Aidessia 0.15 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

aidessia 0.15 mg / 0.03 mg, film-coated tablets EFG

desogestrel/ethinylestradiol

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

• These methods are among 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 have symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse effects listed in section 4, or if you experience any adverse effect not listed in this leaflet, consult your doctor or pharmacist.

Leaflet contents:

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

1. What aidessia is and what it is used for

Composition and type of contraceptive medicine

This medicine is a combined oral contraceptive, also known as the pill.

Each of the 21 white tablets contains a small amount of two different female hormones: desogestrel (a hormone that acts similarly to a progestogen) and ethinylestradiol (a hormone that acts similarly to an oestrogen). Due to the low hormone content, aidessia is considered a low-dose contraceptive. Since the amount of each hormone is the same in all tablets in the blister pack, it is known as a monophasic combined pill.

What it is used for

Take aidessia to prevent pregnancy.

When taken correctly (without missing tablets), the likelihood of becoming pregnant is very low.

2. What you need to know before starting to take aidessia

General considerations Before starting to use aidessia, 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”). This patient information leaflet describes several situations in which you should stop taking the pill or in which the pill's effectiveness may be reduced. In these situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, for example, a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because the pill alters the monthly changes in body temperature and cervical mucus. Like other hormonal contraceptives, aidessia does not protect against HIV (AIDS) infection or any other sexually transmitted infections (STIs).

Do not take aidessia:

You should not use aidessia 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 of the legs (deep vein thrombosis, DVT), in the 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 if you will be immobile for long periods (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 transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following diseases 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) pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood.
• If you have (or have ever had) jaundice (yellowing of the skin or eyes) or severe liver disease.
• If you have (or have ever had) hormone-dependent cancer (breast cancer or cancer of the sex organs).
• If you have (or have ever had) a liver tumor.
• If you have unexplained vaginal bleeding not diagnosed by your doctor.
• If you have abnormal endometrial hyperplasia.
• If you are allergic to ethinylestradiol, desogestrel, or any of the other ingredients of this medicine (listed in section 6). This may present as itching, rash, or swelling.
• If you are allergic to peanuts or soya.
• If you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section “Taking aidessia with other medicines”).

If you experience any of these symptoms for the first time or develop them while taking aidessia, stop taking it immediately and contact your doctor as soon as possible. In the meantime, use another non-hormonal contraceptive method. Also refer to the "General considerations" at the beginning of section 2.

When to be especially careful with aidessia

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot which may indicate that you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you

If any of the following situations occur, or if any of these conditions develop or worsen while you are using aidessia, you must also inform your doctor:

• If you smoke;
• If you have diabetes;
• If you are overweight;
• If you have high blood pressure;
• If you have a heart valve disorder or a certain rhythm disturbance;
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If a close relative has ever had a thrombosis, heart attack, or stroke.
• If you have ever had migraines.
• If you have epilepsy.
• If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• If you require surgery or are unable to stand or move around for long periods (see section 2 “Blood clots”).
• If you have recently given birth, your risk of blood clots is higher. You should ask your doctor how long after delivery you can start taking aidessia.
• If a close relative has had breast cancer.
• If you have a liver or gallbladder disease.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• 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 any condition that first appeared or worsened during pregnancy or during a previous use of sex hormones (for example, hearing loss, a metabolic disorder called porphyria, a skin disease causing blisters during pregnancy called herpes gestationis, a neurological disorder called Sydenham's chorea causing involuntary body movements).
• If you have or have ever had chloasma (golden-brown patches, also known as “pregnancy mask,” especially on the face or neck). In such cases, avoid direct exposure to sunlight or ultraviolet rays.
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly accompanied by difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

aidessia and blood clots (Thrombosis)

BLOOD CLOTS (THROMBOSIS)

The use of a combined hormonal contraceptive such as aidessia increases your risk of developing a blood clot compared to not using it. Rarely, a blood clot may block blood vessels and cause serious complications.

Blood clots may 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 aidessia is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g. if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g. 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. Sensation of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot 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 a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking aidessia, 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 aidessia 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 desogestrel, such as aidessia, 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 pill/patch/ring and who are not pregnant	About 2 out of every 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of every 10,000 women
Women who use Aidessia	About 9–12 out of every 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with aidessia 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 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 might have an inherited blood clotting disorder.
• If you need surgery or if you remain immobile for long periods due to injury, illness, or if your leg is in a cast. You may need to stop using aidessia several weeks before surgery or while you are less mobile. If you need to stop using aidessia, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth less than a few weeks ago.

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

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

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

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

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Just like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can 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 heart attack or stroke from using aidessia is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like aidessia, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disturbances 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 aidessia—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

The pill and cancer

The pill causes a slight increase in breast cancer compared to women who do not use the pill. No difference is seen 10 years after stopping the pill. It is not known whether this difference is caused by the pill. It may be that women who use the pill are examined more frequently, so breast cancer is detected earlier.

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

Chronic infection with Human Papillomavirus (HPV) is the most important risk factor for cervical cancer. In women who use the pill for a long time, the likelihood of developing cervical cancer may be slightly higher. This finding may not be caused by the pill itself but could be related to sexual behavior and other factors (such as more frequent cervical screening).

Psychiatric disorders:

Some women using hormonal contraceptives such as aidessia 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 medical advice as soon as possible.

aidessia and use of other medicines

Always inform the doctor who prescribed aidessia about any medicines or herbal remedies you are taking, have recently taken, or might need to take. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are using aidessia. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

Do not take aidessia if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated liver enzyme ALT).

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

aidessia can be restarted approximately 2 weeks after completion of this treatment. See the section “Do not use aidessia.”

Some medicines:

• may affect the levels of aidessia in the blood
• may make it less effective in preventing pregnancy
• may cause unexpected bleeding.

These include medicines used to treat:

• Epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate).
• Tuberculosis (e.g., rifampicin, rifabutin).
• HIV infections (e.g., ritonavir, nelfinavir, nevirapine, efavirenz).
• Hepatitis C (e.g., boceprevir, telaprevir).
• Other infectious diseases (griseofulvin).
• High blood pressure in the blood vessels of the lungs (bosentan).
• Depressive mood disorders (the herbal remedy St. John’s wort).

If you are taking medicines or herbal products that may reduce the effectiveness of aidessia, you should also use a barrier contraceptive method. Since the effect of another medicine on aidessia may last up to 28 days after stopping the medicine, it is necessary to use an additional barrier contraceptive method during that time.

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

• Those containing cyclosporine.
• The antiepileptic lamotrigine (this may lead to an increase in seizures).

Laboratory tests

If you are undergoing a laboratory test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

Do not take aidessia if you are pregnant or think you might be pregnant. If you suspect you might be pregnant while using aidessia, contact your doctor as soon as possible.

Breastfeeding

The use of aidessia is not recommended during breastfeeding. Contact your doctor if you still wish to use aidessia while breastfeeding.

Driving and use of machines

aidessia has no known effects on the ability to drive or use machines.

aidessia contains lactose and soybean oil

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

If you are allergic to peanuts or soy, do not use this medicine.

Children and adolescents

There are no clinical data on efficacy and safety in adolescents under 18 years of age.

When should you contact your doctor?

Regular check-ups

Your doctor may advise you to schedule regular check-ups for the pill. Your individual health situation will determine how often you need to return for reviews and which tests are required.

Contact your doctor as soon as possible if:

• You notice possible signs that could indicate you have a blood clot. This could mean you have a blood clot in a blood vessel in the leg (deep vein thrombosis), a blood clot in a blood vessel of the lung (pulmonary embolism), a heart attack, or a stroke (see the section "aidessia and blood clots").
• For a description of the symptoms of these serious side effects, see "How to recognize a blood clot."
• You notice any changes in your health, especially related to any of the items mentioned in this leaflet (also see “When not to use aidessia?” and “When to be especially careful with aidessia”); do not forget topics related to your close family.
• You feel a lump in the breast.
• You experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties (see also the section “When to be especially careful with aidessia”).
• You are going to use other medicines (see also “Use of other medicines”).
• Your ability to move is limited for a prolonged period or you are going to undergo surgery (consult your doctor at least 4 weeks in advance).
• You experience persistent or worsening irregular bleeding.
• You missed tablets in the first week of the blister pack and had sex within 7 days.
• You have severe diarrhea.
• You miss your period twice in a row. Do not start the next blister pack until your doctor tells you to do so.

3. How to take aidessia

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure whether you are taking it correctly, consult your doctor or pharmacist.

When and how to take the tablets

Each blister contains 21 tablets. On the blister, each tablet is marked with the day of the week on which it should be taken. Take your tablet at approximately the same time every day, with a little liquid if necessary.

Follow the direction of the arrows on the blister until you have taken all 21 tablets. Do not take any tablets during the following 7 days. During these 7 days, your withdrawal bleed (period) should begin. It usually starts on day 2–3 after the last aidessia tablet.

Start the next blister of aidessia on the eighth day, even if you are still bleeding. This means you will always start new blisters on the same day of the week, and also means you will have your period approximately on the same days each month.

When can you start the first blister?

• When you have not used a hormonal contraceptive in the previous month. Start taking the tablets on the first day of your cycle, that is, the first day of your menstrual bleeding. The medicine will work immediately, and there is no need to use an additional contraceptive method. You may also start on days 2–5 of the cycle, but in that case, make sure to use an additional contraceptive method, such as a condom, during the first 7 days.

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

You may start taking this medicine the day after taking the last tablet of your current blister pack (i.e., without interruption). If your previous hormonal contraceptive blister pack contained inactive tablets, you may start taking aidessia the day after taking the last active tablet (if you are unsure which one this is, consult your doctor or pharmacist). You may also start later, but never later than the day after the tablet-free interval of your previous contraceptive (or the day after the last inactive tablet of your previous treatment).

If you are using a vaginal ring or patch, you should start this medicine on the day of removal. You may also start later, but no more than seven days after removing the ring or the last patch.

If you have taken oral contraceptive tablets, patch, or ring exactly as directed and are certain you are not pregnant, you may stop using them or remove the ring or patch on any day of your current cycle and immediately switch to this medicine.

If you follow these instructions, you do not need to use an additional contraceptive method, such as a condom.

• Switching from a progestogen-only method (mini-pill)

You may stop taking the mini-pill on any day and start taking this medicine the next day, at any time. However, make sure to also use an additional contraceptive method, such as a condom, during the first 7 days of tablet intake.

• Switching from an intrauterine device (IUD), injectable, implant, or progestogen-releasing system

Start taking this medicine on the day your next injection is due, or on the day your implant or IUD is removed. Make sure to use an additional contraceptive method, such as a condom, during the first 7 days of taking aidessia.

• After giving birth

If you have recently given birth, your doctor may advise you to wait until after your first normal period before starting this medicine. Sometimes it may be possible to start earlier. Your doctor will advise you. The same applies if you are breastfeeding and wish to take aidessia.

• After a miscarriage or abortion

Follow your doctor’s advice.

If you take more aidessia than you should

No serious harm has been reported following overdose of this medicine.

If you take too many tablets, you may feel unwell, vomit, or have vaginal bleeding.

If you find that a child has taken this medicine, consult your doctor.

What to do if:

You forget to take your tablets

• If the missed tablet is taken within 12 hours, 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, the reliability of the contraceptive may be reduced. The more consecutive tablets you miss, the greater the risk that contraceptive effectiveness will decrease.

There is a particularly high risk of pregnancy if you miss tablets at the beginning or end of the blister pack. Therefore, you must follow the rules detailed below (see diagram):

Missing more than one tablet in 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. Take the following tablets at your usual time. Use additional contraceptive precautions for the next 7 days. If you had sexual intercourse in the week before missing the tablet, be aware that there is a possibility of pregnancy. In this case, consult your doctor immediately.

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. Take the following tablets at your usual time. Contraceptive reliability is maintained. There is no need to use additional contraceptive precautions.

Missing one tablet in week 3

You may choose either of the following options, without needing additional contraceptive precautions:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at your usual time. When you finish the current blister pack, start the next blister pack the next day without interruption. You may not have a withdrawal bleed until the end of the second blister pack, but you may experience spotting or intermenstrual bleeding during the second blister pack.
2. Stop taking the current blister pack. Take your usual 7-day tablet-free interval or shorter (always note the day you missed the tablet). Then continue with the next blister pack.

By following this method, you can always start your next blister pack on the same day of the week as usual.

• If you have missed any tablets in a blister pack and do not bleed during the tablet-free interval, you may be pregnant. In this case, contact your doctor before starting the next blister pack.

If you have gastrointestinal disorders (e.g., vomiting, severe diarrhea)

If you are sick (vomit) or have severe diarrhea, your body may not absorb the usual dose of hormones from the pill. If you vomit within 3 to 4 hours after taking the pill, it is as if you had missed a tablet. You should follow the advice given above for missed tablets. Speak with your doctor if you experience severe diarrhea.

If you want to delay your period

You can postpone your period, although this is not recommended. You may delay your period in exceptional cases by starting the next blister of aidessia the next day without interruption. You may continue taking this blister for as long as desired, until it is empty. While taking the second blister, you may experience bleeding or spotting. Start your next blister after the usual 7-day tablet-free interval.

If you want to change the day your period starts

If you take the tablets as directed, your period will occur approximately on the same day each month. If you wish to change this, simply shorten (but never extend) the tablet-free interval between two blister packs. For example, if your period usually starts on a Friday and you wish it to start on Tuesday (3 days earlier), you should start your next blister pack 3 days earlier than usual. If you make your tablet-free interval very short (e.g., 3 days or less), you may not have bleeding during the interval. You may experience intermenstrual bleeding or spotting during the use of the next blister pack.

If you have unexpected bleeding

When taking any contraceptive tablet, during the first few months you may experience irregular vaginal bleeding (spotting or intermenstrual bleeding) between periods. You may need to use feminine hygiene protection, but continue taking your tablets as usual. Irregular vaginal bleeding usually stops once your body has adjusted to the treatment (usually after about 3 blister packs). Contact your doctor if bleeding continues, increases, or starts again.

If your period does not occur

If you have taken all tablets at the correct times, and have not vomited, had severe diarrhea, or taken other medicines, it is very unlikely that you are pregnant. Start your next blister pack as usual.

If you miss two periods in a row, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack of this medicine until your doctor has confirmed you are not pregnant.

If you want to stop taking aidessia

You may stop taking this medicine at any time. If you do not wish to become pregnant, consult your doctor for advice on using other reliable contraceptive methods. If you stop because you wish to become pregnant, it is generally recommended that you wait until you have had one natural period before trying to conceive. This helps you determine your 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 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 health that you think may be due to aidessia, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in 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 use aidessia”.

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”).

As with all pills, during the first few months your menstrual pattern may change. This may be reflected in the frequency of bleeding (absent, less frequent, more frequent, or continuous), the amount of bleeding, or the duration of bleeding.

Frequent (may affect up to 1 in 10 women):

• Depression or mood changes.
• Headache.
• Nausea.
• Abdominal pain.
• Tender or painful breasts.
• Weight gain.

Uncommon (may affect up to 1 in 100 women):

• Fluid retention.
• Decreased sexual appetite.
• Migraine.
• Vomiting.
• Diarrhea.
• Skin rash or hives.
• Breast enlargement.

Rare (may affect up to 1 in 1,000 women):

• 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/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).

• Hypersensitivity reactions
• Increased libido
• Eye discomfort if wearing contact lenses
• Nodular erythema (bruise-like swelling on the shins), erythema multiforme (rash with ulcers or irregular red spots)
• Breasts producing a milky discharge from the nipples, changes in vaginal secretions
• Weight loss

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 aidessia

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

Do not store above 30°C. Store in the original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the container, after 'EXP'. The expiry date refers to the last day of the month indicated.

Do not use aidessia if you notice any colour change, broken tablets, or any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. In this way, you will help protect the environment.

6. Contents of the pack and other information

Composition of aidessia

• The active substances are: desogestrel and ethinylestradiol. Each tablet contains 0.150 milligrams of desogestrel and 0.030 milligrams of ethinylestradiol.
• The other components are: lactose monohydrate, corn starch, povidone K-30 (E1201), alpha-tocopherol (E307), soybean oil, hydrated colloidal silica (E551), anhydrous colloidal silica (E551), stearic acid (E570), hypromellose 2910 (E464), triacetin (E1518), polysorbate, titanium dioxide (E171).

Appearance of aidessia and contents of the pack

Film-coated tablets, white in colour, round, marked with “C” on one side and “7” on the other.

Available in packs of 1, 3, 6 and 13 blisters, each containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 – Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera; La Vallina s/n,

24008 - Villaquilambre, León.

Spain

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

Netherlands: Ethinylestradiol/Desogestrel 0.03 mg/0.15 mg Focus, fimomhulde tabletten

Belgium: Desolina 150/30 microgram, comprimé pelliculé

Luxembourg: Desolina 30 0.150 mg/0.030 mg, comprimés pelliculés

Spain: aidessia 0.15 mg/0.03 mg, film-coated tablets EFG

Date of the most recent review of this leaflet: March 2024

Detailed and up-to-date 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 can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77783/P_77783.html

QR code link: https://cima.aemps.es/cima/dochtml/p/77783/P_77783.html