Drosurelle Diario 0.02 mg/3 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drosurelle Diario 0.02 mg/3 mg film-coated tablets EFG

ethinylestradiol/drospirenone

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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are 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”).

Leaflet contents

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

1. What Drosurelle Diario is and what it is used for

• Drosurelle Diario is a contraceptive used to prevent pregnancy.
• Each of the 21 pink active tablets contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.
• The 7 white tablets do not contain 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 Drosurelle Diario

General considerations

Before starting to use Drosurelle Diario, 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 Drosurelle Diario, 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 Diario, or in which the effectiveness of Drosurelle Diario may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or another barrier method. Do not use rhythm or temperature methods. These methods may not be reliable because Drosurelle Diario alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drosurelle Diario

You must not use Drosurelle Diario 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 long periods (see section 2 “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 transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of developing a clot in the arteries:
  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) liver disease and your liver function has not yet returned to normal.
• If your kidneys are not working properly (renal failure).
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had), or suspect you may 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 cause itching, rash, or swelling.
• Do not take Drosurelle Diario 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 Diario”).

Additional information on special populations

Children and adolescents

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

Elderly women

Drosurelle Diario is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

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

Warnings and precautions

When should you consult your doctor?

Seek urgent medical help

• 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 clots” 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 Diario or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using Drosurelle Diario, 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. Some women using hormonal contraceptives such as Drosurelle Diario have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.
• 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 long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at higher risk of blood clots. You should ask your doctor when you can start taking Drosurelle Diario 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 Diario”).
• 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 “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet rays.
• Contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, difficulty swallowing, or hives potentially accompanied by difficulty breathing. Medicines containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Drosurelle Diario 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 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 Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or 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 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 such as 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)
Pain, discomfort, pressure, heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. 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 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 of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to 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 higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart 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 Drosurelle Diario, 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 Drosurelle Diario is low.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within 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 within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drosurelle Diario, between 9 and 12 women will develop a blood clot within one year.
• Your personal risk of developing a blood clot also depends on your individual 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/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 Diario	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 Diario is small, but some 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 may have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for long periods due to injury, illness, or a plaster cast on your leg. You may need to stop taking Drosurelle Diario several weeks before surgery or while you are less mobile. If you need to stop taking Drosurelle Diario, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth less than a few weeks ago.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

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

If any of the above conditions change while you are using Drosurelle Diario, for example, if a close relative experiences a thrombosis without a known cause or you gain a lot of 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 a heart attack or stroke while using Drosurelle Diario is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Drosurelle Diario, 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 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 disorders, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Drosurelle Diario—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight—inform your doctor.

Drosurelle Diario 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 tumours may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumours 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.

Benign liver tumours have rarely been reported in users of hormonal contraceptives, and even more rarely, malignant tumours. See your doctor if you experience unusual severe abdominal pain.

Bleeding between periods

During the first few months of taking Drosurelle Diario, you may experience unexpected bleeding (bleeding outside the week when you are taking the white tablets). If this bleeding persists beyond a few months or starts after a few 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 active pink tablets correctly, have not vomited or had severe diarrhoea, and have not taken other medications, it is very unlikely that you are pregnant.

If your expected period does not occur for two consecutive cycles, 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 Diario

Inform your doctor 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 another medicine (or your pharmacist) that you are taking Drosurelle Diario. 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 Diario 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 infection and hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
  • fungal infections (e.g. griseofulvina, ketoconazole),
  • arthritis, osteoarthritis (etoricoxib),
  • high blood pressure in the blood vessels of the lungs (bosentan).
• herbal preparations containing St. John’s wort.

Drosurelle Diario may influence 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 breathing problems),
• tizanidine (used to treat pain and/or muscle spasms).

Do not take Drosurelle Diario if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Drosurelle Diario can be restarted approximately 2 weeks after completion of this treatment. See section “Do not take Drosurelle Diario”.

Consult your doctor or pharmacist before using any medicine.

Taking Drosurelle Diario with food and drinks

Drosurelle Diario can be taken with or without food, and with 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 hormonal contraceptives may influence the results of certain tests.

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

In general, Drosurelle Diario is not recommended during breast-feeding. If you wish to take the 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 to suggest that the use of Drosurelle Diario has any effect on the ability to drive or use machines.

Drosurelle Diario contains lactose and sodium.

If your doctor has diagnosed you with 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 Diario

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

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

The two different colored tablets in Drosurelle Diario are arranged in order. One pack contains 28 tablets.

Take one tablet of Drosurelle Diario 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 every day for the first 21 days, followed by one white tablet each day for the last 7 days. After this, start a new pack (21 pink and 7 white tablets). In this way, there is no break between packs.

Because of the different composition of the tablets, you must start with the first tablet located in the upper left corner and then take one tablet each day. To maintain the correct order, follow the direction of the arrows on the pack.

Preparing the pack

To help you follow the correct order of intake, each pack of Drosurelle Diario includes seven adhesive strips labeled with the days of the week.

Choose the adhesive strip that starts with the day you take your first tablet. For example, if you take your first tablet on a Wednesday, use the adhesive strip starting with “WED”.

Attach the weekly adhesive strip to the top left of the pack, in the “Start” position.

This way, each tablet is marked with a day of the week above it, so you can see whether you have taken a particular tablet. The arrows indicate the order in which the tablets should be taken.

During the 7 days when you take the white placebo tablets (the placebo days), your period (also called withdrawal bleeding) usually begins. Typically, the period starts on the second or third day after taking the last pink active tablet of Drosurelle Diario. After taking the last white tablet, you should 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 as you started the previous one, and your menstruation should occur during the same days every month.

If you take Drosurelle Diario as directed, you will also be protected against pregnancy during the 7 days when you are taking the white placebo tablets.

When can you start the first pack?

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

Start taking Drosurelle Diario on the first day of your cycle (i.e., the first day of your period). If you start Drosurelle Diario on the first day of your period, you are protected immediately against pregnancy. You may also start on days 2–5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You may start taking Drosurelle Diario preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the break period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal ring or contraceptive patch, follow your doctor’s recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine device, IUD).

You may switch from a progestogen-only pill on any day (if using an implant or IUD, on the same day of removal; if using an injectable, at the time of the next scheduled injection), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Drosurelle Diario tablets.

• After an abortion or termination of pregnancy.

Follow your doctor’s recommendations.

• After giving birth.

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

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

Read the “Breastfeeding” section.

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

If you take more Drosurelle Diario than you should

No serious harm has been reported from overdosing on Drosurelle Diario.

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

If you forget to take Drosurelle Diario

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these, it will have no effect on the effectiveness of Drosurelle Diario. Discard the forgotten placebo tablet.

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

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

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

• Forgetting more than one tablet in the pack

Consult your doctor.

• Forgetting one tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking 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 forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetting one tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking tablets at your usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Forgetting one tablet in week 3

You have two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking tablets at your usual time. Instead of taking the white placebo tablets from this pack, discard them and start the next pack immediately.

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

2. Alternatively, you may stop taking the active pink tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, note down the day you forgot the tablet). If you wish to start a new pack on the day you usually start, take the placebo tablets for fewer than 7 days.

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

• If you have forgotten to take any tablets and do not have a period during the placebo days, 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 diarrhea

If you vomit within 3–4 hours after taking a pink active tablet, or if you have severe diarrhea, there is a risk that the active ingredients of the contraceptive may not be fully absorbed by your body. In this case, you may need to use additional protection (such as a condom). This situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take another pink 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 Diario”.

Delaying your menstrual period: what you should know

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

You should consult 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 period will begin during the placebo week. If you wish to change this day, reduce the number of placebo days – the days when you take the white placebo tablets – (but never increase them—maximum 7 days!). For example, if you normally start taking the placebo tablets on Fridays and wish to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the placebo interval 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.

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

If you stop taking Drosurelle Diario

You may stop taking Drosurelle Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking Drosurelle Diario and wait until your next menstrual period before trying to conceive. This will make it easier to calculate your estimated due date.

If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think could be due to Drosurelle Diario, 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 Drosurelle Diario”.

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

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):

• Candida (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 heartbeat,
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or hives, together with difficulty breathing (angioedema),
• hair loss (alopecia), eczema, itching, skin rashes, dry skin, oily skin disorders (seborrheic dermatitis),
• neck pain, limb pain, muscle cramps,
• bladder infection,
• lumps in the breasts (benign or cancer), milk production without being pregnant (galactorrhea), ovarian cysts, hot flushes, absence of periods, heavy periods, vaginal discharge, vaginal infection or inflammation, vaginal dryness, pain in the lower abdominal (pelvic) area, abnormal cervical smears (Papanicolaou or Papanicolaou staining), decreased interest in sex,
• fluid retention, lack of energy, feeling thirsty, increased sweating,
• weight loss,
• generalized pain.

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

• asthma,
• hearing problems,
• nodular erythema (characterized by painful reddish nodules on the skin),
• 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).

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through 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 Drosurelle Diario

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 is 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 the SIGRE collection point at your pharmacy. If you are unsure, 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 Diario

The Drosurelle Diario blister pack contains 21 pink active tablets in the 1st, 2nd and 3rd rows, and 7 white placebo tablets in the 4th row.

Active tablets

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).

Placebo tablets

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of the product and contents of the pack

The active tablets are film-coated, round, pink tablets with an approximate diameter of 5.7 mm.

The placebo tablets are film-coated, round, white tablets with an approximate diameter of 5.7 mm.

Drosurelle Diario is available in packs of 1, 2, 3, 6 and 13 blister packs, each containing 28 tablets (21 active tablets plus 7 placebo 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

or

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

Oddzial Produkcyjny W Nowej Debie, Ul. Metalowca 2

39-460 Nowa Deba

Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

Czech Republic	Jangee
Greece	Pirestrol 0.02 mg/3 mg film-coated tablet
Spain	Drosurelle Diario 0.02 mg/3 mg film-coated tablets EFG
Ireland	Ethinylestradiol/Drospirenone Leon Farma & placebo 0.02 mg/3 mg film-coated tablets
Poland	Vibin Mini

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

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