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

Package leaflet: Information for the user

Introduction

Package leaflet: patient information

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

Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

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

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

Leaflet contents

1. What Etinilestradiol/Drospirenona Stada is and what it is used for

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

• Do not take Etinilestradiol/Drospirenona Stada
• Warnings and precautions
• Etinilestradiol/Drospirenona Stada and blood clots in veins and arteries
• Etinilestradiol/Drospirenona Stada and cancer
• Bleeding between periods
• What to do if you do not have your period during the placebo days
• Other medicines and Etinilestradiol/Drospirenona Stada
• Laboratory tests
• Pregnancy, breastfeeding and fertility
• Driving and use of machines
• Etinilestradiol/Drospirenona Stada contains lactose

3. How to take Etinilestradiol/Drospirenona Stada

• Blister pack preparation
• When can you start the first pack?
• If you take more Etinilestradiol/Drospirenona Stada than you should
• If you forget to take Etinilestradiol/Drospirenona Stada
• What to do in case of vomiting or severe diarrhoea
• Delay of your period: what you should know
• Change in the first day of your period: what you should know
• If you stop treatment with Etinilestradiol/Drospirenona Stada

4. Possible side effects

5. How to store Etinilestradiol/Drospirenona Stada

6. Contents of the pack and other information

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

• Etinilestradiol/drospirenone is a contraceptive used to prevent pregnancy.
• Each of the 24 active pink tablets 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 containing two hormones are known as combined contraceptives.

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

General considerations Before starting to use ethinylestradiol/drospirenone, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot – see section 2 “Blood clots”. Before you start taking ethinylestradiol/drospirenone, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health status, may carry out some additional tests. This patient information leaflet describes several situations in which you should stop using ethinylestradiol/drospirenone, or in which the effectiveness of ethinylestradiol/drospirenone may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or another barrier method. Do not use the rhythm method or temperature method. These methods may not be reliable because ethinylestradiol/drospirenone alters the monthly changes in body temperature and cervical mucus. Ethinylestradiol/drospirenone, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Ethinylestradiol/Drospirenone Stada

Do not use ethinylestradiol/drospirenone 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 which other form of contraception would be more suitable.

• If you have had (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you require surgery or will 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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions 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 ever had) liver disease and your liver function has not yet returned to normal.
• If your kidneys are not working properly (renal failure).
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had), or suspect you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown cause.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, rash, or swelling.

Do not use ethinylestradiol/drospirenone if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Ethinylestradiol/Drospirenone Stada”).

• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section “Other medicines and Ethinylestradiol/Drospirenone Stada”).

Additional information on special populations

Children and adolescents

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

Women of advanced age

Ethinylestradiol/drospirenone is not indicated for use after menopause.

Women with hepatic impairment

Do not take ethinylestradiol/drospirenone if you suffer from liver disease. See sections “Do not take Ethinylestradiol/Drospirenone Stada” and “Warnings and precautions”.

Women with renal impairment

Do not take ethinylestradiol/drospirenone if you are experiencing impaired kidney function or acute renal failure. See sections “Do not take Ethinylestradiol/Drospirenone Stada” and “Warnings and precautions”.

Warnings and precautions

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

In certain situations, you should exercise special caution when using ethinylestradiol/drospirenone or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically.

Inform your doctor if any of the following conditions develop or worsen while you are taking ethinylestradiol/drospirenone.

Inform your doctor or pharmacist before taking ethinylestradiol/drospirenone:

• if any close family member has 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 (other than those mentioned in the section “Do not take Ethinylestradiol/Drospirenone Stada”) and are taking other medications that increase potassium levels in the blood. Your doctor may check your blood potassium levels
• if you have diabetes
• if you have depression. Some women using hormonal contraceptives such as ethinylestradiol/drospirenone have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or 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 affecting your body's natural defense system)
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anemia (a hereditary red blood cell disorder)
• 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 require surgery or will be immobile for long periods (see section 2 “Blood clots”)
• if you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking ethinylestradiol/drospirenone after childbirth.
• if you have inflammation of veins beneath the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have epilepsy (see “Other medicines and Ethinylestradiol/Drospirenone Stada”)
• if you have any condition that may have first occurred during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham's chorea))
• if you have high blood pressure during treatment that is not controlled by other medication
• if you have ever had or currently have brownish-yellow patches (chloasma), also known as “pregnancy mask,” especially on the face. In this case**, avoid direct exposure** to sunlight or ultraviolet radiation 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 hives with difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as ethinylestradiol/drospirenone increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems. Blood clots can form:

• In veins (called “venous thrombosis,” “venous thromboembolism,” or VTE).
• In arteries (called “arterial thrombosis,” “arterial thromboembolism,” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to ethinylestradiol/drospirenone is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
? Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: ? Pain or tenderness in the leg, which may only be noticeable when standing or walking. ? Increased warmth in the affected leg. ? Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
? Sudden shortness of breath without known cause or rapid breathing. ? Sudden cough without clear cause, possibly bringing up blood. ? Sharp chest pain that may worsen with deep breathing. ? Severe dizziness or lightheadedness. ? Rapid or irregular heartbeat. ? Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: ? Sudden loss of vision, or ? Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
? Pain, discomfort, pressure, or heaviness in the chest. ? Feeling of tightness or fullness in the chest, arm, or below the breastbone. ? Feeling of fullness, indigestion, or suffocation. ? Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. ? Sweating, nausea, vomiting, or dizziness. ? Extreme weakness, anxiety, or shortness of breath. ? Rapid or irregular heartbeat.	Heart attack.
? Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. ? Sudden confusion, difficulty speaking or understanding speech. ? Sudden vision difficulty in one or both eyes. ? Sudden difficulty walking, dizziness, loss of balance or coordination. ? Sudden, severe, or prolonged headache without known cause. ? Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
? Swelling and slight bluish discoloration of a limb. ? Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

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

? If a blood clot forms in a vein of 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.

? Very rarely, a blood clot may 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 you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart 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 still slightly higher than if you were not taking a combined hormonal contraceptive. When you stop taking ethinylestradiol/drospirenone, 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 venous thromboembolism (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 ethinylestradiol/drospirenone is low.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone such as ethinylestradiol/drospirenone, between about 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see "Factors that increase your risk of a blood clot" below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women using ethinylestradiol/drospirenone	About 9–12 out of 10,000 women

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

The risk of having a blood clot due to using ethinylestradiol/drospirenone is small, but certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of about 50). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for long periods due to injury, illness, or having your leg in a cast. You may need to stop using ethinylestradiol/drospirenone several weeks before surgery or while you are less mobile. If you need to stop taking ethinylestradiol/drospirenone, ask your doctor when you can start again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop using ethinylestradiol/drospirenone.

If any of the conditions listed above change while you are using ethinylestradiol/drospirenone—for example, a close relative experiences a thrombosis without a known cause, or you gain a significant amount 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 lead to 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 heart attack or stroke while using ethinylestradiol/drospirenone is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as ethinylestradiol/drospirenone, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, a heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions listed above change while you are using ethinylestradiol/drospirenone—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Ethynilestradiol/Drospirenone Stada and cancer

Slightly more cases of breast cancer have been observed in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

Benign liver tumors have been reported rarely, and even more rarely malignant liver tumors, in users of hormonal contraceptives. See your doctor if you experience unusually severe abdominal pain, abdominal swelling (which may be due to liver enlargement), vomiting blood, or notice blood in your stools or tarry stools, as these may be signs of gastrointestinal bleeding.

Bleeding between periods

During the first few months of taking ethinylestradiol/drospirenone, you may experience unexpected bleeding (bleeding outside the week when you are taking the white tablets). If this bleeding persists beyond a few months or starts after several months, your doctor will investigate the cause.

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 vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If you miss your expected period for two consecutive cycles, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and Ethinylestradiol/Drospirenone Stada

Inform your doctor about any medicines or herbal preparations you are taking, have recently taken, or might need to take. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are using ethinylestradiol/drospirenone. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

Do not take ethinylestradiol/drospirenone 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 function test results (elevation of the liver enzyme ALT).

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

Ethinylestradiol/drospirenone may be restarted approximately 2 weeks after completion of this treatment. See the section “Do not take Ethinylestradiol/Drospirenone Stada”.

• Some medications may affect blood levels of ethinylestradiol/drospirenone and may cause it to lose contraceptive effectiveness, or may cause 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 infection and hepatitis C (medications called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz), or other infections (griseofulvin or ketoconazole),

o arthritis, osteoarthritis (etoricoxib), or high blood pressure in the pulmonary blood vessels (bosentan),

o herbal preparations containing St. John's wort.

Ethinylestradiol/drospirenone may influence 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 cramps).

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

Laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking an oral contraceptive, as hormonal contraceptives may influence the results of certain tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you must not take ethinylestradiol/drospirenone. If you become pregnant while taking ethinylestradiol/drospirenone, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking ethinylestradiol/drospirenone at any time (see “If you stop taking Ethinylestradiol/Drospirenone Stada”).

Breastfeeding

In general, ethinylestradiol/drospirenone is not recommended during breastfeeding. If you wish to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and use of machines

There is no information suggesting that the use of ethinylestradiol/drospirenone has any effect on the ability to drive or operate machinery.

Ethinylestradiol/Drospirenone Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, and is therefore considered essentially “sodium-free”.

3. How to take Etinilestradiol/Drospirenone Stada

Follow exactly the instructions for use of this medicine as given 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 types of coloured tablets of ethinylestradiol/drospirenone are arranged in order. One pack contains 28 tablets.

Take one tablet of ethinylestradiol/drospirenone every day, with some water if necessary. You may take the tablets with or without food, but always at approximately the same time each 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 start a new pack (24 pink and 4 white tablets). In this way, there is no break between packs.

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

Blister preparation

To help you follow the correct order of intake, each pack of ethinylestradiol/drospirenone includes seven adhesive strips printed with the seven days of the week. Choose the weekly strip starting with the day on which you take the first tablet. For example, if you start on Wednesday, apply the strip marked “WED” as the initial tablet.

Apply the weekly adhesive strip to the top of the blister where it says “Place label here”, so that the first day is positioned above the tablet marked “START”. In this way, each tablet will have a day of the week indicated above it, allowing you to see whether 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 the white placebo tablets (placebo days), menstruation (also called withdrawal bleeding) should occur. Menstruation usually begins on the 2nd or 3rd day after taking the last active pink tablet of ethinylestradiol/drospirenone. After taking the last white tablet, you must start the next pack, even if your period has not finished. This means you should start each pack on the same day of the week as you started the previous one, and your period should occur during the same days every month.

If you take ethinylestradiol/drospirenone as directed, you will also be protected against pregnancy during the 4 days when you are taking the placebo tablets.

When to start the first pack

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

Start taking ethinylestradiol/drospirenone on the first day of your cycle (i.e., the first day of your menstruation). If you start ethinylestradiol/drospirenone on the first day of your period, you will be protected against pregnancy immediately. You may also start on days 2–5 of the 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 contraceptive ring, or contraceptive patch.

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

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

You may switch from a progestogen-only pill on any day (if it is an implant or IUS, you should switch on the same day of removal; if it is an injectable, at the time of the next scheduled injection), 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 giving birth

After giving birth, you may start taking ethinylestradiol/drospirenone between 21 and 28 days after delivery. If you start later, use one of the so-called barrier contraceptive methods (e.g., a condom) during the first 7 days of using ethinylestradiol/drospirenone.

If, after giving birth, you have already had sexual intercourse before starting to take ethinylestradiol/drospirenone (again), you must be sure you are not pregnant or wait until your next menstrual period.

?If you are breastfeeding and want to start taking ethinylestradiol/drospirenone (again) after giving birth.

Read the section “Breast-feeding”.

Ask your doctor if you are unsure about when to start.

If you take more Etinylestradiol/Drospirenone Stada than you should

No cases have been reported in which overdose of ethinylestradiol/drospirenone has caused serious harm.

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

If you have taken too many tablets of ethinylestradiol/drospirenone, or if you find that a child has taken them, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Etinylestradiol/Drospirenone Stada

The last 4 tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these placebo tablets, the contraceptive effect of ethinylestradiol/drospirenone will not be lost. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet (tablets 1–24 of the blister), follow the steps below:

? If you are less than 24 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and continue taking the following tablets at your usual time.

? If you are more than 24 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is highest if you miss a pink tablet at the beginning or end of the pack. The recommendations below apply in this situation (see diagram below):

? Missing more than one tablet in the pack

Consult your doctor.

? Missing one tablet during days 1–7 (first row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions, e.g., a condom, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, contact your doctor, as there is a possibility you may be pregnant.

? Missing one tablet during days 8–14 (second row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

? Missing one tablet between days 15–24 (third or fourth row)

You have two options:

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

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

2. You may also interrupt the intake of active pink tablets and go directly to the 4 white placebo tablets (including the days you missed, before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, take fewer than 4 placebo tablets.

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

? If you have missed any tablets and do not have your period during the placebo days, you may be pregnant. Contact your doctor before starting the next pack.

The following diagram describes what to do if you forget to take your tablets:

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking an active pink tablet, or if you have severe diarrhoea, there is a risk that the active ingredients of the contraceptive are not fully absorbed by the body. This situation is almost equivalent to missing a tablet. After vomiting or severe diarrhoea, take another pink tablet from a spare pack as soon as possible. If possible, take it within 24 hours of your usual time of taking the contraceptive. If this is not possible or more than 24 hours have passed, follow the advice in the section “If you forget to take Etinylestradiol/Drospirenone Stada”.

Delaying your period: what you should know

Although not recommended, you may delay your menstrual period by not taking the white placebo tablets in the fourth row and instead starting a new pack of ethinylestradiol/drospirenone and completing it. You may experience light bleeding or spotting during the use of the second pack. Finish this second pack by taking the 4 white tablets in the 4th row. Then start a new pack.

You should consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your period will begin during the placebo days. If you wish to change this day, you may do so by reducing the number of placebo days (the days when you take the white tablets) (but never increase them—maximum 4 days). For example, if you usually start the placebo tablets on Fridays and want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. Bleeding may not occur during these days. You may then experience light bleeding or spotting.

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

If you stop taking Etinylestradiol/Drospirenone Stada

You may stop taking ethinylestradiol/drospirenone at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking ethinylestradiol/drospirenone and wait until your next menstrual period before trying to conceive. This will make it easier to calculate the estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, ethinylestradiol/drospirenone may cause adverse effects, although not everyone experiences them.

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

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

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

• Common adverse effects (may affect between 1 and 10 in every 100 people):

o mood changes

o headache

o nausea

o breast pain, problems with your periods, such as irregular periods, absence of periods

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

o depression, nervousness, drowsiness

o dizziness, "tingling"

o migraine, varicose veins, increased blood pressure

o stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhoea

o acne, itching, rash

o pains and discomforts, for example, back pain, limb pain, muscle cramps

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

o lack of energy, increased sweating, fluid retention

o weight gain

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

o Candida (a fungal infection)

o anaemia, increased number of platelets in the blood

o allergic reaction

o hormonal disorder (endocrine)

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

o inability to achieve orgasm, insomnia

o dizziness, tremor

o eye disorders, for example, eyelid inflammation, dry eyes

o abnormally rapid heartbeat

o harmful blood clots in a vein or artery, for example:

o in a leg or foot (i.e., DVT)

o in a lung (i.e., PE)

o heart attack

o stroke

o symptoms of mini-stroke or transient stroke, known as transient ischaemic attack (TIA)

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

o inflammation of a vein, nosebleeds, fainting

o abdominal swelling, intestinal disorders, bloated feeling, stomach hernia, fungal infection in the mouth, constipation, dry mouth

o bile duct or gallbladder pain, inflammation of the gallbladder

o yellow-brown patches on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, inflamed skin with lumps, dry skin, skin sensitive to light, skin nodules

o difficult or painful sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth on the mucosal surface of the cervix, shrinking or deterioration of the uterine lining, ovarian cysts, uterine enlargement

o feeling generally unwell

o weight loss

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

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (rash with redness or target-shaped sores).

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 hives potentially accompanied by difficulty breathing (see also section "Warnings and precautions").

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ethinylestradiol/Drospirenone Stada

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

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Etinilestradiol/Drospirenone Stada

• The active substances are ethinylestradiol and drospirenone.

Each active pink film-coated tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.

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

• Other components are:

Pink film-coated tablets:

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

Film coating: partially hydrolysed 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).

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

Appearance of the product and contents of the pack

• Each blister of Etinilestradiol/Drospirenone Stada contains 24 active pink film-coated tablets, located in rows 1, 2, 3 and 4 of the blister, and 4 white film-coated placebo tablets, located in row 4.

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio 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.,

Production Site in Nowa Dęba,

ul. Metalowca 2, 39-460 Nowa Dęba

Poland

Date of the most recent revision of this leaflet: November 2022

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