Ethinylestradiol/drospirenone Diario 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 Diario 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given 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 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 blood clots 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 Etinylestradiol/Drospirenone Diario Stada is and what it is used for
2. What you need to know before taking Etinylestradiol/Drospirenone Diario Stada

? Do not take Etinylestradiol/Drospirenone Diario Stada

? Warnings and precautions

? Blood clots

? Etinylestradiol/Drospirenone Diario Stada and cancer

? Bleeding between menstrual periods

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

? Taking Etinylestradiol/Drospirenone Diario Stada with other medicines

? Etinylestradiol/Drospirenone Diario Stada with food and drink

? Laboratory tests

? Pregnancy, breastfeeding and fertility

? Driving and use of machines

? Important information about some of the ingredients of Etinylestradiol/Drospirenone Diario Stada

3. How to take Etinylestradiol/Drospirenone Diario Stada
   • Blister pack preparation

? When you can start the first pack

? If you take more Etinylestradiol/Drospirenone Diario Stada than you should

? If you forget to take Etinylestradiol/Drospirenone Diario Stada

? What to do in case of illness 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 taking Etinylestradiol/Drospirenone Diario Stada

4. Possible side effects
5. How to store Etinylestradiol/Drospirenone Diario Stada
6. Contents of the pack and other information

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

Etinilestradiol/drospirenone is a contraceptive used to prevent pregnancy.

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

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

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

2. What you need to know before taking Etinilestradiol/Drospirenone Diario 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 you start taking etinilestradiol/drospirenone, your doctor will ask you 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 other tests.

This leaflet describes several situations in which you should stop using etinilestradiol/drospirenone, or in which the effectiveness of etinilestradiol/drospirenone may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm method or the 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 infection (AIDS) or any other sexually transmitted disease.

DO NOT take Etinilestradiol/Drospirenone Diario 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 if you are going to be immobile for a long time (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 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 your risk of developing a clot in the arteries:

• severe diabetes with blood vessel damage.

• very high blood pressure.

• very high levels of fat in the blood (cholesterol or triglycerides).

• a condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have (or have ever had) 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 if you 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.

• 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 Diario 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 attention 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 adverse 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 must 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 long periods (see section 2 “Blood clots”)

? if you have recently given birth, you are at higher risk of developing blood clots. You should ask your doctor when you can start taking ethinylestradiol/drospirenone after childbirth.

? if you have inflammation of the veins beneath the skin (superficial thrombophlebitis)

? if you have varicose veins

? if you have epilepsy (see “Taking Ethinylestradiol/Drospirenone Diario Stada with other medicines”)

? if you have or have ever had any condition that first occurred during pregnancy or during previous use of sex hormones; for example, hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous disorder causing involuntary movements)

? 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 rays.

• 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 and 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 long-lasting serious effects, and very rarely, they can 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 help 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., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without a 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 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 loss of vision.	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. 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 veins (venous thrombosis). However, these adverse events are rare. They occur more frequently during the first year of using 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 travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a 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 of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it remains somewhat 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 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will experience 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 experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as daily ethinylestradiol/drospirenone, between 9 and 12 women will experience 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/vaginal 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 approximately 50 years of age). 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 or illness, or if your leg is 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 less than a few weeks ago.

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 uncertain. Your doctor may decide that you need to stop taking ethinylestradiol/drospirenone.

If any of the conditions listed above change while you are taking ethinylestradiol/drospirenone daily—for example, if a close relative experiences a thrombosis without a known cause or if 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also 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 have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, 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, the risk of developing a blood clot may be further increased.

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

Ethinylestradiol/Drospirenone Daily Stada 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 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.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in users of hormonal contraceptives. See your doctor if you experience sudden severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as ethinylestradiol/drospirenone have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

Bleeding between menstrual periods

During the first months of using ethinylestradiol/drospirenone, unexpected bleeding (bleeding outside the placebo phase) 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 placebo phase?

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

If you miss two consecutive menstrual 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 Daily Stada with other medicines

Always inform the doctor who prescribed ethinylestradiol/drospirenone about any medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking ethinylestradiol/drospirenone. They may advise you whether you need additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of another treatment you require.

Some medicines:

• may affect the levels of ethinylestradiol/drospirenone in the blood,
• may make it less effective in preventing pregnancy,
• may 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 medicine St. John's wort.

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

• medicines containing cyclosporine,
• the antiepileptic lamotrigine (this may lead to an 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 the section “Do not take Ethinylestradiol/Drospirenone Daily Stada”.

Consult your doctor or pharmacist before using any medicine.

Taking Ethinylestradiol/Drospirenone Daily 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 affect 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 during treatment with 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 Daily 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.

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

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

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

3. How to take Etinilestradiol/Drospirenone Diario Stada

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

The two different colored tablets of etinilestradiol/drospirenone are arranged in order. One blister contains 28 tablets.

Take one tablet of etinilestradiol/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 yellow tablet daily for the first 21 days, followed by one white tablet daily for the last 7 days. Then start a new blister (21 yellow and 7 white tablets). In this way, there is no break between two blisters.

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 blister.

Blister preparation

To help you follow the correct dosing schedule, each blister of etinilestradiol/drospirenone contains 7 adhesive strips with the 7 days of the week. Choose the strip that starts with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with “WED”.

Then, attach the corresponding strip to the upper left corner of the blister, in the area marked “Start”. This way, each tablet will have a day of the week indicated above it, allowing you to visually check whether you have taken a specific tablet.

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

During the 7 days when you take the placebo tablets (the placebo days), your period (also called withdrawal bleeding) usually begins. Typically, the period starts on the second or third day after taking the last yellow active tablet of etinilestradiol/drospirenone. After taking the last white tablet, you should start the next blister, even if your menstrual period has not yet ended. This means you should start each blister on the same day of the week as you started the previous one, and your period should occur during the same days each month.

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

When to start the first blister

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

Start taking etinilestradiol/drospirenone on the first day of your cycle (i.e., the first day of your menstrual period). If you start etinilestradiol/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 start taking etinilestradiol/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 break period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal ring or contraceptive patch, follow your doctor's recommendations.

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

You may switch from the progestogen-only pill on any day (if using an implant or IUS, on the same day of removal; if using 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 recommendations.

• After childbirth

You may start taking etinilestradiol/drospirenone between 21 and 28 days after childbirth. If you start later, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using etinilestradiol/drospirenone.

If, after childbirth, you have already had sexual intercourse before starting to take etinilestradiol/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 etinilestradiol/drospirenone (again) after childbirth

Read the section “Breastfeeding”.

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

If you take more Etinilestradiol/Drospirenone Diario Stada than you should

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

Symptoms that may occur if you take too many tablets include nausea or 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 etinilestradiol/drospirenone, or if you discover 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 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Etinilestradiol/Drospirenone Diario Stada

The tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these tablets, this will have no effect on the reliability of etinilestradiol/drospirenone. Discard the forgotten placebo tablet.

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

• If you are less than 12 hours late in taking a tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

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

• Missing more than one tablet from the blister

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 your 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 your usual time. Contraceptive protection 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 your usual time. Instead of taking the white placebo tablets from this blister, discard them and start the next blister immediately.

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

2. You may also stop taking the active pale yellow tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must record the day on which you missed the tablet). If you wish to start a new blister on the day you usually start, take the placebo tablets for fewer than 7 days.

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

• If you have missed any tablets and do not have a withdrawal bleed during the placebo days, you may be pregnant. Contact your doctor before starting the next blister.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking an active pale yellow tablet, or if you have severe diarrhea, there is a risk that the active ingredients of the contraceptive are not fully absorbed by the body. The situation is almost equivalent to missing a tablet. After vomiting or diarrhea, take another pale yellow tablet from a spare blister 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 Etinilestradiol/Drospirenone Diario Stada”.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your period by not taking the white placebo tablets in the fourth row and instead starting a new blister of etinilestradiol/drospirenone and completing it. You may experience light bleeding or spotting during the second blister. Finish this second blister by taking the 7 white tablets in the 4th row. Then start a new blister.

You should seek advice from 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 begin during the placebo week. If you wish to change that day, reduce the number of placebo days—when you take the white placebo tablets—(but never increase them—maximum 7 days!). For example, if you usually start taking placebo tablets on Fridays and wish to change to Tuesdays (3 days earlier), start a new blister 3 days earlier than usual. If you make the placebo interval very short (e.g., 3 days or less), you may not have bleeding during these days. In that case, you may experience light bleeding or spotting.

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

If you stop taking Etinilestradiol/Drospirenone Diario Stada

You may stop taking etinilestradiol/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 etinilestradiol/drospirenone and wait until your next period before trying to conceive. This will make it easier to estimate your due date.

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 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 your 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 the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information about the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Ethinylestradiol/Drospirenone Diario Stada”.

The following is a list of adverse effects associated with the use of ethinylestradiol/drospirenone.

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

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

• headache, depression,

• migraine,

• nausea, lethargy, white vaginal discharge and fungal vaginal infection.

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

• changes in libido (interest in sex),

• 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 up to 1 in 1,000 women):

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing problems,
• skin disorders such as nodular erythema (characterized by painful reddish skin nodules) or erythema multiforme (characterized by target-shaped skin rashes or ulcers)
• harmful blood clots in a vein or artery, for example:
• In a leg or foot (i.e. DVT)
• In a lung (i.e. PE).
• Heart attack.
• Stroke.
• Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
• Blood clots in the liver, stomach/intestine, 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 about 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, 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 national reporting system included in 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 Diario Stada

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not take 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 unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ethinylestradiol/Drospirenone Diario Stada:

Active tablets

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, crospovidone, povidone, polysorbate 80, magnesium stearate.

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

Placebo tablets:

Tablet core: lactose, povidone, magnesium stearate.

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

Appearance of the product and contents of the container

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

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

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

This leaflet was last approved in: September 2022

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