Adieris Diario 2 mg/0.03 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

adieris Daily 2 mg/0,03 mg film-coated tablets EFG

dienogest/ethinylestradiol

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

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

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, as it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What adieris Daily is and what it is used for
What you need to know before taking adieris Daily
How to take adieris Daily
Possible side effects
How to store adieris Daily
Contents of the pack and other information

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

adieris Daily is:

an oral contraceptive tablet used to prevent pregnancy.
and for the treatment of women with moderate acne who require contraceptive therapy following failure of appropriate topical therapy or oral antibiotic treatment.

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

Oral contraceptives containing two hormones are known as "combined pills" or "combined hormonal contraceptives".

Each of the 7 pink tablets contains no active ingredients and are referred to as placebo tablets.

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 particularly important that you read about 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 individual situation, may perform additional tests.

This patient leaflet describes several situations in which you must stop taking adieris Daily, or in which the effectiveness of adieris Daily is reduced. In such cases, you should not have sexual intercourse without using additional non-hormonal contraceptive precautions, such as 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 body 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 infections.

Acne usually improves after 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 you must not take adieris Daily

Do 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 which 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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you need surgery or will be immobile for a long time (see section “Blood clots”).
If you have ever had a heart attack or stroke.
If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
If you have any of the following conditions that may increase your risk of developing 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 ingredients of this medicine (listed in section 6).
If you have or have ever had inflammation of the pancreas (pancreatitis) together with very high levels of fats (lipids) in the blood (hypertriglyceridemia).
If you have or have previously had severe liver disease and your liver function is still not normal.
If you have or have had a benign or malignant liver tumour.
If you have or have ever had, or if it is suspected that you have, hormone-dependent breast cancer or cancer of the genital organs or breasts (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 containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and adieris Daily”).

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

Warnings and precautions

When you should take special care with adieris Daily

When should you consult your doctor?

Seek urgent medical attention

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

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have 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 affecting your natural defence system).
If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).
If you have sickle cell anaemia (a hereditary red blood cell disorder).
If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
If you need surgery or will be immobile for a long time (see section 2 “Blood clots”).
If you have recently given birth, you are at higher risk of blood clots. You should ask your doctor when you can start taking adieris Daily after childbirth.
If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you have heart valve abnormalities or heart rhythm disorders.
If you have close relatives with breast cancer.
If you suffer from liver or gallbladder disease, gallstones.
If you have jaundice or itching due to bile congestion.
If you have yellow-brown patches on the skin, especially on the face (chloasma), or have had them during a previous pregnancy. In this case, avoid intense sunlight and UV radiation.
If you have certain disorders affecting haemoglobin formation (porphyria).
If you have depression.
If you have epilepsy.
If you have Sydenham's chorea (St. Vitus' dance).
If you had a blistering skin rash during a previous pregnancy (herpes gestationis).
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 together with difficulty breathing, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots may form:

In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
In arteries (called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to adieris Daily is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What could you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory illness (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance, or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

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

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking adieris Diario, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with adieris Diario is low.

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as adieris Diario, between 8 and 11 women will develop a blood clot in one year.
Your risk of developing a blood clot will depend on your personal medical history (see "Factors that increase your risk of a blood clot" below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women who use adieris Diario	About 8-11 out of 10,000 women

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

The risk of having a blood clot with adieris Daily is small, but certain conditions increase the risk. Your risk is higher:

If you are overweight (body mass index or BMI above 30 kg/m²).
If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
If you need surgery or remain immobile for long periods due to injury, illness, or if your leg is in a cast. You may need to stop using adieris Daily several weeks before surgery or while you are less mobile. If you need to stop taking adieris Daily, ask your doctor when you can start taking it again.
With increasing age (especially over approximately 35 years).
If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you need to stop using adieris Daily.

If any of the above conditions change while you are using adieris Daily—for example, if a close relative experiences a thrombosis without a known cause or you gain significant 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 may cause a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke while using adieris Daily is very small, but it may increase:

With age (especially over approximately 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 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 a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke.
If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
If you suffer from migraines, especially migraines with aura.
If you have a heart condition (valve 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 developing a blood clot may be further increased. 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 significant weight—inform your doctor.

adieris Daily and cancer

A slightly higher frequency of breast cancer has been observed in women who use combined oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they are examined more frequently by their doctors. The risk of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you notice any lump.

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of contraceptive pills. In isolated cases, these tumors have caused potentially life-threatening internal bleeding.

Consult your doctor if you have severe abdominal pain.

Some studies suggest that long-term use of the pill increases the risk of cervical cancer.

However, it is unclear to what extent sexual behavior (e.g., frequent change of partners) and other factors such as human papillomavirus (HPV) contribute to this risk.

When should you consult your doctor?

Periodic check-ups:

If you take the pill, your doctor will ask you to have periodic examinations. Normally, you should consult your doctor at least once a year.

Additionally, 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 illnesses affecting your family;
You feel a lump in your breast;
You are taking other medications (see also the section "Other medicines 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 experience severe and unusual vaginal bleeding between periods;
You have missed taking coated tablets during the first week of pill intake and had sexual intercourse within the previous 7 days;
You have not had your period twice in a row despite taking the coated tablets regularly and suspect you are pregnant.

Psychiatric disorders:

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

Medical consultation/examination

Before you start taking adieris Daily, your doctor will take a detailed medical history, including that of your close relatives. A general and gynecological examination will be performed, including a breast examination and cervical cytology. Pregnancy must be ruled out. These examinations should be repeated periodically while taking contraceptive tablets. Inform your doctor if you smoke or are taking any other medication.

If you have unexpected bleeding between periods

During the first few months of taking adieris Daily, you may experience unexpected bleeding. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (normally after about 3 tablet cycles). If you experience vaginal bleeding heavier than normal menstruation or light vaginal bleeding lasting several days, you should consult your doctor.

If you do not have a normal period

If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant. Continue taking the medicine as usual.

If you miss your period twice in a row, or if you have not taken adieris Daily as directed before the missed period, pregnancy is possible. 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 medicines and adieris Daily

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may cause intermenstrual bleeding and/or interfere with the contraceptive effect of adieris Daily.

Effects of other medicines on adieris Daily

Always inform your doctor about any medications or herbal remedies you are using. Also inform any other doctor or dentist prescribing you medications (or the pharmacist) that you are taking adieris Diario. They can advise you whether you need to take additional contraceptive precautions (for example, condoms) and for how long, or whether you should change the use of any other medication you require.

Some medicines:

have an effect on adieris Diario blood levels.
may make it less effective in preventing pregnancy.
may cause unexpected bleeding.

These include:

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

If you are taking any of the medicines listed above, you must also use a barrier method (e.g. a condom) temporarily or choose another contraceptive method. Use additional local contraception while you are taking other medicines together with adieris Diario and also for 28 days after stopping treatment with the other medicines.

If your treatment extends beyond the adieris Diario blister pack, start the next adieris Diario blister pack immediately, without the usual tablet-free interval.

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

Effects of adieris Diario on other medicines

adieris Diario may influence the effect of other medicines:

lamotrigine (could cause an increase in seizure frequency)
cyclosporine
theophylline (used to treat respiratory problems)
tizanidine (used to treat muscle pain or muscle cramps)

Also take into account the package leaflets of other prescribed products. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

Interactions with laboratory tests

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

adieris Diario with food and drinks

adieris Diario 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you are pregnant, do not take adieris Diario. If you become pregnant while taking adieris Diario, you must stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking it at any time (see “If you stop treatment with adieris Diario”).

Breastfeeding

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

Driving and use of machines

Dienogest/ethinylestradiol has no known effects on the ability to drive or operate machinery.

adieris Diario contains lactose

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

3. How to take adieris Diario

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

When and how should the tablets be taken?

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

Each pack includes 7 adhesive strips with the days of the week. This adhesive strip should be applied on the day you start taking the tablets. For example, if you start taking the tablets on a Tuesday, select the adhesive strip starting with "TUE" and apply it to the first row marked: “Place the adhesive strip matching your start date here”.

Take the tablets with water if necessary, at the same time each day, until the pack is finished. After taking the last tablet, start a new pack the following day. Always begin the next pack on the same day of the week.

During the 7 days when you take the pink placebo tablets, withdrawal bleeding usually begins. This typically starts on day 2 or 3 after taking the last white active tablet of adieris Diario. Once you have taken the last pink placebo tablet, start a new blister pack the next day, regardless of whether your bleeding has stopped. This means you will always start a new pack on the same day of the week and experience withdrawal bleeding on the same days each month.

If you use adieris Diario as directed, you will be protected against pregnancy also during the 7 days when you take the placebo tablets.

Starting the first pack of adieris Diario

When no hormonal contraceptive has been used in the previous month

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

When previously using another combined oral contraceptive tablet

You may preferably start taking adieris Diario the day after taking the last active tablet (the last tablet containing active ingredient) of your previous contraceptive, or at the latest the day after the tablet-free or placebo period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive).

When previously using a vaginal ring or transdermal patch

You may start taking adieris Diario on the same day of removal of the last vaginal ring or transdermal patch of a cycle pack, or at the latest on the day when reapplication of the ring or patch would normally occur.

When previously using a progestogen-only pill (also called “mini-pill”)

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

When previously using an injectable, implant, or intrauterine system (IUS) releasing progestogen

Start taking adieris Diario on the day your next injection is due, or on the day the implant or IUS is removed. However, you must use another contraceptive method (a barrier method) during the first 7 days of taking the new tablets when having sexual intercourse.

After childbirth

Do not start taking adieris Diario earlier than 21 to 28 days after childbirth. During the first 7 days of taking the tablets, you must also use a barrier contraceptive method (e.g., a condom). If you have already had sexual intercourse, pregnancy must be ruled out before starting adieris Diario, or you should wait until your first menstrual bleeding occurs. For use during breastfeeding, see “Pregnancy and breastfeeding”.

After a spontaneous or induced abortion

Your doctor will advise you accordingly.

If you take more adieris Diario than you should

No serious harmful effects have been reported following the intake of too many adieris Diario tablets at once. If you have taken several tablets at once, you may experience nausea, vomiting, and vaginal bleeding. If you find that a child has taken adieris Diario, seek advice from your doctor. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915620420, stating the medicine and the amount ingested.

If you forget to take adieris Diario

If you forget to take one of the pink placebo tablets, the effect of adieris Diario will not be affected. Discard the forgotten placebo tablet. If you forget to take a white active tablet, follow the recommendations below:

If the delay in taking a tablet is less than 12 hours, protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets at your usual time.
If the delay in taking any tablet is more than 12 hours, protection against pregnancy may be reduced. The more consecutive tablets you miss, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is especially high if you miss tablets at the beginning or end of the pack. Therefore, follow the rules given below (see also the diagram below).

More than 1 tablet missed from a pack

Consult your doctor.

1 tablet missed in week 1

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time), and take the next tablet at your usual time. Use an additional barrier contraceptive method (such as a condom) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a possibility you may be pregnant. Therefore, inform your doctor immediately.

1 tablet missed in week 2

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time), and take the next tablet at your usual time. Protection against pregnancy is not reduced, provided the tablets were taken correctly in the 7 days before the missed tablet. In this case, there is no need to use additional contraceptive methods. However, if you have missed more than one tablet, you must use an additional barrier contraceptive method for 7 days.

1 tablet missed in week 3

You may choose one of the following options, without needing to take additional precautions, provided the tablets were taken correctly in the 7 days before the missed tablet:

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time), and take the next tablet at your usual time. Instead of taking the pink placebo tablets from this pack, discard them and start the next pack immediately. You may not have a menstrual bleed until the end of the second pack, although you may experience irregular bleeding during the second pack.

Or:

Stop taking the white active tablets from the current pack and proceed directly to the 7 pink placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, take fewer than 7 placebo tablets.

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

More than one missed tablet	?	Consult your doctor
		?
		Yes
		?
	Week 1?	Did you have sexual intercourse in the week before the missed tablet?
		?
		No
		?
		Take the missed tablet as soon as possible Use additional contraceptive precautions for 7 days Finish the pack
Only one tablet missed (delay of more than 12 hours)
	Week 2?	Take the missed tablet as soon as possible Finish the pack

		Take the missed tablet as soon as possible Finish the pack Instead of taking the 7 placebo tablets, start the new pack immediately
	Week 3?	Or
		Stop taking the current pack Take the 7 placebo tablets (no more than 7 days, including the day the tablet was missed) Then continue with the next pack

What to do if you experience stomach problems (e.g., vomiting, severe diarrhoea)

If you vomit within 3 to 4 hours after taking the adieris Diario tablet, the active ingredients may not have been fully absorbed. This is equivalent to having missed a tablet. Therefore, follow the instructions for missed tablets. If you experience severe diarrhoea, consult your doctor.

What to do if you wish to delay menstrual bleeding

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

You may experience light bleeding or breakthrough bleeding during use of the second pack. After the seven days of placebo tablets, start the next pack.

You may consult your doctor before deciding to delay your menstrual period.

What to do if you wish to change the day when menstrual bleeding starts

If you take the tablets as directed, you will have your menstrual bleeding approximately on the same day every 4 weeks (during the placebo week). If you wish to change this day, you can shorten (but never extend) the number of placebo days. For example, if your menstrual bleeding usually starts on Friday and you want it to start on Tuesday (3 days earlier), start the new 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 use of the following pack.

If in doubt, consult your doctor.

If you stop treatment with adieris Diario

You may stop taking adieris Diario at any time. If you do not wish to become pregnant, consult your doctor about other methods of contraception.

If you stop taking adieris Diario because you wish to become pregnant, it is generally recommended to wait until you have a natural menstrual period before trying to conceive. This will make it easier to determine the expected date of delivery.

After stopping adieris Diario, it may take some time before a natural menstrual period occurs.

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

Additional information for special populations

Paediatric population

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

Elderly patients

adieris Diario is not indicated after menopause.

Hepatic impairment

adieris Diario is contraindicated in women with severe liver disorders (see section 2 of the package leaflet “Do not take adieris Diario”).

Renal impairment

The use of adieris Diario in women with renal impairment has not been studied. 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 everyone will experience them.

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to adieris Diario, consult your doctor.

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

Serious adverse effects

Serious 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". Please read these sections carefully and, if necessary, consult your doctor immediately.

Other possible adverse effects

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

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

Headache
Breast pain, including breast discomfort and breast tenderness

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

Inflammation of the vagina and/or external genitalia (vaginitis/vulvovaginitis), vaginal fungal infections (candidiasis, vulvovaginal infections)
Increased appetite
Depressed mood
Migraine, sensation of dizziness (vertigo)
Hypertension, hypotension
Abdominal pain (including bloating)
Nausea, vomiting, diarrhoea
Acne
Skin rash
Pruritus
Hair loss (alopecia)
Abnormal menstruation, such as heavy periods (menorrhagia), light periods (hypomenorrhoea), infrequent periods (oligomenorrhoea), or absence of menstruation (amenorrhoea)
Bleeding between periods, including vaginal bleeding and irregular bleeding between periods (metrorrhagia), painful bleeding (dysmenorrhoea)
Genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in internal genital organs, breast enlargement, breast oedema
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), fungal infections (e.g., Candida), viral infections (e.g., cold sores), flu (influenza), bronchitis, upper respiratory tract infections, inflammation of the paranasal sinuses (sinusitis)
Benign tumours in the uterus (fibroids), benign tumours in the fatty tissue of the breast (mammary lipoma)
Decrease in the number of red blood cells (anaemia)
Allergic reactions (hypersensitivity)
Development of male characteristics (virilism)
Loss of appetite (anorexia)
Depression, mental disorders, aggression, insomnia, sleep disturbances
Circulatory problems in the brain or heart
Dystonia (muscle disorder that may cause, for example, 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 veins, elevated diastolic blood pressure, dizziness or fainting upon standing up after sitting or lying down (orthostatic hypotension)
Varicose veins (varicose veins), venous disorders, pain in veins
Hot flushes
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
transient stroke-like symptoms or minor stroke, known as transient ischaemic attack (TIA)
blood clots in the liver, stomach/intestine, kidneys or eye.
The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).
Asthma, rapid or deep breathing (hyperventilation)
Inflammation of the stomach lining (gastritis), inflammation of the intestine (enteritis), indigestion (dyspepsia)
Allergic skin inflammation (dermatitis), skin rash (e.g., neurodermatitis), skin disease with thickened red patches (psoriasis), excessive sweating (hyperhidrosis), changes or disorders in skin colour (e.g., chloasma), overproduction of fat by sebaceous glands (seborrhoea), dandruff, skin lesions, orange-peel skin (cellulitis), spider veins, for example, chloasma, overproduction of fat by sebaceous glands (seborrhoea), dandruff, skin lesions, orange-peel skin (cellulitis), accumulation of blood vessels in a spider-like pattern with a central red spot on the skin (spider angioma).
Back pain, pain in bones, joints and muscles (e.g., myalgia), pain in arms and legs
Abnormal growth of cells on the surface of the cervix (cervical dysplasia)
Pain or cysts in uterine appendages (ovaries and fallopian tubes)
Breast cysts
Milk-like discharge from the breasts (galactorrhoea)
Pain or spasms during intercourse (dyspareunia)
Menstrual discomfort
Chest pain, swelling of hands, ankles or feet (peripheral oedema), flu-like symptoms, inflammation, fever, irritability.
Elevated levels of fat in the blood (increased 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
Increase or decrease in sexual desire (libido)
Intolerance to contact lenses
Urticaria
-Skin and/or mucosal reactions with rash, nodules,
Erythema nodosum or erythema multiforme
Breast discharge
Fluid retention (oedema)

Tumours

The frequency of diagnosis of breast cancer slightly increases in users of COCs. As breast cancer is rare in women under 40 years of age, the risk of developing breast cancer in relation to the overall risk is low. For more information, see section “adieris Diario and cancer”
Liver tumours (benign and malignant)
Cervical cancer

Other conditions

Hypertriglyceridaemia (elevated fat levels leading to an increased risk of pancreatitis with use of COCs)
Hypertension
Onset or worsening of conditions whose relationship with combined oral contraceptives is not established: jaundice and/or itching associated with cholestasis (bile flow obstruction); gallstone formation; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uraemic syndrome (a blood clotting disorder); a neurological disorder called Sydenham's chorea; herpes gestationis (a type of skin disease occurring 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 oestrogens may induce or worsen angioedema symptoms
Hepatic dysfunction
Changes in glucose tolerance or influenced peripheral insulin resistance
Crohn's disease, ulcerative colitis
Chloasma

Interactions

Unexpected intermenstrual bleeding and/or contraceptive failure may occur due to interactions between other medicines and oral contraceptives (e.g., the herbal product St. John's wort or medicines used to treat epilepsy, tuberculosis, HIV infections and other infections; see “Other medicines and adieris Diario”).

Other serious reactions associated with taking this contraceptive, as well as related symptoms, are described in the section “Warnings and precautions”.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of adieris Daily

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of adieris Diario

Active tablets:

The active substances are ethinylestradiol and dienogest. Each coated tablet contains: 2 mg of dienogest and 0.03 mg of ethinylestradiol.
Other components are: Povidone K30, corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol/macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc (E553b).

Placebo tablets:

Components are: Povidone K30, corn starch, 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 contents of the pack

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

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

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

Pack sizes:

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

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

Only certain pack sizes may be commercially available.

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 the most recent review of this leaflet: September 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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