Prospect: Information for the User

aidessia 0.15 mg/ 0.02 mg tablets EFG

desogestrel/etinilestradiol

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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a pause 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 this prospect thoroughly before starting to take this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospect.Ver section4.

1. What is aidessia and for what it is used

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

3. How to take aidessia

4. Possible adverse effects

5. Conservation of aidessia

6. Contents of the package and additional information

Thismedicationis a combined oral contraceptive.

Each tablet contains a small amount of two types of female hormones: a progestin desogestrel and an estrogen etinilestradiol.

These help you not become pregnant, just like your natural hormones prevent you from conceiving again when you are already pregnant.

These hormones:

1.prevent the ovary from releasing an egg each month (ovulation),

2.also thicken the fluid (in the cervix), making it harder for sperm to reach the egg,

3.alter the inner lining of the uterus to make it less likely to accept the fertilized egg.

General Notes

Before you can start taking aidessia, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending on your personal situation, may perform other tests.

In this prospectus, several situations are described in which you should stop using aidessia or in which the reliability of the pill may be reduced. In these situations, you should not have sex or you should take additional non-hormonal contraceptive precautions (e.g., use a condom or another barrier method). Do not use the Ogino method based on the menstrual cycle or the basal body temperature method. These methods may not be reliable because aidessia alters the monthly changes in body temperature and cervical mucus.

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

General Considerations

Before starting to use aidessia, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood Clots").

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 what other form of contraception would be more suitable. See also the section "When to be especially careful with aidessia."

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

• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without getting up (see section "Blood Clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular 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 pancreatitis (inflammation of the pancreas), along with high levels of fat in your blood.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have had a cancer that grows in response to sex hormones (e.g., breast or genital organ cancer).
• If you have or have had a tumor in the liver.
• If there is any unexplained vaginal bleeding.
• If you have abnormal growth of the internal uterine tissue.
• If you are pregnant or think you may be pregnant.
• If you are allergic to desogestrel, ethinylestradiol, or any of the other components of this medication (including in section 6).
• If you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Taking aidessia with other medications").

If any of these circumstances occur for the first time while using the pill, do not take more and consult your doctor immediately. In the meantime, use non-hormonal contraceptive methods.

Warnings and Precautions

When to be especially careful with aidessia

Before starting treatment with aidessia

Inform your doctor if you suffer from any of the following conditions.

If the condition develops or worsens while you are using aidessia, you should also inform your doctor:

• If you are a smoker.
• If you are diabetic.
• If you are overweight.
• If you have high blood pressure.
• If you have heart rhythm disorders or certain heart diseases.
• If you have superficial thrombophlebitis.
• If you have varicose veins.
• If a close relative has had a blood clot, heart attack, or cerebral embolism.
• If you have migraines.
• If you have epilepsy.
• If you have high levels of fat in your 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 need surgery or spend a lot of time without getting up (see section 2 "Blood Clots").
• If you are at greater risk of blood clots after childbirth. You should ask your doctor when you can start taking aidessia after childbirth.
• If a close relative has had breast cancer.
• If you have 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 that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney insufficiency).
• If you have sickle cell anemia (a genetic disorder of red blood cells).
• If you have a disease that appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disorder called porphyria, a skin disease called herpes gestational, a disease called Sydenham's chorea).
• If you have melasma (brown-yellow skin patches, especially on the face); in this case, you should avoid intense sun exposure or ultraviolet radiation.
• If you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Estrogen-containing products can cause or worsen symptoms of hereditary and acquired angioedema.

If any of the above situations occur for the first time, recur, or worsen while using the pill, you should consult your doctor, who may recommend that you stop taking the pill.

Aidessia, like all hormonal contraceptives, does not protect against HIV or any sexually transmitted disease.

Once treatment with aidessia has started

While taking the pill, your doctor will require you to undergo regular check-ups, usually once a year.

Contact your doctor as soon as possible in the following cases:

• If you notice possible signs of a blood clot that may mean you are suffering from 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).

To get a description of the symptoms of these serious side effects, see "How to recognize a blood clot."

• If you notice any change in your health, especially in any of the points mentioned in this prospectus (see also "When not to use aidessia" and "What you need to know before starting to take aidessia"); do not forget to mention the points related to your close relatives;
• If you find a lump in the breasts;
• If you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing, or urticaria with possible difficulty breathing;
• If you are taking other medications (see also "Taking aidessia with other medications");
• If you need to be immobile or are about to undergo surgery, as your risk of thrombosis increases temporarily; consult your doctor at least four weeks in advance;
• If you have unexplained vaginal bleeding;
• If you forget to take pills in the first week of the blister pack and have had sex in the previous seven days;
• If you have severe diarrhea;
• If you have two consecutive missed pills or suspect you may be pregnant, do not start the next blister pack until your doctor tells you to.

BLOOD CLOTS

The use of a combined hormonal contraceptive like aidessia increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called "deep vein thrombosis," "venous thromboembolism," or VTE).
• In arteries (which is called "arterial thrombosis," "arterial thromboembolism," or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to aidessia is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

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 thromboembolism, VTE). However, these adverse effects are rare. They occur more frequently in the first year of use of 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 breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

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

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

When you stop taking aidessia, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with aidessia is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing desogestrel like aidessia, 9-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal risk factors (see "Factors that increase your risk of a blood clot" below).

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

The risk of a blood clot is higher during the first year when taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) after a break of 4 weeks or more.

The risk of a blood clot is higher if you:

• Have excess weight (body mass index or BMI greater than 30 kg/m2).
• Have a close relative who has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have an inherited disorder of blood clotting.
• Need surgery or spend a lot of time without getting up due to an injury or illness or have your leg immobilized. You may need to stop using aidessia for several weeks before the surgery or while you have less mobility. If you need to stop using aidessia, ask your doctor when you can start using it again.
• Are older (especially over about 35 years old).
• Have given birth recently.

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

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

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

If any of the above conditions change while you are using aidessia, for example, a close relative experiences a blood clot 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 blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to aidessia is very small, but it may increase:

• With age (over about 35 years old).
• If you smoke.You are advised to quit smoking when using a combined hormonal contraceptive like aidessia. If you cannot quit smoking and are over 35 years old, your doctor may recommend that you 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 (less than about 50 years old). You may also be at higher risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

The risk of a blood clot in an artery may increase even more if you have one or more of these conditions or if any of them are particularly severe.

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

Blood Pressure

If you have high blood pressure or any related disease (including certain kidney diseases), it is recommended that you use other contraceptive methods. If you decide to use hormonal contraceptives, you should monitor your blood pressure, but if it increases and cannot be controlled with medication, you should stop treatment.

Tumors

Cases of breast cancer have been observed in women using oral contraceptives, with a slightly higher frequency than in women of the same age who do not use them. This slight increase in diagnosed breast cancers decreases gradually over the next 10 years after stopping treatment. It is not known whether this difference is due to the treatment with the pill. It may be that women using oral contraceptives visit their doctor more frequently.

Rarely, cases of benign liver tumors and even more rarely malignant liver tumors have been reported in women using oral contraceptives. This can cause internal bleeding, leading to severe abdominal pain. If this occurs, you should contact your doctor immediately.

The situation that most affects the risk of cervical cancer is ongoing infection with the human papillomavirus. In women using oral contraceptives for many years, the risk of cervical cancer is slightly higher. However, it is not clear whether the oral contraceptive plays a direct role in this risk or if other factors (such as sexual habits and other factors) do.

Vaginal Bleeding

You may not have your "period" during the week of rest. If the oral contraceptive has been taken correctly, it is very unlikely that you are pregnant. However, if you have two missed pills, you should consult your doctor as you may need to rule out pregnancy. If you have not taken the oral contraceptive as instructed in section "3. How to take aidessia" and have a missed pill, you should stop treatment and use a non-hormonal contraceptive method until pregnancy has been ruled out.

Aidessia may cause vaginal bleeding or spotting between periods. If this happens, continue taking aidessia and if the bleeding continues after three cycles, consult your doctor immediately. Errors in using the pill can also cause light vaginal bleeding and spotting.

When you stop using aidessia, you may experience irregular, light, or no bleeding, especially in the first three months and especially if your periods were irregular before starting hormone treatment.

Mental Health Disorders:

Some women who use hormonal contraceptives like aidessia have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Children and Adolescents

There are no available clinical data on safety and efficacy in adolescents under 18 years old.

Taking aidessia with other medications

Always inform your doctor about any medications or herbal supplements you are taking. Also, inform any doctor, dentist, or pharmacist who prescribes another medication that you are using aidessia. They can advise you on whether you need to take additional contraceptive precautions (e.g., use a condom) and for how long, or if you need to modify the use of the other medication.

Some medications:

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

These include medications used to treat:

• epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C infection (e.g., boceprevir, telaprevir);
• other infectious diseases (e.g., griseofulvin);
• high blood pressure in the blood vessels leading to the lungs (bosentan);
• mood disorders (St. John's Wort herbal supplement).

If you are taking medications or herbal supplements that may make aidessia less effective, you should also use a barrier contraceptive method. Since the effect of the other medication on aidessia may last for up to 28 days after stopping the medication, you will need to use a barrier contraceptive method during that time.

Aidessiamay affect the effectof other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (this could lead to an increase in seizure frequency).

You should not take aidessia if you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver test results (elevated ALT levels).

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

Aidessia can be used again about 2 weeks after completing this treatment. See the section "Do not take aidessia."

Laboratory Tests

The use of hormonal contraceptives may affect the results of certain laboratory tests. If you are told to undergo any laboratory test, inform your doctor that you are taking aidessia.

Pregnancy and Breastfeeding

If you are pregnant or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Aidessia should never be used by pregnant women or women who suspect they may be pregnant.

In general, aidessia is not recommended during breastfeeding. If you want to take the pill while breastfeeding, consult your doctor.

Driving and Operating Machinery

No effects have been observed.

Aidessia contains lactose

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take one tablet of this medication every day, if necessary with a small amount of water. You can take the tablets with or without food, but you must take them every day at approximately the same time.

The blister contains 21 tablets. Next to each tablet is printed the day of the week on which it should be taken. If, for example, you start on a Wednesday, take a tablet where it says "WED". Follow the direction of the arrow on the blister until you have taken the 21 tablets.

Do not take tablets for 7 days after that. During these 7 days without tablets (also called "week of interruption" or "week of rest") you must start bleeding, which is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the week of rest.

On the 8th day after the last tablet of aidessia (i.e., after the 7-day week of rest), you must start the next blister, whether you have stopped or continued bleeding. This means that you must start each blister on the same day of the week and that withdrawal bleeding must occur on the same days of each month.

Use in children and adolescents

No clinical data are available on safety and efficacy in adolescents under 18 years.

First blister

If you have not used hormonal contraception in the previous month.

Start taking this medication on the first day of the cycle, i.e., the first day of menstruation. Aidessia will start acting immediately. You do not need to take additional contraceptive measures. You can also start on days 2 to 5 of your cycle, but in this case, make sure to use an additional contraceptive method (e.g., a barrier method) while taking the first 7 tablets of the first cycle. Do not use methods based on menstrual cycle or temperature, as these methods are not reliable while taking the pill.

Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch)

You can start taking aidessia the day after taking the last tablet of the current blister. This means that you do not need to leave a break. If your current preparation has inactive tablets, you can start aidessia the day after the last active tablet (if unsure, consult your doctor or pharmacist). You can also start later, but never after the break of your current preparation (or after the last inactive tablet of your current preparation). If you are using a vaginal ring or a transdermal patch, start taking aidessia preferably on the day of removal of the vaginal ring, or on the day when the patch should be removed. You can also start, but no later than the day when the next application of the patch or the vaginal ring would be due.

If you have taken the pill, or used the vaginal ring or the patch continuously and correctly and are sure you are not pregnant, you can also stop taking the pill, or remove the vaginal ring or the patch on any day of your cycle and start with aidessia immediately.

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

Switching from a progestin-only pill

You can stop taking your current pill on any day and start taking aidessia the next day at the same time, but make sure to use an additional contraceptive method (e.g., a barrier method) while taking the first 7 tablets in case of sexual intercourse.

Switching from an injectable, an implant, or an Intrauterine System (IUS) with progestin only

Start using aidessia at the time when you should receive the next injection or the day when the implant or IUS is removed, but make sure to use an additional contraceptive method (barrier method) while taking the first 7 tablets in case of sexual intercourse.

After childbirth

If you have just given birth, your doctor may advise you to wait for your first normal period before starting aidessia. Sometimes it is possible to start earlier, but your doctor will advise you how. If you are breastfeeding and want to use aidessia, discuss it first with your doctor.

After an abortion

Consult your doctor.

You can stop aidessia at any time. If you stop aidessia because you want to become pregnant, it is generally recommended to wait until you have had your first natural period before trying to conceive, which will help you calculate the due date.

If you take more aidessia than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

No serious effects have been reported for taking an excess of aidessia tablets at one time. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.

If you forget to take aidessia

If more than 12 hours have passed since the usual time, the reliability of the pill may be reduced. The more consecutive tablets you have forgotten, the higher the risk of reduced efficacy. The risk of becoming pregnant is particularly high if you forget tablets at the beginning or end of the blister. Therefore, follow the recommendations below (see also the diagram).

If you forget more than one tablet in a blister

Consult your doctor.

If you forget 1 tablet in the first week

Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual time. Take additional contraceptive precautions (barrier method) for the next 7 days.

If you have had sexual intercourse in the previous week, there is a possibility that you may be pregnant. Inform your doctor immediately.

If you forget 1 tablet in the second week

Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual time. The reliability of the pill is maintained and you do not need to take additional contraceptive precautions.

If you forget 1 tablet in the third week

You can choose one of the following options, without needing to take additional contraceptive precautions.

1-Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual time. Start the next blister the next day after finishing the current blisterwithout leaving a break between blisters. You may not have your period until the end of the second blister, although you may have spotting or a small period while taking the tablets of the second blister.

Or,

2-Stop taking the tablets of the current blister, leave a maximum break of 7 days (also count the day you forgot the tablet) and continue with the next blister. Following this method, you can always start your next blister on the same day of the week as you normally do.

If you have forgotten tablets in a blister and do not have your expected period in the first normal break, you may be pregnant.

Consult your doctor before starting the next blister.

If you vomit or have intense diarrhea

If you vomit or have intense diarrhea in the 3 or 4 hours after taking your aidessia tablet, the active ingredients may not be fully absorbed, which is equivalent to forgetting a tablet. Therefore, follow the recommendations for a forgotten tablet.

In the case of intense diarrhea, consult your doctor.

If you want to change the day when your period starts

If you take the tablets as instructed, you will have your period approximately on the same day every 4 weeks. If you want to change it, you must shorten (never lengthen) the next break. For example, if your period usually starts on Friday and you want it to start on Tuesday in the future, i.e., three days earlier, you must start the next blister three days earlier than usual. If the break is too short, from 1 to 3 days, you may not have your period during the break and may have spotting during the next blister.

If you have unexpected bleeding

As with all pills, you may experience irregular vaginal bleeding between periods during the first months (called spotting or intermenstrual bleeding). In this case, continue taking the tablets normally. This irregular vaginal bleeding usually disappears once your body has adapted to the pill, usually after three cycles.

If it continues, becomes more intense, or appears again, consult your doctor.

If you do not have your period

If you have taken all tablets at the same time and have not vomited, had intense diarrhea, or taken other medications, it is very unlikely that you are pregnant. Continue taking aidessia as usual.

If you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not start the next blister of aidessia until your doctor has confirmed that you are not pregnant.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be related to aidessia, consult your doctor.

All women taking combined hormonal contraceptives are at a higher 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 of 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 angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

The side effects are listed below, classified by frequency according to the following criterion:

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

Infrequent: (may affect up to 1 in 100 people).

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

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

-depressed mood, mood changes

-headache

-nausea, abdominal pain

-breast pain, breast tenderness

-weight gain

Infrequent (may affect up to 1 in 100 people):

• fluid retention
• decreased libido
• migraines
• vomiting, diarrhea
• skin eruptions, urticaria
• breast enlargement

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

-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,
• mild stroke or temporary symptoms similar to a stroke, known as a transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having 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 the symptoms of a blood clot).

-allergic reactions

-increased libido

-contact lens intolerance

-erythema nodosum, erythema multiforme (which are skin diseases)

-altered menstrual flow, breast secretion

-weight loss

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C).

Storeintheoriginal packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of aidessia

The active principles are desogestrel and etinilestradiol. Each tablet contains 0.15 mg of desogestrel and 0.02 mg of etinilestradiol.

The other components are: cornstarch, lactose monohydrate, stearic acid (E-570), anhydrous colloidal silica (E-551), povidone K30 (E-1201), magnesium stearate (E-470b) and all-rac-alpha-tocopherol.

Appearance of the product and contents of the packaging

Aidessia 0.15 mg/0.02 mg tablets are cylindrical, biconvex, white tablets with a diameter of approximately 6 mm.

This medication is packaged in PVC/Aluminum blisters. Each blister contains 21 tablets.
Each blister is packaged in a PE/Aluminum/PETR overwrap.

The packaging is available in 21 (1x21), 42 (2x21), 63 (3x21), 126 (6x21) and 273 (13x21) tablets.

A cardboard insert is included in each package to store the blister.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

CYNDEA PHARMA S.L.

Emiliano Revilla Sanz Industrial Estate, Av. de Agreda 31

42110 Ólvega, Soria (Soria), Spain

Date of the last review of this leaflet:July 2024

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/79192/P_79192.html

QR code to:https://cima.aemps.es/cima/dochtml/p/79192/P_79192.html