OEDIEN 2 MG/0.03 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dienacne 2mg/0.03mg film-coated tablets EFG

Dienogest/ethinylestradiol

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

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

Read the entire package leaflet carefully before starting totakethis 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.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Oedien and what is it used for

Oedien is a combined oral contraceptive (COC) tablet that contains two types of hormones, an estrogen (ethinylestradiol) and a progestogen (dienogest).

Clinical studies in women have shown that Oedien has an increased effect on male hormones, leading to the appearance of acne, and it improves symptoms.

Oedien 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 treatments or oral antibiotics.

Each of the 21 white tablets contains a small amount of two hormones, which are ethinylestradiol and dienogest.

The 7 pink tablets do not contain any active ingredients and are also called placebo tablets

2. What you need to know before taking Oedien

• General observations

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 the presence of a blood clot (see section 2 "Blood clots").

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

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

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

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

Do not takeOedien:

You should not use this medication 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 (non-hormonal) would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you are allergic to ethinylestradiol, dienogest, or any of the other components of this medication (including those listed in section 6).
• If you suffer or have ever suffered from pancreatitis (inflammation of the pancreas).
• If you suffer or have suffered in the past from liver disease and your liver function is still not normal.
• If you have or have had a benign or malignant liver tumor.
• If you have or have had breast cancer or cancer of the genital organs.
• If you have vaginal bleeding of unknown origin.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Using Oedien with other medications").

If you have any of the conditions listed, inform your doctor before starting to use this medication. Your doctor will discuss with you what other form of contraception (non-hormonal) would be more suitable.

When you should be particularly careful with Oedien

Warnings and precautions

Before using this medication, you will need to see your doctor for a medical examination.

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

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

• Increasing age.
• If you smoke.
• If you have diabetes or if your ability to metabolize glucose is limited (decreased glucose tolerance).
• If you are overweight
• If you have high blood pressure
• If you have a heart valve disease or a heart rhythm disorder
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If any of your close relatives suffer or have suffered from thrombosis, a heart attack, or a stroke.
• If you suffer from migraines.
• If you suffer from epilepsy.
• If you suffer from depression.
• 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 spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking Oedien after childbirth.
• If any of your close relatives have had breast cancer.
• If you have liver or biliary disease.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system)
• If you suffer from a disease that first appeared during pregnancy or previous use of sex hormones, such as hearing loss, porphyria (a blood disease), gestational herpes (blistering rash during pregnancy), Sydenham's chorea (a nervous system disease that causes sudden body movements).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).

• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you suffer or have suffered from chloasma (extensive, irregularly shaped, brown patches on the skin, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet radiation.
• If you suffer from symptoms of angioedema such as swelling of the face, tongue, and/or pharynx and/or difficulty swallowing or urticaria with possible difficulty breathing, you should seek immediate medical attention. Medications that contain estrogens can cause or worsen symptoms of hereditary or acquired angioedema.

If any of the conditions described above occur for the first time, reappear, or worsen while you are taking Oedien, you should consult your doctor.

Blood clots

The use of a combined hormonal contraceptive like Oedien increases your risk of suffering from 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 (which is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to 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 moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

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

When you stop taking Oedien, 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 Oedien is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.

Of every 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, such as Oedien, approximately 8-11 women will have a blood clot in a year.

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

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

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

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50).
• If you need 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 Oedien several weeks before surgery or while you have reduced mobility. If you need to stop using Oedien, ask your doctor when you can start using it again.
• As you get older (especially over 35 years).
• If you have recently given birth.

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

Long-distance air travel (>4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

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

If any of the conditions above change while you are using Oedien, for example, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

It is essential to note that the risk of a heart attack or stroke due to this medication is very small, but it can increase:

• With age (over 35 years).
• If you smoke.When using a combined hormonal contraceptive like this medication, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have a high level of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

Breast cancer has been diagnosed slightly more frequently in women who take the contraceptive pill than in women of the same age who do not use it. This slight increase in the number of breast cancer diagnoses disappears gradually over the 10 years following the cessation of use of the contraceptive pill. Since breast cancer is rare in women under 40 years old, the additional number of breast cancer cases in women who are taking or have recently taken the contraceptive pill is small compared to the overall risk of breast cancer. It is unknown whether the contraceptive pill is the cause of the difference. It is possible that women are examined more frequently, which leads to earlier detection of breast cancer.

There have been rare reports of liver tumors Note: The translation provided is complete and accurate to the best of my abilities, but please review it carefully to ensure that it meets your specific requirements.

Benign tumors, and in even more exceptional cases of malignant liver tumors in users of the contraceptive pill. These tumors can cause internal bleeding. Consult your doctor immediately if you suffer from severe stomach pain.

Some studies indicate that long-term use of hormonal contraception is a risk factor for cervical cancer in women whose cervix is infected with certain sexually transmitted viruses (human papillomavirus). However, the degree to which other factors influence this outcome (e.g., differences in the number of sexual partners or the use of mechanical contraceptive methods) has not yet been established.

Psychiatric disorders:

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

Medical consultation/examination

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

Intermenstrual bleeding

During the first few months of taking this medication, you may experience unexpected bleeding (blood loss outside of the week with placebo pills). If the bleeding occurs for more than a few months or starts after a few months, your doctor should determine what is wrong.

What to do if bleeding does not occur during the week with placebo pills

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

If the expected bleeding does not appear twice in a row, you may be pregnant. Consult your doctor immediately. Do not start the next strip until you are sure you are not pregnant.

Taking dienogest/ethinylestradiol with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may take other medications, including over-the-counter medications.

Some medications may cause intermenstrual bleeding or a loss of contraceptive efficacy of dienogest/ethinylestradiol.

Effect of other medications on dienogest/ethinylestradiol

Some medications

may affect the blood levels of this medication, making it less effective in preventing pregnancy or causing unexpected bleeding.

These include:

Medications used to treat:

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

herbal medicines that contain St. John's Wort

If you are being treated with one of the above medications, you should use a barrier contraceptive method (e.g., condom) temporarily, or choose another contraceptive method. Use local additional contraceptive methods while taking other medications with this medication, even up to 28 days after finishing treatment with the other medication.

If your treatment continues beyond the pills in the Oedien blister pack, start the next Oedien blister pack immediately, without the usual interval of placebo pills.

Choose a non-hormonal contraceptive method if you need long-term treatment with one of the medications mentioned above.

Effect of dienogest/ethinylestradiol on other medications

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

the antiepileptic lamotrigine (may lead to an increased frequency of seizures)

cyclosporine

theophylline (used in the treatment of respiratory problems)

tizanidine (used in the treatment of muscle pain or cramps)

Do not use Oedien if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in blood (increase in liver enzyme ALT).

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

Oedien can be restarted approximately 2 weeks after completing this treatment. See section “Do not take Oedien”.

Also, consult the package insert of other prescribed medications. Inform your doctor or pharmacist if you are taking, have recently taken, or may take other medications, including over-the-counter medications.

Interactions with laboratory tests

The use of this medication may affect the results of some laboratory tests, including liver, adrenal, kidney, and thyroid function values, as well as the amount of certain proteins in the blood, e.g., proteins that affect fat digestion, carbohydrate metabolism, or blood coagulation and fibrinolysis. However, these changes usually maintain values within normal ranges. Inform your doctor or laboratory personnel if you are taking the pill.

Laboratory analysis

If you need a blood test, inform your doctor or laboratory personnel that you are taking Oedien, as hormonal contraceptives can affect the results of some tests.

Periodic check-ups

Your doctor may advise you to attend periodic check-ups while taking this medication. The frequency and nature of these check-ups will depend on your personal situation.

Pregnancy and lactation

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

Pregnancy

Women who are or think they may be pregnant should not use Oedien. If you become pregnant while taking this medication, stop taking it immediately and consult your doctor (see section 2, Do not take Oedien).

Lactation

In general, breastfeeding women should not take this medication, as it may reduce the amount of milk produced and small amounts of the medication may be excreted in breast milk. You should consult your doctor if you want to take Oedien during breastfeeding.

Driving and using machines

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

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

3. How to take Oedien

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

When and how to take the tablets?

A pack of Oedien contains 21 active white coated tablets and 7 inactive pink tablets.

The tablets of Oedien of different colors are placed in order. A blister pack contains 28 tablets.

Take one Oedien tablet every day with a little water, if necessary. You can take the tablets with or without food, but remember to take them every day at approximately the same time.

Do not confuse the tablets:take a white tablet during the first 21 days and, afterwards, a pink tablet during the last 7 days. Then, you must start immediately a new blister pack (21 white tablets and then 7 pink tablets), without realizing a tablet-free interval between each blister pack.

Due to the different composition of the tablets, it is necessary that you start with the first tablet from the top left and take one tablet every day. To follow the correct order, follow the direction of the arrows on the blister pack.

Preparation of the blister pack

To help you follow the order, 7 stickers are provided, each with the 7 days of the week for each Oedien blister pack. Choose the sticker with the days of the week that starts with the day you started taking the tablets. For example, if you start on Wednesday, use the sticker that starts with "WED".

Stick the sticker with the days of the week on the top of the Oedien blister pack where it says "Place the week sticker here", so that the first day is above the tablet marked with "Start".

Now, a day is indicated on each tablet so you can see if you have taken a particular tablet. The arrows indicate the order in which you must take the tablets.

During the 7 days when you take the pink placebo tablets (placebo interval), you may start bleeding (also called withdrawal bleeding). This usually occurs 2-3 days after the last active white Oedien tablet. Once you have taken the last pink tablet, start the next blister pack, whether the bleeding has stopped or not. This means that you must start each blister pack on the same day of the week, and that the withdrawal bleeding must occur on the same days every month.

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

Starting the first pack of Oedien

When you have not used a hormonal contraceptive in the previous month

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

If you start taking it on the first day of your period, you will be immediately protected against pregnancy. You can also start between day 2-5 of your cycle, but then you must use an additional barrier contraceptive method (e.g., a condom) during the first 7 days.

When you have used another combined contraceptive tablet, a vaginal ring, or a transdermal patch before

You can start taking this medication the day after taking the last tablet from the current pack of tablets (which means that there will be no tablet-free period) or after removing the vaginal ring or transdermal patch. If the current pack of tablets also contains inactive tablets, you can start taking it the day after taking the last active tablet (if you are not sure which tablet this is, consult your doctor or pharmacist).

You can also start taking it on the last day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of the previous treatment.

When you have used a progestogen-only tablet before

You can stop taking the tablet at any time and start taking this medication the next day at the same time. However, you must always use another contraceptive method (a barrier method) during the first 7 days of taking the new tablets when having sexual intercourse.

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

Start taking this medication when the next injection is due or on the day the implant or IUS is removed. However, you must always 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 this medication during at least 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, you should rule out pregnancy before starting to take it, or you should wait until you have your first period. For use during breastfeeding, see "Pregnancy and breastfeeding".

After a spontaneous or induced abortion

Your doctor will advise you on this matter.

If you take more Oedien tablets than you should

No serious harmful effects have been reported due to taking too many Oedien tablets at once. If you have taken several tablets at once, you may experience nausea, vomiting, and vaginal bleeding. If you discover that a child has taken Oedien, ask your doctor for advice.

If you forget to take Oedien

The tablets in the 4throw of the blister pack are placebo tablets. If you forget to take one of these tablets, the reliability of Oedien will not be affected. Discard the forgotten placebo tablet.

If you forget to take an active white tablet from rows 1, 2, or 3, do the following:

• If the delay in taking an active tablet is less than 12 hours, the reliability of the tablet is the same. Take the tablet as soon as you remember, and take the following tablets at the usual time.

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

More than 1 forgotten tablet from a pack

Consult your doctor.

1 forgotten tablet in week 1

Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. Take additional contraceptive precautions (barrier method) for the next 7 days. If you have had sexual intercourse in the week prior to forgetting the tablet, there is a possibility that you may become pregnant. Therefore, you must inform your doctor immediately.

1 forgotten tablet in week 2

Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. The reliability of the tablet is maintained. You do not need to take additional contraceptive precautions.

1 forgotten tablet in week 3

You can choose one of the following options, without needing to take additional precautions:

1. Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. You must start the next pack immediately after taking the last active tablet from the current pack, without a placebo tablet interval between packs. You may not have your period until you finish the second pack, and you may experience irregular bleeding during the use of active tablets from the second pack.

Or:

1. Stop taking the tablets from the current pack and go directly to the 7-day placebo period or less (counting the day you forgot the tablet) and continue with the next pack. If you follow this method, you can always start the next pack on the same day of the week that you usually do.

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

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

If you vomit or have diarrhea within 3 to 4 hours after taking an active tablet, it is possible that the active ingredients have not been fully absorbed. In these cases, follow the procedures that apply if you forgot to take a tablet. Take another tablet as soon as you can, but no later than 12 hours. If more than 12 hours have passed, follow the instructions in the section "If you forget to take Oedien".

What to do if you want to delay your period

You can delay your period if you start the next pack of this medication immediately after finishing the active tablets from the current pack, without a placebo tablet interval. You can continue with this pack for as long as you want, until you finish it. When you want to have your period, start taking the 7 inactive tablets. While taking the second pack, you may experience irregular bleeding. Start the next pack after taking the 7 placebo tablets.

What to do if you want to change the day you start your period

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

What to do if you experience unexpected bleeding

With all contraceptive tablets, bleeding (irregular bleeding) can occur between periods during the first few months. You may need to use sanitary pads or tampons, but you must continue taking the tablets as usual. The irregular bleeding usually stops when your body has adapted to the contraceptive tablet (usually after 3 cycles of taking the tablet). If it continues, worsens, or comes back, inform your doctor.

What to do if you do not have a period

If you have taken all the tablets at the right time and have not vomited or taken other medications, it is unlikely that you are pregnant. Continue taking this medication as usual. If you have not had your period twice in a row, you may be pregnant. Inform your doctor immediately. Do not start the next pack until your doctor has checked that you are not pregnant.

If you stop taking Oedien

You can stop taking this medication at any time. If you do not want to become pregnant, ask your doctor about other contraceptive methods. If you stop taking this medication because you want to become pregnant, it is generally recommended to wait until you have a natural period before trying to become pregnant. This way, it will be easier to determine that the absence of bleeding is due to pregnancy.

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

4. Possible Adverse Effects

Like all medicines, Oedien can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any health change that you think may be due to Oedien, consult your doctor.

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

Severe Adverse Effects

Severe reactions associated with the use of the dienogest/ethinylestradiol tablet are described in the "Warnings and Precautions" section. You can find more information there. Consult your doctor immediately if necessary.

Contact your doctor immediately if you experience any of the following symptoms of hereditary or acquired angioedema (frequency not known): swelling of the face, tongue, and/or pharynx and/or difficulty swallowing or urticaria with possible difficulty breathing (see also the "Warnings and Precautions" section).

Other Possible Adverse Effects

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

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

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

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

• Genital inflammation (vaginitis/vulvovaginitis), vaginal yeast infections (candidiasis, vulvovaginal infections)
• Increased appetite
• Depressed mood
• Migraine
• Dizziness
• High blood pressure (hypertension) or low blood pressure (hypotension)
• Abdominal pain (including upper and lower abdominal pain, abdominal discomfort, flatulence)
• Nausea, vomiting, diarrhea
• Acne
• Rash (including skin rash)
• Itching (sometimes all over the body)
• Hair loss (alopecia)
• Irregular withdrawal bleeding [including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), and absence of bleeding (amenorrhea)]
• Intermenstrual bleeding (including vaginal bleeding and metrorrhagia)
• Increased breast size (including breast swelling and breast edema)
• Painful menstruation (dysmenorrhea)
• Vaginal discharge
• Ovarian cysts
• Pelvic pain
• Exhaustion, including weakness, fatigue, and general malaise
• Weight changes (increase, decrease, or fluctuation)

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

• Inflammation of the fallopian tubes or ovaries (salpingo-oophoritis)
• Urinary tract infections, bladder infections (cystitis)
• Breast infection (mastitis)
• Cervical inflammation (cervicitis)
• Fungal infections (e.g., Candida), viral infections, cold sores
• Flu, bronchitis, upper respiratory tract infection, sinusitis
• Benign uterine tumors (fibroids)
• Benign breast tumors (breast lipoma)
• Anemia
• Allergic reactions (hypersensitivity)
• Development of male characteristics (virilization)
• Loss of appetite (anorexia)
• Depression, mental disorders, irritability, aggression
• Insomnia, sleep disturbances
• Circulatory disorders of the brain and heart, stroke
• Dystonia (muscle disorder that can cause, e.g., abnormal posture)
• Dryness or irritation of the eyes
• Blurred vision
• Sudden hearing loss, hypoacusis
• Tinnitus
• Balance problems
• Rapid heartbeat
• Thrombosis, blood clot in a vein or artery, e.g.,
• • In a leg or foot (i.e., deep vein thrombosis)
  • In a lung (i.e., pulmonary embolism)
  • Heart attack
  • Stroke
  • Mild stroke or temporary stroke-like symptoms, called transient ischemic attack (TIA)
  • Blood clot in the liver, stomach/intestine, kidneys, or eye

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

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

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

Tumors

• The incidence of breast cancer diagnosis is slightly increased with the use of Oedien. Since breast cancer rarely occurs in women under 40 years of age, the risk of developing breast cancer in relation to the average risk is low. For more information, see the "The pill and cancer" section.
• Liver tumors (benign and malignant).
• Cervical cancer.

Other Conditions

• Women with hypertriglyceridemia (high levels of fat in the blood result in an increased risk of pancreatitis when using combined oral contraceptives)
• High blood pressure
• Appearance or worsening of processes in which the cause is not definitively related to combined oral contraceptives: jaundice or itching related to cholestasis (bile flow blockage); gallstones; a metabolic process called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a blood clotting disorder); a neurological process called Sydenham's chorea; herpes gestationis (a type of skin process that occurs during pregnancy), and hearing loss-related hypoacusis.
• Altered liver function
• Changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

Interactions

Unexpected bleeding or contraceptive failure may occur due to interactions between other medications and oral contraceptives (e.g., St. John's Wort preparations, epilepsy medications, tuberculosis, HIV, and other infections). See the "Effect of other medications on Oedien" section.

Reporting Adverse Effects

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

5. Storage of Dienacne

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

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

Do not store above 30°C.

Store in the original packaging to protect it from light.

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 the pharmacy. If in 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 ofOedien

• The active ingredients are ethinylestradiol and dienogest. Each active film-coated tablet contains: 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• The pink film-coated tablets do not contain active ingredients

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

• The components of the placebo tablets are: Povidone K30, cornstarch, lactose monohydrate, magnesium stearate, polyethylene glycol/macrogol 3350, titanium dioxide (E171), polyvinyl alcohol, talc, red iron oxide (E172), yellow iron oxide (E172).

Appearance of the Product and Package Contents

Each Oedien blister pack contains 21 active film-coated white tablets in rows 1, 2, and 3 of the blister pack and 7 pink film-coated placebo tablets in row 4.

Oedien is a white, cylindrical, and biconvex film-coated tablet with a diameter of approximately 6 mm.

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

Oedien is packaged in PVC/aluminum blister packs and presented in a calendar pack.

Package sizes:

28 film-coated tablets (28-tablet blister pack).

84 film-coated tablets (3 blister packs of 28 tablets).

168 film-coated tablets (6 blister packs of 28 tablets).

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratoires BAILLEUL S.A.

14-16 Avenue Pasteur

2310 Luxembourg

Luxembourg

Manufacturer:

Cyndea Pharma S.L

Polígono Industrial Emiliano Revilla, Av. de Ágreda 31,

42110 Olvega (Soria)

Spain

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

Date of the last revision of this prospectus:November 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/