ADIERIS DIARIO 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

adieris Diario 2 mg/0.03 mg film-coated tablets EFG

dienogest/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, 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 adieris Diario and what is it used for
2. What you need to know before starting to take adieris Diario
3. How to take adieris Diario
4. Possible side effects
5. Storage of adieris Diario
6. Package contents and additional information

1. What is adieris Diario and what is it used for

adieris Diario is:

• an oral contraceptive pill used to prevent pregnancy.
• and for the treatment of women with moderate acne who accept receiving contraceptive treatment after failure of adequate local or oral antibiotic treatment.

Each of the 21 white tablets contains two types of hormones, an estrogen (ethinylestradiol) and a progestogen (dienogest).

Contraceptive pills that contain two hormones are called "combined pills" or "combined hormonal contraceptives".

Each of the 7 pink tablets does not contain active ingredients and is called a placebo tablet.

2. What you need to know before starting to take adieris Daily

General observations

Before starting to take adieris Daily, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

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

This prospectus describes several situations in which you should stop taking adieris Daily, or in which the effectiveness of adieris Daily is reduced. In such situations, you should not have sexual intercourse without taking additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because contraceptive pills alter the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

adieris Daily, like all contraceptive pills, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Acne will normally improve within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after starting and periodically thereafter.

When not to take adieris Daily

You should not take adieris Daily 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.

Do not take adieris Daily

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or 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 spend a lot of time without getting up (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 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 mellitus 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 are allergic to ethinylestradiol, dienogest, or any of the other components of this medication (including those listed in section 6).
• If you suffer or have ever suffered from inflammation of the pancreas (pancreatitis) along with very high levels of fat (lipids) in the blood (hypertriglyceridemia).
• If you suffer or have suffered in the past from severe liver disease and your liver function is still not normal.
• If you have or have had a benign or malignant liver tumor.
• If you have or have had breast cancer or cancer of the genital organs or breasts affected by sex hormones (e.g., breast or uterine cancer).
• If you have vaginal bleeding of unknown origin.
• If you are pregnant or suspect you may be pregnant.

Do not take adieris Daily 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 "Other medications and adieris Daily").

If you experience any of the above situations while taking adieris Daily, do not take any more pills and contact your doctor immediately. In the meantime, use another non-hormonal contraceptive method. For more information, see also the section "Warnings and precautions".

Warnings and precautions

When should you be particularly careful with adieris Daily

When should you consult your doctor?

Seek urgent medical attention

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 clot (thrombosis)" below).

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

Tell your doctor if you suffer from any of the following conditions

In some situations, special care is needed when taking adieris Daily or any other combined pill, and your doctor may need to examine you regularly.

If the condition develops or worsens while you are using adieris Daily, you should also inform your doctor.

• 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 high levels of fat in the blood (hypertriglyceridemia) or 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 blood clots. You should ask your doctor when you can start taking adieris Daily after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have abnormalities in the heart valves, heart rhythm disorders.
• If you have close relatives with breast cancer.
• If you suffer from liver or gallbladder diseases, gallstones.
• If you have jaundice or itching due to bile congestion.
• If you have yellow-brown spots on the skin, especially on the face (chloasma), or have had them during a previous pregnancy. In this case, you should avoid intense sunlight and UV radiation. If you have certain problems with hemoglobin formation (porphyria).
• If you have depression.
• If you have epilepsy.
• If you have Sydenham's chorea (Saint Vitus' dance).
• If you have had a skin rash with blisters during a previous pregnancy (gestational herpes).
• If you have hearing loss in the inner ear (hearing loss related to otosclerosis).
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives along with difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like adieris Daily 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 (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 adieris Daily 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 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 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 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 adieris Daily, 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 adieris Daily 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 dienogest and ethinylestradiol, such as adieris Daily, between 8 and 11 women will develop 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 adieris Daily 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 an operation 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 adieris Daily several weeks before the operation or while you have less mobility. If you need to stop using adieris Daily, ask your doctor when you can start using it again.
• As you get older (especially over 35 years).
• If you have given birth recently.

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 adieris Daily.

If any of the above conditions change while you are using adieris Daily, 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 essential to note that the risk of a heart attack or stroke due to adieris Daily is very small, but it can increase:

• With age (over 35 years).
• If you smoke. When using a combined hormonal contraceptive like adieris Daily, 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 high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased further. If any of the above conditions change while you are using adieris Daily, 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.

adieris Daily and cancer

It has been observed that breast cancer is slightly more common in women who use combined pills, but it is not known if this is due to the treatment. For example, it is possible that more tumors are detected in women who take combined pills because the doctor examines them more frequently. The risk of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to check your breasts regularly and contact your doctor if you notice any lump.

In rare cases, benign liver tumors, and in even fewer cases, malignant liver tumors have been described in users of oral contraceptives. In isolated cases, these tumors have caused potentially life-threatening internal bleeding.

Consult your doctor if you have abdominal pain.

Intense.

Some studies suggest that prolonged use of the pill increases the risk of cervical cancer.

However, it is not clear to what extent sexual behavior (e.g., frequent change of partner) and other factors such as the human papillomavirus (HPV) increase this risk.

When should you consult your doctor?

Periodic reviews:

If you are taking the pill, your doctor will ask you to have tests done periodically. Normally, you should consult your doctor at least once a year.

In addition, consult your doctor immediately if:

• you notice any change in your health, especially those mentioned in the section "Do not take adieris Daily". Do not forget about diseases that affect your family;
• you feel a lump in your breast
• you are taking other medications (see also the section "Other medications and adieris Daily");
• you are confined to bed for a prolonged period or are going to undergo surgery (consult your doctor at least four weeks in advance);
• you have severe and unusual vaginal bleeding between periods;
• you have forgotten to take the coated tablets in the first week of taking the pill and have had sexual intercourse within 7 days prior;
• you have not menstruated twice in a row despite taking the coated tablets regularly and suspect you are pregnant. pregnant.

Psychiatric disorders:

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

Medical consultation/examination

Before you take adieris Daily, your doctor will thoroughly question you about your medical history and that of your close relatives. A general medical and gynecological examination will be performed, including a breast examination and a cervical cytology study. Pregnancy should be ruled out. These examinations should be repeated periodically when taking contraceptive pills. Inform your doctor if you smoke and if you are taking any other medication.

If you have unexpected bleeding between periods

During the first few months you take adieris Daily, you may experience unexpected bleeding. Irregular vaginal bleeding stops once your body has gotten used to taking the pill (usually after about 3 cycles of pills). If you experience heavier vaginal bleeding similar to a normal menstrual period or light vaginal bleeding that lasts for several days, you should consult your doctor.

If you do not have a normal menstrual period

If you have taken all the pills correctly, have not suffered from vomiting or severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant. Continue taking the medication as usual.

If you miss two menstrual periods in a row, or if you have not been taking adieris Daily as directed before missing your menstrual period, there is a possibility of pregnancy. Consult your doctor immediately. Do not take adieris Daily until your doctor has ruled out pregnancy.

Children and adolescents

adieris Daily can only be used after the first menstrual period (menarche).

Other medications andadieris Daily

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medications.

Some medications can cause intermenstrual bleeding and/or alter the contraceptive effect of adieris Daily.

Effects of other medications on adieris Daily

Some medications

• have an effect on adieris Daily blood levels.
• can make it less effective in preventing pregnancy.
• can cause unexpected bleeding.

These include:

• Medications used to treat:
• epilepsy (e.g., barbiturates, phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate)
• tuberculosis (e.g., rifampicin)
• infections caused by the HIV or hepatitis C virus (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• fungal infections (griseofulvin, ketoconazole)
• arthritis, osteoarthritis (etoricoxib)
• St. John's Wort (Hypericum perforatum);

If you are being treated with any of the above medications, you should also use a barrier method (e.g., a condom) temporarily or choose another contraceptive method. Use additional local contraceptives while taking other medications with adieris Daily and also for 28 days after stopping treatment with other medications.

If your treatment is prolonged beyond the strip of blisters of adieris Daily, start with the next strip of blisters of adieris Daily immediately, without the usual pill-free interval.

If prolonged treatment with any of the above medications is required, you should choose another reliable non-hormonal contraceptive method.

Effects of adieris Daily on other medications

adieris Daily may affect the effect of other medications:

• lamotrigine (may cause an increased frequency of seizures)
• cyclosporine
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain or muscle cramps)

Also, note the instructions for use of other prescribed products. Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Do not take adieris Daily if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in liver enzyme ALT).

Interactions with laboratory tests

The use of adieris Daily may affect the results of certain laboratory tests, including liver function, adrenal, renal, and thyroid function, as well as the amount of certain proteins in the blood, such as proteins that affect fat digestion, carbohydrate metabolism, or blood coagulation and fibrinolysis. However, these changes usually remain within normal limits. Inform your doctor or laboratory personnel that you are taking the pill.

adieris Daily with food and drinks

adieris Daily can be taken with or without food, if necessary with a small amount of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

If you are pregnant, do not take adieris Daily. If you become pregnant while taking adieris Daily, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking it at any time (see "If you stop treatment with adieris Daily").

Breastfeeding

In general, breastfeeding women should not take adieris Daily, as it may reduce the amount of milk produced and small amounts of the medication may be excreted in breast milk.

Driving and using machines

Dienogest/ethinylestradiol has no known effects on the ability to drive or use machines.

adieris Dailycontains lactose

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

3. How to take adieris Daily

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

When and how are the tablets taken?

A pack of adieris Daily contains 28 coated tablets: 21 active white tablets and 7 placebo pink tablets.

Inside each box, there are 7 adhesive strips with the days of the week. This adhesive strip should be stuck on the day you start taking the tablets. For example, if you start taking the tablets on a Tuesday, you should select the adhesive strip that starts with "TUE" and stick it in the first row where it is written: "Place the strip that matches the start date here".

Take the tablets with water if necessary and at the same time every day until the pack is finished. Once you finish the last tablet, start a new pack of tablets the next day. You should always start the next pack on the same day of the week.

During the 7 days when you take the placebo tablets (pink), bleeding (also called withdrawal bleeding) usually starts. It usually starts on the 2nd or 3rd day after taking the last active white tablet of adieris Daily. Once you have taken the last placebo pink tablet, you should start a new blister pack, regardless of whether your bleeding has stopped or not. This means that you will always start a new pack on the same day of the week and that you will have withdrawal bleeding on the same days every month.

If you use adieris Daily in this way, you will also be protected against pregnancy during the 7 days when you take the placebo tablets.

Starting the first pack ofadieris Daily

When no hormonal contraceptive has been used in the previous month

Start taking adieris Daily on the first day of your cycle, i.e., the first day of your menstrual period. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked "Friday". Then continue with the days in order.

When you have used another combined contraceptive pill before

You can start taking adieris Daily preferably the day after taking the last active tablet (the last tablet that contains the active ingredient) of your previous contraceptive, or at the latest on the day after the rest week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive).

When you have used a vaginal ring or a transdermal patch before

You can start taking adieris Daily on the same day you remove the last vaginal ring or transdermal patch from the pack of a cycle or at the latest on the day you would normally reapply the ring or patch.

When you have used a progestogen-only pill (also called a "mini-pill") before

You can stop taking the pill at any time and start taking adieris Daily the next day at the same time. During the first 7 days, use a non-hormonal contraceptive method (such as a condom).

When you have used an injectable, an implant, or an intrauterine system (IUS) that releases progestogen before

Start taking adieris Daily when your next injection is due or on the day the implant or IUS is removed. However, you should always use another contraceptive method (a barrier method) during the first 7 days you take the new tablets when you have sex.

After childbirth

Do not start taking adieris Daily for at least 21 to 28 days after childbirth. During the first 7 days you take the tablets, you should also use a barrier contraceptive method (e.g., a condom). If you have already had sex, you should rule out pregnancy before starting adieris Daily or wait until you have your first menstrual period. For use during breastfeeding, see "Pregnancy and breastfeeding".

After a spontaneous or induced abortion

Your doctor may advise you on this.

If you take moreadieris Dailythan you should

No serious harmful effects have been reported as a result of taking too many adieris Daily tablets at once. If you have taken several tablets at once, you may experience nausea, vomiting, and vaginal bleeding. If you discover that a child has taken adieris Daily, ask your doctor for advice. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forget to takeadieris Daily

If you forget to take one of the placebo pink tablets, the effect of adieris Daily will not be affected. Discard the forgotten placebo tablet. If you forget to take an active white tablet, you should follow the following recommendations:

• If the delay in taking a tablet is less than 12 hours, the protection against pregnancy will not be reduced. Take the tablet as soon as you remember and then take the following tablets at the usual time.

• If the delay in taking any tablet is more than 12 hours, the protection against pregnancy may be reduced. The more consecutive tablets you have forgotten, the higher the risk of decreased contraceptive efficacy. There is a particularly high risk of becoming pregnant if you forget to take tablets at the beginning or end of the pack. Therefore, you should follow the rules given below (see also the diagram below).

More than 1 forgotten tablet from a pack

Consult your doctor.

1 forgotten tablet in week 1

Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time. Use an additional barrier contraceptive method (such as a condom) for the next 7 days. If you have had sex in the week before forgetting the tablet, there is a possibility that you may have become pregnant. Therefore, you should inform your doctor immediately.

1 forgotten tablet in week 2

Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time. The protection against pregnancy will not be reduced, provided that you have taken the tablets correctly in the 7 days before forgetting the tablet. In this case, it is not necessary to use additional contraceptive methods. However, if you have forgotten to take more than 1 tablet, you should use an additional barrier contraceptive method for 7 days.

1 forgotten tablet in week 3

You can choose one of the following options, without needing to take additional precautions, provided that you have taken the tablets correctly in the 7 days before forgetting the tablet:

1. Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time. Instead of taking the 7 placebo pink tablets from this pack, discard them and start the next pack. You may not have menstrual bleeding until you finish the second pack, while you are taking the placebo pink tablets, although you may experience irregular bleeding during the second pack.

Or:

1. Stop taking the active white tablets from the current pack and go directly to the 7 placebo pink tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new pack on the fixed day you always start, take the placebo tablets for less than 7 days.

If you have forgotten to take tablets and do not have menstrual bleeding during the placebo days, you may be pregnant. Consult your doctor before starting the next pack.

What to do if you have stomach problems (e.g., vomiting, severe diarrhea)

If you vomit within 3 to 4 hours after taking the adieris Daily tablet, it is possible that the active ingredients have not been fully absorbed. This is like forgetting to take a tablet. Therefore, follow the instructions for forgotten tablets. If you have severe diarrhea, consult your doctor.

What to do if you want to delay your menstrual period

Although it is not recommended, it is possible to delay your menstrual period by starting a new blister pack of adieris Daily after taking the last active white tablet from the current blister pack, without taking the placebo pink tablets. You can continue taking the active tablets from the second blister pack until you want to have your menstrual period. However, do not finish this second blister pack until you have taken all the tablets, including the 7 placebo pink tablets from the 4th row.

You may experience some bleeding or spotting during the use of the second blister pack. After the 7 days of placebo tablets, start with the next blister pack.

You can ask your doctor for advice before deciding to delay your menstrual period.

What to do if you want to change the day your menstrual period starts

If you take the tablets as indicated, you will have your menstrual period approximately on the same day every 4 weeks (during the placebo week). If you want to change this day, simply shorten (never prolong) the number of placebo days. If, for example, your menstrual period usually starts on a Friday and you want it to start on a Tuesday (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), you may not have menstrual bleeding during these days. You may experience some irregular bleeding during the use of the next pack.

In case of doubt, consult your doctor.

If you stop takingadieris Daily

You can stop taking adieris Daily at any time. If you do not want to become pregnant, ask your doctor about other contraceptive methods.

If you stop taking adieris Daily because you want to become pregnant, it is generally recommended to wait until you have a natural period before trying to become pregnant. This way, it will be easier to determine the expected date of delivery.

After stopping adieris Daily, it may take some time before you have a natural period.

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

Additional information for special populations

Pediatric population

adieris Daily is only indicated after the first menstrual period (menarche).

Elderly patients

adieris Daily is not indicated after menopause.

Hepatic impairment

adieris Daily is contraindicated in women with severe hepatic disorders (see section 2 of the prospectus "Do not take adieris Daily").

Renal impairment

The use of adieris Daily has not been studied in women with renal impairment. The available data do not suggest any change in treatment for this patient population.

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 adieris Diario, 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 adieris Diario".

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").

Severe Adverse Effects

Severe reactions associated with the use of the pill, as well as related symptoms, are described in the following sections: "Blood clots" and "adieris Diario and cancer". Read these sections carefully and, if necessary, consult your doctor immediately.

Other Possible Adverse Effects

Users of the dienogest/ethinylestradiol tablet have reported the following adverse effects:

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

• Headache
• Breast pain, such as breast tenderness and breast sensitivity

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

• Inflammation of the vagina and/or external genitalia (vaginitis/vulvovaginitis), vaginal mycoses (candidiasis, vulvovaginal infections)
• Increased appetite
• Depressed mood
• Migraine, sensation of spinning (vertigo)
• Hypertension, hypotension
• Abdominal pain (including bloating)
• Nausea, vomiting, diarrhea
• Acne
• Rash
• Itching
• Hair loss (alopecia)
• Abnormal menstrual bleeding, such as heavy menstrual bleeding (menorrhagia), light menstrual bleeding (hypomenorrhea), infrequent menstrual bleeding (oligomenorrhea), or absence of menstrual bleeding (amenorrhea)
• Intermenstrual bleeding consisting of vaginal hemorrhage and irregular bleeding between periods (metrorrhagia), painful bleeding (dysmenorrhea)
• Genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in the internal sexual organs, breast enlargement, breast edema
• Fatigue, weakness, malaise
• Weight gain

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

• Inflammation of the Fallopian tubes or ovaries, urinary tract infections, bladder inflammation (cystitis), breast inflammation (mastitis), cervical inflammation (cervicitis), mycoses (e.g., Candida), viral infections (e.g., herpes labialis), flu (influenza), bronchitis, upper respiratory tract infection, sinusitis
• Benign tumors in the uterus (fibroids), benign tumors in the breast tissue (breast lipoma)
• Decreased red blood cell count (anemia)
• Allergic reactions (hypersensitivity)
• Development of male characteristics (virilization)
• Loss of appetite (anorexia)
• Depression, mental disorders, aggression, insomnia, sleep disturbances
• Blood circulation problems in the brain or heart
• Dystonia (muscle disorder that can cause, e.g., an abnormal posture)
• Dryness or irritation of the eyes, vision disorders, blurred vision
• Sudden hearing loss, ringing or other noises in the ears (tinnitus), dizziness, hearing problems
• Rapid heartbeat
• Inflammation of the veins, elevated diastolic blood pressure, dizziness or fainting when standing up after sitting or lying down (orthostatic hypotension)
• Varicose veins, venous disorders, vein pain
• Hot flashes
• Harmful blood clots in a vein or artery, for example:

• in a leg or foot (i.e., deep vein thrombosis)
• in a lung (i.e., pulmonary embolism)
• heart attack
• stroke
• mild or temporary stroke-like symptoms, known as transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys, or eye

• The risk 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).
• Asthma, rapid or deep breathing (hyperventilation)
• Gastritis, enteritis, indigestion (dyspepsia)
• Allergic skin inflammation (dermatitis), skin rash (e.g., neurodermatitis), skin disease with thickened red skin patches (psoriasis), excessive sweating (hyperhidrosis), changes or disorders in skin color (e.g., chloasma), overproduction of fat by the sebaceous glands (seborrhea), dandruff, skin lesions, orange peel skin (cellulitis), spider-like blood vessel accumulation with a central red spot on the skin
• Back pain, pain in bones, joints, and muscles (e.g., myalgia), pain in arms and legs
• Abnormal cell growth on the surface of the cervix (cervical dysplasia)
• Pain or cysts in the uterine appendages (ovaries and Fallopian tubes)
• Breast cysts
• Milk-like secretion from the breasts (galactorrhea)
• Pain/spasms during intercourse (dyspareunia)
• Menstrual discomfort
• Chest pain, swelling of hands, ankles, or feet (peripheral edema), flu-like symptoms, inflammation, fever, irritability
• High levels of fat in the blood (elevated triglyceride and cholesterol levels), weight loss, weight fluctuations
• Inflammation of congenital additional mammary glands outside the breast area (accessory breasts)

Frequency Not Known(cannot be estimated from available data):

• Mood changes
• Increased or decreased sexual desire (libido)
• Intolerance to contact lenses
• Urticaria
• Skin and/or mucous membrane reactions with rash, nodules, erythema nodosum or multiforme
• Breast secretion
• Fluid retention (edema)

Tumors

• The frequency of breast cancer diagnosis is slightly increased in AOC patients. Since breast cancer is rare in women under 40 years of age, the risk of developing breast cancer in relation to the total risk is low. For more information, see the section "adieris Diario and cancer".
• Liver tumors (benign and malignant)
• Cervical cancer

Other Conditions

• Hypertriglyceridemia (elevated levels of fats resulting in an increased risk of pancreatitis with the use of AOCs)
• Hypertension
• Appearance or worsening of conditions whose relationship to combined oral contraceptives is not defined: jaundice and/or itching related to cholestasis (bile flow obstruction); bile stone formation; a metabolic disease called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a blood clotting disease); a neurological disease called Sydenham's chorea; herpes gestationis (a type of skin disease that occurs during pregnancy); hearing loss related to otosclerosis
• In women with hereditary angioedema (characterized by sudden swelling of, for example, the eyes, mouth, throat, etc.), external estrogens may induce or worsen the symptoms of angioedema
• Liver dysfunction
• Changes in glucose tolerance or peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

Interactions

Unexpected intermenstrual bleeding and/or failure of the contraceptive effect may occur due to interactions between other medications and oral contraceptives (e.g., the natural product St. John's Wort or medications for the treatment of epilepsy, tuberculosis, HIV, and other infections; see "Other medications and adieris Diario").

Other severe reactions to taking this contraceptive, as well as related symptoms, are described in the section "Warnings and precautions".

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 adieris Diario

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

Do not store above 30°C.

Do not use this medicineafter the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofadieris Diario

Active tablets:

• The active ingredients are ethinylestradiol and dienogest. Each coated tablet contains: 2 mg of dienogest and 0.03 mg of ethinylestradiol.

• The other components are: Povidone K30, cornstarch, lactose monohydrate, magnesium stearate, polyethylene glycol/macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc (E553b).

Placebo tablets:

The components are: Povidone K30, cornstarch, lactose monohydrate, magnesium stearate, polyethylene glycol/macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc (E553b), Red Iron Oxide (E172), Yellow Iron Oxide (E172).

Appearance of the Product and Package Contents

The active tablet is a white, cylindrical, and biconvex coated tablet with a diameter of approximately 6 mm.

The placebo tablet is a pink, cylindrical, and biconvex coated tablet with a diameter of approximately 6 mm.

adieris Diario is packaged in PVC/aluminum blisters and presented in a calendar pack.

Package sizes:

28 film-coated tablets (blister of 21 active tablets + 7 placebo tablets).

84 film-coated tablets (blister of 21 active tablets + 7 placebo tablets).

Not all package sizes may be marketed.

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 Avda. de Ágreda 36,

42110 Ólvega (Soria)

Spain

Date of Last Revision of this Prospectus:September 2023

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 on this medicine by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80875/P_80875.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80875/P_80875.html