ETHINYLESTRADIOL/DROSPIRENONE DAILY STADA 0.03 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ethinylestradiol/Drospirenone Daily 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 signs of illness are the same as yours.
• If you get 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 you start using a combined hormonal contraceptive again after a break of 4 weeks or more.
• • Be aware and consult your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet

1. What is Ethinylestradiol/Drospirenone Daily Stada and what is it used for
2. What you need to know before you start taking Ethinylestradiol/Drospirenone Daily Stada

? Do not take Ethinylestradiol/Drospirenone Daily Stada

? Warnings and precautions

? Blood clots

? Ethinylestradiol/Drospirenone Daily Stada and cancer

? Bleeding between menstrual periods

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

? Taking Ethinylestradiol/Drospirenone Daily Stada with other medicines

? Ethinylestradiol/Drospirenone Daily 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 Daily Stada

1. How to take Ethinylestradiol/Drospirenone Daily Stada
   • Preparation of the blister

? When can you start with the first blister

? If you take more Ethinylestradiol/Drospirenone Daily Stada than you should

? If you forget to take Ethinylestradiol/Drospirenone Daily Stada

? What to do in case of severe nausea or diarrhea?

? Delay of menstrual period: what should you know?

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

? If you stop taking Ethinylestradiol/Drospirenone Daily Stada

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

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

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

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

The 7 white tablets do not contain active ingredients and are called placebo tablets.

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

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

General considerations

Before starting to use 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 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 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 Daily 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 your 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 (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 Daily 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 it may be necessary for your doctor 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 just 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 Daily Stada with other medicines")

? if you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones; for example, hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease in which involuntary movements appear)

? if you have or have had chloasma (brownish patches, also called "pregnancy patches", especially on the face). In that 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 use of a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ such as the eye (retinal vein thrombosis)

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

The risk of developing a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (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 developing a blood clot returns to normal within a few weeks.

What is the risk of developing 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 developing 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 use 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 developing 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 developing 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 to have surgery or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using 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 given birth less than a few weeks ago.

The risk of developing 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 developing 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 Stada 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 suffer from 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 medical advice.

3. How to take Ethinylestradiol/Drospirenona Diario Stada

Each blister pack contains 21 active yellow tablets and 7 white placebo tablets.

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

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

Do not get confused about the tablet: take a yellow tablet for the first 21 days, and then a white tablet for the last 7 days. Then you should start taking a new blister pack (21 yellow tablets and 7 white tablets). This way, there is no week of rest between two blister packs.

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

Preparing the blister pack

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

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

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

During the 7 days when you take the placebo tablets (the placebo days), you will usually start your period (also called withdrawal bleeding). Usually, your period will start on the second or third day after taking the last active yellow tablet of etinilestradiol/drospirenona. Once you have taken the last white tablet, you should start the next blister pack, even if you have not yet finished your menstrual period. This means that you should start each blister pack on the same day of the weekthat you started the previous one, and that your menstruation should take place during the same days every month.

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

When can you start with the first blister pack

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

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

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

You can start taking etinilestradiol/drospirenona preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the rest days of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When changing from a combined vaginal ring or patch, follow your doctor's recommendations.

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

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

• After an abortion

Follow your doctor's recommendations.

• After having a child

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

If, after having a child, 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 having a child

Read the section "Breastfeeding".

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

If you take more Ethinylestradiol/Drospirenona Diario Stada than you should

No cases have been reported where an overdose of etinilestradiol/drospirenona has caused serious harm.

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

If you have taken too many etinilestradiol/drospirenona tablets, or 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 91 562 04 20, indicating the medication and the amount used.

If you forget to take Ethinylestradiol/Drospirenona Diario Stada

The tablets in the fourthrow of the blister pack are the placebo tablets. If you forget to take one of these tablets, it will have no effect on the reliability of etinilestradiol/drospirenona. Discard the forgotten placebo tablet.

If you forget to take an active yellow tablet from the 1st, 2nd, or 3rdrow, do the following:

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

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

• Forgetfulness of more than one tablet in the blister pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

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

• Forgetfulness of a tablet in week 2

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

• Forgetfulness of a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this blister pack, discard them and start the next blister pack.

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

1. You can also stop taking the active yellow tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new blister pack on the day you always start, take the placebo tablets for less 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 placebo days, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active yellow tablet, or suffer from 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 forgetting a tablet. After vomiting or diarrhea, take another yellow tablet 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/Drospirenona Diario Stada".

Delaying your menstrual period: what you should know

Although it is not recommended, you can delay your period if you do not take the white placebo tablets from the fourth row and start taking a new blister pack of etinilestradiol/drospirenona and finish it. You may experience light bleeding or spotting during the use of the second blister pack. Finish this second blister pack by taking the 7 white tablets from the 4th row. Then start with the new 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 tablets as instructed, your period will start during the placebo week. If you need to change this day, reduce the number of placebo days - when you take the white placebo tablets - (but never increase them - 7 at most!). For example, if you usually start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the interval of taking placebo tablets very short (e.g., 3 days or less), you may not have bleeding during these days. Then you may experience light bleeding or spotting.

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

If you stop treatment with Ethinylestradiol/Drospirenona Diario Stada

You can stop taking etinilestradiol/drospirenona whenever you want. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, stop taking etinilestradiol/drospirenona and wait until your period before trying to become pregnant. This way, you will be able to calculate the estimated date of delivery more easily.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or 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 taking Ethinylestradiol/Drospirenone Daily Stada".

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

Frequent Adverse Effects(may affect up to 1 in 10 women):

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness

• headache, depression,
• migraine,
• nausea, lethargy, white vaginal discharge and vaginal yeast infection.

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

• 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 Adverse Effects(may affect up to 1 in 1,000 women):

• allergic reactions (hypersensitivity), asthma,
• breast secretion,
• hearing problems,
• skin disorders such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by a skin rash with target-like redness or ulcers)
• harmful blood clots in a vein or artery, for example:
• In a leg or foot (i.e. DVT)
• In a lung (i.e. PE).
• Heart attack.
• Stroke.
• Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys or eye.

The 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 potentially life-threatening urticaria with difficulty breathing (see also the section "Warnings and Precautions").

Reporting Adverse Effects

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

5. Storage of Ethinylestradiol/Drospirenone Daily Stada

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

This medicine does not require special storage conditions.

Do not take this medicine after the expiry date that appears on the packaging after "EXP:". 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 medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ethinylestradiol/Drospirenone Daily Stada:

Active Tablets

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

The other components are:

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

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

Placebo Tablets:

Tablet core: lactose, povidone, magnesium stearate.

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

Appearance of the Product and Package Contents

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

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

Ethinylestradiol/Drospirenone Daily Stada is available in packs of 1, 2, 3, 6, and 13 units (blisters), each containing 28 tablets (21 active tablets and 7 placebo tablets).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera.

La Vallina s/n

24193 - Villaquilambre (León)

Spain

This leaflet was last approved in: 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