Leaflet: information for the user

Ethinylestradiol/Drospirenone Stada 0.03 mg/3 mg film-coated tablets

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

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

Important things you should 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 blood clots in veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a break of 4 weeks or more.

•Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

1.What isEthinylestradiol/Drospirenone Stadaand what is it used for

2.What you need to know before starting to takeEthinylestradiol/Drospirenone Stada

• Do not take Ethinylestradiol/Drospirenone Stada
• Warnings and precautions
• Blood clots
• Ethinylestradiol/Drospirenone Stada and cancer
• Spotting between periods
• What to do if you do not have a period during the week of rest
• Taking Ethinylestradiol/Drospirenone Stada with other medicines
• Taking Ethinylestradiol/Drospirenone Stada with food and drink
• Laboratory tests
• Pregnancy, breastfeeding and fertility
• Driving and operating machinery
• Important information about some of the components of Ethinylestradiol/Drospirenone Stada

3.How to takeEthinylestradiol/Drospirenone Stada

• When you can start with the first pack
• If you take more Ethinylestradiol/Drospirenone Stada than you should
• If you forget to take Ethinylestradiol/Drospirenone Stada
• What to do in case of vomiting or severe diarrhea
• Delayed menstrual period: what you should know
• Change in the first day of your menstrual period: what you should know
• If you interrupt the treatment with Ethinylestradiol/Drospirenone Stada

4.Possible side effects

5.Storage ofEthinylestradiol/Drospirenone Stada

6.Contents of the pack and additional information

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

Each tablet contains a small amount of two different female hormones, known as ethinylestradiol and drospirenona.

Contraceptives that contain two hormones are known as "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 should take additional non-hormonal contraceptive precautions, such as the use of a condom or other barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable since 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 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 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 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 the 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, whose cause is unknown.
• If you are allergic to etinilestradiol or drospirenona, or to any of the other components of this medication (including in section 6). This may manifest as 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 Stada with other medications”).

Additional information on special populations

Use in children

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

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.

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

Inform your doctor 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 disease 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 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 surgery or spend a lot of time without standing up (see section 2 “Blood Clots”)
• If you are at increased risk of blood clots after childbirth. Ask your doctor when you can start taking etinilestradiol/drospirenona after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin)
• If you have varicose veins
• If you have epilepsy (see “Taking Etinilestradiol/Drospirenona Stada with other medications”)
• If you have any disease that may have appeared for the first time during pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)
• 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 swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria with difficulty breathing, contact a doctor immediately. Hormone-containing 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 urgent 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 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 of 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 can form in a vein of another organ such as the eye (retinal vein thrombosis)

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

The risk of a blood clot in a vein is higher during the first year in which you 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 are not using a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.

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

-Of every 10,000 women who are using a combined hormonal contraceptive that contains drospirenona like etinilestradiol/drospirenona, between 9 and 12 women will develop a blood clot in a year.

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

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

Your risk of a blood clot is higher:

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

?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 about 50 years). You may have an inherited 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 your leg immobilized. You may need to stop taking etinilestradiol/drospirenona for several weeks before the operation or while you have limited mobility. If you need to stop taking etinilestradiol/drospirenona, ask your doctor when you can start taking it again.

?With increasing age (especially above about 35 years).

?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 listed above, even if you are unsure. Your doctor may decide that you should stop taking etinilestradiol/drospirenona.

If any of the conditions listed 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, just like a blood clot in a vein. 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 a stroke due to etinilestradiol/drospirenona is very small, but it may increase:

?With increasing age (above about 35 years).

?If you smoke. When using a combined hormonal contraceptive like etinilestradiol/drospirenona, 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 close relative has had a heart attack or a stroke at a young age (i.e., before about 50 years). You may also be at increased risk of a heart attack or a stroke.

?If you or any 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 problem (valve disorder, abnormal heart rhythm called atrial fibrillation).

?If you have diabetes.

If you have any of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the conditions listed 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 Daily and Cancer

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

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

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

Mental health disorders

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

Intermenstrual bleeding

During the first few months of using etinilestradiol/drospirenona, you may experience unexpected bleeding (bleeding outside the menstrual 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 to do if you do not have a period during the week of rest

If you have taken all the 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, visit your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Etinilestradiol/Drospirenona Stada with other medications

Some medications

• 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:

?medications used in the treatment of:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• infections with HIV and hepatitis C (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 of the lungs (bosentan).

?St. John's Wort.

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

• medications containing ciclosporin
• the antiepileptic lamotrigine (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 test results (elevated ALT levels).

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

Ethinylestradiol/Drospirenona can be restarted approximately 2 weeks after the end of this treatment. See the section “Do not take Etinilestradiol/Drospirenona Stada”.

Consult your doctor or pharmacist before using any medication.

Taking Etinilestradiol/Drospirenona 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 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 medication.

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 taking etinilestradiol/drospirenona at any time (see also “Stopping treatment with Etinilestradiol/Drospirenona Stada”).

Breastfeeding

Generally, 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 Stada

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

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

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

The blister pack contains 21 tablets. Next to each tablet is printed the day of the week when it should be taken. If, for example, you start on a Wednesday, take a tablet with "MIE" next to it. Follow the direction of the arrow on the blister pack until you have taken all 21 tablets.

Do not take any tablets for 7 days after that. During these 7 days when no tablets are taken (called the withdrawal week), menstruation should occur. Menstruation, also known as withdrawal bleeding, usually starts on the 2nd or 3rd day of the withdrawal week.

Start with a new blister pack on the 8th day after taking the last Etinilestradiol/Drospirenona tablet (i.e., after the 7-day withdrawal week), even if the bleeding has not stopped yet. This means that you should start each blister pack on the same day of the week and that menstruation should occur on the same days every month.

If you use Etinilestradiol/Drospirenona in this way, you are also protected against pregnancy during the 7 days when no tablets are taken.

When to start with the first blister pack

• If you have not used any hormonal contraceptives in the past month

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

• Switching from 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 containing active ingredients) of your previous contraceptive, but no later than the day after the withdrawal week 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 pills, injection, implant, or intrauterine system (IUS))

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

• 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 taking Etinilestradiol/Drospirenona later, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of Etinilestradiol/Drospirenona use.

If, after giving birth, you have already had sexual intercourse before starting to take Etinilestradiol/Drospirenona (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 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 Stada than you should

No serious harm has been reported in cases where an overdose of Etinilestradiol/Drospirenona has been ingested.

The symptoms that may occur 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 Etinilestradiol/Drospirenona tablets, 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 forget to take Etinilestradiol/Drospirenona Stada

• 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 following 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 greater the risk of becoming pregnant.

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

• Forgetting more than one tablet from the blister pack

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 use additional precautions (e.g., a condom) 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 starting the withdrawal week, start the next blister pack.

You may experience bleeding during the use of the second blister pack, which may be light or similar to menstruation. After the usual 7-day withdrawal week,startthe next blister pack.

1. You can also interrupt taking the tablets and go directly to the 7-day withdrawal week (noting the day you forgot to take the tablet). If you want to start a new blister pack on the day you usually start, your withdrawal week should lastless 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 bleeding during the first withdrawal week, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or intense diarrhea

If you have vomiting within 3-4 hours after taking a tablet or 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 a tablet from a spare blister pack 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 advice in the section "If you forgot to take Etinilestradiol/Drospirenona Stada".

Delay of your menstrual period: what you should know

Although not recommended, you can delay your period if you start taking a new Etinilestradiol/Drospirenona blister pack instead of continuing with the withdrawal week and finish it. You may experience bleeding during the use of the second blister pack, which may be light or similar to menstruation. After the usual 7-day withdrawal week,startthe next blister pack.

You should ask your doctor for advice before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your period will start during the withdrawal week. If you need to change that day, reduce the number of withdrawal days(but never increase – 7 at most!). For example, if your withdrawal days usually start on Fridays andyou want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the withdrawal week very short (e.g., 3 days or less), you may not experience 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 treatment with Etinilestradiol/Drospirenona Stada

You can stop taking Etinilestradiol/Drospirenona when you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Etinilestradiol/Drospirenona and wait until your period before trying to become 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 may 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 change 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 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):

• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• Headache, depression
• Migraine
• Nausea
• Drowsiness, white vaginal discharge, and vaginal yeast infection.

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

• Breast enlargement, alterations in libido (sex interest)
• High blood pressure, low blood pressure
• Vomiting, diarrhea
• Acne, skin rash (eczema), intense itching, hair loss (alopecia)
• Vaginal infection
• Fluid retention and changes in body weight.

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

• Allergic reactions (hypersensitivity), asthma
• Milk secretion
• Auditory problems
• Skin disorders such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by skin rash with red rings or ulcers).
• Detrimental blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT) or in a lung (i.e., PE)
• Heart attack.
• Stroke.
• Mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA).
• Blood clots 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 symptoms of a blood clot).

Seek immediate medical attention if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially life-threatening urticaria (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 Spanish System for Pharmacovigilance of Medicines 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 Stada

The active principles are 0.03 mg of etinilestradiol and 3 mg of drospirenona.

The other components are:

Core of the tablet:lactose monohydrate, cornstarch, pregelatinized cornstarch, povidone, crospovidone, polisorbate 80, magnesium stearate.

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

Appearance of the product and content of the packaging

Coated tablets, round, yellow in color.

Ethinylestradiol/Drospirenona Stada is available in boxes of 1, 2, 3, 6, and 13 packaging units (blister packs), each containing 21 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

León Farma Laboratories, S.A.

Navatejera Industrial Estate

La Vallina s/n

24193-Villaquilambre (León)

Spain

Last review date of this leaflet:September 2022

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/.