Drospirenone/ethinylestradiol Exeltis 3 mg/0.03 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drospirenone/Ethinylestradiol Exeltis 3 mg/0.03 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 you should not give it to others, 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the leaflet

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

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

3. How to take Drospirenone/Ethinylestradiol Exeltis

4. Possible side effects

5. How to store Drospirenone/Ethinylestradiol Exeltis

6. Contents of the pack and other information

1. What Drospirenone/Ethinylestradiol Exeltis 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 containing two hormones are known as combined contraceptives.

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

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 using drospirenone/ethinylestradiol, or in which the effectiveness 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

You must not take drospirenone/ethinylestradiol 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 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 are due to have surgery or if you 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 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 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 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 manifest 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”).

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.

Elderly 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” 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” 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 mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Inform 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 (a hereditary red blood cell disorder).
  • If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
  • If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
  • If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking drospirenone/ethinylestradiol after childbirth.
  • If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
  • If you have varicose veins.
• If you have epilepsy (see “Other medicines and Drospirenone/Ethinylestradiol Exeltis”).
• 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 a previous use of sex hormones (e.g., 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 ever had chloasma (skin discoloration, especially on the face or neck, also known as “pregnancy mask”). 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 together with difficulty breathing.

BLOOD CLOTS

Using a combined hormonal contraceptive such as drospirenone/ethinylestradiol increases your risk of developing a blood clot compared to not using it. 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 can 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 noticed 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 clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe lightheadedness or dizziness. 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: Sudden 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, heaviness. Feeling of tightness or fullness in the chest, arm, or under the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision 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 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 most 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 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 remains slightly 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 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 small.

• 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 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal 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 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 have 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 leg in a cast. You may need to stop taking drospirenone/ethinylestradiol several weeks before surgery or while you are less mobile. If you need to stop taking drospirenone/ethinylestradiol, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• 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 (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?

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 a heart attack or stroke while using drospirenone/ethinylestradiol is very small, but it may increase:

• With age (over about 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 quit 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 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 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 and cancer

Breast cancer has been observed slightly more frequently 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 often. 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 have been reported, and even more rarely, malignant liver tumors in users of hormonal 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 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 pill-free week). If this bleeding persists beyond a few months, or if it starts after a few months, your doctor should investigate the cause.

What to 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 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines or herbal preparations. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking drospirenone/ethinylestradiol. They can advise you whether you need to take 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)
  • St. John's wort herbal preparations.

Drospirenone/ethinylestradiol may affect the effect of other medicines, for example:

• Medicines containing cyclosporine
• The antiepileptic lamotrigine (may lead to an increased frequency of seizures)
• Theophylline (used to treat respiratory problems)
• Tizanidine (used to treat pain and/or muscle spasms)

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 test results (elevated 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 completing this treatment. See the section “Do not take Drospirenone/Ethinylestradiol Exeltis”.

Consult your doctor or pharmacist before taking any medicine.

Taking Drospirenone/Ethinylestradiol Exeltis 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").

Consult your doctor or pharmacist before taking any medicine.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

There is no information suggesting that the use of drospirenone/ethinylestradiol affects the ability to drive or use machines.

Drospirenone/Ethinylestradiol Exeltis contains lactose.

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

3. How to take Drospirenone/Ethinylestradiol Exeltis

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take one drospirenone/ethinylestradiol tablet 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.

The blister pack contains 21 film-coated tablets. The day of the week on which you should take each tablet is printed next to it. For example, if you start on a Wednesday, you should take a tablet marked "WED". Follow the direction of the arrow on the blister 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 (called the "rest week"), menstruation should occur. Usually, menstruation—also referred to as withdrawal bleeding—starts 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 menstruation 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 menstruation should occur during the same days each month.

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

When can you 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 menstruation). If you start drospirenone/ethinylestradiol on the first day of your menstruation, you will be protected immediately against pregnancy. 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, combined 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 system IUS).

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

• After an abortion.

Follow your doctor's recommendations.

• After childbirth.

You may start taking drospirenone/ethinylestradiol between 21 and 28 days after childbirth. 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 childbirth, you have already had sexual intercourse before starting to take 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 taking drospirenone/ethinylestradiol (again) after childbirth

Read the section “Breast-feeding”.

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

If you take more Drospirenone/Ethinylestradiol Exeltis than you should

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

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 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

• 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 take 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 greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest 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):

• Missed more than one tablet in the pack

Consult your doctor.

• Missed 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, for example, a condom, for the next 7 days. If you had sexual intercourse during the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

• Missed 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.

• Missed 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, start the next blister pack.

You will likely have your menstruation (withdrawal bleeding) 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 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 should last fewer 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 period, you may be pregnant. In this case, you must see your doctor before continuing with 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 your body. This is similar to what happens when you miss a tablet. After vomiting or severe diarrhoea, take a tablet from a reserve 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”.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your menstrual period (withdrawal bleeding) by starting a new drospirenone/ethinylestradiol blister pack 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 begin during the week corresponding to the rest week. If you need 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 want 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 fewer), you may not have any bleeding 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 treatment with Drospirenone/Ethinylestradiol Exeltis

You may stop taking drospirenone/ethinylestradiol whenever you wish. If you do not want 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 menstrual period before trying to conceive. This will make it easier to calculate the estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, this medicine can 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 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”.

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):

• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness.

• Headache, emotional instability.

• Migraine.

• Nausea.

• Thick, whitish vaginal discharge and fungal vaginal infection.

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

• Breast enlargement, changes in sex drive.

• High blood pressure, low blood pressure.

• Vomiting, diarrhea.

• Acne, skin rash, intense itching, hair loss (alopecia).

• Vaginal infection.

• Fluid retention and changes in body weight.

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

• Allergic reactions (hypersensitivity), asthma.

• Breast milk secretion.

• Hearing problems.

• Skin disorders such as erythema nodosum (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/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 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, talk to 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

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 which is stated on the packaging after CAD or EXP. The date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drospirenone/Ethinylestradiol Exeltis

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.

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

Appearance of Drospirenone/Ethinylestradiol Exeltis and pack contents

It is presented as yellow, round, film-coated tablets.

Available in boxes containing 1, 2, 3, 6 or 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 the most recent 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/