DIENOGEST/ETHINYLESTRADIOL ARISTO 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dienogest/Ethinylestradiol Aristo 2 mg/0.03 mg Film-Coated Tablets EFG

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 not listed in this package leaflet. See section 4.

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

Package Leaflet Contents

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

1. What is Dienogest/Ethinylestradiol Aristo and what is it used for

• Dienogest/Ethinylestradiol is a medication

• to prevent pregnancy ("the pill" contraceptive);
• for the treatment of women with moderate acne who accept receiving a contraceptive pill after the failure of adequate local or oral antibiotic treatments.

• Each of the 21 film-coated tablets contains a small amount of the female hormones ethinylestradiol and dienogest.
• The tablets containing two hormones are called "combined" pills.
• Clinical trials have shown that, in women where a pronounced effect of male hormones (called "androgens") causes acne, this medication improves these symptoms.

2. What you need to know before taking Dienogest/ethinylestradiol Aristo

Consult your doctor or pharmacist before starting to take this medication.

General considerations

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

Before you start taking this medication, your doctor will ask you some questions about your medical history and that of your closest relatives. Your doctor will also take your blood pressure and, depending on your state of health, may perform other tests.

This prospectus describes some situations in which you should stop using this medication, or cases in which its reliability may decrease. In these situations, you should not have sexual intercourse or should take other non-hormonal contraceptive measures, such as using a condom or another barrier method. Do not use calendar or temperature methods. These methods are not reliable, as the use of dienogest/ethinylestradiol alters body temperature and cervical mucus.

Like other hormonal contraceptives, this medication does not protect against HIV infection (AIDS) or any other sexually transmitted disease (STD).

Your acne will generally improve between three and six months after starting treatment, and may continue to improve even after six months. You should consult with your doctor about the need to continue treatment three or six months after starting and then regularly.

When not to use dienogest/ethinylestradiol

You should not use dienogest/ethinylestradiol if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not take dienogest/ethinylestradiol if:

• you are allergic to ethinylestradiol or dienogest or any of the other components of this medication (included in section 6);
• you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs;
• 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;
• you need an operation or if you spend a lot of time without getting up (see section "Blood clots");
• you have ever suffered a heart attack or stroke;
• you have (or have ever had) angina pectoris (a condition that causes severe chest pain and can be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of stroke);
• 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.
• you have (or have ever had) a type of migraine called "migraine with aura".
• you have (or have ever had) inflammation of the pancreas (pancreatitis) along with very high levels of fat in the blood (hypertriglyceridemia);
• you have (or have ever had) severe liver disease, unless liver function tests in blood have returned to normal;
• you have (or have ever had) benign or malignant liver tumors;
• you have, have had, or are suspected of having cancer (e.g., breast or endometrial cancer) that is affected by sex hormones;
• you suffer from vaginal bleeding of unknown origin;
• you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section 2 "Other medications and Dienogest/ethinylestradiol Aristo").

If you are affected by any of the above conditions for the first time while taking this medication, you should stop taking the medication immediately and consult your doctor. In the meantime, you should use a different non-hormonal contraceptive method. See also section 2 "Warnings and precautions".

Warnings and precautions

When you should be particularly careful with dienogest/ethinylestradiol

Stop taking dienogest/ethinylestradiol immediately,

• if you are pregnant or think you may be pregnant,
• if you have any sign of phlebitis or blood clots (see also "Blood clots"),
• if your blood pressure increases constantly to reach values of 140/90 mmHg,
• if a surgical intervention is planned (at least 4 weeks before) or if you are immobilized for a long time (see also "Blood clots"),
• if you have migraine for the first time or if it worsens,
• if you have unusually frequent, persistent, or severe headaches,
• if you experience severe pain in the upper abdomen (see also "Dienogest/ethinylestradiol and cancer"),
• if your skin or the whites of your eyes turn yellow, your urine turns brown, and your stools become very pale (jaundice), or if you have itching all over your body,
• if you are diabetic (diabetes mellitus) and your blood sugar levels increase suddenly,
• if you have a certain metabolic disorder (porphyria).

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

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

If the condition develops or worsens while using dienogest/ethinylestradiol, you should also inform your doctor if:

• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus erythematosus (SLE - a disease that affects your natural defense system);
• you have hemolytic uremic syndrome (HUS: a blood clotting disorder that causes kidney failure);
• you have sickle cell anemia (a hereditary disease of red blood cells);
• you have high levels of fat in the blood (hypertriglyceridemia) or a positive family history of this disease. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• you need to undergo surgery or spend a lot of time without getting up (see section 2 "Blood clots");
• you have just given birth and are at higher risk of blood clots. You should ask your doctor when you can start taking dienogest/ethinylestradiol after childbirth;
• you have inflammation in the veins that are under the skin (superficial thrombophlebitis);
• you have varicose veins;
• you have a heart valve disease or heart rhythm disorders;
• one of your close relatives has had or has breast cancer;
• you have liver or biliary disease or gallstones;
• you have a liver or biliary disease;
• you have brown-yellow spots on the skin, especially on the face (chloasma), or if you had them during a previous pregnancy; if this happens, you should avoid direct sunlight or UV radiation;
• you have certain problems with hemoglobin formation (porphyria);
• you suffer from depression;
• you have epilepsy;
• you have a nervous system disease, Sydenham's chorea;
• you had a skin rash during a previous pregnancy (gestational herpes);
• you have hearing loss in the inner ear (hearing loss related to otosclerosis);
• you have symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with potential difficulty breathing, contact your doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like dienogest/ethinylestradiol increases the risk of developing 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 (called "venous thrombosis", "venous thromboembolism" or VTE),
• in the arteries (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 dienogest/ethinylestradiol 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 breaks loose from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of 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 of taking 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 this medication, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

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

The overall risk of a blood clot in the leg or lung (DVT or PE) with dienogest/ethinylestradiol is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop 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 develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal contraceptive that contains dienogest and ethinylestradiol, like this medication, between 8 and 11 women will develop a blood clot in a year.

The risk of a blood clot depends on your personal history (see "Factors that increase your risk of a blood clot" below).

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

The risk of a blood clot with dienogest/ethinylestradiol is small, but some conditions increase the risk.

Your risk is higher:

• if you are overweight (body mass index or BMI over 30 kg/m2);
• if any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50); in this case, you may have a hereditary disorder of blood clotting;
• if you need surgery or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using this medication several weeks before surgery or while you have reduced mobility. If you need to stop using this medication, ask your doctor when you can start using it again;
• as you get older (especially above 35 years);
• if you have recently given birth.

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

Long-distance flights (more than 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide to stop the use of dienogest/ethinylestradiol.

If any of the above conditions change while you are using this medication, 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 blood clots in the veins, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

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

It is worth noting that the risk of a heart attack or stroke with the use of dienogest/ethinylestradiol is very small, but it can increase:

• with age (above 35 years);
• if you smoke. When using a combined hormonal contraceptive like this medication, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke;
• if you or any of your close relatives have 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, rhythm disturbance).

• if you have a heart valve disorder or a certain heart rhythm disorder (called atrial fibrillation);
• if you have diabetes.

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

If any of the above conditions change while you are using dienogest/ethinylestradiol, 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.

Dienogest/ethinylestradiol and cancer

Cases of breast cancer have been observed with a slightly higher frequency in women using "combined oral contraceptives", but it is not known if this is due to the treatment. For example, it could be that more cancers are detected in women taking combined pills because they attend medical consultations more frequently. The incidence of breast cancer decreases after discontinuing treatment with combined hormonal contraceptives. Regular breast examination is important, and you should contact your doctor as soon as possible if you notice any lump.

Rare cases of benign liver tumors, and even more rarely, malignant liver tumors have been reported in women taking the pill. In isolated cases, these tumors have caused potentially life-threatening internal bleeding.

Contact your doctor immediately if you have severe abdominal pain in the upper abdomen.

Some studies suggest that long-term use of the "pill" increases the risk of developing cervical cancer. However, it is not clear to what extent sexual behavior (e.g., frequent change of partner) and other factors such as the human papillomavirus (HPV) increase this risk.

When should you consult your doctor?

Regular check-ups

If you are taking the pill, your doctor will ask you to undergo regular check-ups. Normally, you should consult your doctor at least once a year.

Also, consult your doctor immediately ifyou

• notice any change in your state of health, especially those mentioned in sections 2 under "Do not take Dienogest/ethinylestradiol Aristo" and "When should you be careful with Dienogest/ethinylestradiol Aristo". Do not forget about diseases that affect your family;
• feel a lump in your breast;
• are taking other medications at the same time (see also section 2 "Other medications and Dienogest/ethinylestradiol Aristo");
• are bedridden for a prolonged period or are going to undergo surgery (consult your doctor at least four weeks in advance);
• have any severe and unusual vaginal bleeding between periods;
• have forgotten to take the film-coated tablets in the first week of taking tablets and have had sexual intercourse in the previous 7 days;
• have not menstruated twice in a row despite taking the film-coated tablets regularly and suspect you are pregnant.

Psychiatric disorders

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

If you have unexpected bleeding between periods

With all tablets, non-consecutive bleeding (bleeding between periods) may occur, especially in the first few months of taking the tablet. You may need to use pads or tampons, but you do not need to stop taking dienogest/ethinylestradiol. Mild bleeding between periods usually stops once your body gets used to taking the tablet, which usually happens within 3 months. If you experience heavier vaginal bleeding similar to a normal menstrual period or light vaginal bleeding that lasts for several days, you should consult your doctor.

If you do not have a normal menstrual period

If you have taken your tablets correctly, have not had any vomiting or severe diarrhea, and have not taken any other medication, the likelihood of you being pregnant will be extremely low. Continue taking this medication as usual.

If you miss your menstrual period twice in a row, or if you have not been taking this medication according to the instructions before the first missed period, there is a possibility of pregnancy. Consult your doctor immediately. Do not take this medication until your doctor has ruled out pregnancy.

Children and adolescents

This medication can only be used after the first menstrual period (menarche).

Other medications and Dienogest/ethinylestradiol Aristo

Effect of other medications on dienogest/ethinylestradiol

Some medications

• may affect dienogest/ethinylestradiol levels in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include

• medications used to treat

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (e.g., griseofulvin, ketoconazol);
• arthritis, arthrosis (etoricoxib);

• the herbal remedy St. John's Wort.

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

If your treatment is prolonged beyond the blister strip of dienogest/ethinylestradiol, start with the next blister strip immediately, without the usual pill-free interval.

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

Effect of dienogest/ethinylestradiol on other medications

This medication may affect the effect of other medications, e.g.,

• the antiepileptic lamotrigine (may increase the frequency of seizures)
• medications containing cyclosporin
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat pain and/or muscle cramps)

Do not take this medication if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, 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.

This medication can be used again approximately 2 weeks after the end of this treatment. See section 2 "Do not take dienogest/ethinylestradiol").

Also, note the instructions for use of the other prescribed medications.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication, including medications without a prescription.

Interactions with laboratory tests

The use of this medication may affect the results of certain laboratory tests, including liver values, adrenal cortex, renal function, and thyroid function, as well as the amount of certain proteins in the blood, such as those that affect lipid metabolism, carbohydrate metabolism, blood coagulation, and fibrinolysis. However, these changes are usually still within normal limits.

Dienogest/ethinylestradiol with food and beverages

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

Pregnancy and breastfeeding

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

Pregnancy

You should not take dienogest/ethinylestradiol during pregnancy. You should not be pregnant before starting to take this medication. If you become pregnant while taking this medication, you should stop taking it immediately and contact your doctor.

Breastfeeding

Do not use dienogest/ethinylestradiol while breastfeeding, as it may reduce milk production, and small amounts of the active ingredient may pass into breast milk. You should use a non-hormonal contraceptive method while breastfeeding.

Driving and using machines

This medication does not affect your ability to drive or use machines.

Dienogest/ethinylestradiol Aristo contains lactose

Each film-coated tablet contains 44.57 mg of lactose (as lactose monohydrate).

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 Dienogest/etinilestradiol Aristo

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

Dienogest/etinilestradiol should be taken according to the following instructions for both pregnancy prevention and treatment of women with moderate acne. Note the instructions in section 3 "If you forget to take dienogest/etinilestradiol" to maintain the contraceptive effect.

Take one tablet of this medication per day. The tablets are taken without chewing and, if necessary, with a little water. The tablets should be taken approximately at the same time every day. It does not matter if you take the tablets on an empty stomach or with meals.

Each blister pack contains 21 film-coated tablets. Next to each tablet is printed the day of the week on which it should be taken; take one tablet per day. If, for example, your menstruation starts on a Friday, remove the first tablet from the calendar pack marked with Fri (Friday), pushing it through the aluminum foil. Then, take one tablet after another, day after day.

The time of day is irrelevant, but once chosen, you must stick to it. Follow the direction of the arrow on the strip until you have taken all 21 tablets. Then, do not take any tablets for 7 days. During these 7 days without tablets, menstruation (withdrawal bleeding) should occur 2-3 days after taking the last tablet.

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

If you take this medication as prescribed, you will also be protected against pregnancy during the 7 days when you do not take any tablets.

When to start taking this medication

If you have not used hormonal contraceptives in the previous month:

Start treatment on the first day of your cycle, i.e., the first day of your menstruation.

If you are switching to dienogest/etinilestradiol from another combined hormonal contraceptive:

You can start taking dienogest/etinilestradiol the day after taking the last pill of your previous contraceptive, but no later than the day after the usual pill-free interval or after taking the inactive pills of the previously taken oral contraceptive.

If you are switching from a vaginal ring or transdermal patch to dienogest/etinilestradiol:

You should start taking dienogest/etinilestradiol 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, injection, implant) or an intrauterine system (IUS, hormonal spiral) of progestogen to dienogest/etinilestradiol:

The change from mini-pills can be made on any day. The change from an implant or intrauterine system is made on the day the implant is removed, and from an injectable when the next injection is due; in any case, you must use an additional contraceptive method during the first 7 days of taking the tablets.

If you want to use dienogest/etinilestradiol after a spontaneous abortion in the first trimester of pregnancy:

Please consult your doctor. In principle, you can start taking the tablets immediately.

If you want to use it after a spontaneous abortion in the second trimester of pregnancy or after childbirth:

If you want to start taking the tablets, your doctor will recommend that you start taking them between 21 and 28 days after childbirth or a spontaneous abortion in the second trimester. If you start taking this medication later, you must use an additional contraceptive method (e.g., a condom) during the first 7 days of taking this medication.

However, if you have already had sexual intercourse before starting to take dienogest/etinilestradiol, you must first ensure that you are not pregnant or wait until your next period.

If you want to breastfeed after the birth of your child and start taking dienogest/etinilestradiol:

Please read the "Breastfeeding" section.

If you take more dienogest/etinilestradiol 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.

There are no reports of serious adverse effects after taking too many dienogest/etinilestradiol tablets.

If you have taken several tablets at once, you may experience nausea and vomiting or vaginal bleeding. Even girls who have not yet started menstruating but have accidentally taken this medication may experience this type of bleeding.

If you have taken too many dienogest/etinilestradiol tablets, or if you discover that a child has accidentally ingested some tablets, consult your doctor or pharmacist.

If you forget to take dienogest/etinilestradiol

If you are less than 12 hours late in taking a tablet, contraceptive protection is still guaranteed. You should take the forgotten tablet as soon as possible and then take the following tablets at the usual time of day.

If you are more than 12 hours late in taking a tablet, you may no longer have complete protection against pregnancy. The more tablets you have forgotten, the higher the risk of the contraceptive effect of the pill.

There is a particularly high risk of becoming pregnant if you forget to take a tablet at the beginning or end of the strip. Therefore, you should follow the rules given below:

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

Contact your doctor.

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

Take the forgotten tablet as soon as you realize it - even if it means taking 2 tablets in a row on the same day - and take the following tablets at the usual time of day. Take additional contraceptive precautions (use a barrier method) for the next 7 days. If you have already had sexual intercourse in the week before forgetting the tablet, there is a possibility of pregnancy. Inform your doctor immediately.

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

Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablet at the usual time of day. The effect of the tablet is maintained, provided that the tablet has been taken correctly in the 7 days prior to forgetting the tablet. You do not need to use any additional barrier method. However, if you have forgotten to take more than 1 tablet, you should use additional contraceptive precautions for 7 days.

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

You can choose between the following options without having to use additional contraceptives, provided that you have been taking the tablet correctly for the 7 days prior to forgetting the tablet:

1. Take the forgotten tablet as soon as you remember (even if it means taking two tablets at once). Then, continue taking the following tablets at the usual time of day. Start taking the next blister pack immediately after finishing the last pack, i.e., without making any pause. It is unlikely that you will have bleeding until the end of the second pack; however, you may experience spotting or bleeding even on the days you take the tablet.

Or

1. Do not take any more tablets. After a pause of no more than 7 days, including the day you forgot to take the tablet, start taking the tablets from the next blister pack. With this method, you can also start taking the tablets on the day of the week you are used to. If you want to start a new pack on the day of the week you are used to, you can make the tablet-free interval less than 7 days.

If you have forgotten to take tablets and do not have menstrual bleeding during the tablet-free period, there is a possibility of pregnancy. Therefore, consult your doctor before starting to take dienogest/etinilestradiol from the next blister pack.

What you should know if you have vomiting or diarrhea

In case of severe gastrointestinal disorders (e.g., vomiting or diarrhea), it is possible that the body has not yet fully absorbed the active ingredients of the tablets. Therefore, the effect may be reduced, similar to forgetting a tablet. Additional contraceptive measures are required. If you vomit within 3 or 4 hours after taking dienogest/etinilestradiol, take a new tablet (replacement) as soon as possible. If possible, the new tablet should be taken within 12 hours of the usual time of taking the tablet. If more than 12 hours have passed, follow the advice as in the case of forgotten tablets. However, if you want to maintain your usual tablet-taking rhythm, you can also take a replacement tablet from another blister pack and use it later as a reserve pack.

If you want to change the days of your period

Although it is not recommended, you can delay your menstruation by starting the next blister pack without making a pause, i.e., as soon as you have finished the current blister pack. You can continue taking the tablets until you want your menstruation to start. However, stop taking the tablet no later than when the second blister pack is empty. You may experience slight bleeding during the use of this second pack. Start the next blister pack after the usual 7-day break.

You should ask your doctor for advice before deciding to delay your menstruation

If you want to change the day of the week your period starts

If you take the tablets according to the instructions, you will have your menstruation approximately every 4 weeks on the same day. If you want to change this, simply shorten (never lengthen) the tablet-free interval. If your menstruation usually starts on a Friday and you want it to start on a Tuesday (3 days earlier), take the first tablet from the new blister pack three days earlier than usual. The shorter the interval (e.g., 3 days or less), the higher the possibility that you will not have withdrawal bleeding during this shortened interval. However, you may experience intermittent bleeding.

If you are not sure about the use of this medication, ask your doctor.

If you want to stop taking dienogest/etinilestradiol

You can stop taking this medication at any time. If you do not want to become pregnant, consult your doctor about other reliable contraceptive methods.

If you want to become pregnant, stop taking dienogest/etinilestradiol and wait until you have your period before trying to become pregnant. You will be able to calculate the expected date of delivery more easily.

Additional information for special patient groups

Girls and adolescents

This medication can only be used after the first menstrual period (menarche).

Older patients

This medication can only be used in women before menopause.

Patients with liver function disorders

This medication should not be used in women with severe liver disease (see section 2 "Do not take dienogest/etinilestradiol").

Patients with kidney function disorders

The use of this medication has not been studied in women with impaired renal function.

The available data do not suggest any change in treatment for this group of patients.

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

4. Possible Adverse Effects

Like all medications, this medication can produce 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 this medication, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)).

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 section 2. "Warnings and Precautions").

For more detailed information on the different risks associated with the use of combined hormonal contraceptives, see section 2 "What you need to know before taking dienogest/ethinylestradiol".

The serious adverse effects associated with this medication are listed in section 2.

"When to have special care with dienogest/ethinylestradiol".

In clinical studies with 0.03 mg of ethinylestradiol and 2.0 mg of dienogest, the following adverse effects were observed, listed by frequency:

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

• vaginal and/or external genital inflammation (vaginitis/vulvovaginitis), vaginal fungal infections (candidiasis, other vulvovaginal infections),
• increased appetite,
• depressive mood,
• migraine, somnolence,
• hypertension, hypotension,
• abdominal pain (including bloating),
• nausea, vomiting, diarrhea,
• acne,
• hair loss (alopecia), skin rash, itching,
• irregular periods, including heavy periods (menorrhagia), light periods (hypomenorrhea), infrequent periods (oligomenorrhea), and absence of periods (amenorrhea)
• intermenstrual bleeding (vaginal hemorrhage and metrorrhagia), painful bleeding (dysmenorrhea)
• genital/vaginal discharge, ovarian cyst, pelvic pain, breast enlargement, breast edema,
• exhaustion including weakness, fatigue, general malaise,
• weight gain.

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

• inflammation of the ovaries or fallopian tubes, urinary tract infection, bladder inflammation (cystitis), breast inflammation (mastitis), cervical inflammation (cervicitis), fungal infections (e.g., Candida), viral infections (e.g., herpes labialis), flu (influenza), bronchitis, infection of the nasal sinuses (sinusitis), upper respiratory tract infections,
• benign tumors in the uterus (leiomyoma), benign tumors in the fatty tissues of the breasts (breast lipoma),
• decrease in the number of red blood cells (anemia),
• allergic reactions,
• development of male characteristics (virilization),
• loss of appetite (anorexia),
• depression, psychiatric disorders, insomnia, sleep disorders, aggression,
• stroke, blood circulation problems in the brain or heart; muscle disorders that can cause abnormal postures or movements (dystonia),
• dry or irritated eyes, eye problems, visual disturbances,
• sudden hearing loss, tinnitus, dizziness, hearing problems,
• rapid heart rate,
• inflammation of the veins, diastolic hypertension, dizziness or fainting when standing up after sitting or lying down (orthostatic dysregulation), hot flashes, varicose veins (varicosis), venous diseases, painful veins, asthma, rapid or deep breathing (hyperventilation),
• inflammation of the stomach lining (gastritis), intestinal inflammation (enteritis), stomach upset (dyspepsia),
• allergic dermatitis, neurodermatitis, eczema, psoriasis, excessive sweating (hyperhidrosis), chloasma (yellowish-brown spots), skin pigmentation disorders, increased pigmentation, overproduction of oil by the sebaceous glands (seborrhea), dandruff, skin lesions, orange peel skin, cutaneous nevus (a network of blood vessels in a spider-like pattern with a central red spot on the skin),
• back pain, bone and muscle pain, muscle pain (myalgia), pain in the arms and legs,
• cervical dysplasia (abnormal cell growth on the surface of the cervix), pain or cysts in the uterine appendages (fallopian tubes and ovaries), breast cysts, pain/spasms during sexual intercourse (dyspareunia), secretion of the mammary glands similar to milk (galactorrhea), menstrual discomfort,
• chest pain, peripheral edema (fluid retention in the body), flu-like symptoms, inflammation, fever, irritability,
• high levels of triglycerides and cholesterol in the blood (high blood fat levels), weight loss, weight fluctuations,
• inflammation of congenital and additional mammary glands outside the breast area (accessory breasts),
• harmful blood clots in a vein or artery, for example:

• in a leg or foot (i.e., deep vein thrombosis, DVT),
• in a lung (pulmonary embolism, PE),
• 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 eyes.

The possibility 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 the symptoms of a blood clot).

Other adverse effects observed in users of this medication, but whose exact frequency is not known, are:

Mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, urticaria, skin and/or mucous membrane reactions with rash, nodules, blisters, or tissue death (erythema nodosum or multiforme); breast secretion, fluid retention (edema).

Tumors

• The frequency of breast cancer diagnosis among users of this medication increases slightly. Since breast cancer rarely occurs in women under 40 years of age, the risk of developing breast cancer in relation to the general risk is low. For more information, see section 2 "Dienogest/ethinylestradiol and cancer".
• Liver tumors (benign and malignant).
• Cervical cancer.

Other conditions

• Women with hypertriglyceridemia (the increase in fat levels in the blood may increase the risk of pancreatitis during the use of combined oral contraceptives).
• Increased blood pressure.
• Appearance or worsening of diseases whose relationship with combined oral contraceptives is not defined: jaundice and/or itching associated with bile flow obstruction; gallstone formation; metabolic disorder (porphyria); systemic lupus erythematosus (autoimmune disease); hemolytic uremic syndrome (a disease caused by blood clot formation); neurological disease (called Sydenham's chorea); gestational herpes (a type of skin disease that occurs during pregnancy); hearing loss related to otosclerosis.
• externally administered estrogens can cause or worsen the symptoms of hereditary or congenital angioedema (sudden swelling of the eyes, mouth, throat, etc.).
• Liver impairment.
• Changes in glucose tolerance or peripheral insulin resistance.
• Crohn's disease, ulcerative colitis.
• Chloasma.

Interactions

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

Other serious reactions to taking dienogest/ethinylestradiol, 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 it is a possible adverse effect that is not listed in this prospectus. 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 Dienogest/Ethinylestradiol Aristo

This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dienogest/Ethinylestradiol Aristo

• The active ingredients are 2 mg of dienogest and 0.03 mg of ethinylestradiol.

• The other components (excipients) are:

• Core of the tablet: lactose monohydrate, corn starch, maltodextrin, magnesium stearate.
• Coating material: hypromellose, macrogol, povidone, titanium dioxide (E 171).

Appearance of the Product and Package Contents

White, round, and biconvex film-coated tablet. Each tablet has a thickness of 2.4 - 2.8 mm and a diameter of 5.5 - 5.7 mm.

It is available in packages containing 21, 3 x 21, and 6 x 21 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Pharbil Waltrop GmbH

Im Wirrigen 25

45731 Waltrop

Germany

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Italy Dienillete 2 mg/0.03 mg film-coated tablets

Germany Aristelle 2 mg/0.03 mg film-coated tablets

Czech Republic Lobreza 2 mg/0.03 mg film-coated tablets

Spain Dienogest/Ethinylestradiol Aristo 2 mg/0.03 mg film-coated tablets EFG

Date of the last revision of this prospectus:September 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/