Drosure Diario 0.03 mg/3 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Drosure Diario 0.03 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 blood clots 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 Drosure Diario is and what it is used for
2. What you need to know before taking Drosure Diario
3. How to take Drosure Diario
4. Possible side effects
5. How to store Drosure Diario
6. Contents of the pack and other information

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

• Drosure Diario is a contraceptive used to prevent pregnancy.
• Each of the 21 yellow 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 called placebo tablets.
• Contraceptives containing two hormones are known as "combined contraceptives".

2. What you need to know before starting to take Drosure Diario

General considerations

Before starting to use Drosure 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 to take Drosure 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 individual situation, may carry out some additional tests.

This leaflet describes several situations in which you should stop using Drosure Diario, or in which the effect of Drosure Diario may be reduced. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because Drosure Diario alters the monthly changes in body temperature and cervical mucus.

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

Do not take Drosure Diario

You must not use Drosure 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 if you are immobile for long periods (see section 2 “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 forming 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) inflammation of the pancreas (pancreatitis).
• 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 function 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 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 Drosure 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 Drosure Diario”).

Additional information for special populations

Children and adolescents

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

Women of advanced age

Drosure Diario is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

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 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 when using Drosure Diario or any other combined contraceptive, and your doctor may need to examine you periodically. If any condition develops or worsens while you are using Drosure Diario, you should also inform your doctor.

• If a close family member has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have any kidney problem and are taking medicines that increase potassium levels in the blood.
• If you have diabetes.
• If you have depression. Some women using hormonal contraceptives such as Drosure Diario have reported depression or a 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 (inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE: a disease affecting your 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 are immobile for long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Drosure Diario after childbirth.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Other medicines and Drosure Diario”).
• If you have a condition that first occurred 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 chloasma (skin discoloration, especially on the face or neck, known as “pregnancy mask”). In such cases, direct sun exposure should be avoided.
• If you have hereditary angioedema, products containing oestrogens may cause or worsen symptoms. You should contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives, together with difficulty breathing.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Drosure 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 ATE).

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 Drosure Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticed when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen 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)
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or beneath 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 events are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medication) 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 Drosure 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 Drosure Diario is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drosure Diario, 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 Drosure 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 Drosure Diario 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 an early age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Drosure Diario several weeks before surgery or while you are less mobile. If you need to stop taking Drosure Diario, ask your doctor when you can start again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

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

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

If any of the above conditions change while you are using Drosure Diario—for example, 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?

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

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

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

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Drosure 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 an early 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 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 Drosure 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.

Drosure 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, it may be that more tumors are 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 unusual severe abdominal pain.

Bleeding between periods

During the first few months of using Drosure 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 several months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the active yellow tablets correctly, have not vomited or had diarrhea, and have not taken any other medicines, 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 Drosure Diario

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines or herbal preparations. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Drosure 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 Drosure Diario in your 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 and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations containing St. John's wort.

If you are taking any of these medicines together with Drosure Diario, you should use additional contraceptive precautions (e.g., condoms) for at least 28 days after finishing the treatment.

Drosure Diario 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 pain and/or muscle spasms)

Do not take Drosure 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 (increase in liver enzyme ALT).

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

Drosure Diario can be restarted approximately 2 weeks after completion of this treatment. See the section “Do not take Drosure Diario.”

Consult your doctor or pharmacist before taking any medicine.

Taking Drosure Diario with food and drinks

Drosure 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 hormonal contraceptives may influence the results of certain tests.

Pregnancy

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

Consult your doctor or pharmacist before taking any medicine.

Breast-feeding

In general, Drosure Diario is not recommended during breast-feeding. If you wish to use contraception while breast-feeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

There is no information suggesting that the use of Drosure Diario affects the ability to drive or use machinery.

Drosure Diario contains lactose

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

3. How to take Drosure 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 yellow active tablets and 7 white placebo tablets.

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

Take one tablet of Drosure 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 a yellow tablet for the first 21 days, followed by a white tablet for the last 7 days. Then start a new pack (21 yellow and 7 white tablets). In this way, there is no break week between packs.

Due to 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 keep track, the Drosure Diario pack includes 7 adhesive strips with the days of the week.

Choose the strip that starts with the day you take your first tablet. For example, if you start on Wednesday, use the one marked “WED”.

Attach the weekly strip to the top left of the Drosure Diario blister, so that the first day is in the “Start” position. This way, each tablet has a day of the week indicated above it, allowing you to see whether you have taken a given tablet. The arrows show 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 usually begins (also called withdrawal bleeding). Your period usually starts on the second or third day after taking the last yellow active tablet of Drosure Diario. Once you have taken the last white tablet, you must start the next pack, even if bleeding has not yet stopped. This means you should start each new pack on the same day of the week as you started the previous one, and your period should occur during the same days each month.

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

When can you start the first pack?

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

Start taking Drosure Diario on the first day of your cycle (i.e., the first day of your period). If you start Drosure Diario on the first day of your period, you will be 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 another combined hormonal contraceptive, combined vaginal ring, or patch.

You may start taking Drosure 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 patch, follow your doctor’s recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine progestogen-releasing system [IUS]).

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

• After an abortion or termination of pregnancy.

Follow your doctor’s recommendations.

• After giving birth.

You may start taking Drosure 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 Drosure Diario.

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

Read the section “Breast-feeding”.

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

If you take more Drosure Diario than you should

No serious harmful effects have been reported from overdosing on Drosure Diario.

Symptoms that may occur if you take too many tablets 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 Drosure Diario tablets, or if you find that a child has taken them, consult your doctor or pharmacist.

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

If you forget to take Drosure Diario

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

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

• If you are less than 12 hours late in taking a tablet, contraceptive protection 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, contraceptive protection may be reduced. The more tablets you miss, the greater the risk of becoming pregnant.

The risk of incomplete contraceptive protection is highest if you miss a yellow 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, e.g., a condom, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

• Missing one tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Contraceptive protection 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 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-like bleeding during the second pack.

2. Alternatively, you may stop taking the yellow active tablets and go directly to the 7 white placebo tablets, including the days you missed the tablet (before taking the placebo tablets, you must note the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, take fewer than 7 days of placebo tablets.

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

• If you have missed any tablets and do not have bleeding during the placebo days, you may be pregnant. Contact 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 yellow 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 the body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhea, take another yellow 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 Drosure Diario”.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your period by not taking the white placebo tablets in the fourth row, and instead starting a new pack of Drosure Diario and completing it. During use of the second pack, you may experience light bleeding or spotting. After finishing this second pack, take 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 menstrual period: what you should know

If you take the tablets as directed, your period will begin during the placebo week. If you wish to change that day, reduce the number of placebo days—when you take the white placebo tablets—(but never increase them—maximum 7 days!). For example, if you usually 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 less), 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 Drosure Diario

You may stop taking Drosure 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 Drosure Diario and wait for your period before trying to conceive. This will make it easier to calculate your estimated due 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 may cause adverse effects, although not everyone will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Drosure 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 to take Drosure Diario”.

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

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

• headache, depressed mood,
• migraine,
• nausea,
• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• thick, whitish vaginal discharge and vaginal fungal infection.

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

• increased breast size, changes in sex drive,
• high blood pressure, low blood pressure,
• vomiting, diarrhoea,
• acne, skin rash, severe itching, hair loss (alopecia),
• vaginal infection,
• fluid retention and changes in body weight.

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

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing problems,
• blockage of a blood vessel by a clot formed elsewhere in the body,
• skin disorders such as nodular erythema (characterized by painful reddish skin nodules) or erythema multiforme (characterized by skin rash with target-like 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 transient stroke-like symptoms, known as transient ischaemic attack (TIA),
  • blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on 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 accompanied by difficulty breathing (see also the section “Warnings and precautions”).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drosure 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drosure Diario

Each Drosure Diario blister contains 21 yellow active tablets in the 1st, 2nd, and 3rd rows of the blister, and 7 white placebo tablets in the 4th row.

Active tablets

The active substances are 0.03 mg ethinylestradiol and 3 mg drospirenone.

Other components are:

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

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and yellow iron oxide (E172).

Placebo tablets

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of the product and contents of the pack

The active tablets are film-coated, round, yellow 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.

Drosure Diario is available in packs of 1, 2, 3, 6 and 13 blisters, 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. C/ 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 Member States of the European Economic Area under the following names:

Czech Republic	Jangee
Greece	Eronileight 0.03 mg/3 mg film-coated tablet
Spain	Drosure 0.03 mg/3 mg film-coated tablets EFG
Ireland	Ethinylestradiol/Drospirenone Leon Farma & placebo 0.03 mg/3 mg film coated tablets
Poland	Vibin
Romania	Jangee 0.03 mg/3 mg 28 film-coated tablets
Slovakia	KarHleight

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 for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.