ETHINYL ESTRADIOL/DROSPIRENONE STADA 0.02 mg/3 mg FILM-COATED TABLETS (24+4) Generic

Introduction

Package Leaflet: Information for the Patient

Ethinylestradiol/Drospirenone Stada 0.02 mg/3 mg film-coated tablets (24+4) EFG

Read this entire 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 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 talk to 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 Ethinylestradiol/Drospirenone Stada is 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
   • Ethinylestradiol/Drospirenone Stada and blood clots in veins and arteries
   • Ethinylestradiol/Drospirenone Stada and cancer
   • Irregular bleeding
   • What to do if you do not have your period during the placebo days
   • Other medicines and Ethinylestradiol/Drospirenone Stada
   • Lab tests
   • Pregnancy, breastfeeding, and fertility
   • Driving and using machines
   • Ethinylestradiol/Drospirenone Stada contains lactose

1. How to take Ethinylestradiol/Drospirenone Stada
   • Preparing the blister
   • When can you 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 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 Ethinylestradiol/Drospirenone Stada is and what it is used for

• Ethinylestradiol/drospirenone is a contraceptive and is used to prevent pregnancy.
• Each of the 24 active tablets, which are pink in color, contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.
• The 4 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 you start taking Etinilestradiol/Drospirenona Stada

Do not take Etinilestradiol/Drospirenona Stada

Do 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 in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or 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 are going to be immobile for a long time (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following diseases that may increase the risk of forming a blood 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 hyperhomocysteinaemia
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have had in the past) liver disease and your liver function has not yet returned to normal.
• If your kidneys are not working well (renal failure).
• If you have (or have had in the past) a liver tumor.
• If you have (or have had in the past), or if you suspect you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, the cause of which is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may be shown by an itchy skin rash, hives, or swelling.

Do not use etinilestradiol/drospirenona if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and Etinilestradiol/Drospirenona Stada").

• If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also the section "Other medicines and Etinilestradiol/Drospirenona Stada").

Additional information on special populations

Children and adolescents

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

Older women

Ethinylestradiol/drospirenona is not indicated for use after menopause.

Women with liver insufficiency

Do not take etinilestradiol/drospirenona if you are suffering from liver disease. See sections "Do not take Etinilestradiol/Drospirenona Stada" and "Warnings and precautions".

Women with renal insufficiency

Do not take etinilestradiol/drospirenona if you are suffering from kidney failure or acute renal failure. See sections "Do not take Etinilestradiol/Drospirenona Stada" and "Warnings and precautions".

Warnings and precautions

In some situations, you will need to be extra careful while using etinilestradiol/drospirenona or any other combined hormonal contraceptive, and your doctor may need to examine you regularly.

Tell your doctor if any of the following conditions develop or worsen while you are using etinilestradiol/drospirenona.

Tell your doctor or pharmacist before taking etinilestradiol/drospirenona:

• if a close relative has had or has breast cancer
• if you have cancer
• if you have any liver disease (such as blockage of the bile ducts which can cause jaundice and symptoms like itching) or gallbladder disease (such as gallstones)
• if you have kidney problems (other than those mentioned in the section "Do not take Etinilestradiol/Drospirenona Stada") and are taking other medicines that increase potassium levels in the blood. Your doctor may check your potassium blood levels
• if you have diabetes
• if you have depression. Some women using hormonal contraceptives like etinilestradiol/drospirenona have reported depression or depressed mood. Depression can be serious and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible.
• 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 (an inherited disease of the red blood cells)
• if you have high levels of fat in the blood (hypertriglyceridemia) or 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 are going to be immobile for a long time (see section 2 "Blood clots")
• if you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking etinilestradiol/drospirenona after childbirth.
• if you have inflammation of the veins under the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have epilepsy (see "Other medicines and Etinilestradiol/Drospirenona Stada")
• if you have any disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., loss of hearing, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disease in which involuntary movements appear (Sydenham's chorea))
• if you have high blood pressure during treatment that is not controlled by treatment with another medicine
• if you have or have ever had brownish discoloration of the skin (chloasma), also known as "pregnancy spots", especially on the face. In this case avoid direct exposureto the sun or ultraviolet radiation while taking this medicine
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives 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 having 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 important to remember that the overall risk of having 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 linked to 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 in your leg or foot, it can cause deep vein thrombosis (DVT).

? If a blood clot moves from your leg to your lungs, it can cause a pulmonary embolism.

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

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

The risk of having 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 a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive. When you stop taking etinilestradiol/drospirenona, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having 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 have 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 have 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 have a blood clot in a year.
• The risk of having a blood clot depends on your personal history (see "Factors that increase your risk of a blood clot" below)

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

The risk of having a blood clot due to 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 are going to be immobile for a long time due to an injury or illness, or if you have your leg in a plaster cast. You may need to stop taking etinilestradiol/drospirenona several weeks before the operation or while you are less mobile. If you need to stop taking etinilestradiol/drospirenona, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years of age).
• If you have recently given birth.

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

Long-distance 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 important to tell your doctor if you have any of the conditions listed above, even if you are not sure. 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 thrombosis without a known cause or you gain much 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 stroke.

Factors that increase your risk of a blood clot in an artery

It is important 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 of age).
• 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 of age). In this case, you may also have a 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).

• Women with migraine, 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 further increased.

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.

Etinilestradiol/Drospirenona Stada and cancer

Breast cancer has been slightly more frequently observed in women using combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by the doctor more frequently. The incidence of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to undergo regular breast exams, and you should see your doctor if you notice any lump.

Rarely, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of contraceptives. See your doctor if you experience unusually severe abdominal pain, abdominal swelling (which may be due to liver enlargement), vomit blood, or observe blood in your stool or black, tarry stools, as these may be signs of stomach bleeding.

Bleeding between periods

During the first few months you are taking etinilestradiol/drospirenona, you may experience unexpected bleeding (bleeding outside of the week you are taking the white tablets). If this bleeding persists for more than a few months or starts after a few months, your doctor will investigate what is wrong.

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

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

If your expected period does not arrive in two consecutive instances, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medications and Etinilestradiol/Drospirenona Stada

Do not take etinilestradiol/drospirenona if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver test results (increase in liver enzyme ALT).

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

Etinilestradiol/drospirenona can be used again approximately 2 weeks after the end of this treatment. See the section "Do not take Etinilestradiol/Drospirenona Stada".

• Some medications may affect the blood levels of etinilestradiol/drospirenona and may cause loss of contraceptive effector unexpected bleeding/spotting. This may occur with medications used to treat:

o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate),

o tuberculosis (e.g., rifampicin),

o HIV and hepatitis C infection (drugs called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or other infections (griseofulvin or ketoconazole),

o arthritis, arthrosis (etoricoxib) or high blood pressure in the blood vessels of the lungs (bosentan),

o St. John's Wort preparations.

Etinilestradiol/drospirenona may affect the effect of other medications, e.g.:

o medications containing cyclosporine,

o the antiepileptic lamotrigine (may lead to an increased frequency of seizures)

o theophylline (used to treat respiratory problems)

o tizanidine (used to treat muscle pain and/or muscle spasms)

If you are taking certain medications for heart problems (such as diuretics), your doctor may monitor your blood potassium levels.

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you should not take etinilestradiol/drospirenona. If you become pregnant during treatment with etinilestradiol/drospirenona, stop the treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking etinilestradiol/drospirenona at any time (see "If you stop treatment with Etinilestradiol/Drospirenona Stada").

Breastfeeding

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

Driving and using machines

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

Etinilestradiol/Drospirenona Stada contains lactose and sodium

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

This medication contains less than 1 mmol (23 mg) of sodium per tablet, so it is considered essentially "sodium-free".

3. How to Take Etinilestradiol/Drospirenona Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each blister pack contains 24 active pink tablets and 4 white placebo tablets.

The two different types of colored etinilestradiol/drospirenona tablets are placed in order. One package contains 28 tablets.

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

Do not confuse the tablets: take one pink tablet every day for the first 24 days, followed by one white tablet for the last 4 days. Then you should start taking a new package (24 pink tablets and 4 white tablets). This way, there is no break between two packages.

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

Preparing the Blister Pack

To help you follow the order of intake, each etinilestradiol/drospirenona package includes seven adhesive strips that have the 7 days of the week printed on them. Choose the strip of the week that starts with the day you take the first tablet. For example, if you start on Wednesday, stick the one that says "WED" as the initial tablet.

Stick the weekly adhesive strip on the top of the blister pack where it says "Place the label here", so that the first day is placed above the tablet marked with "START". This way, there is a day of the week indicated above each tablet and you can see if you have taken a certain tablet. The arrows show the order in which the tablets should be taken.

During the 4 days when you take white placebo tablets (placebo days), menstruation (also called withdrawal bleeding) should occur. Usually, menstruation starts on the 2nd or 3rd day after taking the last active pink tablet of etinilestradiol/drospirenona. Once you have taken the last white tablet, you should start the next package, even if you have not finished your period. This means that you should start each package on the same day of the weekthat you started the previous one, and that menstruation should occur during the same days every month.

If you take etinilestradiol/drospirenona as indicated, you will also be protected against pregnancy during the 4 days when you are taking the placebo tablets.

When Can You Start with the First Package

?If you have not taken 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 menstruation). If you start etinilestradiol/drospirenona on the first day of your menstruation, 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., a condom) during the first 7 days.

?Switching from another combined hormonal contraceptive, combined vaginal ring, or patch.

You should 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 (or after taking the last inactive tablet) of your previous contraceptive. When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

?Switching from a progestin-only method (pill, injection, implant, or intrauterine system (IUS) of progestin).

You can switch from the progestin-only pill at any time (if it's an implant or IUS, you should switch on the day of its removal; if it's an injectable, when the next injection is due), but in all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

?After an abortion or termination of pregnancy

Follow your doctor's recommendations.

?After having a baby.

After having a baby, 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 contraceptive methods (e.g., a condom) during the first 7 days of using etinilestradiol/drospirenona.

If, after having a baby, you have already had sexual intercourse before starting to take etinilestradiol/drospirenona again, you must be sure that you are not pregnant or wait for your next menstrual period.

?If you are breastfeeding and want to start taking etinilestradiol/drospirenona again after having a baby.

Read the "Breastfeeding" section.

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

If You Take More Etinilestradiol/Drospirenona Stada Than You Should

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

If you take many tablets at once, you may feel unwell or have 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 etinilestradiol/drospirenona tablets, or discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service 91 562 04 20 indicating the medication and the amount used.

If You Forget to Take Etinilestradiol/Drospirenona Stada

The last 4 tablets of the fourth row of the package are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of etinilestradiol/drospirenona. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet (tablets 1-24 of the blister pack), you should follow these steps:

? If you are less than 24 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 24 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 greatest if you forget to take the pink tablet at the beginning or end of the package. The following recommendations should be followed in this situation (see the diagram below):

? Forgetfulness of more than one tablet from the package

Consult your doctor.

? Forgetfulness of a tablet during days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time and use additional precautions, e.g., a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should contact your doctor as there is a possibility that you may have become pregnant.

? Forgetfulness of a tablet during days 8-14 (second row)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. 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 between days 15-24 (third or fourth row)

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this package, discard them and start the next package (the day you take the first tablet will be different).

You will likely have your period at the end of the second package – during the intake of the white placebo tablets – although you may experience light bleeding or spotting during the intake of the second package.

1. You can also interrupt the intake of active pink tablets and go directly to the 4 white placebo tablets (including the days you did not take the tablets, before taking the placebo tablets, you should note the day you forgot to take the tablet). If you want to start a new package on the fixed day you always start, take the placebo tablets for less than 4 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 your period during the placebo days, you may be pregnant. Contact your doctor before starting the next package.

The following diagram describes how to proceed if you forget to take your tablets:

What to Do in Case of Vomiting or Severe Diarrhea

If you vomit within 3-4 hours after taking an active pink tablet, or if you 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 forgetting a tablet. After vomiting or diarrhea, take another pink tablet from a reserve package as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If this is not possible or more than 24 hours have passed, follow the advice in the "If you forget to take Etinilestradiol/Drospirenona Stada" section.

Delaying Your Period: What You Should Know

Although it is not recommended, you can delay your menstrual period if you do not take the white placebo tablets from the fourth row and start taking a new package of etinilestradiol/drospirenona and finish it. You may experience light bleeding or spotting during the use of the second package. Finish this second package by taking the 4 white tablets from the 4th row. Then start with the new package.

You should ask your doctor before deciding to delay your period.

Changing the First Day of Your Period: What You Should Know

If you take the tablets as instructed, your period will start during the placebo days. If you need to change this day, you can do so by reducing the placebo days (the days you take the white tablets) (but never increase them - 4 at most!). For example, if you start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), start a new package 3 days earlier than usual. You may not experience bleeding during these days. Then you can experience light bleeding or spotting.

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

If You Interrupt Treatment with Etinilestradiol/Drospirenona Stada

You can stop taking etinilestradiol/drospirenona 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 etinilestradiol/drospirenona and wait until your menstrual period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

If you have any additional doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, etinilestradiol/drospirenona 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 change in health that you think may be due to etinilestradiol/drospirenona, 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 you start taking Etinilestradiol/Drospirenona Stada".

The following is a list of side effects that have been associated with the use of etinilestradiol/drospirenona:

• Frequent side effects (may affect 1 to 10 out of 100 people):

• mood changes

• headache

• nausea

• breast pain, problems with periods, such as irregular periods, absence of periods

• Uncommon side effects (may affect 1 to 10 out of 1,000 people):

• depression, nervousness, drowsiness

• dizziness, "tingling"

• migraine, varicose veins, increased blood pressure

• stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea

• acne, itching, rash

• pain and discomfort, e.g., back pain, pain in the limbs, muscle cramps

• vaginal yeast infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually disappears during continued treatment), genital discharge, hot flashes, vaginal inflammation (vaginitis), problems with periods, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical smear, decreased interest in sex

• lack of energy, increased sweating, fluid retention

• weight gain

• Rare side effects (may affect 1 to 10 out of 10,000 people):

• Candida (a fungal infection)

• anemia, increased platelet count in the blood

• allergic reaction

• endocrine disorder

• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood

• inability to experience an orgasm, insomnia

• dizziness, tremors

• eye disorders, e.g., eyelid inflammation, dry eyes

• abnormally rapid heartbeats

• harmful blood clots in a vein or artery, e.g.,

• in a leg or foot (i.e., DVT)

• in a lung (i.e., PE)

• heart attack

• stroke

• symptoms of a mini-stroke or temporary stroke, known as a transient ischemic attack (TIA)

• blood clots in the liver, stomach/intestine, kidneys, or eyes.

• vein inflammation, nosebleeds, fainting

• abdominal enlargement, intestinal disorders, feeling of bloating, stomach hernia, fungal infection in the mouth, constipation, dry mouth

• bile duct or gallbladder pain, gallbladder inflammation

• brownish-yellow patches on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with bumps, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, skin sensitive to light inflammation, skin nodules.

• difficult or painful sex, vaginal yeast infection, post-coital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, malignant breast lumps, abnormal growth on the mucous membrane of the cervix, shrinkage or deterioration of the uterine lining, ovarian cysts, uterine enlargement

• feeling unwell in general

• weight loss

The possibility of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (rash with redness or blisters in a target shape).

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 potentially with difficulty breathing (see also the "Warnings and Precautions" section).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that 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 Etinilestradiol/Drospirenona Stada

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the package, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Etinilestradiol/Drospirenona Stada

• The active ingredients are etinilestradiol and drospirenona.

Each active pink film-coated tablet contains 0.02 milligrams of etinilestradiol and 3 milligrams of drospirenona.

• The white film-coated tablets do not contain active ingredients.

• The other components are:

Pink film-coated tablets:

Tablet core: lactose monohydrate, pregelatinized corn starch, povidone K-30 (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572).

Tablet film 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).

White film-coated tablets:

Tablet core: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572).

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

Appearance of the Product and Package Contents

• Each Etinilestradiol/Drospirenona Stada blister pack contains 24 active pink film-coated tablets in the 1st, 2nd, 3rd, and 4th row of the blister pack, and 4 white film-coated placebo tablets in the 4th row.

• Ethinylestradiol/Drospirenona Stada tablets, both pink and white, are film-coated tablets; the tablet core is coated.

• Ethinylestradiol/Drospirenona Stada is available in packs of 1, 3, 6, and 13 blister packs, each with 28 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

[email protected]

Manufacturer

Laboratorios León Farma, S.A.

La Vallina s/n, Pol. Ind. Navatejera

24193 Villaquilambre (León)

Spain

or

Zaklady Farmaceutyczne Polpharma S.A.,

Oddzial Produkcyjny w Nowej Debie,

ul. Metalowca 2, 39-460 Nowa Deba

Poland

Date of the Last Revision of this Leaflet:November 2022

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

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