DROSPIRENONE/ETHINYLESTRADIOL CINFALAB 3mg / 0.02mg FILM-COATED TABLETS (24+4) Generic

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

drospirenone/ethinylestradiol cinfalab 3 mg/0.02 mg film-coated tablets(24+4)EFG

drospirenone/ethinylestradiol

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

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

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

When not to use drospirenone/ethinylestradiol cinfalab

Warnings and precautions

Blood clots

drospirenone/ethinylestradiol cinfalab and cancer

Irregular bleeding

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

Using drospirenone/ethinylestradiol cinfalab with other medicines

Taking drospirenone/ethinylestradiol cinfalab with food and drink

Laboratory tests

Pregnancy, breastfeeding

Driving and using machines

drospirenone/ethinylestradiol cinfalab contains lactose.

1. How to take drospirenone/ethinylestradiol cinfalab

Preparing the blister

When you can start with the first pack

If you take more drospirenone/ethinylestradiol cinfalab than you should

If you forget to take drospirenone/ethinylestradiol cinfalab

What to do in case of vomiting or severe diarrhea

Delayed period: what you should know

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

If you stop taking drospirenone/ethinylestradiol cinfalab

1. Possible side effects

1. Storing drospirenone/ethinylestradiol cinfalab

1. Package contents and further information

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

• drospirenone/ethinylestradiol cinfalab is a contraceptive and is used to prevent pregnancy.
• Each of the 24 active tablets, pink in color, contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.
• The 4 white tablets do not contain active ingredients and are called placebo tablets.

Contraceptives that contain two hormones are called combined contraceptives.

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

When not to use drospirenone/ethinylestradiol cinfalab

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 (see also the section on taking drospirenone/ethinylestradiol cinfalab with other medications).

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.

• 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 that 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 blood clot in the arteries. This refers to the following diseases:

• 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) inflammation of the pancreas (pancreatitis).
• 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 in the past) a tumor in the liver.
• If you have (or have had in the past), or if you suspect that you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medication (included in section 6). This may manifest with itching, rash, or inflammation.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take drospirenone/ethinylestradiol cinfalab.

When to be careful with drospirenone/ethinylestradiol cinfalab

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

In some situations, you will need to be careful while using drospirenone/ethinylestradiol cinfalab or any other combined hormonal contraceptive, and your doctor may need to examine you periodically. 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 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 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 "Using drospirenone/ethinylestradiol cinfalab with other medications").
• If you have any disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous disease in which involuntary movements appear (Sydenham's chorea).
• If you have or have had brownish-yellow spots (chloasma), also called "pregnancy spots", especially on the face. In this case, avoid direct exposure to the sunor 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 (which is called "venous thrombosis", "venous thromboembolism", or VTE).

• In the arteries (which 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 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 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 blood 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 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 again (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 that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as 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 50).
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using drospirenone/ethinylestradiol cinfalab several weeks before the operation 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 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) may 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 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 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 blood 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 drospirenone/ethinylestradiol cinfalab is very small, but it can increase:

• With age (above 35 years).
• If you smoke. When using a combined hormonal contraceptive like drospirenone/ethinylestradiol cinfalab, you are advised to quit smoking. If you are not able to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 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 even 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 a lot of weight, inform your doctor.

drospirenone/ethinylestradiol cinfalab and cancer

There has been a slightly higher incidence of breast cancer in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that women who use combined contraceptives are more likely to have regular check-ups, which may lead to earlier detection of breast cancer.

3. How to Take Drospirenone/Ethinylestradiol Cinfalab

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

The two different types of colored tablets of drospirenone/ethinylestradiol cinfalab are placed in order. One pack contains 28 tablets.

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

Do not confuse the tablets:take one pink tablet every day for the first 24 days, followed by one white tablet for the last 4 days. Then, start a new pack (24 pink tablets and 4 white tablets). This way, there is no break between two packs.

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

Preparing the Blister Pack

To help you follow the order of intake, each pack of drospirenone/ethinylestradiol cinfalab includes seven adhesive strips with the 7 days of the week printed on them. Choose the strip that starts with the day you take the first tablet. For example, if you start on Wednesday, attach the strip that indicates "WED" as the initial tablet.

Attach the adhesive strip to the top of the blister pack where it says "Place the strip here", so that the first day is above the tablet marked with "1". This way, there is a day of the week indicated above each tablet, and you can see if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

During the 4 days when you take the white placebo tablets (placebo days), you should have your period (also called withdrawal bleeding). Usually, the period starts on the 2nd or 3rd day after taking the last active pink tablet of drospirenone/ethinylestradiol cinfalab. Once you have taken the last white tablet, you should start the next pack, even if you have not finished your period. This means that you should start each pack on the same day of the weekthat you started the previous one, and your period should take place during the same days every month.

If you take drospirenone/ethinylestradiol cinfalab as indicated, you will also be protected against pregnancy during the 4 days when you are taking the placebo tablets.

When to Start 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 period). If you start drospirenone/ethinylestradiol cinfalab on the first day of your period, 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) for the first 7 days.

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

You can start taking drospirenone/ethinylestradiol 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 (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 (pill, injection, implant, or intrauterine system (IUS) of progestin).

You can switch from the progestin-only pill at any time (if it's an implant or IUS, on the day of its removal; if it's 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) for the first 7 days of tablet intake.

• 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 after giving birth. If you start later, use a barrier method (e.g., a condom) for the first 7 days of drospirenone/ethinylestradiol cinfalab use.

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

Ask your doctor if you are unsure when to start.

If You Take More Drospirenone/Ethinylestradiol Cinfalab Than You Should

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

If you take many tablets at once, you may experience nausea or vomiting. Adolescent girls may suffer from 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

The last 4 tablets of the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of drospirenone/ethinylestradiol cinfalab. Discard the forgotten placebo tablet.

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

• 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 missed, the higher the risk of pregnancy.

The risk of incomplete protection against pregnancy is highest if you miss a pink tablet at the beginning or end of the pack. The following recommendations should be followed in this situation (see the diagram below):

• Missing more than one tablet from the pack

Consult your doctor.

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

Take the missed 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, e.g., a condom, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

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

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

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

You can choose between two options:

1. Take the missed 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 pack, discard them and start the next pack (the day you take the first tablet will be different).

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

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

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

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

What to Do in Case of Vomiting or Severe Diarrhea

If you vomit within 3-4 hours after taking an active pink tablet or experience severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to missing a tablet. After vomiting or diarrhea, take another pink tablet from a reserve pack as soon as possible. If possible, take it within 12 hours after the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take drospirenone/ethinylestradiol cinfalab".

Delayed Period: What You Should Know

Although it is not recommended, you can delay your menstrual period if you do not take the white placebo tablets from the fourth row and start a new pack of drospirenone/ethinylestradiol cinfalab and finish it. You may experience light bleeding or spotting during the intake of the second pack.

Ask your doctor before deciding to delay your period.

Changing the First Day of Your Period: What You Should Know

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

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

If You Stop Treatment with Drospirenone/Ethinylestradiol Cinfalab

You can stop taking drospirenone/ethinylestradiol cinfalab at any time. 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 until your menstrual period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

If you have any additional doubts about the use of this product, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, drospirenone/ethinylestradiol cinfalab can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or if you 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 the 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 taking drospirenone/ethinylestradiol cinfalab".

The following list of adverse effects has been associated with the use of drospirenone/ethinylestradiol cinfalab.

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

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

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

• Depression, nervousness, drowsiness
• Dizziness, tingling, and numbness,
• Migraine, varicose veins, increased blood pressure
• Stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea
• Acne, itching, skin rash
• Discomfort and pain, such as back pain, pain in the limbs, muscle cramps
• Vaginal yeast infection, pain in the lower abdominal region (pelvic), breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavy periods, vaginal dryness, abnormal cervical smear, loss of interest in sex

• Lack of energy, increased sweating, fluid retention
• Weight gain

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

• Candida (a fungal infection)
• Anemia, increased platelet count in the blood.
• Allergic reaction.
• Hormonal disorder (endocrine)
• Increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood
• Inability to experience an orgasm, insomnia
• Dizziness, tremors

• Eye disorders, such as eyelid inflammation, dry eyes
• Unusually rapid heart rate.
• Inflammation of a vein, nosebleeds, fainting
• Enlargement of the abdomen, intestinal disorder, feeling of bloating, gastric hernia, oral thrush, constipation, dry mouth.
• Pain in the bile ducts or gallbladder, inflammation of the gallbladder.
• Brownish-yellow spots on the skin, skin inflammation with swelling, excessive hair growth, skin disorders due to photosensitivity, skin nodules.
• Difficult or painful sex, vaginal inflammation (vulvovaginitis), bleeding after sex, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucous membrane of the cervix, shrinkage or loss of uterine lining, ovarian cysts, enlargement of the uterus
• Discomfort
• Weight loss
• Harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT)
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

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

Reporting Adverse Effects

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

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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 use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE pointof the pharmacy. In case of doubt, askyour pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Drospirenone/Ethinylestradiol Cinfalab

The active ingredients are ethinylestradiol and drospirenone.

Each active film-coated pink tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.

The white film-coated tablets do not contain active ingredients.

The other components are:

Film-coated pink tablets:

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

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

Film-coated white tablets:

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

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

Appearance of the Product and Package Contents

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

La Vallina s/n;

24008-Villaquilambre, León

Spain

Date of the Last Revision of this Prospectus: June 2024

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