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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 have symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

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

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

   • Do not take Ethinylestradiol/Drospirenone Stada
   • Warnings and precautions
   • Blood clots
   • Ethinylestradiol/Drospirenone Stada and cancer
   • Bleeding between menstrual periods
   • What to do if you do not have your period during the rest week
   • Taking Ethinylestradiol/Drospirenone Stada with other medicines
   • Taking Ethinylestradiol/Drospirenone Stada with food and drink
   • Laboratory tests
   • Pregnancy, breastfeeding and fertility
   • Driving and use of machines
   • Important information about some of the components of Ethinylestradiol/Drospirenone Stada

3. How to take Ethinylestradiol/Drospirenone Stada

   • When you can start with the first blister 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 diarrhoea
   • Delayed menstrual period: what you should know
   • Change in the first day of your menstrual period: what you should know
   • If you stop treatment with Ethinylestradiol/Drospirenone Stada

4. Possible side effects

5. How to store Ethinylestradiol/Drospirenone 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 tablet contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.

Contraceptives containing two hormones are known as "combined" contraceptives.

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

General considerations

Before starting etinilestradiol/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 starting etinilestradiol/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 perform other tests.

This leaflet describes several situations in which you should stop taking etinilestradiol/drospirenone, or in which the effectiveness of etinilestradiol/drospirenone may be reduced. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm method or temperature method. These methods may not be reliable because etinilestradiol/drospirenone alters the monthly changes in body temperature and cervical mucus.

Etinilestradiol/drospirenone, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

DO NOT take Etinilestradiol/Drospirenone Stada

You must not use etinilestradiol/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 (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 need 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 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 do not work properly (renal failure).
• If you have (or have had) a liver tumour.
• If you have (or have had), or suspect you may 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 present as itching, rash, or swelling.
• If you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Etinilestradiol/Drospirenone Stada with other medicines”).

Additional information on special populations

Use in children

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

Warnings and precautions

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot which may indicate that 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 clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

In some situations, you should take special care when using ethinylestradiol/drospirenone or any other combined hormonal contraceptive, and your doctor may need to perform periodic check-ups.

Tell your doctor if you have any of the following conditions:

If any of these conditions develop or worsen while you are using ethinylestradiol/drospirenone, you should also inform your doctor.

• if a close family member has or has had breast cancer
• if you have any liver or gallbladder disease
• if you have diabetes
• if you have depression
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease 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 (an inherited 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 a prolonged period (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 “Taking Ethinylestradiol/Drospirenone Stada with other medicines”)
• if you have or have ever had a condition that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham's chorea))
• if you have or have ever had chloasma (golden-brown patches, also known as “pregnancy mask,” especially on the face). In such cases, avoid direct exposure to sunlight or ultraviolet radiation
• 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 when taking a deep breath. Severe dizziness or lightheadedness. Fast 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 such as 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 sternum. 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. Fast 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 problems 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 the veins (venous thrombosis). However, these adverse effects are rare. They occur more 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 travels to 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 in which 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 always 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 small.

• Among every 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 every 10,000 women who are using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among every 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as ethinylestradiol/drospirenone, between 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 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 in 10,000 women
Women who use ethinylestradiol/drospirenone	About 9-12 in 10,000 women

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

The risk of having a blood clot with 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 have had a blood clot in the leg, lung, or another organ at a young age (i.e., before the age of approximately 50). In this case, you may 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 taking 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 taking it 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 listed risk factors.

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

If any of the above conditions change while you are using ethinylestradiol/drospirenone—for example, a close relative experiences a thrombosis without a known cause or you gain significant 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 (over about 35 years).

• If you smoke. You are advised to stop smoking when using a combined hormonal contraceptive such as ethinylestradiol/drospirenone. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraception.

• 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 (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.

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

• If you 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 are particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions 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 significant weight—inform your doctor.

Ethinylestradiol/Drospirenone Daily and cancer

Women who use combined contraceptives have a slightly higher rate of breast cancer, but it is not known whether this is due to the treatment. For example, more tumours may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumours 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 tumours have been reported rarely, and malignant liver tumours even more rarely, in users of hormonal contraceptives. See your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as ethinylestradiol/drospirenone have reported depression or a 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.

Bleeding between menstrual periods

During the first months of using ethinylestradiol/drospirenone, unexpected bleeding (bleeding outside the pill-free interval) may occur. If you experience such bleeding for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What should you do if you do not have your period during the pill-free week?

If you have taken all the tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is very unlikely that you are pregnant.

If you miss two consecutive periods, you may be pregnant. In this case, see your doctor immediately. Do not start the next pack until you have confirmed that you are not pregnant.

Taking Ethinylestradiol/Drospirenone Stada with other medicines

Always inform the doctor who prescribed you ethinylestradiol/drospirenone about any medications or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medication (or your pharmacist) that you are taking ethinylestradiol/drospirenone. They can advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or whether you should modify the use of any other treatment you require.

Some medicines

• can influence the levels of ethinylestradiol/drospirenone in the blood
• can make it less effective in preventing pregnancy
• can cause unexpected bleeding.

This may occur with:

? medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• HIV and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, osteoarthritis (etoricoxib),
• high blood pressure in the blood vessels of the lungs (bosentan).

? the herbal remedy St. John's wort.

Ethinylestradiol/drospirenone may influence the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (may lead to increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat pain and/or muscle cramps)

Do not take ethinylestradiol/drospirenone if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (increase in liver enzyme ALT).

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

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

Consult your doctor or pharmacist before using any medicine.

Taking Ethinylestradiol/Drospirenone Stada with food and drinks

You may take the tablets with or without food, with a glass of water if needed.

Laboratory tests

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 also “Stopping treatment with 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 using machines

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

Important information about some of the components of Ethinylestradiol/Drospirenone Stada

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

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

3. How to take Ethinylestradiol/Drospirenone Stada

Take one ethinylestradiol/drospirenone tablet every day, with some water if necessary. You may take the tablets with or without food, but at approximately the same time each day.

The blister pack contains 21 tablets. Next to each tablet is printed the day of the week on which it should be taken. For example, if you start on a Wednesday, take a tablet marked "WED". Follow the direction of the arrow on the blister pack until you have taken all 21 tablets.

Afterwards, do not take any tablets for 7 days. During these 7 days without tablets (called the "rest week"), your menstrual period should occur. The menstruation, which may also be referred to as withdrawal bleeding, usually begins on the 2nd or 3rd day of the rest week.

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

If you use ethinylestradiol/drospirenone in this way, you will also be protected against pregnancy during the 7 days when no tablets are taken.

When to start the first blister pack

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

Start taking ethinylestradiol/drospirenone on the first day of your cycle (i.e., the first day of your period). If you start ethinylestradiol/drospirenone on the first day of your period, you will be protected 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 a combined hormonal contraceptive, combined vaginal ring, or contraceptive patch

You may preferably start taking ethinylestradiol/drospirenone 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 week of your previous contraceptive (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 (progestogen-only pill, injection, implant, or intrauterine progestogen-releasing system [IUD])

You may switch from the progestogen-only pill on any day (if it is an implant or IUD, on the same day of its removal; if it is an injectable, at the time the next injection would be due), but in all cases use additional contraceptive measures (e.g., a condom) during the first 7 days of taking the tablets.

• After an abortion

Follow your doctor's advice.

• After giving birth

You may start taking ethinylestradiol/drospirenone between 21 and 28 days after giving birth. If you start later, use one of the so-called barrier 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 wish to start taking ethinylestradiol/drospirenone (again) after giving birth

Read the section "Breastfeeding".

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

If you take more Ethinylestradiol/Drospirenone Stada than you should

No serious harmful effects have been reported following overdose with ethinylestradiol/drospirenone.

Symptoms that may occur if you take many tablets at once include feeling unwell, 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 ethinylestradiol/drospirenone tablets, or find out that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Ethinylestradiol/Drospirenone Stada

• If you are less than 12 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 the usual time.

• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you forget, the greater the risk of becoming pregnant.

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

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 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 the usual time and use additional precautions, for example, a condom, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

• Missing one tablet in week 2

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 the usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

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 the usual time. Instead of starting the rest week, start the next blister pack.

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

2. You may also stop taking tablets and go directly into the 7-day rest period (noting the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period will need to last less than 7 days.

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

• If you have missed taking any tablets and do not have bleeding during the first rest week, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or 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 a tablet from a reserve pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Ethinylestradiol/Drospirenone Stada".

Delaying your menstrual period: what you should know

Although not recommended, you may delay your period by starting a new blister pack of ethinylestradiol/drospirenone instead of continuing with the rest week, and complete it. During the second pack, you may experience light bleeding or spotting. After the usual 7-day rest week, start the next pack.

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

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

If you take the tablets as instructed, your period will start during the rest week. If you wish to change that day, reduce the number of rest days (but never increase them – maximum 7!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or fewer), bleeding may not occur during these days. In this case, you may experience light bleeding or spotting later.

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

If you stop taking Ethinylestradiol/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 contraception. If you wish to become pregnant, stop taking ethinylestradiol/drospirenone and wait until your next period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any health changes 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 the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on 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 adverse effects related to the use of ethinylestradiol/drospirenone.

Frequent adverse effects (may affect up to 1 in 10 women):

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

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

• breast enlargement, changes in libido (sex drive)
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash (eczema), severe itching, hair loss (alopecia)
• vaginal infection
• fluid retention and changes in body weight.

Rare adverse effects (may affect between 1 and 10 in 1,000 women):

• allergic reactions (hypersensitivity), asthma

• breast discharge

• hearing problems

• skin disorders such as erythema nodosum (characterized by painful reddish skin nodules) or erythema multiforme (characterized by skin rash with target-like redness or ulcers).

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

• In a leg or foot (i.e., DVT) or in a lung (i.e., PE)

• Heart attack.

• Stroke.

• Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).

• Blood clots in the liver, stomach/intestines, kidneys or eye.

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 on conditions that increase the risk of blood clots and symptoms of a blood clot).

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially accompanied by difficulty breathing (see also section “Warnings and precautions”).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may 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 sight and reach of children.

This medicine does not require any special storage conditions.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, 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 0.03 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

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

Appearance of the product and contents of the pack

Film-coated tablets, round, yellow in colour.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193-Villaquilambre (León)

Spain

Date of the most recent review of this leaflet: September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.