Information for the user: package insert

Ethinylestradiol/Drospirenone Daily Stada 0.02 mg/3 mg film-coated tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

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

2. What you need to know before starting to take Ethinylestradiol/Drospirenone Daily Stada

3. How to take Ethinylestradiol/Drospirenone Daily Stada

• Preparing the blister pack
• • When you can start with the first blister pack
  • If you take more Ethinylestradiol/Drospirenone Daily Stada than you should
  • If you forget to take Ethinylestradiol/Drospirenone Daily Stada
  • What to do if you feel unwell or have intense diarrhea
  • Delayed menstrual period: what you should know
  • Change in the first day of your menstrual period: what you should know
  • If you interrupt treatment with Ethinylestradiol/Drospirenone Daily Stada

4. Possible side effects

5. Storage of Ethinylestradiol/Drospirenone Daily Stada

6. Contents of the package and additional information

Ethinylestradiol/drospirenona is a contraceptive and is used to prevent pregnancy.

Each of the 21 active pink tablets contains a small amount of two different female hormones, called ethinylestradiol and drospirenona.

The 7 white tablets without active ingredients are called placebo tablets.

Contraceptives that contain two hormones are called "combined" contraceptives.

General Considerations

Before starting to use etinilestradiol/drospirenona, 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, 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 health status, perform other tests.

This leaflet describes several situations in which you should interrupt the use of etinilestradiol/drospirenona, or in which the effect of etinilestradiol/drospirenona may be reduced. In these situations, you should not have sexual intercourse or take additional non-hormonal contraceptive precautions, such as the use of a condom or other barrier method.

Do not use the rhythm or temperature method. These methods may not be reliable because etinilestradiol/drospirenona alters the monthly changes in body temperature and cervical mucus.

Ethinylestradiol/Drospirenona, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

Do not take Etinilestradiol/Drospirenona Diario Stada

You should not use etinilestradiol/drospirenona 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 vein (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 surgery or if you spend a lot of time without standing 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, symptoms of a 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 vascular damage.
• very high blood pressure.
• very high levels of fat in the blood (cholesterol or triglycerides).
• a condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function well (renal failure).
• If you have (or have had) a liver tumor.
• If you have (or have had), or if you suspect that you have breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, the cause of which is unknown.
• If you are allergic to etinilestradiol or drospirenona, or to any of the other components of etinilestradiol/drospirenona (see section 6). This may manifest itself with itching, rash or inflammation.
• 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 “Taking Etinilestradiol/Drospirenona Diario Stada with other medicines”).

Warnings and Precautions

In some situations, you should take special care while using etinilestradiol/drospirenona or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor.

Inform your doctor if you suffer from any of the following conditions:

If the condition develops or worsens while you are using etinilestradiol/drospirenona, you should also inform your doctor.

• if a close relative has had breast cancer.
• if you have any liver or gallbladder disease.
• if you have diabetes.
• if you have depression.
• if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• if you have sickle cell anemia (a hereditary disease of the 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 surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• if you recently gave birth, you are at greater risk of blood clots. Ask your doctor when you can start taking etinilestradiol/drospirenona after childbirth.
• if you have superficial vein inflammation under the skin (superficial thrombophlebitis).
• if you have varicose veins.
• if you have epilepsy (see “Taking Etinilestradiol/Drospirenona Diario Stada with other medicines”).
• if you have any disease that appeared for the first time during pregnancy or during a 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 occur).
• if you have or have had melasma (brown or yellowish patches, also called “pregnancy patches”, 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 facial swelling, tongue and/or throat swelling and/or difficulty swallowing or urticaria with difficulty breathing, contact a doctor immediately. Hormonal products can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like etinilestradiol/drospirenona increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif 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 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 may cause deep vein thrombosis (DVT).

•If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.

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

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

The risk of a blood clot in a vein is higher during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break 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, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

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

The overall risk of a blood clot in the leg or lung (DVT or PE) with etinilestradiol/drospirenona is small.

-Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.

-Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, noretisterone or norgestimato, 5-7 will develop a blood clot in a year.

-Of every 10,000 women who use a combined hormonal contraceptive that contains drospirenona, such as etinilestradiol/drospirenona, 9-12 will develop a blood clot in a year.

-The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

The risk of having a blood clot with etinilestradiol/drospirenona is small, but some conditions increase the risk. Your risk is higher:

•If you are overweight (body mass index (BMI) of 30 kg/m2or higher).

•If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50). You may have a hereditary disorder of blood clotting.

•If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to interrupt the use of etinilestradiol/drospirenona for several weeks before the surgical procedure or while you have reduced mobility. If you need to interrupt the use of etinilestradiol/drospirenona, ask your doctor when you can start taking it again.

•With increasing age (especially above the age of 35).

•If you have given birth recently.

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

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

It is essential to inform your doctor if you suffer from any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you need to interrupt the use of etinilestradiol/drospirenona.

If any of the conditions mentioned above change while you are using etinilestradiol/drospirenona, for example, a close relative experiences a blood clot 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?

A blood clot in an artery can cause serious problems, such as 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 etinilestradiol/drospirenona is very small, but it may increase:

•With age (above the age of 35).

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

•If you are overweight.

•If you have high blood pressure.

•If a close relative has had a heart attack or stroke at a young age (less than 50 years). You may also be at higher risk of having a heart attack or stroke.

•If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).

•If you have migraines, especially migraines with aura.

•If you have a heart condition (valve disorder, arrhythmia 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 a blood clot may be even higher.

If any of the conditions mentioned above change while you are using etinilestradiol/drospirenona, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Ethinylestradiol/Drospirenona Diario Stada and cancer

Women who use combined hormonal contraceptives have a slightly higher risk of breast cancer, but it is not known whether this is due to the treatment. For example, tumors may be more likely to be detected in women who take combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.

It is essential to have regular breast examinations and you should consult your doctor if you notice any lump.

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

Mental health disorders

Some women who use combined hormonal contraceptives have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Spotting between menstrual periods

During the first few months of using etinilestradiol/drospirenona, you may experience unexpected bleeding (bleeding outside of the placebo period). If you experience these bleedings for more than a few months or if they start after a few months, your doctor needs to investigate the cause.

What to do if you do not have a period during the placebo phase?

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

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

Taking Etinilestradiol/Drospirenona Diario Stada with other medicines

Always inform your doctor who prescribed etinilestradiol/drospirenona about the medicines or herbal preparations you are taking. You should also inform any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking etinilestradiol/drospirenona. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or modify the use of another treatment you need.

Some medicines

• may affect the levels of etinilestradiol/drospirenona in the blood
• may make it lesseffective in preventing pregnancy
• may cause unexpected bleeding

This may occur with:

• medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• HIV and Hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, osteoarthritis (etoricoxib),
• high blood pressure in the blood vessels in the lungs (bosentan).

• St. John's Wort.

Ethinylestradiol/Drospirenonamay affect the effectof other medicines, for example:

• medicines that contain ciclosporin,
• the antiepileptic lamotrigine (this may lead to an increase in seizure frequency).
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or cramps)

Do not take etinilestradiol/drospirenona 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 may cause increases in liver enzyme test results (elevated ALT levels).

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

You can start taking etinilestradiol/drospirenona again approximately 2 weeks after completing this treatment. See the section “Do not take Etinilestradiol/Drospirenona Diario Stada”.

Consult your doctor or pharmacist before using any medicine.

Taking Etinilestradiol/Drospirenona Diario Stada with food and drinks

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

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are pregnant, do not take etinilestradiol/drospirenona. If you become pregnant while taking etinilestradiol/drospirenona, stop taking it immediately and contact your doctor.If you want to become pregnant,you can stop takingetinilestradiol/drospirenonaat any time (see also: “Stopping treatment with etinilestradiol/drospirenona”).

Breastfeeding

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

Driving and operating machinery

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

Important information about some of the components of Etinilestradiol/Drospirenona Diario Stada

This medicine contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Each blister contains 21 active pink tablets and 7 white placebo tablets.

The two different colored tablets of etinilestradiol/drospirenona are arranged in order. A blister contains 28 tablets.

Take one tablet of etinilestradiol/drospirenona every day, with water if necessary. You can take the tablets with or without food, but at approximately the same time every day.

Do not confuse the tablets:take one pink tablet every day for the first 21 days, followed by one white tablet for the last 7 days. Then, start taking a new blister (21 pink tablets and 7 white tablets). In this way, there is no break between two blisters.

Due to the different composition of the tablets, you need 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 blister.

Preparation of the blister:

To help you follow the taking order, each blister of etinilestradiol/drospirenona contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with "WED".

Then, you need to stick the corresponding strip on the upper left corner of the blister in the "Start" position. In this way, there is a day of the week indicated above each tablet and you can check visually if you have taken a specific tablet.

The arrows show the order in which you should take the tablets.

During the 7 days when you take placebo tablets (the placebo days), you usually start your period (also called withdrawal bleeding). Normally, your period starts the second or third day after taking the last active tablet, which is a pale pink tablet of etinilestradiol/drospirenona. Once you have taken the last white tablet, you should start a new blister, even if you have not finished your period yet. This means that you should start each blisteron the same day of the weekthat you started the previous one, and your period should occur on the same days every month.

If you take etinilestradiol/drospirenona Daily as indicated, you are also protected against pregnancy during the 7 days when you are taking placebo tablets.

When to start with the first blister:

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

Start taking etinilestradiol/drospirenona Daily on the first day of the cycle (i.e., the first day of your menstrual period). If you start etinilestradiol/drospirenona Daily on the first day of your menstrual period, you will be protected immediately against pregnancy. You can also start on days 2-5 of the cycle, but you need to use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking etinilestradiol/drospirenona 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 break days of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow the recommendations of your doctor.

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

You can switch from the progestin-only pill on any day (if it is an implant or an IUS, on the day of its removal; if it is an injection, on the day of the next injection), but in all cases, use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

• After an abortion

Follow the recommendations of your doctor.

• After giving birth

You can start taking etinilestradiol/drospirenona between 21 and 28 days after giving birth. If you start later, use one of the barrier methods (e.g., a condom) during the first 7 days of taking etinilestradiol/drospirenona. If, after giving birth, you have already had sexual intercourse before starting to take etinilestradiol/drospirenona (again), you must be sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking etinilestradiol/drospirenona again after giving birth

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take more Etinilestradiol/Drospirenona Daily Stada than you should

No serious cases of overdose of etinilestradiol/drospirenona have been reported.

The symptoms that may appear if you take many tablets at once can be feeling unwell, vomiting, or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

If you have taken too many tablets of etinilestradiol/drospirenona, or if you discover that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken.

If you forgot to take Etinilestradiol/Drospirenona Daily Stada

The tablets in thefourthrow of theblisterare the placebo tablets. If you forget to take one of these tablets, it will have no effect on the effect of etinilestradiol/drospirenona. Dispose of the forgotten placebo tablet. If you forget to take an active pink tablet from the1st, 2nd, or 3rdrow, do the following:

• If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are latemore than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of pregnancy.

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

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetting a tablet in week 2

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

• Forgetting a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from thisblister, dispose of them and start a newblister.

You may experience bleeding during the use of the secondblister, which may be light or similar to menstruation. Finish this secondblisterby taking the 7 white placebo tablets from the 4th row. Then, start a newblister.

1. You can also interrupt the taking of active pink tablets and pass directly to the 7 white placebo tablets, before taking the placebo tablets, note the day on which you forgot to take the tablet.

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 bleeding during the placebo days, you may be pregnant. Contact your doctor before starting a newblister.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3-4 hours following the taking of an active pink tablet, or if you have intense 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 forgetting a tablet. After vomiting or diarrhea, take another active pink tablet from a reserve blister as soon as possible, if possible, take itwithin 12 hoursafter the usual time when you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the instructions in the section "If you forgot to take Etinilestradiol/Drospirenona Daily Stada".

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 placebo tablets and start taking a new blister of etinilestradiol/drospirenona and finish it. You may experience bleeding during the use of the second blister, which may be light or similar to menstruation. Finish this second blister by taking the 7 white placebo tablets from the 4th row. Then, start a new blister.

You should ask your doctor for advice 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 indicated, your menstrual period will start during theweek of placebo. If you want to change that day, reduce the number of days with placebo tablets –when you take the white placebo tablets-(but never increase - 7 at most!).For example, if you normally start taking the placebo tablets on Fridays, and you want to change it to Tuesdays (3 days earlier) start a new blister 3 days earlier than usual. If you make the interval of taking placebo tablets very short (e.g., 3 days or less), you may not have bleeding during these days. Then, you may experience light bleeding or similar to menstruation.

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

If you interrupt the treatment with Etinilestradiol/Drospirenona Daily Stada

You can stop taking etinilestradiol/drospirenona when you want. If you do not want to get pregnant, consult your doctor about other effective birth control methods. If you want to get pregnant, stop taking etinilestradiol/drospirenona and wait until your menstrual period before trying to get pregnant. This way, you can calculate your estimated due date more easily.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due to etinilestradiol/drospirenona, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Etinilestradiol/Drospirenona Diario Stada”.

The following is a list of side effects related to the use of etinilestradiol/drospirenona.

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

• Mood swings
• Headaches
• Abdominal pain (stomach pain)
• Acne
• Breast tenderness, breast enlargement, painful or irregular periods
• Weight gain.

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

• Vaginal candidiasis (vaginal infection)
• Herpes simplex (on the lips)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders
• Prickling and pins and needles, dizziness
• Visual problems
• Irregular or unusually fast heart rhythm
• Clots (thrombosis) in a blood vessel in the legs or lungs (pulmonary embolism), high blood pressure, migraine, varicose veins
• Sore throat
• Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
• Swelling of the skin and/or mucous membranes (e.g. the tongue or throat), and/or difficulty swallowing or urticaria with difficulty breathing (angioedema), hair loss (alopecia), itching, skin rash, dry skin, seborrheic dermatitis
• Neck pain, pain in the limbs, muscle cramps
• Urinary tract infection

• Breast lumps (benign and cancerous), milk production in the nipples, ovarian cysts, hot flashes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, abdominal pain (pelvic), abnormal cervical smears (Papanicolau or Papanicolau staining), decreased interest in sex

• Fluid retention, lack of energy, excessive thirst, increased sweating
• Weight loss.

Rare side effects(may affect between 1 and 10 in every 1,000 women):

• Asthma
• Auditory problems
• Nettle rash (characterized by painful red nodules on the skin)
• Multi-form erythema (characterized by skin rash with red spots in the shape of a target or ulcers)
• Clots of blood that are harmful in a vein or artery, for example:
• In a leg or foot (i.e. TVP).
• In a lung (i.e. EP).
• Heart attack.
• Stroke.
• Mild or temporary symptoms similar to a stroke, known as a transient ischemic attack (TIA).
• Clots of blood in the liver, stomach/intestine, kidneys, or eye.

The chances 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 the symptoms of a blood clot).

Seek medical attention immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria potentially with difficulty breathing (see also the section “Warnings and precautions”).

Reporting side effects

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

Keep this medication out of the 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 packaging after “CAD:” The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Etinilestradiol/Drospirenona Diario Stada

Active tablets:

The active principles are 0.02 mg of etinilestradiol and 3 mg of drospirenona.

The other components are:

Tablet core:monohydrate lactose, pregelatinized cornstarch, povidone, sodium croscarmellose, polisorbate 80, magnesium stearate.

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

Placebo tablets:

Tablet corecorecore: lactose, povidone, magnesium stearate.

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

Appearance of the product and content of the container

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

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

Ethinylestradiol/Drospirenona Diario Stada is available in boxes of 1, 2, 3, 6, and 13 containers (blister packs), each containing 28 tablets (21 active tablets plus 7 placebo tablets).

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Responsible manufacturer

León Farma Laboratories, S.A.

Navatejera Industrial Estate

La Vallina s/n

24193-Villaquilambre (León)

Spain

Last review date of this leaflet: September 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.