ADIERIS 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

adieris 2 mg/0.03 mg film-coated tablets EFG

dienogest/ethinylestradiol

Important things 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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots").

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet

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

1. What is adieris and what is it used for

adieris contains a small amount of female hormones called progesterone (dienogest) and an estrogen (ethinylestradiol).

The birth control pills that contain two hormones are called "combined" pills or combined oral contraceptives.

Oral contraceptive pills (taken by mouth) are a very effective method of family planning. If taken regularly (without missing pills), the chance of becoming pregnant is very low.

Clinical trials have shown that, in women with pronounced effects of male hormones (called "androgens") that cause acne, adieris improves these symptoms.

adieris is used:

• to prevent pregnancy;
• to treat women with moderate acne who accept receiving a birth control pill after the failure of adequate local treatments or oral antibiotics.

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

The 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 its initiation and periodically thereafter.

Do not take adieris

You should not use adieris 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 are allergic to ethinylestradiol, dienogest, or any of the other components of this medication (including those listed in section 6).
• If you have (or have ever had) a blood clot in a blood vessel in 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 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) chest pain (a condition that causes severe pain in the chest and can 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 can 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) along with very high levels of fat (lipids) in the blood (hypertriglyceridemia).
• If you have or have had benign or malignant liver tumors.
• If you smoke (see "The 'pill' and vascular disorders").
• If you have or have had liver disease, which can cause yellowing of the skin (jaundice) or itching all over the body, and indicate a liver function abnormality.
• If you have, have had, or are suspected of having cancer (e.g., breast or endometrial cancer) that is affected by sex hormones.
• If you have vaginal bleeding of unknown origin.
• If you do not have menstruation (period) and the cause has not been determined.
• 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").

If any of the above conditions affect you for the first time while you are taking the pill, you should stop taking the product immediately and consult your doctor. In the meantime, you should use a different non-hormonal contraceptive method. See also the section "General considerations".

Additional information on special user groups

Children and adolescents

adieris is not intended for women (girls) who are not yet menstruating.

Use in older women

adieris is not for postmenopausal women.

Liver failure

Do not take adieris if you have liver disease. (See also "Do not take adieris" and "Warnings and precautions").

Kidney failure

Consult your doctor. Available data do not indicate the need to change the use of adieris.

Warnings and precautions

When you should be particularly careful with adieris

Consult your doctor or pharmacist before starting to take adieris.

In some situations, you may need to have special care when taking adieris or other "combined pills" and may need to visit your doctor regularly.

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

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

• If you smoke;

If any of these situations occur for the first time, recur, or worsen while you are taking the pill, consult your doctor.

BLOOD CLOTS

The use of a combined hormonal contraceptive like adieris 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 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 having a blood clot in a vein is higher during the first year that 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, 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 adieris 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, like adieris, between 8 and 11 women will develop 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 adieris 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 a leg in a cast. You may need to stop using adieris several weeks before surgery or while you have reduced mobility. If you need to stop using adieris, ask your doctor when you can start using it again;
• as you get older (especially above 35 years of age).
• if you have recently given birth.

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

Long-distance 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 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 adieris.

If any of the above conditions change while you are using adieris, 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 is very small, but it can increase:

• with age (above 35 years of age).
• if you smoke.When using a combined hormonal contraceptive like adieris, 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 of age). In this case, you may also be at higher risk of having a heart attack or stroke;

• if you have high blood pressure, or if you have had a heart attack or stroke;
• if you have a history of blood clots, including deep vein thrombosis or pulmonary embolism;
• if you have a history of migraine headaches, especially migraines with aura;
• if you have a heart problem (valvular heart disease, irregular heartbeat 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 developing a blood clot may be increased even further.

If any of the above conditions change while you are using adieris, 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

Breast cancerhas been observed more frequently in women who use oral contraceptives, but it is not known if this is caused by the treatment. It may be that more tumors are detected in women who take oral contraceptives because they are examined by their doctor more frequently. The occurrence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential that you regularly check your breasts and should contact your doctor if you notice any lump.

Benign liver tumors have been reported in rare cases, and in even more exceptional cases, malignant liver tumorshave been reported in users of the oral contraceptive pill. In isolated cases, these tumors can cause life-threatening internal bleeding. Consult your doctor immediately if you experience severe stomach pain.

The most significant risk factor for cervical canceris persistent infection with the human papillomavirus (HPV).

Some studies suggest that long-term use of hormonal contraceptives is a risk factor for developing cervical cancer in women. However, it is not clear to what extent this risk increases due to sexual behavior or other factors such as the human papillomavirus.

Other diseases

• High blood pressure

An increase in blood pressure has been documented in women who take the 'pill'. More commonly, this occurs in older users and with longer use of the medication. The frequency of cases with high blood pressure increases with the progesterone content. Use another contraceptive method if you have suffered from diseases caused by high blood pressure, or if you have certain kidney diseases (in this case, consult your doctor; see also the sections "Do not take adieris", "Stop taking adieris immediately", and "Your doctor will perform regular check-ups").

• Pigmented spots

Occasionally, yellowish-brown spots (chloasma) may appear on the skin, especially in women who already had them during pregnancy. For this reason, women with this disposition should not expose themselves to sunlight or ultraviolet light (e.g., artificial tanning) while taking the "pill".

• Hereditary angioedema (inflammation)

If you suffer from hereditary angioedema, medications containing estrogen may cause or worsen the symptoms of angioedema. Consult your doctor immediately if you notice any symptoms of angioedema, such as swelling of the face, tongue, and/or skin eruptions, and/or difficulty swallowing, or skin eruptions, in addition to respiratory problems.

• Irregular bleeding (bleeding between periods)

During the first few months of using the 'pill', irregular bleeding (spotting or bleeding) may occur. Contact your doctor if the irregular bleeding continues for more than 3 months or if the bleeding reappears after the end of a regular cycle.

It is possible that during the period without taking the 'pill', menstruation may not occur. If you have taken adieris correctly, pregnancy is unlikely. However, if you have not taken the 'pill' correctly before the first missing bleed, or if you do not have bleeding twice in a row, you could be pregnant. Pregnancy should be ruled out with certainty before continuing to take adieris.

When you have stopped taking the 'pill', it may take some time before your cycle returns to normal.

Reduced efficacy

The efficacy of the 'pill' may be reduced if you forget to take it, if you vomit, if you have intestinal diseases, severe diarrhea, or if you are taking other medications simultaneously.

If you take adieris with medications that contain St. John's Wort, you should use an additional barrier contraceptive method (e.g., condoms) (see the section "Using adieris with other medications").

Visits to the doctor/check-ups

Before using adieris, your doctor will ask about your medical history and that of your close relatives. You will undergo a general medical and gynecological check-up, including a breast examination and a cervical smear. Pregnancy should be ruled out absolutely. These check-ups should be repeated regularly while you are taking the 'pill'. Inform your doctor if you smoke or if you are taking other medications.

adieriswill not protect you against HIV (AIDS) or other sexually transmitted diseases.

Other medications and adieris

Some medications may influence the levels of dienogest/ethinylestradiol in the blood and may make it less effective in preventing pregnancy, or may cause unexpected bleeding.

• These include the following medications used to treat:

• epilepsy (e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin, azole antifungals like itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin);
• certain heart diseases, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem);
• arthritis, osteoarthritis (etoricoxib).

• medications that increase intestinal motility (e.g., metoclopramide);
• preparations based on natural plants such as St. John's Wort (Hypericum perforatum);
• grapefruit juice.

adieris may influence the efficacy of other medications, for example:

• lamotrigine
• cyclosporine
• melatonin
• midazolam
• theophylline
• tizanidine

Do not take adieris 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).

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

adieris can be used again approximately 2 weeks after the end of this treatment. See the section "Do not take adieris").

Ask your doctor or pharmacist for advice before taking any medication. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. They can advise you on additional protective measures while taking another medication with adieris.

Diabetes

In diabetic women, the need for hypoglycemic agents (e.g., insulin) may be modified.

Laboratory tests

If you need to have a blood test, inform your doctor or laboratory personnel that you are taking an oral contraceptive, as this medication may affect the results of some tests, including liver values, adrenal cortex, renal function, and thyroid function, as well as the amount of certain proteins in the blood, such as proteins that affect lipid metabolism, carbohydrate metabolism, blood coagulation, and fibrinolysis. However, these changes are generally still within normal limits.

Pregnancy and lactation

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

Pregnancy

Do not take adieris during pregnancy. If you become pregnant while taking adieris, you should stop taking it immediately and contact your doctor. If you wish to become pregnant, you can stop taking adieris at any time (see "If you interrupt treatment with adieris").

Breastfeeding

Using adieris is generally not recommended during breastfeeding. If you want to take the pill while breastfeeding, you should inform your doctor.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.

adieriscontains lactose

This medication contains 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

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

If your doctor does not tell you otherwise, the usual dose is one Adieris tablet per day.

Each Adieris blister pack contains 21 film-coated tablets. The day of the week on which it should be taken is printed next to each tablet. Take the tablet at the same time every day; with some liquid if necessary. Follow the direction of the arrows every day until you have taken all 21 tablets. Do not take any tablets during the following 7 days. Menstruation (withdrawal bleeding) should occur during these 7 days. This normally starts 2 or 3 days after you take the last Adieris tablet.

Start a new blister pack on the 8th day, whether or not bleeding has stopped. This means you should start each blister pack on the same day of the week and that withdrawal bleeding should occur on the same days of each month.

With proper use of combined oral contraceptives, failure is around 1% per year. If you forget to take a tablet or take it incorrectly, the failure rate may increase.

When to start taking Adieris

If you have not taken any contraceptive pills during the previous month:

Start Adieris on the first day of your menstrual cycle (the first day of menstruation will be counted as Day 1), taking the tablet that corresponds to the day of the week you are on. Follow the correct order for the following days. In this way, Adieris works from the first moment, and no other contraceptive method is necessary.

If you start taking Adieris between the 2nd and 5th day, use an additional barrier contraceptive method during the first 7 days of taking the 'pill'.

If you are switching from another hormonal contraceptive (combined oral contraceptive, vaginal ring, or patch)

You can start taking Adieris the day after taking the last pill from your previous contraceptive pack (this means there will be no interval without taking a tablet). If your previous pack also contained inactive tablets (placebo tablets), you can start taking Adieris the day after taking the last active tablet (if you are unsure whether the tablets contain active ingredients, ask your doctor or pharmacist). You can start taking it later, but no later than the day after finishing the tablet-free days of your previous pill (or after taking the last placebo tablet of your previous pill). In the case of a patch or vaginal ring, you should start taking Adieris preferably on the day you remove it, but no later than the day you would normally replace it.

If you are switching from a progestogen-only method (mini-pill that contains only progesterone, injection, implant, or intrauterine system (IUS) of progestogen)

You can stop taking the mini-pills at any time and start taking Adieris the next day at the usual time. However, if you have had sexual intercourse, you should use an additional contraceptive method (barrier method) during the first 7 days of taking Adieris. From an injection, implant, or IUS, start taking Adieris on the day you would normally have received the next injection or the day the implant or IUS is removed. However, if you have had sexual intercourse, you should use an additional contraceptive method (barrier method) during the first 7 days of taking the tablets.

After giving birth

If you have just had a baby, your doctor may advise you to start taking Adieris after your first period. However, in some cases, you may start hormonal contraception earlier; please consult your doctor.

If, after having a baby, you have had sexual intercourse before starting Adieris, you must first ensure you are not pregnant or wait until your next period.

If you are breastfeeding and want to start taking Adieris, consult your doctor.

After an abortion

Consult your doctor about the possibility of taking Adieris.

If you take more Adieris than you should

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

Possible signs of overdose are, for example, nausea, vomiting (usually after 12 to 24 hours, with possible duration of several days), breast tenderness, dizziness, stomach pain, drowsiness/fatigue; adult women and adolescents may experience vaginal bleeding. You should consult a doctor if you have taken relatively large amounts or if you discover that a child has taken the pill.

If you forget to take Adieris

If it has been less than 12 hourssince you should have taken the tablet, the contraceptive effect of the pill is maintained. Take the forgotten tablet as soon as possible and continue taking the following tablets at the usual time.

If it has been more than 12 hourssince you should have taken the tablet, protection against pregnancy is reduced. The more consecutive tablets you have forgotten, the higher the risk of becoming pregnant.

There is a particularly high risk of becoming pregnant if you forget to take a tablet at the beginning or end of the pack. Therefore, you should follow the rules given below (see also the following diagram).

More than one forgotten tablet

Contact your doctor.

Do not take more than 2 tablets in one day to make up for the forgotten tablet.

If you did not take several tablets and there is no bleeding during the first break period, there is a possibility of pregnancy. In this case, contact your doctor before starting a new pack.

Follow the instructions below if you have forgotten to take a tablet:

If you have forgotten to take 1 tablet in week 1:

If you forget to start a new pack or forget to take a tablet within the first 7 days, there is a risk that you may be pregnant (if you have had sexual intercourse within the 7 days prior to forgetting the tablet). Contact your doctor before taking the new pack. See also the following diagram.

If you have not had sexual intercourse before forgetting the tablet, take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. Take additional contraceptive precautions (use a barrier method, such as a condom) for the next 7 days.

If you have forgotten to take 1 tablet in week 2:

Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. The efficacy of the pill is maintained, and no additional contraceptive measures are necessary.

If you have forgotten to take 1 tablet in week 3:

If you follow one of the following options, no additional contraceptive measures are necessary:

• Option 1:Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time). Then continue taking the following tablets at the usual time. The next pack should be started immediately after taking the last tablet of the current pack, i.e., do not leave a tablet-free period between packs. It is unlikely that you will have bleeding until the end of the second pack, but you may experience bleeding or spotting even on tablet-taking days.

Or,

• Option 2: You can stop taking tablets from the current blister pack. In this case, keep a maximum of 7 days of tablet-free period, including the day you forgot to take the tablet, and then continue with the tablets from a new blister pack.

If you have forgotten to take more than 1 tablet in the current blister pack:

If you have forgotten to take more than 1 tablet from the current blister pack, you will no longer be protected against pregnancy.

The probability of becoming pregnant increases the more tablets you have forgotten to take and the closer the forgotten tablets are to the tablet-free interval. Until your next normal menstruation, use an additional barrier contraceptive method (e.g., condoms). If bleeding does not occur after finishing the current blister pack, you may be pregnant. In this case, consult your doctor before starting a new blister pack.

If you have vomiting or diarrhea

If you have gastrointestinal problems, such as vomiting or diarrhea, the active ingredients of Adieris may not be fully absorbed into your body. If you vomit within 3 or 4 hours after taking the tablet, the effect is the same as if you forgot to take the tablet. Follow the instructions in case of forgetting a tablet. If you do not want to deviate from your normal rhythm, take a replacement tablet from another blister pack. If gastrointestinal symptoms persist for several days or are recurrent, use a barrier contraceptive method (e.g., condom) and inform your doctor.

If you want to delay your menstruation (your period)

If you want to delay your period, you should continue with the next Adieris blister pack immediately after taking the last tablet from the current blister pack. You can take all the tablets from this new blister pack that you want, until the end of the second blister pack. If you want bleeding to start, stop taking it. When using the second blister pack, you may experience bleeding or spotting. Regular Adieris intake is resumed after the 7-day tablet-free period.

If you want to change the start day of your period

If you take the tablets as indicated, you will have your period approximately on the same day every 4 weeks. If you want to change the day, you can shorten (but never prolong) the next tablet-free period between packs. If, for example, your period usually starts on a Friday and you want it to start on a Tuesday (3 days earlier) from now on, you should start the next pack 3 days earlier than usual. If you have a very short tablet-free period (e.g., 3 days or less), you may not have bleeding during the break, and you may experience bleeding or spotting during the use of the next pack.

If you interrupt treatment with Adieris

You can stop taking Adieris at any time. If you want to avoid becoming pregnant, ask your doctor about other reliable contraceptive methods.

If you stop taking Adieris because you want to become pregnant, it is generally recommended that you wait until you have had a natural period before trying to become pregnant. This way, you will be able to calculate the expected date of delivery more easily.

If you have any other questions about the use of 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 experience any adverse effect, particularly if it is severe or persistent, or if you notice any change in your health that you think may be due to adieris, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking adieris".

Severe Side Effects

Contact your 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 potentially with difficulty breathing (see also the section "Warnings and Precautions").

If any of the adverse effects is severe, or if you notice any adverse effect not described in this leaflet, consult your doctor.

Other Possible Adverse Effects

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

• headaches,
• breast pain, including discomfort and sensitivity in the breasts.

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

• inflammation of the genitals (vaginitis/vulvovaginitis), vaginal fungal infections (candidiasis, vulvovaginal infections),
• increased appetite,
• depressive mood,
• dizziness,
• migraine,
• high or low blood pressure, rarely increased diastolic blood pressure (lower value of blood pressure),
• abdominal pain (including upper/lower abdominal pain, discomfort/bloating),
• nausea, vomiting, or diarrhea,
• acne,
• hair loss (alopecia),
• skin rash (including localized rashes),
• itching (sometimes all over the body),
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea),
• spotting (vaginal hemorrhage and metrorrhagia),
• painful menstruation (dysmenorrhea), pelvic pain,
• breast enlargement, including breast swelling, breast edema,
• vaginal discharge,
• ovarian cysts,
• fatigue, including weakness and general malaise,
• changes in body weight (increase, decrease, or fluctuations).

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

• urinary tract infection,
• bladder infection (cystitis),
• breast infection (mastitis),
• cervicitis (inflammation of the cervix),
• fungal infections,
• cold sores,
• flu (influenza),
• bronchitis,
• sinus infection (sinusitis),
• upper respiratory tract infections,
• viral infections,
• uterine fibroids (benign tumors in the uterus),
• breast lipomas (benign tumors in breast tissue),
• anemia,
• hypersensitivity (allergic reactions),
• development of male characteristics (virilization),
• loss of appetite (anorexia),
• depression,
• mental disorders,
• insomnia,
• sleep disorders,
• aggressiveness,
• ischemic stroke (reduced or interrupted blood flow to the brain),
• cerebrovascular disorders (disorder of blood flow to the brain),
• change in muscle tone - dystonia (muscle disorders that can cause abnormal postures or movements),
• dry or irritated eyes,
• oscillopsia (eye disorder when objects appear to be moving) or other vision disorders,
• sudden hearing loss,
• ringing in the ears,
• vertigo,
• hearing impairment,
• cardiovascular disorders (disorders of blood flow to the heart),
• rapid heart rate (tachycardia),
• harmful blood clots in a vein or artery, for example:

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

The 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).

• increased diastolic blood pressure (the lowest blood pressure value reached between two heartbeats),
• orthostatic hypotension (dizziness or fainting when standing up after sitting or lying down),
• hot flashes,
• varicose veins,
• venous disorders, vein pain,
• asthma,
• rapid deep breathing (hyperventilation),
• gastritis,
• inflammation of the intestine,
• indigestion (dyspepsia),
• skin reactions,
• skin problems, allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (yellowish-brown patches, called "pregnancy patches" especially on the face),
• disorders of pigmentation/increased pigmentation,
• oily skin (seborrhea),
• dandruff,
• male pattern hair growth (hirsutism),
• orange peel skin,
• spider-like blood vessels with a central red spot on the skin (nevus),
• back pain,
• discomfort in the bones and muscles,
• muscle pain,
• pain in the arms and legs,
• abnormal cell growth on the surface of the cervix (cervical dysplasia),
• pain or cysts in the uterine appendages (Fallopian tubes and ovaries),
• breast cysts,
• fibrocystic breast disease (benign growths in the breast),
• pain during intercourse (dyspareunia),
• breast secretion (galactorrhea),
• menstrual disorders,
• chest pain,
• peripheral edema (fluid retention in the body),
• flu-like illness,
• fever,
• irritability,
• increased levels of triglycerides and cholesterol in the blood (hypertriglyceridemia, hypercholesterolemia).

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

• mood changes,
• increased or decreased sexual desire (libido),
• intolerance to contact lenses,
• hives (urticaria),
• skin disorders such as red, painful nodules (erythema nodosum) or rash with redness in a target shape or blisters (erythema multiforme),
• breast secretion,
• fluid retention.

If you suffer from hereditary angioedema, estrogen-containing medications may cause or worsen the symptoms of angioedema (see section "Warnings and Precautions").

Description of Selected Adverse Reactions

Adverse reactions with a very low incidence or late onset of symptoms related to the group of combined oral contraceptives are listed below (see also "Do not take adieris" and "What you need to know before taking adieris").

Tumors

• The frequency of breast cancer diagnosis among users of the "pill" increases slightly. Because breast cancer rarely occurs in women under 40 years of age, the risk of developing breast cancer is minimal compared to the general risk. It is not known if there is a causal relationship with the use of combined oral contraceptives.
• Liver tumors (benign and malignant).
• Cervical cancer.

Other Conditions

• Women with hypertriglyceridemia (increased amounts of fat in the blood may increase the risk of pancreatitis during the use of combined oral contraceptives).
• Increased blood pressure.
• Onset or worsening of conditions in which the association with combined oral contraceptives is unclear: jaundice and/or itching associated with cholestasis (blockage of bile flow), gallstones, porphyria (metabolic disorder), systemic lupus erythematosus (chronic autoimmune disease), hemolytic uremic syndrome (a disease caused by the formation of blood clots), a nervous disease called Sydenham's chorea, gestational herpes (a blistering disease that occurs during pregnancy), hearing loss caused by otosclerosis.
• In women with congenital angioedema (sudden swelling of the eyes, mouth, throat, etc.), externally administered estrogens may cause or worsen the symptoms of angioedema.
• Liver impairment.
• Changes in glucose tolerance or peripheral insulin resistance.
• Crohn's disease, ulcerative colitis.
• Chloasma (yellowish-brown patches on the skin).

Interactions

Unexpected bleeding and/or failure of contraceptives may be due to interactions of other medications with oral contraceptives (e.g., St. John's Wort, medications for treating epilepsy, tuberculosis, HIV infection, and other infections). See also "Other medications and adieris".

Reporting of Adverse Effects

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

5. Storage of adieris

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

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

Do not store above 30°C.

Keep the blister in the outer packaging to protect it from light.

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

6. Package Contents and Additional Information

Composition of adieris

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

Core:lactose monohydrate, magnesium stearate, cornstarch, povidone K-30.

Coating: Aquarius coating system, which contains: hypromellose 2910, macrogol 400 (PEG), titanium dioxide.

Appearance of the Product and Package Contents

adieris is a white, round, biconvex film-coated tablet.

adieris is available in packages containing 21, 3x21, and 6x21 film-coated tablets.

Not all 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

Laboratorios León Farma SA

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

24193, Villaquilambre, León, Spain

Date of the Last Revision of this Leaflet: December 2021

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 leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78572/P_78572.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78572/P_78572.html