"

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

6. Contents of the pack and additional information

Composition of drospirenone/ethinylestradiol cinfalab

The active ingredients are 0.03 mg of ethinylestradiol and 3 mg of drospirenone. The other components are:

Core of the tablet: 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, yellow iron oxide (E-172).

Appearance of drospirenone/ethinylestradiol cinfalab and contents of the pack

Film-coated tablets, round, yellow in color.

drospirenone/ethinylestradiol cinfalab is available in boxes of 1, 2, 3, 6, and 13 packs (blisters), each containing 21 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;

La Vallina s/n;

24008-Villaquilambre, León

Spain

Date of the last revision of this leaflet: June 2024

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