Drospirenone/ethinylestradiol Exeltis Healthcare 3 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drospirenone/Ethinylestradiol Exeltis Healthcare 3 mg/0.02 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, since it could 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 the 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 Drospirenone/Ethinylestradiol Exeltis Healthcare is and what it is used for

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

3. How to take Drospirenone/Ethinylestradiol Exeltis Healthcare

4. Possible side effects

5. How to store Drospirenone/Ethinylestradiol Exeltis Healthcare

6. Contents of the pack and other information

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

Drospirenone/Ethinylestradiol is a contraceptive used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

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

General considerations

Before starting drospirenone/ethinylestradiol, 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 drospirenone/ethinylestradiol, 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 additional tests.

This leaflet describes several situations in which you should stop taking drospirenone/ethinylestradiol, or in which the effect of drospirenone/ethinylestradiol may be reduced.

In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method.

Do not use the rhythm method or the temperature method. These methods may not be reliable because drospirenone/ethinylestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drospirenone/Ethinylestradiol Exeltis Healthcare

You must not take drospirenone/ethinylestradiol if you have any of the conditions listed below. Inform your doctor if you have any of the following conditions. Your doctor will discuss with you other forms of contraception that may 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 require surgery or will 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 an early 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 returned to normal.

• If your kidneys do not work properly (renal insufficiency).

• If you have (or have ever had) a liver tumour.

• If you have (or have ever had), or if it is suspected that 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 present as itching, rash, or swelling.

• If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section “Other medicines and Drospirenone/Ethinylestradiol Exeltis Healthcare”).

Additional information on special populations

Children and adolescents

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

Older women

Drospirenone/ethinylestradiol is not indicated for use after menopause.

Women with hepatic impairment

Do not take Drospirenone/Ethinylestradiol if you have liver disease. See sections “Do not take Drospirenone/Ethinylestradiol Exeltis Healthcare” and “Warnings and precautions”.

Women with renal impairment

Do not take Drospirenone/Ethinylestradiol if you have impaired kidney function or acute renal failure. See sections “Do not take Drospirenone/Ethinylestradiol Exeltis Healthcare” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take drospirenone/ethinylestradiol.

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”.

Tell your doctor if you have any of the following conditions

In certain situations, you must take special care while taking drospirenone/ethinylestradiol or any other combined contraceptive, and your doctor may need to carry out periodic check-ups. If any of these conditions develop or worsen while you are taking drospirenone/ethinylestradiol, you must also inform your doctor.

• If any 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 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 increased risk of blood clots. Ask your doctor when you can start taking drospirenone/ethinylestradiol after childbirth.
  • If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
  • If you have varicose veins.
• If you have epilepsy (see “Other medicines and Drospirenone/Ethinylestradiol Exeltis Healthcare”).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
• If you have a condition that may have first occurred during pregnancy or during previous use of sex hormones (for example, hearing loss, porphyria (a blood disorder), gestational herpes (skin rash with blisters during pregnancy), Sydenham’s chorea (a nervous disorder causing involuntary movements)).
• If you have or have ever had chloasma (skin discoloration, especially on the face and neck, also known as “pregnancy mask”). 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 together with breathing difficulties, consult your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

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

Blood clots may form:

• In the veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In the 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 may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to drospirenone/ethinylestradiol 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 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 a 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. Rapid or irregular heartbeat. Severe abdominal 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: Immediate loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. 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 difficulty seeing in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a 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 abdominal 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 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 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 highest during the first year that 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 medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking drospirenone/ethinylestradiol, 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 on 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 drospirenone/ethinylestradiol 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 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as drospirenone/ethinylestradiol, 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 contraceptive pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use drospirenone/ethinylestradiol	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 with drospirenone/ethinylestradiol 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 approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you remain immobile for long periods due to injury, illness, or having a cast on your leg. You may need to stop using drospirenone/ethinylestradiol several weeks before surgery or while you are less mobile. If you need to stop using drospirenone/ethinylestradiol, ask your doctor when you can start taking it again.
• With increasing age (especially above approximately 35 years).
• 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 (over 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 uncertain. Your doctor may decide that you need to stop using drospirenone/ethinylestradiol.

If any of the above conditions change while you are using drospirenone/ethinylestradiol—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?

Just like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke while using drospirenone/ethinylestradiol is very small, but it may increase:

• With age (above approximately 35 years).
• If you smoke. When using a combined hormonal contraceptive such as drospirenone/ethinylestradiol, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under approximately 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 disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have more than one 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 above conditions change while you are using drospirenone/ethinylestradiol—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Drospirenone/Ethinylestradiol Exeltis Healthcare 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 lump.

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

Psychiatric disorders

Some women using hormonal contraceptives such as drospirenone/ethinylestradiol have reported depression or depressive 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 periods

During the first few months of taking drospirenone/ethinylestradiol, you may experience unexpected bleeding (bleeding outside the rest week). If this bleeding persists beyond a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if you do not have your period during the rest week

If you have taken all 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 two consecutive expected periods, 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 Drospirenone/Ethinylestradiol Exeltis Healthcare

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine or herbal preparation. Also inform any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are taking drospirenone/ethinylestradiol. They can 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 medicine you require.

Some medicines:

• may affect the levels of drospirenone/ethinylestradiol 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 or Hepatitis C virus infection (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)

• Herbal preparations containing St. John’s wort.

• Drospirenone/ethinylestradiol may affect 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 drospirenone/ethinylestradiol 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.

Drospirenone/ethinylestradiol can be restarted approximately 2 weeks after completion of this treatment. See the section “Do not take Drospirenone/Ethinylestradiol Exeltis Healthcare”.

Consult your doctor or pharmacist before taking any medicine.

Taking Drospirenone/Ethinylestradiol Exeltis Healthcare with food and drink

Drospirenone/ethinylestradiol can be taken with or without food, and with some water if needed.

Laboratory tests

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you must not take drospirenone/ethinylestradiol. If you become pregnant while taking drospirenone/ethinylestradiol, stop treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking drospirenone/ethinylestradiol at any time (see: "If you stop taking Drospirenone/Ethinylestradiol Exeltis Healthcare").

Consult your doctor or pharmacist before taking any medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Drospirenone/Ethinylestradiol Exeltis Healthcare contains lactose.

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

Drospirenone/Ethinylestradiol Exeltis Healthcare contains sodium

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

3. How to take Drospirenone/Ethinylestradiol Exeltis Healthcare

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.

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

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

Afterwards, you should not take any tablets for 7 days. During these 7 days when no tablets are taken (referred to as the "rest week"), your menstrual period should occur. Usually, menstruation, which may also be called withdrawal bleeding, begins on the second or third day of the rest week.

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

If you take drospirenone/ethinylestradiol in this way, you will also be protected against pregnancy during the 7 days when you do not take any tablets.

When to start the first blister pack?

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

Start taking drospirenone/ethinylestradiol on the first day of your cycle (i.e., the first day of your menstrual period). If you start drospirenone/ethinylestradiol on the first day of your period, you will be protected against pregnancy immediately. You may also start on days 2–5 of your cycle, but in this case you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You may start taking drospirenone/ethinylestradiol preferably the day after taking the last active tablet 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 delivery system IUS).

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

• After an abortion.

Follow your doctor's advice.

• After giving birth.

You may start taking drospirenone/ethinylestradiol between 21 and 28 days after giving birth. If you start later than day 28, you must use a barrier method (e.g., a condom) during the first 7 days of using drospirenone/ethinylestradiol.

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

• If you are breastfeeding and wish to start (or restart) drospirenone/ethinylestradiol after giving birth.

Read the section “Breast-feeding”.

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

If you take more Drospirenone/Ethinylestradiol Exeltis Healthcare than you should

No serious harm has been reported from overdosing on drospirenone/ethinylestradiol.

Symptoms that may occur if you take several 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 drospirenone/ethinylestradiol tablets, 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 Drospirenone/Ethinylestradiol Exeltis Healthcare

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

The risk of incomplete protection against pregnancy is greatest if you miss a tablet at the beginning of the pack (1st row) or at the end of week 3 (3rd row of the pack). Therefore, you should take the following measures (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 following tablets at your usual time and use additional precautions, such as 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 following tablets at your 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 following tablets at your usual time. Instead of starting the rest week, begin taking the next blister pack immediately.

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

2. Alternatively, you may stop taking tablets and go directly into the rest week (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 be shorter 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 your period during the first rest week, you may be pregnant. In this case, you must see 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 suffer from severe diarrhoea, there is a risk that the active ingredients of the contraceptive are not fully absorbed by your body. This is similar to what happens when you miss a tablet. After vomiting or severe diarrhoea, take a tablet from a spare pack as soon as possible. If possible, 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 Drospirenone/Ethinylestradiol Exeltis Healthcare”.

Delayed menstrual period: what you should know?

Although not recommended, you can delay your menstrual period (withdrawal bleeding) by starting a new blister pack of drospirenone/ethinylestradiol instead of taking the rest week, and completing it. You may experience light bleeding or spotting during the second pack. After the usual rest week, start the next pack.

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

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

If you stop taking Drospirenone/Ethinylestradiol Exeltis Healthcare

You may stop taking drospirenone/ethinylestradiol 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 drospirenone/ethinylestradiol and wait until your next menstrual 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 change in your health that you think may be due to drospirenone/ethinylestradiol, 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 Drospirenone/Ethinylestradiol Exeltis Healthcare”.

Serious adverse effects

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 with possible difficulty breathing (see also section “Warnings and precautions”).

The following list of adverse effects has been associated with the use of drospirenone/ethinylestradiol.

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

• Mood changes.
• Headache.
• Abdominal pain (stomach ache).
• Acne.
• Breast pain, breast enlargement, breast tenderness, painful or irregular periods.
• Weight gain.

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

• Candidiasis (a fungal infection).
• Cold sores (herpes simplex).
• Allergic reactions.
• Increased appetite.
• Depression, nervousness, sleep disorders.
• Vision problems.
• Irregular or unusually rapid heartbeat.
• Blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, low blood pressure, migraine, varicose veins.
• Sore throat.
• Nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation.
• Hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis (fatty skin disorders).
• Neck pain, limb pain, muscle cramps.
• Bladder infection.
• Breast lumps (benign and cancer), milk production without being pregnant (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, pain in the lower abdominal area (pelvic pain), abnormal cervical smears (Papanicolaou or Papanicolaou staining), decreased interest in sex.
• Fluid retention, lack of energy, excessive thirst, increased sweating.
• Weight loss.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Asthma.

• Hearing problems.

• Erythema nodosum (characterized by painful reddish skin nodules).

• Erythema multiforme (characterized by skin rash with target-shaped redness 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).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible 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 Drospirenone/Ethinylestradiol Exeltis Healthcare

Keep this medicine out of the 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 CAD or EXP. The date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drospirenone/Ethinylestradiol Exeltis Healthcare

The active substances are 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

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

Appearance of Drospirenone/Ethinylestradiol Exeltis Healthcare and contents of the pack

It is presented as film-coated tablets, round, pink in colour.

It is available in boxes containing 1, 2, 3, 6 and 13 blisters, each blister containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Pol. Ind. Miralcampo, Avda. de Miralcampo 7, 19200
Azuqueca de Henares,
Guadalajara, Spain

Manufacturer

Laboratorios León Farma, S.A.
Pol. Ind. Navatejera, C/ La Vallina, s/n;
24193 - Villaquilambre, León
Spain

Date of latest review of this leaflet: November 2023

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