AIDESSIA 0.15 mg / 0.02 mg TABLETS

Introduction

Package Leaflet: Information for the User

aidessia 0.15 mg/0.02 mg EFG tablets

desogestrel/ethinylestradiol

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 having a blood clot in the veins and arteries, especially in 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 package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is aidessia 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. Storage of aidessia
6. Package contents and additional information

1. What is aidessia and what it is used for

This medication is a combined oral contraceptive.

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

These help prevent you from becoming 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 more difficult for sperm to reach the egg,

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

2. What you need to know before taking aidessia

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 also 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 must either not have sexual intercourse or 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 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 other 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 careful with aidessia".

• 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 that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation 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 stroke 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 had pancreatitis (inflammation of the pancreas), along with high levels of fat in your blood.
• If you have jaundice (yellowish color of the skin) or severe liver disease.
• If you have or have had a cancer that grows under the influence of sex hormones (e.g., breast or genital 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 tissue inside the uterus.
• 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 medicine (listed 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 medicines").

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

Warnings and Precautions

When to be careful with aidessia

Before starting treatment with aidessia

Tell 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 conditions.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If a close relative has had a thrombosis, heart attack, or cerebral embolism.
• If you have migraines.
• If you suffer from epilepsy.
• 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 need an operation or spend a lot of time without getting up (see section 2 "Blood Clots").
• If you have just given birth, you are at a higher risk of suffering from blood clots. 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 failure).
• If you have sickle cell anemia (a hereditary disease 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 disease called porphyria, a skin disease called gestational herpes, a disease called Sydenham's chorea).
• If you have or have had chloasma (yellowish-brown spots on the skin, particularly on the face); in this case, you should avoid intense sun exposure or ultraviolet radiation.
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

In the event that any of the above situations appear for the first time, recur, or worsen with treatment with the pill, you should consult your doctor, who may recommend that you stop taking the pill.

aidessia, like all contraceptive pills, does not protect against AIDS or any other sexually transmitted disease.

Once you have started treatment with aidessia

While you are taking the pill, your doctor will require you to undergo periodic 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 your leg (i.e., deep vein thrombosis), a blood clot in your lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood Clots" below).

To obtain 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 the points related to your close relatives;
• If you find a lump in your breasts;
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or urticaria with difficulty breathing;
• If you are going to take other medications (see also "Taking aidessia with other medicines");
• If you need to remain immobile or are going to have surgery, as in these cases, the risk of thrombosis temporarily increases; consult your doctor at least four weeks in advance;
• If you have unusual and heavy vaginal bleeding;
• If you forget to take pills in the first week of the blister pack and have had sexual intercourse in the previous seven days;
• If you have severe diarrhea;
• If you have two consecutive missed periods or suspect you are 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 from 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 the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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 urgent medical attention if 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 the veins (venous thrombosis). However, these side 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 your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.
• In very rare cases, a 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 you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after an interruption 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 within 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.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains desogestrel, like aidessia, between 9 and 12 women will have a blood clot in a year.
• The risk of a blood clot will depend on your personal history (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 with aidessia is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50).
• If you need to have surgery or spend a lot of time without getting up due to an injury or illness or if you have your leg in a cast. You may need to stop using aidessia 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.
• As you get older (especially over 35 years).
• If you have recently given birth.

The risk of a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) can temporarily increase the 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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide to stop you from 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 a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

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

• With age (over 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 advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have a condition that increases the risk of a heart attack or stroke.

3 se traduce como:

3

Cómo tomar aidessia se traduce como:

How to take aidessia:

Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico o farmacéutico se traduce como:

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist.

En caso de duda, consulte de nuevo a su médico o farmacéutico se traduce como:

In case of doubt, consult your doctor or pharmacist again.

Tome un comprimido de este medicamento cada día, si es necesario con una pequeña cantidad de agua se traduce como:

Take one tablet of this medication every day, if necessary with a small amount of water.

Puede tomar los comprimidos con o sin alimentos, pero debe tomarlos cada día a la misma hora aproximadamente se traduce como:

You can take the tablets with or without food, but you should take them at the same time every day.

El blíster contiene 21 comprimidos se traduce como:

The blister pack contains 21 tablets.

Al lado de cada comprimido figura impreso el día de la semana en que debe tomarse se traduce como:

Next to each tablet, the day of the week on which it should be taken is printed.

Si, por ejemplo, comienza un miércoles, tome un comprimido donde figure "MIE" se traduce como:

If, for example, you start on a Wednesday, take a tablet where "WED" is indicated.

Siga la dirección de la flecha del blíster hasta que haya tomado los 21 comprimidos se traduce como:

Follow the direction of the arrow on the blister pack until you have taken all 21 tablets.

A continuación no tome comprimidos durante 7 días se traduce como:

Then, do not take any tablets for 7 days.

Durante estos 7 días sin comprimidos (que también se denominan "semana de interrupción" o "semana de descanso") debe empezar el sangrado, que se denomina "hemorragia por privación" y suele comenzar el 2º o 3er día de la semana de descanso se traduce como:

During these 7 days without tablets (also known as the "interruption week" or "rest week"), you should start bleeding, which is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the rest week.

El 8º día después del último comprimido de aidessia (es decir, después de la semana de descanso de 7 días), debe comenzar el siguiente blíster, tanto si ha cesado como si continúa el sangrado se traduce como:

On the 8th day after the last tablet of aidessia (i.e., after the 7-day rest week), you should start the next blister pack, whether or not you have stopped bleeding.

Esto significa que debe empezar cada blíster el mismo día de la semana y que la hemorragia por privación debe producirse en los mismos días de cada mes se traduce como:

This means that you should start each blister pack on the same day of the week and that withdrawal bleeding should occur on the same days every month.

Uso en niños y adolescentesse traduce como:

Use in Children and Adolescents

No hay datos clínicos disponibles sobre seguridad y eficacia en adolescentes menores de 18 años se traduce como:

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

El primer blísterse traduce como:

The First Blister Pack

Si no ha usado anticoncepción hormonal en el mes anteriorse traduce como:

If you have not used hormonal contraception in the previous month

Empiece a tomar este medicamento el primer día del ciclo, es decir, el primer día de la menstruación se traduce como:

Start taking this medication on the first day of your cycle, i.e., the first day of your period.

aidessia empezará a actuar inmediatamente se traduce como:

aidessia will start working immediately.

No necesita tomar medidas anticonceptivas adicionales se traduce como:

You do not need to take any additional contraceptive measures.

También puede empezar en los días 2 a 5 de su ciclo, pero en este caso asegúrese de utilizar también un método anticonceptivo complementario (por ejemplo un método de barrera) mientras tome los primeros 7 comprimidos del primer ciclo se traduce como:

You can also start on days 2 to 5 of your cycle, but in this case, make sure to use an additional contraceptive method (for example, a barrier method) while taking the first 7 tablets of the first cycle.

No use métodos basados en el ciclo menstrual ni la temperatura ya que estos métodos no son fiables mientras toma la píldora se traduce como:

Do not use methods based on the menstrual cycle or temperature, as these methods are not reliable while taking the pill.

Cambio a partir de otro anticonceptivo hormonal combinado (píldora anticonceptiva combinada, anillo vaginal o parche transdérmico)se traduce como:

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

Puede empezar a tomar aidessia al día siguiente después de tomar el último comprimido del blíster actual se traduce como:

You can start taking aidessia the day after taking the last tablet of your current blister pack.

Esto significa que no tiene que dejar un período de descanso se traduce como:

This means that you do not need to take a break.

En caso de que su preparado actual tenga comprimidos inactivos puede empezar aidessia al día siguiente del último comprimido activo(si no está segura consúltelo a su médico o farmacéutico) se traduce como:

If your current preparation has inactive tablets, you can start aidessia the day after the last activetablet (if you are unsure, consult your doctor or pharmacist).

También puede empezar más tarde, pero nunca después del período de descanso de su preparado actual, (o bien después del último comprimido inactivo de su preparado actual) se traduce como:

You can also start later, but never after the rest period of your current preparation, (or after the last inactive tablet of your current preparation).

En el caso de que esté utilizando un anillo vaginal o un parche transdérmico, debe empezar a tomar aidessia preferiblemente el mismo día de la extracción del anillo vaginal, o en el día que debe quitarse el parche se traduce como:

In the case of using a vaginal ring or transdermal patch, you should start taking aidessia preferably on the same day as the removal of the vaginal ring or on the day the patch is to be removed.

También puede empezar, pero como muy tarde el día en que correspondería la siguiente aplicación del parche o el anillo vaginal se traduce como:

You can also start, but no later than the day when the next application of the patch or vaginal ring would be due.

Si ha tomado la píldora, o usado el anillo vaginal o el parche de forma continuada y correcta y está segura de que no está embarazada, también puede dejar de tomar la píldora, o quitarse el anillo vaginal o el parche cualquier día de su ciclo actual y empezar con aidessia inmediatamente se traduce como:

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

Si sigue estas instrucciones, no es necesario el uso de un método anticonceptivo adicional se traduce como:

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

Cambio desde una píldora con progestágeno solose traduce como:

Switching from a progestin-only pill

Puede dejar de tomar su píldora actual cualquier día y empezar a tomar aidessia al día siguiente a la misma hora, pero asegúrese de utilizar un método anticonceptivo complementario (por ejemplo un método de barrera) mientras tome los primeros 7 comprimidos en caso de que tenga relaciones sexuales se traduce como:

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 (for example, a barrier method) while taking the first 7 tablets if you have sexual intercourse.

Cambio desde un inyectable, un implante o un Sistema de Liberación Intrauterino (SLI) con progestágeno solose traduce como:

Switching from a progestin-only injectable, implant, or Intrauterine Release System (IUS)

Empiece a usar aidessia en el momento en que debería recibir la siguiente inyección o el día en que le extraigan el implante o el SLI, pero asegúrese de utilizar un método anticonceptivo complementario (método de barrera) mientras tome los primeros 7 comprimidos, en caso de que tenga relaciones sexuales se traduce como:

Start using aidessia when you would normally receive your next injection or on the day your implant or IUS is removed, but make sure to use an additional contraceptive method (barrier method) while taking the first 7 tablets if you have sexual intercourse.

Después del partose traduce como:

After childbirth

Si acaba de tener un niño, su médico le puede aconsejar que espere a que aparezca su primera regla normal antes de empezar con aidessia se traduce como:

If you have just given birth, your doctor may advise you to wait until your first normal period appears before starting aidessia.

A veces es posible empezar antes, pero su médico le aconsejará cómo se traduce como:

Sometimes it is possible to start earlier, but your doctor will advise you how.

Si está dando el pecho y desea utilizar aidessia debe discutirlo primero con su médico se traduce como:

If you are breastfeeding and want to use aidessia, you should discuss it with your doctor first.

Después de un abortose traduce como:

After an abortion

Consulte a su médico se traduce como:

Consult your doctor.

Puede dejar aidessia en cualquier momento se traduce como:

You can stop taking aidessia at any time.

Si deja aidessia porque desea quedarse embarazada, se recomienda en general esperar hasta que haya tenido su primera regla natural antes de intentar concebir, lo que le ayudará a calcular la fecha del parto se traduce como:

If you stop taking 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.

Si toma más aidessia del que debese traduce como:

If you take more aidessia than you should

En caso de sobredosis o ingestión accidental consulte inmediatamente a su médico o farmacéutico o llame al Servicio de Información Toxicológica, teléfono 91 562 04 20, indicando el medicamento y la cantidad ingerida se traduce como:

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 se han citado efectos graves por tomar un exceso de comprimidos de aidessia de una sola vez se traduce como:

No serious effects have been reported for taking an excess of aidessia tablets at one time.

Si ha tomado varios comprimidos a la vez puede tener náuseas, vómitos o sangrado vaginal se traduce como:

If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.

Si olvidó tomar aidessiase traduce como:

If you forgot to take aidessia

Si han pasado menos de 12 horasdesde la hora habitual, se mantiene la fiabilidad de la píldora se traduce como:

If it has been less than 12 hourssince the usual time, the reliability of the pill is maintained.

Tome el comprimido tan pronto como lo recuerde y continúe tomando los siguientes comprimidos a la hora habitual se traduce como:

Take the tablet as soon as you remember and continue taking the following tablets at the usual time.

Si han pasado más de 12 horasdesde la hora habitual, la fiabilidad de la píldora puede reducirse se traduce como:

If it has been more than 12 hourssince the usual time, the reliability of the pill may be reduced.

Cuantos más comprimidos seguidos se haya olvidado, es más alto el riesgo de que baje la eficacia anticonceptiva se traduce como:

The more tablets you have forgotten in a row, the higher the risk that the contraceptive efficacy will decrease.

El riesgo de quedarse embarazada es particularmente más alto si se olvida los comprimidos al principio o al final del blíster se traduce como:

The risk of becoming pregnant is particularly higher if you forget tablets at the beginning or end of the blister pack.

Por tanto, debe seguir las recomendaciones que se exponen seguidamente (ver también el diagrama) se traduce como:

Therefore, you should follow the recommendations outlined below (see also the diagram).

Si olvida más de un comprimido en un envase se traduce como:

If you forget more than one tablet in a pack:

Consulte a su médico se traduce como:

Consult your doctor.

Si olvida 1 comprimido en la primera semanase traduce como:

If you forget 1 tablet in the first week

Tome el comprimido olvidado tan pronto como lo recuerde (incluso si ello significa tomar dos comprimidos a la vez) y tómese los siguientes comprimidos a la hora habitual se traduce como:

Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the following tablets at the usual time.

Tome precauciones anticonceptivas complementarias (método de barrera) durante los 7 días siguientes se traduce como:

Take additional contraceptive precautions (barrier method) for the next 7 days.

Si ha tenido relaciones sexuales en la semana anterior existe la posibilidad de que haya quedado embarazada se traduce como:

If you have had sexual intercourse in the previous week, there is a possibility that you may have become pregnant.

Por tanto, comuníqueselo a su médico inmediatamente se traduce como:

Therefore, inform your doctor immediately.

Si olvida 1 comprimido en la segunda semanase traduce como:

If you forget 1 tablet in the second week

Tome el comprimido olvidado tan pronto como lo recuerde (incluso si ello significa tomar dos comprimidos a la vez) y tómese los siguientes comprimidos a la hora habitual se traduce como:

Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the following tablets at the usual time.

La fiabilidad de la píldora se mantiene y no necesita tomar precauciones anticonceptivas complementarias se traduce como:

The reliability of the pill is maintained and you do not need to take additional contraceptive precautions.

Si olvida 1 comprimido en la tercera semanase traduce como:

If you forget 1 tablet in the third week

Puede escoger cualquiera de las siguientes opciones, sin que haga falta tomar precauciones anticonceptivas complementarias se traduce como:

You can choose either of the following options, without needing to take additional contraceptive precautions:

1- Tome el comprimido olvidado tan pronto como lo recuerde (incluso si ello significa tomar dos comprimidos a la vez) y tome los siguientes comprimidos a la hora habitual se traduce como:

1. Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the following tablets at the usual time.

Empiece el siguiente blíster al día siguiente de acabar el envase actual sin dejar un período de descanso entre blísteresse traduce como:

Start the next blister pack the day after finishing the current pack without taking a break between packs.

Puede ser que no tenga la regla hasta el final del segundo blíster, aunque puede tener manchado o un pequeño período mientras toma los comprimidos del segundo blíster se traduce como:

You may not have your period until the end of the second blister pack, although you may experience spotting or a light period while taking the tablets from the second blister pack.

O bien, se traduce como:

Or:

2- Deje de tomar los comprimidos del blíster actual, deje un período de descanso máximo de 7 días (cuente también el día que ha olvidado el comprimido) y continúe con el siguiente blíster se traduce como:

2. Stop taking the tablets from the current blister pack, take a maximum break of 7 days (including the day you forgot the tablet), and continue with the next blister pack.

Siguiendo este método siempre puede empezar su siguiente blíster el mismo día de la semana que lo hace habitualmente se traduce como:

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

Si ha olvidado comprimidos en un blíster y no tiene la regla esperada en el primer período de descanso normal puede estar embarazada se traduce como:

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

Consulte a su médico antes de empezar el siguiente blíster se traduce como:

Consult your doctor before starting the next blister pack.

Si vomita o tiene diarrea intensase traduce como:

If you vomit or have severe diarrhea

Si vomita o tiene una diarrea intensa en las 3 o 4 horas siguientes después de tomar su comprimido de aidessia puede ser que los principios activos no se absorban completamente, lo que equivale a olvidar un comprimido se traduce como:

If you vomit or have severe diarrhea within 3-4 hours after taking your aidessia tablet, the active ingredients may not be fully absorbed, which is equivalent to forgetting a tablet.

Por tanto, siga las recomendaciones para un comprimido olvidado se traduce como:

Therefore, follow the recommendations for a forgotten tablet.

En el caso de diarrea intensa, consulte a su médico se traduce como:

In the case of severe diarrhea, consult your doctor.

Si desea cambiar el día en que empieza su períodose traduce como:

If you want to change the day your period starts

Si toma los comprimidos como se le ha indicado, tendrá su período aproximadamente el mismo día cada 4 semanas se traduce como:

If you take the tablets as directed, you will have your period approximately on the same day every 4 weeks.

En caso de que desee cambiarlo, tiene que acortar (nunca alargar) el siguiente período de descanso se traduce como:

If you want to change it, you need to shorten (never lengthen) the next rest period.

Por ejemplo, si su período suele empezar en Viernes y desea que empiece en Martes en el futuro, es decir tres días antes, deberá empezar el siguiente blíster tres días antes del día que empezaba se traduce como:

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 should start the next blister pack three days before the day you usually start.

Si el período de descanso se queda muy corto, de 1 a 3 días, puede ser que no tenga el sangrado durante el descanso y que tenga algo de manchado durante el siguiente blíster se traduce como:

If the rest period is very short, 1-3 days, you may not have bleeding during the rest period and may experience some spotting during the next blister pack.

Si tiene un sangrado inesperadose traduce como:

If you have unexpected bleeding

Como con todas las píldoras, puede aparecer sangrado vaginal irregular entre las reglas durante los primeros meses (se llama manchado o sangrado intermenstrual) se traduce como:

As with all pills, irregular vaginal bleeding may occur between periods during the first few months (this is called spotting or intermenstrual bleeding).

En este caso, continúe tomando los comprimidos normalmente se traduce como:

In this case, continue taking the tablets as usual.

Este sangrado vaginal irregular normalmente desaparece una vez que su cuerpo se ha adaptado a la píldora, normalmente después de tres ciclos se traduce como:

This irregular vaginal bleeding usually disappears once your body has adapted to the pill, usually after three cycles.

Si continúa, se hace más intenso o aparece de nuevo, consulte a su médico se traduce como:

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

Si no aparece la reglase traduce como:

If your period does not appear

Si ha tomado todos los comprimidos a la misma hora y no ha vomitado, tenido diarrea intensa, ni tomado otros medicamentos, es muy poco probable que esté embarazada se traduce como:

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

Continúe tomando aidessia de la forma habitual se traduce como:

Continue taking aidessia as usual.

Si tiene 2 faltas seguidas puede estar embarazada, por lo que debe comunicárselo a su médico inmediatamente se traduce como:

If you have two missed periods in a row, you may be pregnant, so you should inform your doctor immediately.

No empiece el siguiente blíster de aidessia hasta que su médico haya confirmado que no está embarazada se traduce como:

Do not start the next aidessia blister pack until your doctor has confirmed that you are not pregnant.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to aidessia, consult your doctor.

All women who take 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 taking 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 urticaria with possible difficulty breathing (see also the section "Warnings and Precautions").

Adverse effects are listed below, classified according to their frequency, based on the following criteria:

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

Uncommon: (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):

• depressive mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• weight gain

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

• fluid retention
• decreased sexual desire
• migraines
• vomiting, diarrhea
• skin rash, 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 those of a stroke, known as a transient ischemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood 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 symptoms of a blood clot).

• allergic reactions
• increased sexual desire
• intolerance to contact lenses
• erythema nodosum, erythema multiforme (which are skin diseases)
• altered menstrual flow, breast secretion
• 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 use this medicine 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 30°C.

Store in the original packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information.

Composition of aidessia

The active ingredients are desogestrel and ethinylestradiol. Each tablet contains 0.15 mg of desogestrel and 0.02 mg of ethinylestradiol.

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

Appearance of the Product and Package Contents

The aidessia 0.15 mg/0.02 mg tablets are cylindrical, biconvex, white, and approximately 6 mm in diameter.

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

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

Each package includes a cardboard sleeve to store the blister.

Only some package 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.

Polígono Industrial Emiliano Revilla Sanz, Av. de Agreda 31

42110 Ólvega, Soria (Soria), Spain

Date of the Last Revision of this Prospectus:July 2024

Detailed and updated information on this medicine 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 updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (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