Aidessia 0.15 mg/0.02 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

aidessia 0.15 mg/0.02 mg tablets EFG

desogestrel/ethinylestradiol

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

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

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

This medicine is a combined oral contraceptive.

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

These hormones help prevent you from becoming pregnant, in the same way that your natural hormones prevent conception once 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 inner lining of the uterus to make it less likely to accept a fertilised egg.

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

General information

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

This leaflet describes several situations in which you must stop using aidessia or in which the reliability of the pill may be reduced. In these situations, you should either avoid sexual intercourse or use 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 all other hormonal contraceptives, does not protect against HIV (AIDS) infection 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 about the symptoms of a blood clot (see section 2 “Blood clots”).

Do not take aidessia

You must 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 most suitable. See also the section “When you must be especially 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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

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

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

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

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

• Severe diabetes with blood vessel damage.

• Very high blood pressure.

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

• A condition called hyperhomocysteinemia.

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

• If you have or have ever had inflammation of the pancreas (pancreatitis), together with high levels of fats in your blood.

• If you have jaundice (yellowing of the skin) or severe liver disease.

• If you have or have ever had cancer influenced by sex hormones (e.g., of the breast or genital organs).

• If you have or have ever had a liver tumour.

• If you have unexplained vaginal bleeding.

• If you have abnormal growth of the internal tissue of the uterus.

• If you are pregnant or think you might be pregnant.

• If you are allergic to desogestrel, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6).

• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking aidessia with other medicines”).

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

Warnings and precautions

When you must 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 you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Before starting treatment with aidessia

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

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

• If you are a smoker.
• If you have diabetes.
• If you are overweight.
• If you have high blood pressure.
• If you have heart rhythm disorders or certain cardiac conditions.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If any of your close relatives have had thrombosis, heart attack, or stroke.
• If you have migraine.
• If you have 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 require surgery or will be immobile for long periods (see section 2, “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking aidessia after childbirth.
• If any of your close relatives have 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 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 (an inherited red blood cell disorder).
• If you have a condition that developed or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disorder called porphyria, a skin condition called herpes gestationis, or a condition called Sydenham’s chorea).
• If you have or have had chloasma (yellowish-brown skin patches, particularly on the face); in this case, avoid intense exposure to sunlight or ultraviolet radiation.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

If any of the above conditions occur for the first time, recur, or worsen during treatment with the pill, consult your doctor, who may advise you to stop taking the pill.

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

Once treatment with aidessia has started

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

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

• If you notice possible signs of a blood clot, which may indicate a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below).

For a description of the symptoms of these serious adverse 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 leaflet (see also “When not to use aidessia” and “What you need to know before starting aidessia”); do not forget to mention conditions affecting your close relatives;
• If you detect 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 hives accompanied by difficulty breathing;
• If you are going to take other medications (see also “Taking aidessia with other medicines”);
• If you are to be immobilized or are undergoing surgery, as your risk of thrombosis temporarily increases in these cases; consult your doctor at least four weeks in advance;
• If you have unusual and heavy vaginal bleeding;
• If you miss tablets during the first week of the blister pack and have had sexual intercourse in the previous seven days;
• If you have severe diarrhea;
• If you miss two periods in a row or suspect you are pregnant, do not start the next blister pack until your doctor advises you to do so.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In the arteries (known as “arterial thrombosis”, “arterial thromboembolism” or TEA).

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., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. 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 like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or beneath the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe 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 more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

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

After the first year, the risk decreases, but it is always 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 small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing 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 10,000 women
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out of 10,000 women
Women using aidessia	About 9-12 out of 10,000 women

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

The risk of having a blood clot with aidessia is small, but some 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 of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are 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 within the last few weeks.

The risk of developing a blood clot increases the more 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.

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 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 stroke.

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

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

• With age (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 advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or 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 disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions, or if any of them are particularly severe, your risk of developing a blood clot may be further increased.

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

Blood pressure

If you have hypertension (high blood pressure) or any condition related to hypertension (including certain kidney diseases), it is preferable to use other contraceptive methods. If you decide to use hormonal contraceptives, your blood pressure should be monitored, but if it increases and cannot be controlled with medication, treatment must be discontinued.

Tumors

Cases of breast tumors have been observed slightly more frequently in women using contraceptive pills compared to women of the same age who do not use them. This slight increase in diagnosed breast tumors gradually decreases over the ten years following discontinuation of treatment. It is not known whether this difference is due to the pill treatment. It could be that women who use contraceptive pills visit their doctor more frequently.

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

The factor most affecting the risk of cervical (cervix) tumors is persistent infection with human papillomavirus (HPV). In women who use contraceptive pills for many years, the likelihood of cervical cancer is slightly higher. However, it is unclear whether the contraceptive pill plays a direct role in this risk, or whether sexual habits and other factors (such as more frequent medical check-ups) are responsible.

Vaginal bleeding

You may not have your "period" during the rest week. If the contraceptive pill has been taken correctly, it is very unlikely that you are pregnant. However, if you miss two periods, you should consult your doctor, as pregnancy must be ruled out. If you have not taken the contraceptive pill according to the instructions in section "3. How to take aidessia" and you miss a period, 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 treatment with aidessia, and if the bleeding continues after the first three cycles, consult your doctor immediately. Mistakes in taking the pill can also cause spotting and light vaginal bleeding.

When you stop using aidessia, you may experience irregular, scanty bleeding or no bleeding at all, especially during the first 3 months and particularly if your periods were already irregular before starting hormonal treatment.

Psychiatric disorders:

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

Children and adolescents

No clinical data on safety and efficacy are available for adolescents under 18 years of age.

Taking aidessia with other medicines

Always inform your doctor about any medicines or herbal remedies you are taking. Also inform any doctor, dentist, or pharmacist who prescribes another medicine that you are using aidessia. They will advise you whether you need to take additional contraceptive measures (for example, use of condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

Some medicines:

• may affect the levels of aidessiain 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 virus infection (e.g.: boceprevir, telaprevir);
• other infectious diseases (e.g.: griseofulvin);
• high blood pressure in the blood vessels leading to the lungs (bosentan);
• depressive mood states (the herbal remedy St. John's wort).

If you are taking medicines or herbal remedies that could reduce the effectiveness of aidessia, you should also use a barrier contraceptive method. Since the effect of the other medicine on aidessia may last up to 28 days after stopping the medicine, a barrier contraceptive method must be used during that time.

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

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this could lead to an increase in the frequency of seizures).

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

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

aidessia can be used again approximately 2 weeks after completion of 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 scheduled for any laboratory test, inform your doctor that you are taking aidessia.

Pregnancy and breastfeeding

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

aidessia must never be used by pregnant women or women who suspect they may be pregnant.

aidessia is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.

Driving and use of machines

No effects have been observed.

aidessia contains lactose

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

3. How to take aidessia

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

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

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

After this, do not take any tablets for 7 days. During these 7 days without tablets (also known as the "tablet-free week" or "rest week"), you should experience bleeding, known as "withdrawal bleeding", which usually begins on the 2nd or 3rd day of the rest week.

On the 8th day after the last aidessia tablet (i.e., after the 7-day rest period), start the next blister pack, regardless of whether bleeding has stopped or is still ongoing. This means you should start each new blister pack on the same day of the week, and withdrawal bleeding should occur during the same days each month.

Use in children and adolescents

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

Starting the first pack

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

Begin taking this medicine on the first day of your cycle, i.e., the first day of your menstrual period. aidessia will start working immediately. You do not need to use additional contraceptive measures. You may 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) during the first 7 days of taking the first pack. Do not use methods based on the menstrual cycle or body 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 may start taking aidessia the day after taking the last active tablet of your current pack. This means you do not need to have a rest period. If your current preparation includes inactive tablets, start aidessia the day after the last active tablet (if you are unsure, consult your doctor or pharmacist). You may also start later, but never after the rest period of your current preparation (or after the last inactive tablet of your current preparation). If you are using a vaginal ring or transdermal patch, you should preferably start taking aidessia on the same day the ring is removed or the patch is taken off. You may also start, but no later than the day the next patch or ring application would have been due.

If you have been taking the pill, or using the vaginal ring or patch continuously and correctly, and are sure you are not pregnant, you may stop taking your current method or remove the ring or patch on any day of your cycle and start aidessia immediately.

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

Switching from a progestogen-only pill.

You may stop taking your current pill on any day and start aidessia the next day at the same time, but make sure to use an additional contraceptive method (e.g., a barrier method) during the first 7 days of taking aidessia if you have sexual intercourse.

Switching from a progestogen-only injectable, implant, or intrauterine system (IUS).

Start using aidessia on the day you are due for your next injection, or on the day your implant or IUS is removed, but make sure to use an additional contraceptive method (barrier method) during the first 7 days of taking aidessia if you have sexual intercourse.

After childbirth.

If you have recently given birth, your doctor may advise you to wait until your first normal menstrual period before starting aidessia. Sometimes it may be possible to start earlier, but your doctor will advise you accordingly. If you are breastfeeding and wish to use aidessia, discuss this with your doctor first.

After a miscarriage.

Consult your doctor.

You may stop taking aidessia at any time. If you stop aidessia because you wish to become pregnant, it is generally recommended to wait until you have had your first natural menstrual period before trying to conceive, as this will help determine the due date.

If you take more aidessia than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

No serious effects have been reported from taking an excessive amount of aidessia tablets at once. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.

If you forget to take aidessia

If less than 12 hours have passed since your usual time, the contraceptive reliability remains intact. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.

If more than 12 hours have passed since your usual time, the contraceptive reliability may be reduced. The more consecutive tablets you miss, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly higher if you miss tablets at the beginning or end of the pack. Therefore, follow the recommendations below (see also the diagram).

If you miss more than one tablet in a pack

Consult your doctor.

If you miss 1 tablet in the first week

Take the missed tablet as soon as you remember (even if this means taking two tablets at once) and continue taking the following tablets at your usual time. Use additional contraceptive precautions (barrier method) for the next 7 days.

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

If you miss 1 tablet in the second week

Take the missed tablet as soon as you remember (even if this means taking two tablets at once) and continue taking the following tablets at your usual time. The contraceptive reliability remains intact, and you do not need to use additional contraceptive precautions.

If you miss 1 tablet in the third week

You may choose either of the following options, without the need for additional contraceptive precautions.

1- Take the missed tablet as soon as you remember (even if this means taking two tablets at once) and continue taking the following tablets at your usual time. Start the next pack the day after finishing the current pack, without a break between packs. You may not have your period until the end of the second pack, although you may experience spotting or light bleeding during the second pack.

Or,

2- Stop taking tablets from the current pack, have a maximum 7-day break (including the day you missed the tablet), and then start the next pack. By following this method, you can always start your next pack on the same day of the week as usual.

If you have missed tablets in a pack and do not have the expected period during the first normal tablet-free week, you may be pregnant.

Consult your doctor before starting the next pack.

If you vomit or have severe diarrhoea

If you vomit or have severe diarrhoea within 3 to 4 hours after taking your aidessia tablet, the active ingredients may not be fully absorbed, which is equivalent to missing a tablet. Therefore, follow the recommendations for a missed tablet.

In case of severe diarrhoea, consult your doctor.

If you wish to change the day your period starts

If you take the tablets as instructed, your period will occur approximately on the same day every 4 weeks. If you wish to change this day, you must shorten (but never extend) the next tablet-free interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday instead (i.e., three days earlier), you should start the next pack three days earlier than usual. If the tablet-free interval becomes very short (1 to 3 days), you may not have bleeding during the break and may experience some spotting during the next pack.

If you have unexpected bleeding

As with all oral contraceptives, irregular vaginal bleeding between periods may occur during the first few months (known as "spotting" or "intermenstrual bleeding"). In this case, continue taking the tablets as usual. This irregular vaginal bleeding usually stops once your body has adjusted to the pill, typically after three cycles.

If the bleeding continues, becomes heavier, or recurs, consult your doctor.

If your period does not occur

If you have taken all tablets at the same time, without vomiting, severe diarrhoea, or taking other medications, it is very unlikely that you are pregnant. Continue taking aidessia as usual.

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

4. Possible side effects

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 change in health that you think could be due to aidessia, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to 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”).

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

Common: (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).

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

• Depressed mood, mood changes
• Headache
• Nausea, abdominal pain
• Breast pain, breast discomfort
• Weight gain

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

• Fluid retention
• Decreased sexual drive
• Migraine
• Vomiting, diarrhoea
• Skin rashes, 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,
  • 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 medical condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

• Allergic reactions
• Increased sexual drive
• Intolerance to contact lenses
• Erythema nodosum, erythema multiforme (which are skin disorders)
• Irregular menstrual bleeding, galactorrhea

Reporting of side effects:

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side 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 side 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 use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This 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 0.15 mg of desogestrel and 0.02 mg of ethinylestradiol.

The other components are: maize starch, 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 contents of the pack

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

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

Pack sizes available are 21 (1x21), 42 (2x21), 63 (3x21), 126 (6x21), and 273 (13x21) tablets.

Each pack includes a cardboard sleeve for storing the blister.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

CYNDEA PHARMA S.L.

Polígono Industrial Emiliano Revilla Sanz, Av. de Agreda 31

42110 Ólvega, Soria (Soria), Spain

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

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

You can access detailed and current 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/79192/P_79192.html

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