Prospect: information for the user

Dienacne 2mg/0.03mg coated tablets EFG

Dienogest/etinilestradiol

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a pause of 4weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section2 “Blood clots”).

Read this prospect carefully before starting totakethis medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What isDienacneand for what it is used

2.What you need to know before starting totakeDienacne

3.Howto takeDienacne

4.Possible adverse effects

5.Storage ofDienacne

6.Contents of the package and additional information

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

Studies have shown in women with an increased effect of male hormones, which leads to the appearance of acne, that Oedien produces an improvement in symptoms.

Oedien is a medication:

• to prevent pregnancy ("birth control pill")
• for the treatment of women with moderate acne who accept receiving a birth control pill after the failure of suitable 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 ingredient and are also called placebo tablets

- General Observations

Before starting to use this medication, you must read the information about blood clots in section 2. It is particularly important that you read the symptoms 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.

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

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

Your acne should improve normally within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after starting and periodically thereafter.

Do not take Oedien:

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 would be more suitable.

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

Warnings and precautions:

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

Inform 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.

• Age increase.
• If you smoke.
• If you suffer from 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 superficial thrombophlebitis (inflammation of the veins under the skin).
• 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 standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of blood clots. 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 gallbladder disease.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (LES, a disease that affects your natural defense system).
• If you suffer from a disease that appeared for the first time during pregnancy or previous use of sex hormones, such as hearing loss, porphyria (a blood disorder), herpes gestational (a rash during pregnancy), Sydenham's chorea (a nervous disorder that causes sudden body movements).
• If you have hemolytic uremic syndrome (SHU, a blood clotting disorder that causes kidney insufficiency).

• If you have sickle cell anemia (a hereditary disorder of red blood cells).
• If you suffer or have suffered from melasma (large, irregular, dark patches on the skin, especially on the face); if so, avoid excessive sun exposure or ultraviolet radiation.
• If you suffer from angioedema symptoms such as facial swelling, tongue and/or throat swelling and/or difficulty swallowing or urticaria with possible difficulty breathing, you should seek immediate medical attention. Medications containing estrogens can cause or worsen hereditary or acquired angioedema.

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

Blood Clots:

The use of a combined hormonal contraceptive like Oedien increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

It is essential to remember that the overall risk of a harmful blood clot due to dienogest/etinilestradiol is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistance 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 veins (venous thromboembolism). However, these adverse 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 your leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break 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 in a few weeks.

What is the risk of a blood clot?

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

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

• Of every 10,000 women who are not using a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel or noretisterone or norgestimato, about 5-7 will develop a blood clot in a year.

Of every 10,000 women who are using a combined hormonal contraceptive that contains dienogest and etinilestradiol like Oedien, approximately 8-11 women will develop a blood clot in a year.

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

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

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

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If any of your close relatives have had a blood clot in their leg, lung, or other organ at a young age (i.e. before about 50 years old). You may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop taking Oedien for several weeks before the surgery or while you have limited mobility. If you need to stop taking Oedien, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years old).
• If you have recently given birth.

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

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

It is essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you need to stop taking Oedien.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (over about 35 years old).
• 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 contraception.
• 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 about 50 years old). You may also be at higher risk of 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 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, your risk of a blood clot may be increased even further.

If any of the conditions above change while you are using this medication, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Dienogest/etinilestradiol and cancer:

Breast cancer has been diagnosed more frequently in women taking the contraceptive pill than in women of the same age who are not using it. This slight increase in the number of breast cancer diagnoses disappears gradually over the 10 years following the discontinuation of the contraceptive pill. Since breast cancer is rare in women under 40 years old, the additional number of breast cancer cases in women taking or having recently taken the contraceptive pill is small compared to the overall risk of breast cancer.The cause of the difference is unknown. It is possible that women are being investigated more frequently, so that breast cancer is detected earlier.

There have been rare reports of benign liver tumors and, in even rarer cases, malignant liver tumors in women taking the contraceptive pill. These tumors can cause internal bleeding. Consult your doctor immediately if you experience severe stomach pain.

Psychiatric disorders:

Some women who use hormonal contraceptives like Oedien 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 your doctor for additional medical advice as soon as possible.

Medical examination:

Before taking Oedien, your doctor will thoroughly question you about your medical history and that of your close relatives. A general and gynecological medical examination, including a breast examination and cervical cytology study, will be performed. You will need to rule out pregnancy. 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 the week with placebo pills). If the bleeding occurs during more than a few months, or begins after a few months, your doctor will need to determine what is wrong.

What to do if no bleeding occurs during the week with placebo pills:

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

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

Use of dienogest/etinilestradiol with other medications:

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

Some medications may cause intermenstrual bleeding or reduce the effectiveness of dienogest/etinilestradiol:

Effect of other medications on dienogest/etinilestradiol:

Some medications

may affect the levels of this medication in the blood, 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 infectionsand hepatitis C infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib)

herbal medicines containing St. John's Wort

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

If your treatment continues beyond the pills in the Oedien pack, start the next pack of Oedien 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/etinilestradiol on other medications:

This medication may affect the effect of other medications, for example:

the antiepileptic lamotrigine (may increase the frequency of seizures)

ciclosporin

theophylline (used to treat respiratory problems)

tizanidine (used to treat pain or muscle cramps)

You should 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 the blood (elevated 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”.

See also the prospectus of other prescribed medications. Inform your doctor or pharmacist if you are taking, have taken recently, 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 cortex, kidney function, and thyroid function, as well as the amount of certain proteins in the blood, for example, proteins that affect fat digestion, carbohydrate metabolism, or blood clotting and fibrinolysis. However, these changes usually remain within normal ranges. Inform your doctor or laboratory staff if you are taking the pill.

Laboratory tests:

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

Periodic checks:

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

Pregnancy and breastfeeding:

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

Pregnancy

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

Breastfeeding

In general, women who are breastfeeding should not take this medication, as it may reduce milk production 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 operating machinery:

Dienogest/etinilestradiol has no known effects on your ability to drive or operate machinery.

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

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 package of Oediencontains 21 active white tablets and 7 inactive pink tablets.

The tablets ofOedien oftwo different colorsare placed in order. A blister contains 28 tablets.

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

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

Due to the different composition of the tablets, you need to 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.

Preparation of the blister

To help you follow the order, 7 stickers are provided, each with the 7days of the week for each Oedien blister. 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 where it says “Put the week sticker here”, so that the first day is on top of the tablet marked with “Start”.

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

During the 7 days when you take the pink placebo tablets, 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, whether the bleeding has stopped or not. This means that you must start each blisteron the same day of the week, and the withdrawal bleeding should occur on the same days every month.

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

Start of the first Oedien package

When no hormonal contraceptive has been used in the previous month

Start taking this medication on the first day of the cycle, that is, the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if the period starts on Friday, take a tablet marked Friday. Continue then 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 the cycle, but then you must use an additional barrier contraceptive method (e.g., a condom) during the first 7 days.

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

You can start taking this medication the day after taking the last tablet from the current package (which means there will be no period without tablets) or after removing the vaginal ring or transdermal patch. If the current package 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 before the usual period without tablets, without a patch, without a ring, or with a placebo tablet from the previous treatment.

When you have used a progestin-only pill before

You can stop taking the pill on any day and start taking this medication the next day at the same time. But always use another contraceptive method (a barrier method) during the first 7days when you take the new tablets when you have sex.

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

Start taking this medication when it is time for the next injection or on the day the implant or IUS is removed. But always use another contraceptive method (a barrier method) during the first 7days when you take the new tablets when you have sex.

After a delivery

Do not start taking this medication for at least21to28days after a delivery. During the first 7days when you take the tablets, you must also use a barrier contraceptive method (e.g., a condom). If you have already had sex, you should have a pregnancy test before starting to take it, or you should wait until your first period. For use during breastfeeding, see “Pregnancy and breastfeeding”.

After a spontaneous or induced abortion

Your doctor may advise you.

If you take more Oedien tablets than you should

No serious adverse 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 a child has taken Oedien, ask your doctor for advice.

If you forget to take Oedien

The tablets in the4throw of the blister are placebo tablets. If you forget to take one of these tablets, the reliability ofOedien will not be affected. Throw away the forgotten placebo tablet.

If you forget to take an active white tablet from the1st,2nd, or3rdrow, do the following:

- If the delay in taking an active tablet is less than 12hours, the tablet's reliability remains the same. Take the tablet as soon as you remember, and take the next tablets at the usual time.

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

More than 1tablet forgotten from a package

Consult your doctor.

1tablet forgotten in week 1

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. Take additional barrier contraceptive measures (barrier method) for the next 7days. If you had sex in the week before forgetting the tablet, there is a possibility that you may become pregnant. Therefore, you should inform your doctor immediately.

1tablet forgotten in week 2

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. The tablet's reliability remains the same. You do not need to take additional barrier contraceptive measures.

1tablet forgotten in week 3

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

1. 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. You must start the next package immediately after taking the last active tablet from the current package, without a placebo tablet phase between packages. You may not have a period until you finish the second package and may experience irregular bleeding during the active tablets of the second package.

Or:

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

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

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

If you vomit or have intense diarrhea within3to4hours after taking the active tablet, it is possible that the active components 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 possible, no later than 12 hours. If more than 12 hours have passed, follow the instructions in the section “If you forgot to take Oedien”

What to do if you want to delay your period

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

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

If you take the tablets in the indicated way, you will have your period approximately the same day every 4weeks. If you want to change this day, you just need to shorten (never prolong) thenumber of placebo days between packages. If, for example, your period usually starts on Friday and you want it to start on Tuesday (3days earlier), start a new blister3days before the usual time. If you make the placebo period very short (e.g., 3days or less), you may not have a period during these days. You may experience some irregular bleeding during the use of the next package.

What to do if you experience unexpected bleeding

With all contraceptive pills, you may experience bleeding (irregular bleeding) between periods during the first months. You may need to use sanitary pads or tampons, but you should continue taking the pills in the usual way. The irregular bleeding usually stops when your body adapts to the contraceptive pill (usually after 3cycles of taking the pill). If it continues, intensifies, or starts again, 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 a period twice in a row, you may be pregnant. Inform your doctor immediately. Do not start the next package until your doctor has confirmed that you are not pregnant.

If you interrupt treatment with Oedien

You can stop taking this medication at any time. If you do not want to become pregnant, ask your doctor about other birth control methods. If you stop taking this medication because you want to become pregnant, it is usually 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.

Like all medications,Oediencan cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related toOedien, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to useOedien”.

Severe side effects

Severe reactions associated with the use of dienogest/ethinyl estradiol tablets are described in the "Warnings and precautions" section. You can get 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 unknown): 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 side effects

Users of dienogest/ethinyl estradiol tablets have reported the following side effects:

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

• Headache
• Mammary pain, such as breast discomfort and breast tension

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

• Genital inflammation (vaginitis/vulvovaginitis), vaginal mycoses (candidiasis, vulvovaginal infections)
• Increased appetite
• Depressed mood
• Migraine
• Dizziness
• High or low blood pressure (hypertension or hypotension)
• Abdominal pain (including upper and lower abdominal pain, abdominal discomfort, flatulence)
• Nausea, vomiting, diarrhea
• Acne
• Dermatological eruption (including urticaria)
• Pruritus (sometimes all over the body)
• Hair loss (alopecia)
• Irregular menstrual bleeding [including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), infrequent bleeding (oligomenorrhea), and absence of bleeding (amenorrhea)]
• Intermenstrual bleeding (hemorrhage, consisting of vaginal bleeding and metrorrhagia)
• Enlargement of the breast (including swelling and edema of the breast)
• Dysmenorrhea (painful menstruation)
• Vaginal discharge
• Ovarian cysts
• Lower abdominal pain
• Fatigue, including weakness, tiredness, 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)
• Mastitis (breast infection)
• Cervicitis (inflammation of the cervix)
• Mycosis (e.g., Candida), viral infections, herpes labialis
• Influenza, bronchitis, upper respiratory tract infections, sinusitis
• Benign tumors in the uterus (myomas)
• Benign tumors in the breast tissue (lipoma mamario)
• Anemia
• Allergic reactions (hypersensitivity)
• Development of male characteristics (virilism)
• Loss of appetite (anorexia)
• Depression, mental disorders, irritability, aggression
• Insomnia, sleep disturbances
• Cerebral and cardiac circulatory disorders, stroke
• Dystonia (muscular disorder that can cause, e.g., abnormal posture)
• Dryness or irritation of the eyes
• Blurred vision
• Sudden loss of hearing, hearing loss
• Tinnitus
• Balance problems
• Fast heart rate
• Thrombosis, pulmonary embolism (blood clot in a lung vein)
• Phlebitis (inflammation of a vein)
• Varicose veins, venous disorders, pain in the veins
• Dizziness or fainting when standing up from a seated or lying position (orthostatic hypotension)
• Hot flashes
• Asthma
• Increased respiratory rate (hyperventilation)
• Gastritis (inflammation of the stomach lining), enteritis (inflammation of the intestine)
• Indigestion (dyspepsia)
• Skin reactions, including allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• Increased sweating
• Brownish-yellow skin spots (chloasma), especially on the face (melasma), skin disorders/augmentation
• Oily skin (seborrhea)
• Dandruff
• Excessive hair growth (hirsutism)
• Orange skin (cellulitis)
• Araneiform nevus (reticular blood vessels with a red central point on the skin)
• Back pain, chest pain
• Musculoskeletal pain, muscle pain (myalgia), pain in arms and legs
• Abnormal cell growth on the surface of the cervix (cervical dysplasia)
• Pain or cysts in the ovaries and Fallopian tubes
• Breast cysts, benign breast tumors (fibrocystic breast disease), asymptomatic breast manifestation
• Spontaneous milk secretion (galactorrhea)
• Pain during intercourse (dyspareunia)
• Menstrual disorders
• Edema (peripheral edema)
• Pseudogripal disorders, inflammation, pyrexia (fever)
• Increased triglyceride and cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia)
• Detrimental blood clots in a vein or artery, e.g.:
• • In a leg or foot (i.e., deep vein thrombosis)
  • In a lung (i.e., pulmonary embolism)
  • Myocardial infarction
  • Stroke
  • 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 section2 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 unknown, are:

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

Tumors

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

Other conditions

• Women with hypertriglyceridemia (elevated 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 pruritus related to cholestasis (bile duct blockage); gallstones; a metabolic process called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (blood clotting disorder); a neurological process called Sydenham's chorea; herpes gravidarum (a type of skin process that occurs during pregnancy), and hearing loss related to hearing loss.
• Altered liver function
• Changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Melasma

Interactions

Unforeseen bleeding or failure of contraception may occur due to interactions of other medications with oral contraceptives (e.g., St. John's Wort preparations, epilepsy medications, tuberculosis, HIV infection, and other infections). See section “Effect of other medications on Oedien”

Reporting side effects

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

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in its original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofOedien

• The active principles are etinilestradiol and dienogest. Each active film-coated tablet contains: 2mg of dienogest and 0.03mg of etinilestradiol.
• The film-coated tablets without active principles do not contain active principles.

• 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 contents of the package

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

Oedienis a white film-coated, cylindrical, biconvex tablet with an approximate diameter of6mm.

The placebo tablet is a pink film-coated, cylindrical, biconvex tablet with an approximate diameter of6mm.

Oedienis packaged in PVC/aluminum blisters and presented in a calendar pack.

Package sizes:

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

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

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

Only some 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:November 2024

For detailed information on this medicinal product, please visit the website ofthe Spanish Agency of Medicines and Medical Products (AEMPS) http://www.aemps.gob.es/