AIDESSIA 0.15 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Aidessia0.15mg / 0.03 mg, film-coated tablets EFG

Desogestrel / Ethinylestradiol

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

• These methods 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 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 the entire package leaflet carefully before starting to use 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. It may harm them, even if their signs of illness are the same as yours.
• If you experience side effects mentioned in section 4 or if you suffer any side effect not mentioned in this package leaflet, consult your doctor or pharmacist.

Contents of the package leaflet:

1. What is Aidessia and what is it used for
2. What you need to know before starting to take 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 is it used for

Composition and type of contraceptive medication

This medication is a combined oral contraceptive, also called the pill.

Each of the 21 white tablets contains a small amount of two different female hormones, desogestrel (a hormone that works similarly to a progestogen) and ethinylestradiol (a hormone that works similarly to an estrogen). Due to the small amounts of hormones, Aidessia is considered a low-dose contraceptive. Since the amount of each hormone is the same in all the tablets in the blister pack, it is called a combined pill.

What it is used for

Take Aidessia to prevent pregnancy.

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

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

Do not takeaidessiaif:

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.

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder 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 symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood.
• If you have (or have ever had) jaundice (yellowing of the skin or eyes) or severe liver disease.
• If you have (or have ever had) hormone-sensitive cancer (breast cancer or cancer of the sex organs).
• If you have (or have ever had) a liver tumor.
• If you have unexplained vaginal bleeding.
• If you have abnormal inflammation of the endometrium.
• If you are allergic to ethinylestradiol, desogestrel, or any of the other components of this medication (including those listed in section 6). This may manifest as itching, rash, or inflammation.
• If you are allergic to peanuts or soy.
• If you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section "Taking aidessia with other medications").

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

When you should be particularly careful withaidessia

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

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

• If you smoke;
• If you have diabetes;
• If you are overweight;
• If a close relative has ever had a thrombosis, a heart attack, or a stroke.
• If you have ever had migraines.
• if you suffer from epilepsy
• if you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with a higher risk of developing pancreatitis (inflammation of the pancreas);
• if you need an operation or cannot get up for a long time (see section 2 "Blood clots").
• if you have just given birth, you have a higher risk of blood clots. You should ask your doctor how long after delivery you can start taking aidessia.
• if a close relative has had breast cancer
• if you have any 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 any disease that appeared for the first time or worsened during pregnancy or during previous use of sex hormones (e.g., hearing loss, a metabolic disease called porphyria, a skin disease that causes blisters during pregnancy called gestational herpes, a neurological disease called Sydenham's chorea that causes involuntary body movements.
• If you have or have ever had chloasma (brownish discoloration, also called "pregnancy spots", especially on the face or neck). In that case, you should avoid direct exposure to the sun or ultraviolet rays.
• 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 may cause or worsen the symptoms of hereditary and acquired angioedema.

aidessiaand blood clots (Thrombosis)

BLOOD CLOTS (THROMBOSIS)

The use of a combined hormonal contraceptive like aidessia increases your risk of having 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 (which is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (which 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 aidessiais 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 the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ such as the eye (retinal vein thrombosis)

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

The risk of having a blood clot in a vein is higher during the first year in which 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 medication 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 having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having 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, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Of every 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 having 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 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 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). In this case, you may have a hereditary disorder of blood clotting.
• If you need to have surgery or if you spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to stop using aidessia several weeks before 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 above 35 years).
• If you have recently given birth.

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

Long-distance flights (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 essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. 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 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 (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like aidessia, you are advised to quit smoking. If you are unable to quit 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 high level 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.

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

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.

The pill and cancer

The pill slightly increases the risk of breast cancer compared to women who do not use the pill. No difference is found 10 years after stopping the use of the pill. It is not known if this difference is caused by the pill. It may be that women who use the pill are examined more frequently, so breast cancer is detected earlier.

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

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

Psychiatric disorders:

Some women who use hormonal contraceptives like aidessia have reported:

3. How to take aidessia

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure about using it correctly, consult your doctor or pharmacist.

When and how to take the pills

Each blister pack contains 21 pills. In the blister pack, each pill is marked with the day of the week it should be taken. Take your pill approximately at the same time every day, with a little liquid if necessary.

Follow the direction of the arrows in the blister pack until you have taken all 21 pills. Do not take any pills during the next 7 days. During these 7 days, you should start your period (withdrawal bleeding). Usually, this will start on day 2-3 after the last aidessia pill.

Start taking the next aidessia blister pack on the 8th day, even if you are still bleeding. This means you will always start new blister packs on the same day of the week, and you will also have your period approximately on the same days every month.

When can you start with the first blister pack?

• When you have not used a hormonal contraceptive treatment in the previous month.Start taking the pills on the first day of your cycle, i.e., the first day of your menstrual bleeding. The medication will work immediately, and you do not need to use an additional contraceptive method. You can also start on days 2-5 of your cycle, but in that case, make sure to use an additional contraceptive method, such as a condom, during the first 7 days.

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

You can start taking your treatment the day after taking the last pill from your current blister pack (i.e., without interruption). If your previous hormonal contraceptive blister pack contained inactive pills, you can start your treatment with aidessia the day after taking the last active pill (if you are unsure which one it is, consult your doctor or pharmacist). You can also start later, but no later than the day after the pill-free break of your previous contraceptive (or the day after the last inactive pills of your previous treatment).

In the case of using a vaginal ring or patch, you should start using this medication on the day of removal. You can also start using this medication later, but no more than 7 days after removing the ring or the last patch.

If you have used contraceptive pills, patches, or rings completely according to the prescription and are sure you are not pregnant, you can also stop using them or remove the ring or patch any day of your current cycle and switch to using this medication immediately.

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

• When switching from a progestogen-only method (minipill)

You can stop taking the minipill any day and start taking this medication the next day, at any time. But make sure to use an additional contraceptive method, such as a condom, during the first 7 days of taking the pills.

• When switching from an intrauterine device (IUD) injectable, implanted, or releasing progestogens.

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

• After having a child.

If you have just had a baby, your doctor may advise you to wait until after your first normal period before starting to take this medication. Sometimes it is possible to start earlier. Your doctor will advise you. The same applies if you are breastfeeding and want to take aidessia.

• After a miscarriage or abortion

Follow your doctor's advice.

If you take moreaidessiathan you should

No cases have been reported in which an overdose of this medication has caused serious harm.

If you take too many pills, you may feel sick, vomit, or have vaginal bleeding.

If you discover that a child has taken this medication, consult your doctor.

What to do if:

Forgot to takeyour pills

• If the forgotten pill is taken within12 hours,the contraceptive protection will not be reduced. Take the pill as soon as you remember and the following pills at the usual time.
• If you are more than 12 hourslate in taking a pill, the reliability of the treatment may be reduced. The more consecutive pills you have missed, the higher the risk that the contraceptive effectiveness may decrease.

There is a particularly high risk of becoming pregnant if you miss pills at the beginning or end of the blister pack. Therefore, you should follow the rules outlined below (see diagram):

Missed more than one pill from the blister pack

Consult your doctor.

Missed a pill in week 1

Take the missed pill as soon as you remember, even if this means taking two pills at the same time. Take the following pills at the usual time. Use additional contraceptive precautionsfor the next 7 days. If you have had sex in the week before missing the pill, you should be aware that there is a possibility of becoming pregnant. In that case, consult your doctor immediately.

Missed a pill in week 2

Take the missed pill as soon as you remember, even if this means taking two pills at the same time. Take the following pills at the usual time. The reliability of the pill is maintained. There is no need to use additional contraceptive precautions.

Missed a pill in week 3

You can choose one of the following options, without the need for additional contraceptive precautions:

1. Take the missed pill as soon as you remember, even if this means taking two pills at the same time. Take the following pills at the usual time. When you finish the blister pack of pills, start the next blister pack the next day without interruption. You may not have withdrawal bleeding until the end of the second blister pack, but you may have spotting or intermenstrual bleeding during the second blister pack.
2. Stop taking the current blister pack. Take the usual break of 7 days or less (always note the day you missed the pill). Then continue with the next blister pack.

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

• If you have missed taking some pills in a blister pack and do not bleed during the pill-free period, you may be pregnant. In that case, contact your doctor before continuing with the next blister pack.

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

If you are sick (vomit) or have very severe diarrhea, your body may not get the usual dose of hormones from the pill. If you vomit within 3-4 hours after taking the pill, it is as if you missed a pill. You should follow the advice given above for missed pills. Consult your doctor if you suffer from severe diarrhea.

If you want to delay your period

You can postpone your period, although it is not recommended. You can delay your period in exceptional cases by starting the next aidessia blister pack the next day without interruption. You can continue with this blister pack for as long as you want, until it is empty. While using the second blister pack, you may have bleeding or intermenstrual spotting. Start your next blister pack after the usual 7-day pill-free period.

If you want to change the start day of your period

If you take the pills according to the instructions, you will have your period approximately on the same day. If you want to change this, simply shorten (never lengthen) the pill-free period between two blister packs. For example, if your period usually starts on a Friday and in the future you want it to start on a Tuesday (3 days earlier), you should start your next blister pack 3 days earlier than usual. If you make your pill-free period very short (e.g., 3 days or less), you may not have bleeding during the interval. You may have intermenstrual spotting or bleeding during the use of the next aidessia blister pack.

If you have unexpected bleeding

With the use of any contraceptive pill, during the first months, you may have irregular vaginal bleeding (spotting or intermenstrual bleeding) between periods. You may need to use feminine hygiene products, but continue using your pills as usual. The irregular vaginal bleeding usually stops once your body has adapted to the treatment (usually after about 3 blister packs). Contact your doctor if the bleeding continues, increases, or starts again.

If your period does not appear

If you have taken all the pills at the right time and have not vomited or had severe diarrhea or used other medications, it is very unlikely that you are pregnant. Start your next blister pack as usual.

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

If you want to stop treatment with aidessia

You can stop taking this medication at any time you want. If you do not want to become pregnant, consult your doctor for advice on using other reliable contraceptive methods. If you stop because you want to become pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you know when the baby will be born.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

All women who take combined hormonal contraceptives 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 you start using 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").

As with all pills, during the first few months, the pattern of your periods may change. This difference can manifest in the frequency of bleeding (if it does not appear, with less frequency, with more frequency, or continuously), the amount of bleeding, or the duration of bleeding.

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

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

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

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

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

• Harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild stroke or temporary symptoms similar to those of a stroke, called 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 symptoms of a blood clot).

• Hypersensitivity reactions
• Increased libido
• Eye discomfort if you wear contact lenses
• Erythema nodosum (swelling similar to a bruise on the shins), erythema multiforme (rash with ulcers or red and irregular spots)
• Breasts producing a milky liquid from the nipples, changes in vaginal secretions
• Weight loss

Reporting 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 it 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 store at a temperature above 30°C. Store in the original package to protect it from light.

Do not use this medicine after the expiration date that appears on the package, after 'CAD'. The expiration date is the last day of the month indicated.

Do not use aidessia if you notice a color change, broken tablets, or any visible sign of deterioration.

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages 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 0.150 milligrams of desogestrel and 0.030 milligrams of ethinylestradiol.
• The other components are: lactose monohydrate, cornstarch, povidone K-30 (E1201), alpha-tocopherol (E307), soybean oil, colloidal hydrated silica (E551), colloidal anhydrous silica (E551), stearic acid (E570), hypromellose 2910 (E464), triacetin (E1518), polysorbate, titanium dioxide (E171).

Appearance of aidessiaand package contents

Coated tablets, white, round, and marked with "C" on one side and "7" on the other.

Available in boxes of 1, 3, 6, and 13 blisters, each with 21 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 – Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Manufacturer

Laboratorios León Farma, S.A.

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

24008 - Villaquilambre, León.

Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Netherlands: Ethinylestradiol/Desogestrel 0.03 mg/0.15 mg Focus, film-coated tablets

Belgium: Desolina 150/30 microgram, film-coated tablet

Luxembourg: Desolina 30 0.150 mg/0.030 mg, film-coated tablets

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

Date of the last revision of this prospectus:March 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/77783/P_77783.html

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