Drospil 0.02 mg/3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drospil 0.02 mg/3 mg film-coated tablets EFG

ethinylestradiol/drospirenone

Important things you need to 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”).

Read this 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, ask 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, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Drospil is and what it is used for
2. What you need to know before taking Drospil
3. How to take Drospil
4. Possible side effects
5. How to store Drospil
6. Contents of the pack and other information

1. What Drospil is and what it is used for

• Drospil is a contraceptive used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones called ethinylestradiol and drospirenone.
• The 4 white tablets do not contain any active ingredients and are referred to as placebo tablets.
• Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting Drospil

General considerations

Before starting to use Drospil, 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 Drospil, 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 some additional tests.

This leaflet describes several situations in which you should stop using Drospil, or in which the reliability of Drospil may decrease. 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 rhythm or temperature methods. These methods may not be reliable because Drospil alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drospil

You must not use Drospil 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 a stroke.
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of developing a clot in the arteries:
  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) a liver disease and your liver function has not yet 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 suspect you have breast cancer or cancer of the reproductive 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.

Do not take Drospil 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 Drospil”).

Additional information on special populations

Children and adolescents

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

Elderly women

Drospil is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

Do not take Drospil if you are suffering from impaired kidney function or acute renal failure. See sections “Do not take Drospil” 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 when using Drospil or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using Drospil, you must also inform your doctor.

• if a close relative has or has ever had breast cancer
• if you have liver or gallbladder disease
• if you have diabetes
• if you have depression
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defence system)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (a hereditary 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. Ask your doctor when you can start taking Drospil 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 Drospil”)
• if you have a condition that 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 causing involuntary movements [Sydenham’s chorea])
• if you have or have ever had brownish-yellow patches (chloasma), also known as “pregnancy mask,” especially on the face. In this case, avoid direct exposure to sunlight or ultraviolet radiation.
• 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.

Talk to your doctor before taking Drospil.

BLOOD CLOTS

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

Blood clots can form:

• In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

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

It is important to remember that the overall risk of a harmful blood clot due to Drospil is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. 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, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading 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 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 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 when you first start taking a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking Drospil, 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 Drospil 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 to 7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drospil, between about 9 and 12 women will develop a blood clot in one year.
• Your individual risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/vaginal ring and who are not pregnant.	About 2 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 Drospil.	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 Drospil 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 may have an inherited blood clotting disorder.
• If you need surgery or if you spend a long time immobile due to injury, illness, or having a leg in a cast. You may need to stop taking Drospil several weeks before surgery or while you are less mobile. If you need to stop taking Drospil, ask your doctor when you can start taking it again.
• As you get older (especially above about 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 (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

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

If any of the above conditions change while you are using Drospil—for example, a close relative experiences 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 with Drospil is very small, but it may increase:

• With age (especially above about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Drospil, 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 about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative 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 Drospil—for example, you start smoking, a close relative experiences thrombosis without a known cause, or you gain significant weight—inform your doctor.

Drospil and cancer

Slightly more breast cancer has 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 tumors have been reported in users of hormonal contraceptives. See your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Drospil, you may experience unexpected bleeding (bleeding outside the placebo tablet 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 placebo days

If you have taken all the pink 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 Drospil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Always inform your doctor about any medicines or herbal remedies you are taking. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are using Drospil. 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 Drospil levels in the blood,
• may cause Drospil to be less effective in preventing pregnancy,
• may cause unexpected bleeding.

This may occur with:

• Medicines used to treat:

• Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),

• Tuberculosis (e.g., rifampicin),

• HIV and hepatitis C virus infections (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.

Drospil 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 muscle pain and/or cramps).

Do not take Drospil 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 blood markers of liver function (elevated liver enzyme ALT).

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

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

Consult your doctor or pharmacist before using any medicine.

Taking Drospil with food and drink

Drospil 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 affect the results of certain tests.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

In general, Drospil is not recommended 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 Drospil affects the ability to drive or use machines.

Drospil contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

The pink tablets of this medicine contain less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free.”

3. How to take Drospil

Each blister contains 24 pink active tablets and 4 white placebo tablets.

The two different colored tablets in Drospil are arranged in order. One blister contains 28 tablets.

Take one Drospil 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.

Do not confuse the tablets: take one pink tablet daily for the first 24 days, followed by one white tablet daily for the last 4 days. Then start a new pack immediately (24 pink tablets and 4 white tablets). Therefore, there is no break between two packs.

Since the composition of the tablets differs, you must start the pack with the tablet in the upper left corner and take the tablets daily in order. Follow the direction of the arrows on the blister to take the tablets in the correct sequence.

Blister preparation

To help you keep track of your dosing schedule, each Drospil blister includes 7 adhesive strips labeled with the days of the week. Choose the strip that starts with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with "WED".

Apply the weekly adhesive strip to the top of the blister where it says "Place adhesive strip here", so that the first day is positioned above the tablet marked "1". Now each tablet will have a day marked above it, allowing you to visually confirm whether you have taken your tablet. The arrows indicate the order in which to take the tablets.

During the 4 days when you take the white placebo tablets (placebo days), you should experience menstruation (so-called withdrawal bleeding). This usually begins on the 2nd or 3rd day after taking the last pink active tablet of Drospil. After taking the last white tablet, start the next pack immediately, even if your period has not finished. This means you should start the next pack on the same day of the week as you started the previous one, and withdrawal bleeding should occur on the same days each month.

If you take Drospil in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablets.

When to start the first pack

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

Start taking Drospil on the first day of your cycle (i.e., the first day of your menstrual bleeding). If you start Drospil on the first day of your period, you are 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) for the first 7 days.

• Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring, or patch

You may start taking Drospil preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the end of the break (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 intrauterine system (IUS) releasing progestogen)

You may switch from the progestogen-only pill on any day. If switching from an implant or IUS, do so on the day of removal; if switching from an injectable, do so on the day the next injection would have been due. In all cases, it is recommended to use additional contraceptive measures (e.g., a condom) for the first 7 days of taking Drospil tablets.

• After a miscarriage

Follow your doctor's recommendations.

• After childbirth

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

If, after childbirth, you have already had sexual intercourse, you must be sure you are not pregnant before starting Drospil, or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking Drospil

Read the section "Breastfeeding".

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

If you take more Drospil than you should

No serious harm has been reported from overdosing on Drospil.

If you take many tablets at once, you may feel unwell, vomit, or have 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 Drospil tablets, or if you discover 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 medication and the amount ingested.

If you forget to take Drospil

The last 4 tablets in the 4th row of the pack are placebo tablets. If you forget to take one of these tablets, the contraceptive effect of Drospil will not be lost. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet (tablets 1–24 of the blister), follow the advice below:

• If you are less than 24 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 24 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 pink tablet at the beginning or end of the pack. The recommendations below apply in this situation (see diagram below):

• Missed more than one tablet in the pack

Consult your doctor.

• Missed one tablet during days 1–7 (first row)

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, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• Missed one tablet during days 8–14 (second row)

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 between days 15–24 (third or fourth row)

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 continuing with the white placebo tablets, discard them and start the next pack immediately (the day you take the first tablet will be different).

You will likely have your period at the end of the second pack—during the placebo tablet days—although you may experience spotting or menstrual-like bleeding during the second pack.

2. Alternatively, you may stop taking the pink active tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, take the placebo tablets for fewer than 4 days.

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

• If you have missed tablets from a pack and do not have your period during the placebo days, this may mean you are pregnant. You should consult your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking a pink active tablet, or if you experience severe diarrhea, there is a risk that the active ingredients in the tablet are not fully absorbed by your body. This is similar to missing a tablet. After vomiting or severe diarrhea, take a pink tablet from a spare pack as soon as possible. If possible, take it within 24 hours of your usual time for taking the contraceptive. If this is not possible or more than 24 hours have passed, follow the advice in the section "If you forget to take Drospil".

Delayed menstruation: what you should know

Although not recommended, you may delay your period by skipping the white placebo tablets in the 4th row and immediately starting a new pack of Drospil tablets, taking them all. You may experience spotting or menstrual-like bleeding during the second pack. Finish this second pack by taking the 4 white tablets in the 4th row. Then start the next pack.

Ask your doctor before deciding to delay your period.

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

If you take the tablets as instructed, your period will begin during the placebo days. If you wish to change this day, you may do so by reducing the number of placebo days (the days you take the white tablets) (but never increase them—4 days is the maximum!). For example, if you usually start taking the placebo tablets on Fridays and want to change to Tuesdays (3 days earlier), you should start a new pack 3 days earlier than usual. Bleeding during these placebo days may not occur. Afterwards, you may experience light bleeding or bleeding similar to a period.

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

If you stop treatment with Drospil

You may stop taking Drospil 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 Drospil and wait until your next menstrual period before trying to conceive. This will make it easier to calculate your estimated delivery date.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you suffer any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think could be due to Drospil, 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 Drospil”.

Serious adverse effects

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 potentially accompanied by difficulty breathing (see also section “Warnings and precautions”).

The following are adverse effects that have been reported with the use of Drospil.

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

• mood changes,
• headache,
• nausea,
• breast pain, menstrual problems such as irregular periods, absence of periods.

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

• depression, nervousness, drowsiness,
• dizziness, tingling and prickling sensations,
• migraine, varicose veins, increased blood pressure,
• stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea,
• acne, itching, skin rash,
• discomfort and pain, such as back pain, limb pain, muscle cramps,
• vaginal fungal infection, lower abdominal (pelvic) pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flushes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex,
• lack of energy, increased sweating, fluid retention,
• weight gain.

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

• candidiasis (a fungal infection),
• anaemia, increased number of platelets in the blood,
• allergic reaction,
• hormonal disorder (endocrine),
• increased appetite, loss of appetite, abnormally high potassium concentration in the blood, abnormally low sodium concentration in the blood,
• absence of orgasm, insomnia,
• vertigo, tremors,
• eye disorders, such as eyelid inflammation, dry eyes,
• unusually rapid heart rate,
• inflammation of a vein, nosebleeds, fainting,
• abdominal swelling, intestinal disorder, bloated feeling, gastric hernia, fungal infection of the mouth, constipation, dry mouth,
• pain in the bile ducts or gallbladder, inflammation of the gallbladder,
• yellowish-brown patches on the skin, eczema, hair loss, acne-like skin inflammation, skin inflammation with swellings, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, photosensitivity-related skin inflammation, skin nodules,
• painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucosal surface of the cervix, thinning or loss of the uterine lining, ovarian cysts, uterine enlargement,
• malaise,
• weight loss,
• 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).

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (target-shaped skin rash or ulcers).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drospil

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 EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Drospil

• The active substances are ethinylestradiol and drospirenone. Each active pink film-coated tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone. The white film-coated placebo tablets do not contain any active substance.
• The other components are:

Active pink tablets:

Tablet core: monohydrate lactose, pregelatinized corn starch, povidone (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572).

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

White placebo tablets:

Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the product and contents of the pack

• Each Drospil blister contains 24 active pink film-coated tablets, located in the 1st, 2nd, 3rd, and 4th rows of the blister, and 4 white film-coated placebo tablets, located in the 4th row.
• The Drospil tablets (pink and white) are film-coated tablets; the tablet core is coated.
• Drospil is available in boxes containing 1, 3, 6, and 13 blisters, each with 28 (24+4) tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193 Villaquilambre, León

Spain

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

Belgium: Droseffik 0,02 mg/3 mg filmomhulde tabletten

Spain: Drospil 0,02 mg/3 mg comprimidos recubiertos con película EFG

Italy: Drospil 0,02 mg/3 mg compresse rivestite con film

Luxembourg: Droseffik 0.02 mg/3 mg comprimés pelliculés

Portugal: Droseffik 3 mg/0,02 mg comprimidos revestidos por película

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

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