Patient Information: Package Insert

Ethinylestradiol/Drospirenona Stada 0.02 mg/3 mg Coated Tablets (24+4) EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

•Keep this package insert, as you may need to refer to it again.

•If you have any questions, consult your doctor or pharmacist.

•This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Important information you should know about combined hormonal contraceptives (CHCs):

•They are one of the most reliable reversible contraceptive methods if used correctly.

•They slightly increase the risk of blood clots in veins and arteries, especially in the first year or when restarting use of a hormonal contraceptive after a 4-week or longer break.

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

1.What is Ethinylestradiol/Drospirenona Stada and how is it used

2.What you need to know before starting to take Ethinylestradiol/Drospirenona Stada

• Do not take Ethinylestradiol/Drospirenona Stada
• Warnings and precautions
• Ethinylestradiol/Drospirenona Stada and blood clots in veins and arteries
• Ethinylestradiol/Drospirenona Stada and cancer
• Intermenstrual bleeding
• What to do if you do not have your period during the placebo days
• Other medications and Ethinylestradiol/Drospirenona Stada
• Laboratory tests
• Pregnancy, breastfeeding, and fertility
• Driving and operating machinery
• Ethinylestradiol/Drospirenona Stada contains lactose

3.How to take Ethinylestradiol/Drospirenona Stada

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

4.Possible side effects

5.Storage of Ethinylestradiol/Drospirenona Stada

6.Contents of the package and additional information

• Ethinylestradiol/drospirenona is a contraceptive and is used to prevent pregnancy.
• Each of the 24 active tablets, of pink color, contains a small amount of two different female hormones, called ethinylestradiol and drospirenona.
• The 4 white tablets without active ingredients are called placebo tablets.
• Contraceptives that contain two hormones are called combined contraceptives.

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 vein in your leg (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase the risk of forming a blood clot in the arteries:
• severe diabetes with vascular damage
• very high blood pressure
• very high levels of fat in the blood (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function properly (renal failure).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to etinilestradiol or drospirenona, or to any of the other components of this medication (including in section 6). This may manifest with itching, rash or inflammation.

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

• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also the section “Other Medicaments 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 Disease

Do not take etinilestradiol/drospirenona if you suffer from liver disease. See sections “Do not take Etinilestradiol/Drospirenona Stada” and “Warnings and Precautions”.

Women with Renal Disease

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

Warnings and Precautions

In some situations, you should take special care while using etinilestradiol/drospirenona or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor.

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

Inform your doctor or pharmacist before taking etinilestradiol/drospirenona:

• if any close relative has had or has ever had breast cancer
• if you have cancer
• if you have any liver disease (such as obstruction of the bile ducts that may cause jaundice and symptoms such as itching) or gallbladder disease (such as gallstones)
• if you have kidney problems (different from those mentioned in the section “Do not take Etinilestradiol/Drospirenona Stada”) and are taking other medications that increase blood potassium levels. Your doctor may check your blood potassium levels
• if you have diabetes
• if you have depression. Some women who use hormonal contraceptives like etinilestradiol/drospirenona have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.
• 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 disorder of red blood cells)
• if you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas)
• if you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”)
• if you recently gave birth, you are at greater risk of blood clots. Ask your doctor when you can start taking etinilestradiol/drospirenona after delivery.
• if you have superficial thrombophlebitis (inflammation of the veins under the skin)
• if you have varicose veins
• if you have epilepsy (see “Other Medicaments and Etinilestradiol/Drospirenona Stada”)
• if you have any disease that may have appeared for the first time during pregnancy or during a previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)
• if you have high blood pressure during treatment that is not controlled by another medication
• if you have or have ever had melasma (brownish patches on the skin, also known as “pregnancy mask”), especially on the face. In this case, avoid direct exposure to the sun or ultraviolet rays while taking this medication
• 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 can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like etinilestradiol/drospirenona increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems. Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “thromboembolism”, or TEV).
• In arteries (which is called “arterial thrombosis”, “thromboembolism”, or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or, very rarely, fatal effects.

It is essential to remember that the overall risk of a blood clot due to etinilestradiol/drospirenona is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

?The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (deep vein 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 the leg or foot, it may cause deep vein thrombosis (DVT).

?If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).

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

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

The risk of a blood clot in a vein is higher during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.

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

What is the risk of a blood clot?

The risk depends on your natural risk of TEV and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with etinilestradiol/drospirenona is small.

-Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.

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

-Of every 10,000 women who use a combined hormonal contraceptive that contains drospirenona, such as etinilestradiol/drospirenona, 9-12 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 having a blood clot due to using etinilestradiol/drospirenona is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2or higher).
• If any close relative has 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 disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or disease or if you have a leg cast. You may need to interrupt the use of etinilestradiol/drospirenona for several weeks before the operation or while you have less mobility. If you need to interrupt the use of etinilestradiol/drospirenona, ask your doctor when you can start using it again.
• As you get older (especially over the age of about 35).
• If you gave birth recently.

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

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

It is essential to inform your doctor if you have any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you should interrupt the use of etinilestradiol/drospirenona.

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

BLOOD CLOTS IN AN ARTERY

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

A blood clot in an artery can cause serious problems, such as 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 using etinilestradiol/drospirenona is very small, but it may increase:

• With age (over the age of about 35).
• If you smoke. When using a combined hormonal contraceptive like etinilestradiol/drospirenona, you are advised to stop smoking. If you are unable to stop smoking and are over 35, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any close relative has had a heart attack or stroke at a young age (less than about 50). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, irregular heart rhythm 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 even further.

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

Ethinylestradiol/Drospirenona Stada and Cancer

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

In rare cases, benign tumors in the liver and, more rarely, malignant tumors have been reported in women using combined hormonal contraceptives. Consult your doctor if you experience severe abdominal pain, abdominal swelling (which may be due to liver enlargement), vomiting blood, or bloody stools or stools that are black and tar-like, as these may be signs of bleeding in the stomach.

BLEEDING BETWEEN PERIODS

During the first few months of taking etinilestradiol/drospirenona, you may experience unexpected bleeding (bleeding outside the week when you are taking the white pills). If this bleeding persists beyond 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 pills correctly, have not had vomiting or severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

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

Other Medicaments and Etinilestradiol/Drospirenona Stada

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

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

Ethinylestradiol/drospirenona can be 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 the contraceptive to lose its effectiveness, or may cause unexpected bleeding or spotting. This may occur with medications used to treat:

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

tuberculosis (e.g. rifampicin),

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

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

herbal preparations of St. John's Wort.

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

medications that contain ciclosporin,

the antiepileptic lamotrigine (may lead to an increase in seizure frequency)

theophylline (used to treat respiratory problems)

tizanidine (used to treat muscle pain and/or muscle cramps)

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

Laboratory Tests

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

Pregnancy, Breastfeeding, and Fertility

Pregnancy

If you are pregnant, do not take etinilestradiol/drospirenona. If you become pregnant while taking etinilestradiol/drospirenona, stop taking it immediately and consult your doctor. If you want to become pregnant, you can stop taking etinilestradiol/drospirenona at any time (see “Stopping Treatment with Etinilestradiol/Drospirenona Stada”).

Breastfeeding

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

Driving and Operating Machinery

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

Ethinylestradiol/Drospirenona Stada contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The two different colored tablets of etinilestradiol/drospirenona are placed in order. A pack 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 a pink tablet every day for the first 24 days, followed by a white tablet for the last 4 days. Then you should start taking a new pack (24 pink tablets and 4 white tablets). In this way, there is no break between two packs.

Due to the different composition of the tablets, you need to start with the first tablet located in the top left corner and then take one tablet every day. To maintain the order, follow the direction of the arrows on the pack.

Preparation of the blister:

To help you follow the taking order, each pack of etinilestradiol/drospirenona 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 indicates "WED" as the initial tablet.

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

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

When can you start with the first pack:

?If you have not taken any hormonal contraceptive in the previous month.

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

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

You should start taking etinilestradiol/drospirenona preferably on 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 days of rest (or after taking the last inactive tablet) of your previous contraceptive. When changing from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can change from the progestin-only pill, any day (if it is an implant or an IUS, you should change on the same day of its extraction; if it is an injectable, when it is the next injection), but in all cases, it is recommended that you use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

?After an abortion or termination of pregnancy.

Follow your doctor's recommendations.

?After having a child.

After having a child, you can start taking etinilestradiol/drospirenona between 21 and 28 days after having a child. If you start later, use one of the so-called barrier contraceptive methods (e.g., a condom) 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 should 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 child.

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take more Etinilestradiol/Drospirenona Stada than you should:

No serious cases of overdose of etinilestradiol/drospirenona have been reported.

If you take many tablets at once, you may feel unwell, vomit, or have vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

If you have taken too many etinilestradiol/drospirenona tablets, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicological 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 pack are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of etinilestradiol/drospirenona. Dispose of the forgotten placebo tablet.

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

?If you are lateless than 24 hoursin taking a tablet, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.

?If you are latemore than 24 hoursin taking a tablet, the protection against pregnancy may decrease. The more tablets you have forgotten, the higher the risk of pregnancy.

The risk of incomplete protection against pregnancy is maximum if you forget to take the pink tablet at the beginning or end of the pack. The following recommendations should be followed in this situation (see the diagram below):

?Forgetting more than one tablet from the pack

Consult your doctor.

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

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, e.g., a condom, during 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 be pregnant.

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

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

?Forgetting a tablet 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 this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets of this pack, dispose of them and start a new pack (the day you take the first tablet will be different).

Probably you will have your period at the end of the second pack – during the taking of the white placebo tablets – although you may experience light bleeding or menstrual-like bleeding during the taking of the second pack.

2. You can also interrupt the taking 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 pack on the day fixed when you started always, take the placebo tabletsless 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 you do not have your period during the placebo days, you may be pregnant. Contact your doctor before starting the next pack

In the following diagram, it is described how to proceed if you forget to take your tablets:

What to do in case of vomiting or intense diarrhea:

If you have vomiting in the 3-4 hours after taking an active pink tablet, or if you have intense diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take another active pink tablet from a reserve pack 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 instructions in the section "If you forgot to take Etinilestradiol/Drospirenona Stada".

Delay of your period: what you should know:

Although it is not recommended, you can delay your period if you do not take the placebo tablets, dispose of them, and start a new pack of etinilestradiol/drospirenona and finish it. You may experience light bleeding or menstrual-like bleeding during the use of the second pack.

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

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

If you take the tablets as indicated, your period will start duringthe placebo days. If you need to change this day, you can do so by reducingthe placebo days(the days when you take the white tablets) (but never increase them - 4 at most!). For example, if you start taking the placebo tablets on Friday and want to change them to Tuesday (3 days earlier), start a new pack 3 days earlier than usual. It is possible that you will not have bleeding during these days. Then you may experience light bleeding or menstrual-like bleeding.

If you are unsure how to proceed, consult your doctor.

If you interrupt the treatment with Etinilestradiol/Drospirenona Stada:

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

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

Like all medicines, etinilestradiol/drospirenona may cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due to etinilestradiol/drospirenona, consult your doctor.

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

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

•Frequent side effects(may affect between 1 and 10 in every 100 people):

omood changes

oheadaches

onausea

obreast pain, problems with your periods, such as irregular periods, absence of periods

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

oCandida (a fungal infection)

oanemia, increased number of platelets in the blood

oallergic reaction

oendocrine disorder

oincreased appetite, loss of appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood

onot experiencing an orgasm, insomnia

odizziness, tremor

oeye disorders, for example, inflammation of the eyelids, dry eyes

oabnormally rapid heartbeats

oharmful blood clots in a vein or artery, for example:

oin a leg or foot (i.e. DVT)

oin a lung (i.e. PE)

oheart attack

ostroke

otransient ischemic attack (TIA) symptoms, also known as mini-stroke

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

oinflammation of a vein, nosebleeds, fainting

oenlargement of the abdomen, intestinal disorders, feeling bloated, hernia of the stomach, fungal infection in the mouth, constipation, dry mouth

ogallbladder duct pain or gallbladder inflammation

obrownish-yellow patches on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with nodules, excessive hair growth, skin disorders, skin striations, skin inflammation, skin sensitivity to light, skin nodules.

odifficult or painful sex, vaginal inflammation (vulvovaginitis), post-coital bleeding, amenorrhea, breast enlargement, benign breast lumps, abnormal cell growth in the breast tissue, breast cancer, abnormal growth on the surface mucosa of the cervix, uterine atrophy or deterioration, ovarian cysts, uterine enlargement

ofeeling unwell in general

oweight loss

The risk 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).

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 circular pattern).

Seek medical attention immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially difficulty breathing (see also the section “Warnings and precautions”).

Reporting of side effects

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

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Etinilestradiol/Drospirenona Stada

• The active principles areetinilestradiol and drospirenona.

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

• The film-coated tablets of white color do not contain active principle.

• The other components are:

Film-coated tablets of pink color:

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

Tablet 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).

Film-coated tablets of white color:

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

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

Appearance of the product and contents of the package

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

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

• Etinilestradiol/Drospirenona Stada is available in packages of 1, 3, 6, and 13 blisters, each containing 28 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

León Farma, S.A. Laboratories

La Vallina s/n, Pol. Ind. Navatejera

24193 Villaquilambre (León)

Spain

or

Polpharma S.A.,

Production Plant in Nowa Deba,

ul. Metalowca 2, 39-460 Nowa Deba

Poland

Last review date of this leaflet:November 2022

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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