Label: information for the user

adieris 2 mg/0.03 mg film-coated tablets EFG

dienogest/etinilestradiol

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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting 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 this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

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

Pills that contain two hormones are called "combined" or combined oral contraceptives.

Oral contraceptives (administered orally) are a very effective method of family planning. If taken regularly (without missing pills), the likelihood of becoming pregnant is very low.

Clinical trials have shown that, in women in whom a pronounced effect of male hormones (called "androgens") causes acne,adierisimproves these symptoms.

adieris is used:

• to prevent pregnancy;
• for the treatment of women with moderate acne who accept receiving a contraceptive pill after the failure of suitable local treatments or oral antibiotics.

The acne will usually 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.

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 etinilestradiol, 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 vein of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that 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 surgery or if you spend a lot of time without standing 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 blood clot in the arteries:

• Severe diabetes with vascular 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 may cause yellowing of the skin (jaundice) or itching all over the body, and indicate a liver function anomaly.
• If you have, have had, or are suspected of having cancer (for example, breast cancer or endometrial cancer) that affects sex hormones.
• If you have unexplained vaginal bleeding.
• 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 you are affected by any of the above conditions for the first time while taking the pill, you should stop taking it immediately and consult your doctor. Meanwhile, 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 girls who have not yet menstruated.

Use in older women

Adieris is not for postmenopausal women.

Liver insufficiency

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

Renal insufficiency

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

Warnings and precautions

When to be particularly careful with adieris

Consult your doctor or pharmacist before starting to take adieris.

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

Inform 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 you have diabetes mellitus;
• if you have obesity;
• if you have high blood pressure;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (LES – a disease that affects your natural defense system);
• if you have hemolytic uremic syndrome (SUH – a blood clotting disorder that causes kidney insufficiency);
• 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 surgery or spend a lot of time without standing up (see section 2 “Blood Clots”);
• if you recently gave birth, you are at greater risk of blood clots. You should ask your doctor when you can start taking adieris after delivery;
• if you have superficial thrombophlebitis (inflammation of the veins under the skin);
• if you have varicose veins;
• if you have a heart valve disease or heart rhythm disorders;
• if any of your close relatives have had a blood clot (thrombosis in the lower limb, in the lung - pulmonary embolism, or in any other location), a heart attack, or a stroke at a young age;
• if you have migraines;
• if you have depression; some women who use hormonal contraceptives like adieris have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible;
• if you have epilepsy (see “Other medications and adieris”);
• if any close relative has or has had breast cancer;
• if you have liver or gallbladder disease;
• if you have or have had a disease that appeared during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy called herpes gestational, a nervous disease called Sydenham's chorea);
• if you have brownish-yellow patches on your skin, especially on your face (melasma), if this happens to you, you should avoid direct sunlight or ultraviolet light;
• if you have hereditary or acquired angioedema: estrogen-containing products can cause or worsen angioedema symptoms. Contact your doctor immediately if you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with potential difficulty breathing.

In the case of any of these situations appearing for the first time, having recurrences, or worsening while taking the pill, consult your doctor.

BLOOD CLOTS

The use of a combined hormonal contraceptive like adieris increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be lasting or, very rarely, fatal effects.

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 assistanceif 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 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 may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood 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 a combined hormonal contraceptive is taken for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) 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 a blood clot returns to normal in 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 is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who are using a combined hormonal contraceptive containing dienogest and etinilestradiol like adieris, 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

Your risk of a blood clot with adieris is small, but some conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index (BMI) greater than 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 about 50 years). You may have a hereditary disorder of blood clotting;
• if you need surgery or spend a lot of time without standing up due to an injury or disease, or if you have a leg cast. You may need to interrupt the use of adieris for several weeks before the surgical procedure or while you have reduced mobility. If you need to interrupt the use of adieris, ask your doctor when you can start using it again;
• with increasing age (especially over about 35 years);
• if you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (more than 4 hours) may temporarily increase your 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 unsure. Your doctor may decide that you should interrupt the use of adieris.

If any of the above conditions change while you are using adieris, for example, a close relative experiences a blood clot 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 blood 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 adieris is very small, but it may increase:

• with age (over about 35 years);
• if you smoke.When using a combined hormonal contraceptive like adieris, 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 close relative has had a heart attack or stroke at a young age (less than about 50 years). You may also be at higher risk of a heart attack or stroke;
• if you or any close relative has 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, your risk of 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 blood clot without a known cause, or you gain a lot of weight, inform your doctor.

The Pill and cancer

Breast cancer has been observed more frequently in women who use oral contraceptives, but it is not known whether 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 appearance of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts regularly checked and to contact your doctor if you notice any lump.

Benign liver tumors and, in rare cases, malignant liver tumors have been reported in users of oral contraceptives. In rare cases, these tumors can cause life-threatening internal bleeding. Contact your doctor immediately if you experience severe stomach pain.

The most important risk factor for cervical cancer is 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

There has been a documented increase in blood pressure in women taking the pill. More commonly, this occurs in older users and those 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 which case, consult your doctor; see also the sections “Do not take adieris”, “Stop taking adieris immediately” and "Your doctor will perform regular check-ups").

• Melasma

Occasionally, brownish-yellow patches (melasma) may appear on the skin, especially in women who have had them during pregnancy. For this reason, women with this disposition should not expose themselves to sunlight or ultraviolet light while taking the pill.

• Hereditary angioedema

If you suffer from hereditary angioedema, estrogen-containing products can cause or worsen angioedema symptoms. Contact your doctor immediately if you experience angioedema symptoms such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with potential difficulty breathing.

• Irregular bleeding (intermenstrual bleeding)

During the first few months of using the pill, irregular bleeding (spotting or bleeding) may occur. Inform your doctor if the irregular bleeding continues for more than 3 months or if it recurs after 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 missed period or if you have not had two consecutive periods, you may be pregnant. Pregnancy should be ruled out with certainty before continuing to take adieris.

When you stop taking the pill, it may take some time for your cycle to normalize again.

Reduced efficacy

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

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

Doctor visits/check-ups

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

Adieris will not protect you against HIV (AIDS) infection or other sexually transmitted diseases.

Other medications and adieris

Some medications may affect the levels of dienogest/etinilestradiol in the blood and may make itless effective in preventing pregnancy, or may cause unexpected bleeding.

• These include medications used to treat:

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

• medications that increase intestinal motility (for example, metoclopramide);
• herbal remedies such as St. John's Wort;
• grapefruit juice.

Adieris mayinfluence the efficacy of other medications, for example:

• lamotrigine
• ciclosporin
• 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 cause increases in liver function test results (elevated ALT levels).

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”).

Consult your doctor or pharmacist before taking any medication. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. They can advise you on additional protective measures while taking another medication with adieris.

Diabetes

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

Laboratory tests

If you need to have a blood test, inform the doctor or laboratory staff that you are taking a combined oral contraceptive, as this medication may affect the results of some tests, including liver function tests, adrenal function tests, kidney function tests, and thyroid function tests, as well as the levels of certain proteins in the blood, such as those involved in lipid metabolism, carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes are usually within normal limits.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take adieris during pregnancy. If you become pregnant while taking adieris, stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking adieris at any time (see “Stopping treatment with adieris”).

Lactation

The use of adieris is generally not recommended during lactation. If you want to take the pill while breastfeeding, inform your doctor.

Driving and operating machinery

No studies have been conducted on the effect onthe ability to drive and operate machinery.

Adieris contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in 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 contains 21 film-coated tablets. Next to each tablet, the day of the week is printed on which it should be taken. 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 the 21 tablets. Do not take any tablets during the 7 days that follow. Menstruation (bleeding due to deprivation) should occur during these 7 days. This usually starts 2 or 3 days after you take the last Adieris tablet.

Start a new blister on the 8th day, whether the bleeding has stopped or continues. This means that you should start each blister on the same day of the week and that the bleeding due to deprivation should occur on the same days of each month.

With the proper use of combined oral contraceptives, your failure rate 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 in the past month:

Start Adieris on the first day of the menstrual cycle (the first day of menstruation will be counted as Day 1), taking the tablet corresponding to the day of the week on which you are. Follow in the correct order the days that follow. In this way, Adieris works from the very beginning and no other contraceptive method is needed.

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 change from another combined 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 package (that means there will be no interval without taking a tablet). If your previous package 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 days without tablets from your previous pill (or after taking the last placebo tablet from your previous pill). In the case of a patch or vaginal ring, you should start taking Adieris preferably the day you remove it, but no later than the day you would have to put it back on.

If you change from a progestin-only method (mini-pill containing only progesterone, injection, implant, or intrauterine device (IUD) releasing progestin)

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 sex, you should use an additional barrier contraceptive method during the first 7 days of taking Adieris. From an injectable, an implant, or IUD, start taking Adieris on the day you would normally receive the next injection or the day the implant or IUD is removed. However, if you have sex, you should use an additional barrier contraceptive method during the first 7 days of taking the tablets.

After giving birth

If you have just given birth, 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 giving birth, you have had sex before starting to take Adieris, you must first make sure you are not pregnant or wait for your next period.

If you are breastfeeding your baby 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 within 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 quantities or if you discover that a child has taken the pill.

If you forgot 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 missed tablet as soon as possible and continue taking the next ones at the usual time.

If it has been more than 12 hourssince you should have taken the tablet, the 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 package. Therefore, you should follow the rules given below (see also the diagram below).

More than one tablet forgotten

Contact your doctor.

Do not take more than 2 tablets in a day to compensate for the forgotten tablet.

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

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

If you forgot to take 1 tablet in week 1:

If you forget to start taking a new package or if you forget to take the tablet within the first 7 days, there is a risk of pregnancy (if you have had sex within the 7 days before forgetting the tablet). Contact your doctor before taking the new package. See also the diagram below.

If you have not had sex before forgetting the tablet, take the missed tablet as soon as you remember (although this means taking two tablets at once) 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 forgot to take 1 tablet in week 2:

Take the missed tablet as soon as you remember (although this means taking two tablets at once) and take the next tablet at the usual time. The effectiveness of the pill is maintained and additional contraceptive measures are not necessary.

If you forgot to take 1 tablet in week 3:

If you follow one of the following options, additional contraceptive measures are not necessary:

• Option 1:take the missed tablet as soon as you remember (although this means taking two tablets at once). Then continue taking the next tablets at your usual time. The next package should be started immediately after taking the last tablet of your current package, that is,do not leave an interval without tablets between packages. It is unlikely that you will have bleeding until the end of the second package, but you may stain or bleed even on the days of taking the tablet.

Or,

• Option 2: you can stop taking tablets from the current package in use. In that case, keep a maximum of 7 days of break period,including the day you forgot to take the tablet, and then continue with the tablets of a new package.

If you forgot to take more than 1 tablet in thepackagecurrent:

If you forgot to take more than 1 tablet from the current package, you are no longer protected against pregnancy.

The probability of becoming pregnant increases the more tablets you have forgotten to take and the closer the forgetfulness is to the interval without tablets. Until your next normal period, use an additional barrier contraceptive method (e.g. condom). If there is no bleeding after finishing the currentpackage, you may be pregnant. In this case, consult your doctor before starting a newpackage.

If you have vomiting or diarrhea

If you have digestive problems, such as vomiting or diarrhea, the active ingredients of Adieris may not be fully absorbed by 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 usual rhythm, take a replacement tablet from another package. If your 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 package immediately after taking the last tablet from the current package. You can take all the tablets from this new package as you want, until the end of the second package. If you want your period to start, stop taking it. When you use the second package, you may have bleeding or spotting. Regular use of Adieris is resumed after the 7-day break period.

If you want to change the day of the start 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 break period between packages. If, for example, your period usually starts on Friday and you want it to start from now on on Tuesday (3 days earlier), you should start the next package 3 days earlier than usual. If you make a very short break period (e.g. 3 days or less), it is possible that you will not have your period during the break, and you will have bleeding or spotting during the use of the next package.

If you interrupt the 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 usually recommended that you wait until you have had a natural period before trying to become pregnant. In this way, you can calculate your due date more easily.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, particularly if it is severe or persistent, or if you notice any change in your health that you think may be related to Adieris, consult your doctor.

All women taking combined hormonal contraceptives are at increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take 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 potentially life-threatening urticaria (see also the section “Warnings and precautions”).

If any of the side effects are severe, or if you observe any side effect not described in this leaflet, consult your doctor.

Other possible side effects

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

• headaches,
• breast pain, including discomfort and tenderness 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 blood pressure value),
• abdominal pain (including upper/lower abdominal pain, discomfort/swelling),
• nausea, vomiting, or diarrhea,
• acne,
• hair loss (alopecia),
• skin rash (including localized rashes),
• pruritus (sometimes all over the body),
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), weak bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea),
• spotting (vaginal bleeding and metrorrhagia),
• menstrual pain (dysmenorrhea), pelvic pain,
• breast enlargement, including breast swelling, breast edema,
• vaginal discharge,
• ovarian cysts,
• fatigue, including weakness and general malaise,
• weight changes (increased, decreased, or fluctuations).

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

• inflammation of the Fallopian tubes or ovaries,
• urinary tract infection,
• bladder infection (cystitis),
• breast infection (mastitis),
• inflammation of the cervix,
• fungal infections,
• herpes labialis,
• influenza,
• bronchitis,
• sinusitis,
• upper respiratory tract infections,
• viral infections,
• uterine fibroids (benign tumors in the uterus),
• breast lipomas (benign tumors in the fatty tissues of the breast),
• anemia,
• hypersensitivity (allergic reactions),
• development of male characteristics (virilism),
• loss of appetite (anorexia),
• depression,
• mental disorders,
• insomnia,
• sleep disorders,
• aggressiveness,
• ischemic stroke (decreased or interrupted blood flow to the brain),
• cerebrovascular disorders (disorders of blood flow to the brain),
• muscle dystonia (muscular disorders that can cause abnormal postures or movements),
• dry or irritated eyes,
• oscillopsia (ocular disorder when objects appear to move) or other visual disorders,
• sudden loss of hearing,
• tinnitus,
• dizziness,
• 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:

• in a leg or foot (i.e., deep vein thrombosis)
• in a lung (i.e., pulmonary embolism)
• heart attack
• stroke
• mini-stroke or transient 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 (lower blood pressure value),
• orthostatic hypotension (dizziness or fainting when standing up after sitting or lying down),
• hot flushes,
• varicose veins,
• venous disorders, pain in the veins,
• 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,
• melasma (yellow-brown patches, especially on the face),
• skin pigmentation disorders/increased pigmentation,
• oily skin (seborrhea),
• dandruff,
• male pattern hair growth (hirsutism),
• orange skin,
• blood vessels with a spider-like appearance, with a red central spot on the skin (cutaneous nevus),
• back pain,
• bone and muscle discomfort,
• muscle pain,
• pain in arms and legs,
• abnormal growth of cells on the surface of the cervix (cervical dysplasia),
• pelvic pain or cysts in the ovaries or Fallopian tubes,
• breast cysts,
• benign breast growths (fibrocystic disease),
• painful intercourse (dyspareunia),
• breast secretion (galactorrhea),
• menstrual disorders,
• inflammation of tissue outside the breasts (accessory breasts),
• chest pain,
• peripheral edema (fluid retention in the body),
• illness similar to the flu,
• inflammation,
• fever,
• irritability,
• increased triglycerides and cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia).

Unknown frequency(cannot be estimated from available data):

• mood changes,
• increased or decreased libido,
• contact lens intolerance,
• hives (urticaria),
• skin disorders such as painful, red, and painful nodules (erythema nodosum) or a rash with a target-like appearance or blisters (erythema multiforme),
• breast secretion,
• fluid retention.

If you have hereditary angioedema, the estradiol in Adieris may cause or worsen the symptoms of angioedema (see section "Warnings and precautions").

Selected adverse reaction descriptions

The following adverse reactions with 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 starting to take Adieris").

Cancer

• The frequency of breast cancer diagnosis among users of the "pill" increases slightly. Since breast cancer rarely occurs in women under 40, 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.
• Benign and malignant liver tumors.
• Cervical cancer.

Other conditions

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

Interactions

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

Reporting of adverse reactions

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

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30ºC.

Store the blister pack in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of adieris

• The active principles are dienogest and etinilestradiol. A coated tablet contains 2 mg of dienogest and 0.03 mg of etinilestradiol.
• The other components 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 contents of the packaging

adieris is a white, round, biconvex coated tablet.

adieris is available in packaging containing 21, 3x21, and 6x21 coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Laboratorios León Farma SA

La Vallina s/n, Navatejera Industrial Estate,

24193, Villaquilambre, León, Spain

Last review date of this leaflet: December 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and updated information on 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