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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

aidraelle Daily 3 mg/0.02 mg film-coated tablets EFG

drospirenone/ethinylestradiol

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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

1. What aidraelle Daily is and what it is used for
2. What you need to know before taking aidraelle Daily

• Do not take aidraelle Daily
• Warnings and precautions
• Blood clots
• aidraelle Daily and cancer
• Bleeding between menstrual periods
• What to do if you do not have your menstrual period during the placebo days
• Other medicines and aidraelle Daily
• Taking aidraelle Daily with food and drink
• Laboratory tests
• Pregnancy and breastfeeding
• Driving and using machines
• aidraelle Daily contains lactose

3. How to take aidraelle Daily

• When can you start with the first blister pack?
• If you take more aidraelle Daily than you should
• If you forget to take aidraelle Daily
• What to do in case of vomiting or severe diarrhoea
• Delayed menstrual period: what you should know
• Change in the first day of your menstrual period: what you should know
• If you stop treatment with aidraelle Daily

4. Possible side effects
5. How to store aidraelle Daily
6. Contents of the pack and other information

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

aidraelle Diario is a contraceptive used to prevent pregnancy.

Each of the 21 active pink film-coated tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

The 7 white film-coated 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 to take aidraelle Daily

General considerations

Before starting this medicine, you should 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 this medicine, 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 drospirenone/ethinylestradiol, or in which its effectiveness may be reduced.

In these situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because drospirenone/ethinylestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do not take aidraelle Daily

You must not take drospirenone/ethinylestradiol if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be most suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or will be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with blood vessel damage.

• Very high blood pressure.

• Very high levels of fat in the blood (cholesterol or triglycerides).

• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have (or have ever had) liver disease and your liver function has not returned to normal.

• If your kidneys do not function 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 present as itching, rash, or swelling.

Do not take aidraelle Daily 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 aidraelle Daily”).

Additional information on special populations

Children and adolescents

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

Women of advanced age

Drospirenone/ethinylestradiol is not indicated for use after menopause.

Women with hepatic impairment

Do not take drospirenone/ethinylestradiol if you have liver disease. See sections “Do not take aidraelle Daily” and “Warnings and precautions”.

Women with renal impairment

Do not take drospirenone/ethinylestradiol if you are experiencing impaired kidney function or acute renal failure. See sections “Do not take aidraelle Daily” 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 side effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

In certain situations, you should take special care while taking this medicine 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 taking this medicine, you must also inform your doctor.

• If any close family member has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking aidraelle 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 section “Other medicines and aidraelle Diario”).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• If you have a condition that may have first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham's chorea)). If you have or have ever had chloasma (golden-brown patches, also known as “pregnancy mask,” especially on the face and neck). In such cases, avoid direct exposure to sunlight or ultraviolet radiation.
• If you experience symptoms such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives, possibly with difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (called “venous thrombosis,” “venous thromboembolism” or VTE).
• In the arteries (called “arterial thrombosis,” “arterial thromboembolism” or 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 aidraelle 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 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 producing blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition 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, 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. Severe 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 is 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.
• In very rare cases, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is highest during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher 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 this medicine, 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 aidraaelle 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 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 this medicine, between 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot depends 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 contraceptive pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women who use this medicine	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 this medicine 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 a close relative has 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 will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking this medicine several weeks before surgery or while you are less mobile. If you need to stop taking this medicine, consult your doctor about when you can start taking it again.
• With increasing age (especially over about 35 years).
• If you have given birth within the last few weeks.

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

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

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

If any of the above conditions change while you are using this medicine—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 lead to a heart attack or stroke.

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

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

• With age (over about 35 years).
• If you smoke.
• When using a combined hormonal contraceptive such as aidraelle 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 a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, 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 aidraelle 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.

aidraelle Diario and cancer

Women who use combined contraceptives have a slightly higher rate of breast cancer, 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.

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

Psychiatric disorders

Some women using hormonal contraceptives such as aidraelle 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 symptoms of depression, contact your doctor for medical advice as soon as possible.

Bleeding between menstrual periods

During the first few months of taking this medicine, unexpected bleeding (bleeding outside the week when you are taking the white tablets) may occur. If you experience such bleeding for more than a few months, or if it starts after a few months, your doctor should investigate the cause.

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

If you have taken all the pink active tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.

If you miss your expected period for two consecutive cycles, you may be pregnant. In this case, see your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and aidraelle 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 aidraelle Diario. They may 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.

Some medicines may affect the levels of aidraelle Diario in the blood, making it less effective in preventing pregnancy, and 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)
  • St. John’s wort herbal preparations.

Drospirenone/ethinylestradiol 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 aidraelle 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.

Drospirenone/ethinylestradiol can be restarted approximately 2 weeks after completion of this treatment (see section “Do not take aidraelle Diario”).

Consult your doctor or pharmacist before taking any medicine.

Taking aidraelle Diario with food and drink

You may take the tablets with or without food, with a glass of water if needed.

Laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives may influence the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

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

If you are pregnant, do not take this medicine. If you become pregnant while taking aidraelle Diario, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking this medicine at any time (see section “If you stop treatment with aidraelle Diario”).

Breastfeeding

In general, it is not recommended to take this medicine during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Driving and use of machines

There is no information suggesting that the use of this medicine affects the ability to drive or use machines.

aidraelle Diario contains lactose

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

3. How to take aidraelle 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 active pink film-coated tablets and 7 white film-coated placebo tablets.

The two different colored tablets of aidraelle Diario are arranged in order. One blister contains 28 tablets.

Take one aidraelle Diario tablet every day with a glass of water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

Do not take the wrong tablet: take one pink tablet every day for the first 21 days, followed by one white tablet each day for the last 7 days. Then start a new blister (21 pink tablets and 7 white tablets). In this way, there is no break between two blisters.

Due to the different composition of the tablets, you must start with the first tablet located at the top left corner and then take one tablet each day. To maintain the correct order, follow the direction of the arrows on the blister.

Blister preparation

To help you follow the correct order of intake, each aidraelle Diario blister contains 7 adhesive strips with the 7 days of the week. Choose the strip starting 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”.

Attach the weekly adhesive strip to the top of the aidraelle Diario blister, where it says “Place the adhesive strip matching your start date here”, so that the first day is positioned above the tablet marked “Start”.

This way, each tablet has a day of the week indicated above it, allowing you to see whether you have taken a particular tablet. The arrows show the order in which you should take the tablets.

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 active pink tablet of aidraelle Diario. After taking the last white tablet, you must start the next blister, even if your period has not yet finished. This means you should start each blister on the same day of the week as you started the previous one, and your period should occur during the same days every month.

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

When can you start the first blister?

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

Start taking this medicine on the first day of your cycle (i.e., the first day of your menstruation).

If you start aidraelle Diario on the first day of your period, you will be protected against pregnancy immediately.

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 this medicine preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, or at the latest the day after the end of 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 SLI).

You may switch from a progestogen-only pill on any day. If switching from an implant or SLI, do so on the day of removal; if switching from an injectable, do so at the time the next injection would have been due. In all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

After an abortion

Follow your doctor’s recommendations.

After childbirth

You may start taking this medicine 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) during the first 7 days of using this medicine.

If, after childbirth, you have already had sexual intercourse before starting this medicine (again), you must first ensure that you are not pregnant or wait until your next menstrual period.

If you are breastfeeding and wish to start drospirenone/ethinylestradiol (again) after childbirth.

See section “Pregnancy and Breastfeeding”.

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

If you take more aidraelle Diario than you should

No serious harmful effects have been reported following overdose with this medicine.

Symptoms that may occur if you take too many tablets at once include feeling unwell, vomiting, or vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine.

If you have taken too many tablets of this medicine, or if you discover 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take aidraelle Diario

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

If you forget to take an active pink tablet from row 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 higher the risk of pregnancy.

The risk of incomplete contraceptive protection is highest if you miss a pink tablet at the beginning (1st row) or at the end (3rd row) of the blister. Therefore, follow the recommendations below (see diagram below).

Missing more than one tablet from the blister

Consult your doctor.

Missing a 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, for example, 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.

Missing a 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 a tablet in week 3

You have two options:

• 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 blister, discard them and start the next blister immediately.
• You will likely have your period at the end of the second blister, while taking the white placebo tablets, although you may experience light bleeding or spotting during the second blister. Alternatively, you may stop taking the active pink tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day on which you missed the tablet). If you wish to start a new blister 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 missed any tablets and do not have a period during the placebo days, you may be pregnant. In this case, you must see your doctor before starting the next blister.

What should you do in case of vomiting or severe diarrhea?

If you vomit within 3–4 hours after taking an active pink tablet or have severe diarrhea, there is a risk that the active ingredients of the contraceptive are not fully absorbed by your body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhea, take a pink tablet from a spare blister as soon as possible. If possible, take it within 12 hours of your usual time of 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 aidraelle Diario”.

Delayed menstrual period: what you should know?

Although not recommended, it is possible to delay your menstrual period by skipping the white placebo tablets in the fourth row and starting a new blister of drospirenone/ethinylestradiol, taking it completely. You may experience light bleeding or spotting during the second blister. Finish this second blister by taking the 7 white tablets in the 4th row. Then start the next blister.

You must 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 instructed, your period will begin during the placebo week. If you need to change this day, reduce the number of days taking the white placebo tablets (but never increase them—maximum 7 days). For example, if you normally start the placebo tablets on Friday and wish to change it to Tuesday (3 days earlier), you should start the new blister 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), bleeding may not occur during these days. In this case, you may experience light bleeding or spotting.

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

If you stop taking aidraelle Diario

You may stop taking this medicine 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 this medicine and wait until your next menstrual period before trying to conceive. This will allow you to estimate your due date more easily.

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 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 this medicine, consult your doctor.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible difficulty breathing (see also section “Warnings and precautions”).

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 aidraelle Diario”.

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

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 menstruation.
• weight gain.

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

• candidiasis (a fungal infection).
• cold sores (herpes simplex).
• allergic reactions.
• increased appetite.
• depression, nervousness, sleep disorders.
• tingling and pricking sensations, dizziness.
• vision problems.
• irregular or unusually fast heart rate.
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, low blood pressure, migraine, varicose veins.
• sore throat.
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation.
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or hives with breathing difficulties (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, disorders of oily skin (seborrhoeic dermatitis).
• neck pain, limb pain, muscle cramps.
• bladder infection.
• breast lumps (benign or cancer), milk production without being pregnant (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, heavy menstruation, vaginal discharge, 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, excessive thirst, increased sweating.
• weight loss.

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

• asthma.
• hearing problems.
• erythema nodosum (characterised by painful reddish skin nodules).
• erythema multiforme (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.
  • transient ischaemic attack (TIA) or temporary stroke-like symptoms.
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects

If you experience any 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 aidraelle Daily

Keep this medicine out of the sight and reach of children.

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.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of aidraelle Diario

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

Active pink film-coated tablets:

Tablet core: monohydrate lactose, potassium polacrilin, povidone, magnesium stearate.

Coating: Opadry II pink containing: macrogol, poly (vinyl alcohol), titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172) and red iron oxide (E-172).

Inactive white film-coated tablets:

Tablet core: monohydrate lactose, potassium polacrilin, povidone, anhydrous colloidal silica, magnesium stearate.

Coating: Opadry II white containing: macrogol, poly (vinyl alcohol), titanium dioxide (E-171) and talc (E-553b).

Appearance of the product and contents of the pack

Each aidraelle Diario blister contains 21 active pink film-coated tablets in the 1st, 2nd and 3rd rows of the blister and 7 inactive (placebo) white film-coated tablets in the 4th row.

aidraelle Diario is available in cardboard boxes containing 1 or 3 blisters, each blister being made of PVC/PVDC/Aluminum and containing 28 film-coated tablets.

The active tablets of aidraelle Diario are cylindrical, biconvex, pink in colour and have an approximate diameter of 6 mm.

The placebo tablets are cylindrical, biconvex, white in colour and have an approximate diameter of 6 mm.

Each cardboard box includes a pouch for storing the blister.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Cyndea Pharma, S.L

Pol. Ind. Emiliano Revilla Sanz

Avenida de Ágreda, 31

42110 Ólvega (Soria) Spain

Date of the most recent revision of this leaflet: November 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78878/P_78878.html

QR code linking to: https://cima.aemps.es/cima/dochtml/p/78878/P_78878.html