Aidraelle 3 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

aidraelle 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 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 adverse effects not listed in this leaflet. See section 4.

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

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots 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 is and what it is used for

2. What you need to know before taking aidraelle

   • Do not take aidraelle
   • Warnings and precautions
   • Blood clots
   • aidraelle and cancer
   • Bleeding between menstrual periods
   • What to do if you do not have your period during the break week
   • Other medicines and aidraelle
   • Taking aidraelle with food and drinks
   • Laboratory tests
   • Pregnancy and breastfeeding
   • Driving and use of machines
   • Important information about some of the components of aidraelle

3. How to take aidraelle

   • When can you start with the first blister pack?
   • If you take more aidraelle than you should
   • If you forget to take aidraelle
   • What to do in case of vomiting or severe diarrhoea
   • What to do if you do not have your period during the break week
   • Delayed menstruation: what you should know
   • Change in the first day of your menstrual period: what you should know
   • If you stop treatment with aidraelle

4. Possible side effects

5. Storage of aidraelle

6. Contents of the pack and other information

1. What is Aidraelle and what is it used for

Aidraelle is a contraceptive used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting aidraelle

General considerations

Before starting aidraelle, 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 aidraelle, 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 aidraelle, or in which the effect of aidraelle may be reduced.

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

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

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

Do not take aidraelle

You must not take aidraelle 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 require surgery or will be immobile for a long time (see section “Blood clots”).

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

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

• If you have any of the following conditions that may increase your risk of developing a 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 had in the past) 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 had in the past) a liver tumour.

• If you have (or have had in the past) or suspect you have breast cancer or cancer of the reproductive organs.

• If you have vaginal bleeding of unknown cause.

• If you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may present as itching, rash, or swelling.

Do not take aidraelle if you have hepatitis C and are taking medications containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir (see also section Other medicines and aidraelle).

Additional information on special populations

Children and adolescents

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

Elderly women

aidraelle is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

Do not take aidraelle if you have impaired kidney function or acute renal failure. See sections “Do not take aidraelle” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting aidraelle.

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot, which may indicate 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 (thrombosis)” 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 when using aidraelle or any other combined contraceptive, and your doctor may need to perform periodic check-ups. If any of the following disorders affect you, you must inform your doctor before starting to take aidraelle.

If any of these conditions develop or worsen while you are using aidraelle, you must also inform your doctor.

• If a 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 causing kidney failure).
• If you have sickle cell anemia (a hereditary 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. Ask your doctor when you can start taking aidraelle 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 aidraelle”).
• 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 skin 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 called “pregnancy mask,” especially on the face and neck). In such cases, avoid direct sunlight or ultraviolet radiation.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives, possibly with breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders:

Some women using hormonal contraceptives such as aidraelle 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.

BLOOD CLOTS

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

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, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to aidraelle 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., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough with no clear cause, possibly bringing up 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 like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or under 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 a 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 abdominal 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 more frequently during the first year of using a combined hormonal contraceptive.

• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).

• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.

• Very rarely, a blood 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 medicine or a different one) after a break of 4 weeks or more.

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

When you stop taking aidraelle, 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 aidraelle is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as aidraelle, between 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” 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 aidraelle	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 aidraelle 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 of age). 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, illness, or having a leg in a cast. You may need to stop taking aidraelle several weeks before surgery or while you are less mobile. If you need to stop taking aidraelle, 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 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 aidraelle.

If any of the above conditions change while you are using aidraelle—for example, a close relative experiences a thrombosis without a known cause, or you gain a significant amount 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 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 while using aidraelle is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like aidraelle, 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 disorders such as 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—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

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

Bleeding between menstrual periods

During the first few months of taking aidraelle, unexpected bleeding (bleeding outside the rest week) may occur. If you experience such bleeding for more than a few months, or if it starts after several months, your doctor should investigate the cause.

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

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

If you miss two consecutive expected periods, 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

Inform your doctor or pharmacist if you are currently 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 aidraelle. 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 aidraelle 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 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.

Aidraelle may influence the effect of other medicines, for example:

• Medicines containing cyclosporine
• The antiepileptic lamotrigine (may lead to increased frequency of seizures)
• Theophylline (used to treat breathing problems)
• Tizanidine (used to treat pain and/or muscle cramps).

Do not take aidraelle if you have Hepatitis C and are taking medications containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir, as increases in liver function test results (elevation of liver enzyme ALT) may occur.

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

Aidraelle can be restarted approximately 2 weeks after completion of this treatment. See the section "Do not take aidraelle."

Consult your doctor or pharmacist before taking any medicine.

Taking aidraelle 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 hormonal contraceptive, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

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

If you are pregnant, do not take aidraelle. If you become pregnant while taking aidraelle, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking aidraelle at any time (see "If you stop taking aidraelle").

Breastfeeding

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

Aidraelle contains lactose.

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

3. How to take aidraelle

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

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

Each blister contains 21 tablets. The day of the week on which you should take the tablet is printed on each tablet. For example, if you start on a Wednesday, you should take a tablet marked “WED”. Follow the direction of the arrow on the blister until you have taken all 21 tablets.

Afterwards, you must not take any tablets for 7 days. During these 7 days without tablets (called the tablet-free interval), your period should occur. Usually, the menstrual bleeding, which may also be referred to as withdrawal bleeding, begins on the second or third day of the tablet-free week.

On the eighth day after taking the last aidraelle tablet (i.e., after the 7-day tablet-free interval), start the next blister pack, even if your period has not yet finished. This means you should start the next blister pack on the same day of the week as you started the previous one, and your period should occur on the same days each month.

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

When can you start the first blister pack?

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

Start taking aidraelle on the first day of your cycle (i.e., the first day of your menstruation). If you start aidraelle 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 contraceptive ring, or contraceptive patch.

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

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

You may switch from a progestogen-only pill on any day. If switching from an implant or IUD, 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 taking aidraelle tablets.

• After an abortion.

Follow your doctor’s advice.

• After giving birth.

After giving birth, you may start taking aidraelle between 21 and 28 days later. If you start later than this, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using aidraelle.

If, after giving birth, you have already had sexual intercourse before starting to take aidraelle (again), you must first be sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking aidraelle (again) after giving birth.

See section “Pregnancy and Breastfeeding”.

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

If you take more aidraelle than you should

No serious harm has been reported following accidental overdose of aidraelle.

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 aidraelle 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 telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take aidraelle

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and continue taking the following tablets at your usual time.

• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you forget, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you miss a tablet at the beginning of the blister pack (1st row) or at the end of the blister pack (3rd row of the blister). Therefore, you should take the following measures (see also the diagram below):

• Missing more than one tablet from the blister 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 following tablets at your usual time and use additional precautions, for example, a condom, for the next 7 days. If you had sexual intercourse during the week before missing the tablet, be aware that there is a risk of pregnancy. 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. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

You have two options:

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

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

2. Alternatively, you may stop taking tablets and go directly into the tablet-free interval (noting the day on which you missed the tablet). If you wish to start a new blister pack on your usual starting day, the tablet-free interval must last less than 7 days.

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

• If you have missed taking tablets and do not have a period during the tablet-free interval, you may be pregnant. In this case, you must see your doctor before starting the next blister pack.

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

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhoea, there is a risk that the active ingredients of the contraceptive are not completely absorbed by your body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhoea, you should take a tablet from a reserve blister pack 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”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your period by starting a new aidraelle blister pack instead of beginning the tablet-free interval and completing it. During the second pack, you may experience light bleeding or spotting. After the usual tablet-free week, continue with the next blister pack.

You must consult your doctor before deciding to delay your period.

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

If you take the tablets as instructed, your period will begin during the week corresponding to the tablet-free interval. If you wish to change this day, reduce the number of tablet-free days (but never increase them—maximum 7 days). For example, if your tablet-free interval starts on Friday and you wish to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If you make the tablet-free interval very short (e.g., 3 days or less), you may not have any bleeding 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

You may stop taking aidraelle 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 aidraelle and wait until your menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.

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

4. Possible adverse effects

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

The following list of adverse effects has been associated with the use of aidraelle:

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, diarrhea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or hives accompanied by breathing difficulty (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, disorders of oily skin (seborrheic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lumps (benign or cancer), milk production without being pregnant (galactorrhea), ovarian cysts, hot flushes, absence of menstruation, heavy menstrual bleeding, vaginal discharge, vaginal dryness, pelvic pain, abnormal cervical smears (Papanicolaou or Papanicolaou staining), decreased interest in sex
• fluid retention, lack of energy, feeling excessively thirsty, increased sweating
• weight loss

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

• asthma
• hearing problems
• erythema nodosum (characterized by painful reddish skin nodules)
• erythema multiforme (skin rash with target-shaped redness or ulcers)
• harmful blood clots in a vein or artery, for example:
  • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys or eye.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult 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

Keep this medicine out of sight and reach of children.

Do not store above 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 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 in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of aidraelle

• The active substances are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol.
• The other components are:

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

Coating: Opadry II pink, containing macrogol, polyvinyl alcohol, titanium dioxide (E-171), talc, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the pack

Each aidraelle blister contains 21 film-coated tablets.

Aidraelle is available in cardboard boxes containing 1 or 3 blisters, each blister being made of PVC/PVDC/Aluminum and containing 21 film-coated tablets.

Aidraelle tablets are cylindrical, biconvex, pink in colour, with an approximate diameter of 6 mm.

Each cardboard box includes a cardboard envelope for storing the blister.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 review of this leaflet: July 2024

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78877/P_78877.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78877/P_78877.html