ETHINYL ESTRADIOL/DROSPIRENONE STADA 0.03 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet

1. What is Ethinylestradiol/Drospirenone Stada and what it is used for
2. What you need to know before you start taking Ethinylestradiol/Drospirenone Stada
   • Do not take Ethinylestradiol/Drospirenone Stada
   • Warnings and precautions
   • Blood clots
   • Ethinylestradiol/Drospirenone Stada and cancer
   • Irregular bleeding
   • What to do if you do not have your period during the week off
   • Taking Ethinylestradiol/Drospirenone Stada with other medicines
   • Taking Ethinylestradiol/Drospirenone Stada with food and drink
   • Laboratory tests
   • Pregnancy, breastfeeding, and fertility
   • Driving and using machines
   • Important information about some of the ingredients of Ethinylestradiol/Drospirenone Stada

1. How to take Ethinylestradiol/Drospirenone Stada
   • When you can start with the first blister
   • 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 period: what you should know
   • Change of your first day of period: what you should know
   • If you stop taking Ethinylestradiol/Drospirenone Stada

1. Possible side effects
2. Storage of Ethinylestradiol/Drospirenone Stada
3. Contents of the pack and further information

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

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

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

Contraceptives that contain two hormones are called “combined” contraceptives.

2. What you need to know before taking Etinilestradiol/Drospirenona Stada

General considerations

Before using etinilestradiol/drospirenona, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before taking 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 state of health, may perform other tests.

In this prospectus, several situations are described in which you should interrupt the use of etinilestradiol/drospirenona, or in which the effect of etinilestradiol/drospirenona may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm or 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 infection (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 blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase the risk of forming a clot in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fat in the blood (cholesterol or triglycerides)
• a condition 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 yet normalized.
• If your kidneys do not work well (renal failure).
• If you have (or have had) a tumor in the liver.
• If you have (or have had), or if you suspect you have breast cancer or cancer of the genitals.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (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 medicines").

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 will need to be particularly careful while using etinilestradiol/drospirenona or any other combined hormonal contraceptive, and your doctor may need to perform periodic checks on you.

Tell 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 or has had breast cancer
• if you have any liver or gallbladder disease
• if you have diabetes
• if you have depression
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system)
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure)
• if you have sickle cell anemia (a hereditary disease of red blood cells)
• if you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• if you need an operation or spend a lot of time without getting up (see section 2 "Blood clots")
• if you have recently given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking etinilestradiol/drospirenona after childbirth.
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have epilepsy (see "Taking Etinilestradiol/Drospirenona Stada with other medicines")
• if you have any disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous system disease in which involuntary movements appear (Sydenham's chorea))
• if you have or have had chloasma (brownish patches, also known as "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. Products containing estrogens may 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 developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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 attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of using a combined hormonal contraceptive.

If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).

If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.

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

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

The risk of a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption of 4 weeks or more.

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

When you stop taking etinilestradiol/drospirenona, your risk of a blood clot returns to normal within 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.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, 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

The risk of 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 or BMI over 30 kg/m2).

? If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have a hereditary blood clotting disorder.

? If you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using etinilestradiol/drospirenona several weeks before surgery or while you have reduced mobility. If you need to stop using etinilestradiol/drospirenona, ask your doctor when you can start using it again.

? As you get older (especially above about 35 years).

? If you have recently given birth.

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

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

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using etinilestradiol/drospirenona.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a 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 can increase:

? With 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 of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.

? If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).

? If you have migraines, especially migraines with aura.

? If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).

? If you have diabetes.

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

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

Ethinylestradiol/Drospirenona Daily and cancer

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

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

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

Psychiatric disorders

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

3. How to take Ethinylestradiol/Drospirenone Stada

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

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

Then, you should not take any pills for 7 days. During these 7 days when you do not take pills (called the rest week), you should have your period. The period, which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the rest week.

On the 8th day after taking the last ethinylestradiol/drospirenone pill (i.e., after the 7-day rest period), you should start with the next blister pack, even if you have not yet finished bleeding. This means that you should start each blister pack on the same day of the week, and your period should occur during the same days each month.

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

When can you start with the first blister pack

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

Start taking ethinylestradiol/drospirenone on the first day of your cycle (i.e., the first day of your period). If you start ethinylestradiol/drospirenone 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) during the first 7 days.

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

You can start taking ethinylestradiol/drospirenone preferably the day after taking the last active pill (the last pill that contains active ingredients) of your previous contraceptive, but no later than the day after the rest week of your previous contraceptive (or after taking the last inactive pill of your previous contraceptive). When switching from a vaginal ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill at any time (if it's an implant or intrauterine system, on the same day it is removed; if it's an injectable, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of pill taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

You can start taking ethinylestradiol/drospirenone between 21 and 28 days after having a child. If you start later, use a barrier method (e.g., a condom) during the first 7 days of taking ethinylestradiol/drospirenone.

If, after having a child, you have already had sexual intercourse before starting to take ethinylestradiol/drospirenone again, you must be sure you are not pregnant or wait for your next period.

• If you are breastfeeding and want to start taking ethinylestradiol/drospirenone again after having a child

Read the section "Breastfeeding".

Ask your doctor if you are not sure when to start.

If you take more Ethinylestradiol/Drospirenone Stada than you should

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

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

If you have taken too many ethinylestradiol/drospirenone pills, or 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 Ethinylestradiol/Drospirenone Stada

• If you are less than 12 hourslate in taking a pill, protection against pregnancy is not reduced. Take the pill as soon as you remember and the following pills at the usual time.

• If you are more than 12 hourslate in taking a pill, protection against pregnancy may be reduced. The more pills you have missed, the greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a pill at the beginning or end of the blister pack. Therefore, you should follow these recommendations (see also the diagram below):

• Missing more than one pill from the blister pack

Consult your doctor.

• Missing a pill in week 1

Take the missed pill as soon as you remember, even if it means taking two pills at once. Continue taking the pills at the usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the week before missing the pill, you may be pregnant. In this case, consult your doctor.

Missing a pill in week 2

Take the missed pill as soon as you remember, even if it means taking two pills at once. Continue taking the pills at the usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing a pill in week 3

You can choose between two options:

1. Take the missed pill as soon as you remember, even if it means taking two pills at once. Continue taking the pills at the usual time. Instead of starting the rest week, start the next blister pack.

You will probably have your period at the end of the second blister pack, although you may also experience light bleeding or spotting during the second blister pack.

1. You can also stop taking pills and go directly to the 7-day rest week (noting the day you missed the pill). If you want to start a new blister pack on the day you usually start, your rest week should last less than 7 days.

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

• If you have missed a pill and do not have a period during the first rest week, you may be pregnant. Contact your doctor before starting the next blister pack.

What should you do in case of vomiting or severe diarrhea

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

Delayed menstrual period: what you should know

Although it is not recommended, you can delay your period if you start a new blister pack of ethinylestradiol/drospirenone instead of continuing with the rest week and finish it. You may experience light bleeding or spotting during the use of the second blister pack. After the usual 7-day rest week, startthe next blister pack.

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

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

If you take the pills according to the instructions, your period will start during the rest week. If you need to change this day, reduce the number of rest days (but never increase them - 7 at most!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the rest week very short (e.g., 3 days or less), you may not have bleeding during these days. Then, you may experience light bleeding or spotting.

If you are not sure how to proceed, consult your doctor.

If you stop treatment with Ethinylestradiol/Drospirenone Stada

You can stop taking ethinylestradiol/drospirenone whenever 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 ethinylestradiol/drospirenone and wait until your period before trying to become pregnant. This way, you can more easily calculate the estimated due date.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you suffer any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to ethinylestradiol/drospirenone, consult your doctor.

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

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

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

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

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

• breast enlargement, changes in libido (sex drive)
• 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 1,000 women):

• allergic reactions (hypersensitivity), asthma
• breast secretion
• hearing problems
• skin disorders such as erythema nodosum (characterized by painful nodules on the skin) or erythema multiforme (characterized by a skin rash with target-like lesions or ulcers).
• harmful 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 those of a stroke, called a 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).

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with potential difficulty breathing (see also the section "Warnings and precautions").

Reporting side effects

If you experience any 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ethinylestradiol/Drospirenone Stada

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not take this medicine after the expiry date which is stated on the packaging after "CAD:". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ethinylestradiol/Drospirenone Stada

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

The other ingredients are:

Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone, crospovidone, polysorbate 80, magnesium stearate.

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

Appearance of the Product and Package Contents

Film-coated tablets, round, yellow in color.

Ethinylestradiol/Drospirenone Stada is available in packs of 1, 2, 3, 6, and 13 units (blisters), each containing 21 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

León Farma Laboratories, S.A.

Navatejera Industrial Estate

La Vallina s/n

24193-Villaquilambre (León)

Spain

Date of the Last Revision of this Leaflet:September 2022

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