Leaflet: information for the user

Ethinylestradiol/Drospirenone Stada 0.02 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause 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 your 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 machines

?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 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 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 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 in your leg (deep vein thrombosis, DVT), in your 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 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, 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)

?Homo-cysteineemia (a condition that may increase the risk of blood clots)

?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 yet normalized.

?If your kidneys do not function properly (renal failure).

?If you have (or have ever had) a liver tumor.

?If you have (or have ever 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 this medication (including those listed 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”).

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:

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

• If any of your close relatives have 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 genetic disorder 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 getting up (see section 2 “Blood Clots”)
• If you are recently postpartum, you are at increased risk of blood clots. Ask your doctor when you can start taking etinilestradiol/drospirenona after delivery.
• 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 mask”, 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. Products containing estrogens 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 (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (known as “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 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 can 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 an interruption of 4 weeks or more.

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

When you stop taking etinilestradiol/drospirenona, 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, 2 will develop a blood clot in a year.

-Of every 10,000 women who are using a combined hormonal contraceptive containing 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 containing drospirenona, such as 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 organs at a young age (i.e., before the age of about 50). You may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without getting 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 less mobility. If you need to stop taking etinilestradiol/drospirenona, ask your doctor when you can start taking it again.
• With increasing age (especially above the age of about 35).
• If you have given birth recently.

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

Long flights (more than 4 hours) may temporarily increase your 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?

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 essential to note that the risk of a heart attack or stroke due to etinilestradiol/drospirenona is very small, but it may increase:

?With increasing age (above the age of about 35).

?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, your doctor may advise you to use a different type of contraceptive.

?If you are overweight.

?If you have high blood pressure.

?If any of your close relatives have had a heart attack or stroke at a young age (less than about 50). You may also be at increased risk of 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, irregular heartbeat 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 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 taking 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 tumors in the liver have been reported in users of combined hormonal contraceptives, and even more rarely, malignant tumors. Consult your doctor if you experience severe abdominal pain.

Mental Health Disorders

Some women who use combined hormonal contraceptives like etinilestradiol/drospirenona 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 periods

During the first few months of using etinilestradiol/drospirenona, you may experience unexpected bleeding (bleeding outside of your period). If you experience these bleeding episodes for more than a few months or if they start 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, and have not 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 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 Stada with other medications

Some medications

• may affect the levels of etinilestradiol/drospirenona in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding.

This may occur with:

?Medications used to treat:

• 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 function test results (elevated ALT levels).

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

You can restart taking etinilestradiol/drospirenona approximately 2 weeks after completing 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 drink

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 can 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

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 Stada

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, 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, the day of the week is printed on which 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.

On the 8th day after taking the last Etinilestradiol/Drospirenona tablet (i.e., after the 7-day withdrawal week), start with the next blister pack, 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 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 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 pill, injection, implant, or intrauterine system of progestins)

You can switch from the progestin-only pill on any day (if it is an implant or an IUD, 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) for 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 later, use one of the so-called barrier methods (e.g., a condom) for 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 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 damage has been reported in cases where an overdose of etinilestradiol/drospirenona has been ingested.

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 Etinilestradiol/Drospirenona tablets, or if 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 Toxicological 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 does not decrease. 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 decrease. The more tablets you have forgotten, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is maximum if you forget to take the tablet at the beginning or end of the blister pack. Therefore, you should 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 useadditional precautions, for example, 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 does not decrease, 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.

Probably, you will have your period at the end of the second blister pack, but you may also experience light bleeding or spotting during the use of the second blister pack.

1. You can also interrupt taking the tablets and go directly to the 7-day withdrawal week(marking the day you forgot to take the tablet). If you want to start a new blister pack on the day you always 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 ablisterof reserve 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 menstrual period if you start taking a newblisterof etinilestradiol/drospirenona instead of continuing with the withdrawal week and finish it. You may experience light bleeding or spotting during the use of the secondblister. 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 of 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 and you want to change to Tuesdays (3 days earlier), start a newblister3 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 spotting.

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 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 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 pain, 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
• Tickling and pinching, 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
• Throat pain
• Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
• Sudden swelling of the skin and/or mucous membranes (e.g., the tongue or throat), and/or difficulty swallowing or urticaria potentially 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 (galactorrhea), 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 (skin rash with red spots in the shape of a target or ulcers)
• Detrimental blood clots 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 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 medical attention immediately if you experience any of the following angioedema symptoms: 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 not listed 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.

Medications should not be disposed of 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.

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Composition of Etinilestradiol/Drospirenona Stada

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

The other components are:

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

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).

Appearance of the product and content of the packaging

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

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

Only some package sizes may be marketed.

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

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/