Drosurelle 0.02 mg/3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drosurelle 0.02 mg/3 mg film-coated tablets EFG

ethinylestradiol/drospirenone

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse, even if these 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 of use 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 Drosurelle is and what it is used for
2. What you need to know before taking Drosurelle
3. How to take Drosurelle
4. Possible side effects
5. How to store Drosurelle
6. Contents of the pack and other information

1. What Drosurelle is and what it is used for

• Drosurelle is a contraceptive used to prevent pregnancy.
• Each coated tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting to take Drosurelle

General considerations

Before starting to use Drosurelle, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before starting to take Drosurelle, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health status, may carry out other tests.

This leaflet describes several situations in which you should stop using Drosurelle, or in which the effect of Drosurelle may be reduced.

In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

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

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

Do not take Drosurelle

You must not use Drosurelle if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or will be immobile for a long time (see section “Blood clots”).
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or 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 hyperhomocysteinaemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) liver disease and your liver function has not returned to normal.
• If your kidneys do not work properly (renal failure).
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had), or are suspected of having, breast cancer or cancer of the genital organs.
• If you have unexplained vaginal bleeding.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (see section 6). This may cause itching, rash, or swelling.
• Do not take Drosurelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Drosurelle”).

Additional information on special populations

Children and adolescents

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

Women of advanced age

Drosurelle is not indicated for use after menopause.

Women with hepatic impairment

Do not take Drosurelle if you suffer from liver disease. See sections “Do not take Drosurelle” and “Warnings and precautions”.

Women with renal impairment

Do not take Drosurelle if you are suffering from impaired kidney function or acute renal failure. See sections “Do not take Drosurelle” and “Warnings and precautions”.

Warnings and precautions

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” below).

For a description of the symptoms of these serious adverse effects, see

“How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions

In some situations, you should take special care while using Drosurelle or any other combined contraceptive, and your doctor may need to examine you periodically. If the condition develops or worsens while you are using Drosurelle, you must also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have liver or gallbladder disease (such as gallstones).
• If you have diabetes.
• If you have depression. Some women using hormonal contraceptives such as Drosurelle 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 further medical advice as soon as possible.
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defence system).
• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anaemia (an inherited red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or will be immobile for a long time (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 Drosurelle 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 Drosurelle”).
• If you have or have ever had any condition that may have first appeared during pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous disorder with involuntary movements (Sydenham’s chorea)).
• If you have or have ever had chloasma (skin discolouration, especially on the face and neck, known as “melasma” or “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet rays while taking this medicine.
• Seek immediate medical advice if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, difficulty swallowing, or hives potentially accompanied by breathing difficulties. Medicines containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Drosurelle 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 the veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In the arteries (called “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

It is important to remember that the overall risk of a harmful blood clot due to Drosurelle 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 symptoms?	What could 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 clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, 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 vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden severe headache 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 most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• 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 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 Drosurelle, 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 Drosurelle is small.

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

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant.	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use Drosurelle	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 Drosurelle 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 remain immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Drosurelle several weeks before surgery or while you are less mobile. If you need to stop taking Drosurelle, ask your doctor when you can start taking it again.
• As you get older (especially above about 35 years of age).
• If you gave 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 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 taking Drosurelle.

If any of the above conditions change while you are using Drosurelle—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 the risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using Drosurelle is very small, but it may increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Drosurelle, 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, 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 Drosurelle—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Drosurelle and cancer

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

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 unusually severe abdominal pain.

Bleeding between periods

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

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

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

If you miss two consecutive 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 Drosurelle

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines or herbal remedies. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Drosurelle. 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 Drosurelle in the blood,
• may make it less effective in preventing pregnancy,
• may cause unexpected bleeding.

This may occur with:

• medicines used to treat:
  • epilepsy (primidone, phenytoin, barbiturates, carbamazepine, and oxcarbazepine),
  • tuberculosis (e.g., rifampicin),
  • HIV infection and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
  • fungal infections (e.g., griseofulvin or ketoconazole),
  • arthritis, osteoarthritis (etoricoxib),
  • high blood pressure in the blood vessels of the lungs (bosentan).
• herbal remedies containing St. John's wort.

Drosurelle may affect the action of other medicines, for example:

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

Do not take Drosurelle 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 an increase in liver function test results (increase in liver enzyme ALT).

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

Drosurelle can be restarted approximately 2 weeks after completing this treatment. See the section “Do not take Drosurelle.”

Consult your doctor or pharmacist before using any medicine.

Taking Drosurelle with food and drinks

Drosurelle 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 oral contraceptives may influence the results of certain tests.

Pregnancy

If you are pregnant, you must not take Drosurelle. If you become pregnant while taking Drosurelle, stop treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking Drosurelle at any time (see “If you stop taking Drosurelle”).

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

In general, it is not recommended to take Drosurelle during breast-feeding. If you wish to take a contraceptive while breast-feeding, 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 Drosurelle affects the ability to drive or use machinery.

Drosurelle contains lactose and sodium.

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 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free.”

3. How to take Drosurelle

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

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

After this, you must not take any tablets for 7 days. During these 7 days when no tablets are taken (called the "rest period"), your menstrual period should occur. The period, which may also be referred to as "withdrawal bleeding", usually begins on the 2nd or 3rd day of the rest period.

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

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

When can you start the first pack?

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

Start taking Drosurelle on the first day of your regular cycle (i.e., the first day of your period). If you start Drosurelle on the first day of your period, you are 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 contraceptive ring, or patch

You may preferably start taking Drosurelle the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest period of your previous contraceptive (or after 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 progestogen-releasing intrauterine device, IUD)

You may switch from the 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 have been due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Drosurelle tablets.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

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

If, after giving birth, you have already had sexual intercourse before starting to take Drosurelle (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 Drosurelle (again) after giving birth

Read the section “Breast-feeding”.

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

If you take more Drosurelle than you should

No cases have been reported in which an overdose of Drosurelle 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 Drosurelle tablets, or if you find that a child has taken them, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Drosurelle

• 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 greater the risk of becoming pregnant.

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

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant. In that 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. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of starting the rest period, start the next pack immediately.

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

2. You may also stop taking tablets and go directly into the rest period (noting the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period must 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 a period during the first rest period, you may be pregnant. Contact your doctor before starting the next pack.

The following diagram shows what to do if you forget to take a tablet:

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 the body. This situation is almost equivalent to forgetting a tablet. After vomiting or severe diarrhoea, take a tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Drosurelle”.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your menstrual period by starting a new pack of Drosurelle instead of beginning the rest period and completing it. During the second pack, you may experience light bleeding or spotting. After finishing the second pack, observe the usual 7-day rest period and start the next pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your menstrual period will occur during the rest period week. If you need to change the day, reduce the number of rest days (but never extend them – no more than 7 days!). For example, if your rest days usually start on Fridays and you wish to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or fewer), you may not have bleeding during these days. In that case, you may experience light bleeding or spotting later.

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

If you stop treatment with Drosurelle

You may stop taking Drosurelle 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 Drosurelle and wait until your 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 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 Drosurelle, 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 use Drosurelle”.

Contact your 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, possibly accompanied by difficulty breathing (see also section “Warnings and precautions”).

The following list of adverse effects has been associated with the use of Drosurelle.

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

• 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 people):

• candidiasis (a fungal infection),
• cold sores (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling and prickling sensations, dizziness,
• vision problems,
• irregular or unusually fast heart rate,
• 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, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or hives accompanied by difficulty breathing (angioedema),
• hair loss (alopecia), eczema, itching, skin rash, dry skin, disorders of oily skin (seborrheic dermatitis),
• neck pain, limb pain, muscle cramps,
• bladder infection,
• breast lumps (benign or cancer), milk production without being pregnant (galactorrhea), ovarian cysts, hot flushes, absence of menstruation, heavy periods, vaginal discharge, vaginal dryness, lower abdominal (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 people):

• asthma,

• hearing problems,

• nodular erythema (characterized by painful reddish skin nodules),

• erythema multiforme (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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drosurelle

Keep this medicine out of sight and reach of children.

Store below 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drosurelle

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

The other components are:

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

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the medicine and contents of the pack

The tablets are film-coated, round, pink in colour, with a diameter of approximately 5.7 mm.

Drosurelle is available in packs of 1, 2, 3, 6 and 13 blisters, each containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Laboratorios Effik, S.A.
C/ San Rafael, 3
28108 Alcobendas, Madrid
Spain

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
Villaquilambre
24193 León, Spain

or

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Building A And B, 14th Km Athina Lamia National Road 1,
Kifissia, 145 64, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Bulgaria: Jangee 0.02 mg/3 mg ????????? ????????
Greece: Estrofix 0.02 mg/3 mg επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο
Spain: Drosurelle 0.02 mg/3 mg film-coated tablets EFG
Ireland: Ethinylestradiol/Drospirenone Leon Farma 0.02 mg/3 mg film coated tablets
Portugal: Drospirenone + Ethinylestradiol Generis 3 mg + 0.02 mg film-coated tablets

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

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/