Oedien 2 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dienacne 2mg/0.03mg film-coated tablets EFG

Dienogest/ethinylestradiol

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

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

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of this leaflet

1. What Dienacne is and what it is used for
2. What you need to know before taking Dienacne
3. How to take Dienacne
4. Possible side effects
5. How to store Dienacne
6. Contents of the pack and other information

1. What Oedien is and what it is used for

Oedien is a combined oral contraceptive (COC) tablet containing two types of hormones: an oestrogen (ethinylestradiol) and a progestogen (dienogest).

Clinical studies in women with elevated levels of androgenic hormones—which lead to the development of acne—have shown that Oedien improves symptoms.

Oedien is a medicine:

• for pregnancy prevention (the "pill" contraceptive)
• for the treatment of women with moderate acne who are willing to use an oral contraceptive after failure of appropriate topical treatments or oral antibiotics.

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

The 7 pink tablets contain no active ingredient and are also known as placebo tablets.

2. What you need to know before you start taking Oedien

• General observations

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

Before you start taking this medicine, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some additional tests.

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

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

Acne will usually improve after three to six months of treatment and may continue to improve even beyond 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 must not use this medicine if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be most 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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you require surgery or will be immobile for a long time (see section “Blood clots”).
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of forming a blood 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 ingredients of this medicine (listed in section 6).
• If you currently have or have ever had inflammation of the pancreas (pancreatitis).
• If you currently have or have previously had liver disease and your liver function is still abnormal.
• If you have or have ever had a benign or malignant liver tumour.
• If you have or have ever 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 medicines containing ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Oedien with other medicines”).

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

When you should be especially careful with Oedien

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot which may indicate you are experiencing a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Warnings and precautions

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

Tell your doctor if you have any of the following conditions

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

• Advanced age.

• If you smoke.

• If you have diabetes or have impaired glucose metabolism (reduced glucose tolerance).

• If you are overweight.

• If you have hypertension.

• If you have a heart valve disorder or a heart rhythm disorder.

• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).

• If you have varicose veins.

• If any of your close relatives have had or have thrombosis, heart attack, or stroke.

• If you suffer from migraine.

• 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 require surgery or will be immobile for long periods (see section 2 “Blood clots”).

• If you have recently given birth, you are at increased risk of 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 affecting your body’s natural defense system).

• If you have developed a condition for the first time during pregnancy or previous use of sex hormones, such as hearing loss, porphyria (a blood disorder), herpes gestationis (blistering rash during pregnancy), Sydenham’s chorea (a nervous system disorder causing sudden jerky movements).

• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).

• If you have sickle cell anemia (a hereditary red blood cell disorder).

• If you have or have had chloasma (irregularly shaped and sized brownish patches on the skin, especially on the face); if so, avoid excessive exposure to sunlight or ultraviolet radiation.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing, seek immediate medical attention. Medicines containing estrogens may 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 taking Oedien, you must consult your doctor.

Blood clots

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

Blood clots may 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. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

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

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

BLOOD CLOTS IN A VEIN

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

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

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

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

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

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

What is the risk of developing a blood clot?

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

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

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.

Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Oedien, approximately 8 to 11 women will develop a blood clot in one year.

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

Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 out of 10,000 women
Women who use dienogest/ethinylestradiol	Approximately 8–11 out of 10,000 women

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Oedien several weeks before surgery or while you are less mobile. 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 of age).
• If you have given birth in the past few weeks.

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

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

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

If any of the above conditions change while you are using Oedien—for example, a close relative experiences a thrombosis without a known cause, or you gain a significant amount 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 stroke.

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

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

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like this medicine, 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using this medicine—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a significant amount of weight—inform your doctor.

Dienogest/ethinylestradiol and cancer

Breast cancer has been diagnosed slightly more often 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 gradually disappears within 10 years after stopping the contraceptive pill. Since breast cancer is rare in women under 40 years of age, the additional number of breast cancer cases in women who are currently 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 this difference. It is possible that women were examined more frequently, leading to earlier detection of breast cancer.

Rare cases of benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of the contraceptive pill. These tumors can cause internal bleeding. Contact your doctor immediately if you experience severe stomach pain.

Some studies suggest 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 extent to which other factors (e.g., differences in the number of sexual partners or use of mechanical contraceptive methods) influence this outcome has not yet been established.

Psychiatric disorders:

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

Medical consultation/examination

Before you take Oedien, your doctor will take a detailed medical history from you and your close family. A general and gynecological examination, including a breast examination and cervical cytology test, will be performed. Pregnancy must be ruled out. These examinations should be repeated periodically while taking contraceptive pills. Inform your doctor if you smoke and if you are taking any other medicines.

Bleeding between periods

During the first few months of taking this medicine, you may experience unexpected bleeding (bleeding outside the placebo tablet week). If bleeding persists for more than a few months or starts after several months, your doctor should determine the cause.

What to do if no bleeding occurs during the placebo tablet week

If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medicines, it is very unlikely that you are pregnant.

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

Taking dienogest/ethinylestradiol with other medicines

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

Some medicines may cause intermenstrual bleeding or reduce the contraceptive effectiveness of dienogest/ethinylestradiol.

Effect of other medicines on dienogest/ethinylestradiol

Always inform your doctor about any medicines or herbal products you are taking. You should also inform any other doctor, dentist, or pharmacist who prescribes medicines for you that you are taking dienogest/ethinylestradiol. They may advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether any of your current medicines need to be changed.

Some medicines

can affect blood levels of this medicine, may make it less effective in preventing pregnancy, or may cause unexpected bleeding.

These include:

Medicines used to treat:

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

medicinal herbs containing St. John's wort

If you are being treated with any of the above medicines, you should use an additional barrier contraceptive method (e.g., condom) temporarily, or choose another contraceptive method. Use additional local contraceptive methods while taking other medicines together with this medicine, and continue for up to 28 days after stopping treatment with the other medicine.

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

Choose a non-hormonal contraceptive method if you require long-term treatment with any of the medicines mentioned above.

Effect of dienogest/ethinylestradiol with other medicines

This medicine may influence the effect of other medicines, e.g.:

the antiepileptic lamotrigine (may lead to an increase in seizure frequency)

cyclosporine

theophylline (used in the treatment of respiratory problems)

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

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

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

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

Please also refer to the package leaflet of other prescribed medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.

Interactions with laboratory tests

Use of this medicine may affect the results of certain laboratory tests, including liver, adrenal cortex, kidney and thyroid function values, as well as levels of certain proteins in the blood, e.g., proteins affecting fat digestion, carbohydrate metabolism, blood coagulation and fibrinolysis. However, these changes usually keep values within normal ranges. Inform your doctor or laboratory staff if you are taking the pill.

Laboratory tests

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

Periodic check-ups

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Women who are or think they may be pregnant should not use Oedien. If you become pregnant while taking this medicine, 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 medicine, as it may reduce the amount of breast milk produced and small amounts of the medicine may be excreted in breast milk. You should consult your doctor if you wish to take Oedien while 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 informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Oedien

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

When and how should the tablets be taken?

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

The Oedien tablets of two different colours are arranged in order. One blister contains 28 tablets.

Take one Oedien tablet every day with some water, if necessary. You may 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 one white tablet for the first 21 days, then one pink tablet for the last 7 days. After that, immediately start a new blister (21 white tablets followed by 7 pink tablets), without any break between blisters.

Due to the different composition of the tablets, you must start with the first tablet in the upper left corner and take one tablet each day. To follow the correct order, follow the direction of the arrows on the blister.

Blister preparation

To help you keep track, 7 stickers are provided, each showing the 7 days of the week, for each Oedien blister. Choose the sticker with the days of the week starting on the day you began taking the tablets. For example, if you start on Wednesday, use the sticker beginning with "WED".

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

Now each tablet is labelled with a day, so you can see whether you have taken a particular tablet. The arrows indicate the order in which the tablets should be taken.

During the 7 days when you take the pink placebo tablets (placebo interval), bleeding may occur (also called withdrawal bleeding). This usually starts 2–3 days after the last active white tablet of Oedien. Once you have taken the last pink tablet, start the next blister immediately, regardless of whether the bleeding has stopped or not. This means you should start each blister on the same day of the week, and withdrawal bleeding should 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 no hormonal contraceptive has been used in the previous month

Start taking this medicine 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 Friday, take a tablet marked Friday. Then continue with the days in order.

If you start on the first day of your period, you will be immediately protected against pregnancy. You may also start between days 2–5 of the cycle, but in this case you should use an additional barrier contraceptive method (e.g., a condom) for the first 7 days.

When previously using another combined oral contraceptive tablet, vaginal ring, or transdermal patch

You may start taking this medicine the day after taking the last tablet of your current tablet pack (meaning there will be no tablet-free interval) or after removing the vaginal ring or transdermal patch. If your current tablet pack also contains inactive tablets, you may start the day after taking the last active tablet (if you are unsure which tablet this is, consult your doctor or pharmacist).

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

When previously using a progestogen-only pill

You may stop taking the pill on any day and start taking this medicine 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 previously using an injectable, implant, or intrauterine system (IUS) releasing progestogen

Start taking this medicine on the day your 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 medicine for 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, pregnancy must be ruled out before you start taking the medicine, or you should wait until your first period occurs. For use during breastfeeding, see "Pregnancy and breastfeeding".

After a spontaneous or induced abortion

Your doctor will advise you accordingly.

If you take more Oedien tablets than you should

No serious harmful effects have been reported from 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 find that a child has taken Oedien, consult your doctor.

If you forget to take Oedien

The tablets in the 4th row of the blister are placebo tablets. If you forget to take one of these tablets, the effectiveness 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 effectiveness of the tablet remains 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 effectiveness of the tablet may be reduced. The more consecutive tablets you miss, the greater the risk of reduced contraceptive efficacy. There is a particularly high risk of pregnancy if tablets are missed at the beginning or end of the pack. Therefore, you must follow the rules given below (see also the diagram below).

More than 1 tablet missed from a pack

Consult your doctor.

1 tablet missed in week 1

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

1 tablet missed in week 2

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. The effectiveness of the tablet remains unchanged. No additional contraceptive precautions are necessary.

1 tablet missed in week 3

You may choose one of the following options, without needing additional precautions:

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

Or:

1. Stop taking the tablets in the current pack and go directly to a 7-day or shorter placebo period (counting the day you missed the tablet), then continue with the next pack. If you follow this method, you can always start the next pack on the same day of the week as usual.

• If you have missed 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 have stomach problems (e.g., vomiting, severe diarrhoea)

If you vomit or have diarrhoea within 3 to 4 hours after taking the active tablet, the active ingredients may not have been completely absorbed. In such cases, follow the procedures for when you forget to take a tablet. Take another tablet as soon as possible, 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 by starting the next pack of this medicine immediately after finishing the active tablets of the current pack, without a placebo tablet interval. You may continue this pack for as long as you wish, until you decide to stop. When you wish to have your period, start taking the 7 inactive tablets. Irregular bleeding may occur while taking the second pack. Start the next pack after taking the 7 placebo tablets.

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

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

What to do if you experience unexpected bleeding

With all contraceptive pills, breakthrough bleeding (irregular bleeding) may occur between periods during the first few months. You may need to use sanitary towels or tampons, but you should continue taking the tablets as usual. Irregular bleeding usually stops once your body has adapted to the contraceptive pill (usually after 3 cycles of taking the pill). If it continues, worsens, or starts again, inform your doctor.

What to do if you do not have a period

If you have taken all tablets at the correct time and have not had vomiting or taken other medicines, it is unlikely that you are pregnant. Continue taking this medicine as usual. If you do not have a period for two consecutive cycles, you may be pregnant. Inform your doctor immediately. Do not start the next pack until your doctor has confirmed you are not pregnant.

If you stop treatment with Oedien

You may stop taking this medicine at any time. If you do not wish to become pregnant, ask your doctor about other methods of birth control. If you stop taking this medicine because you wish to become pregnant, it is generally recommended to wait until you have a natural period before trying to conceive. This makes it easier to determine that the absence of bleeding is due to pregnancy.

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

4. Possible adverse effects

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

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

Serious adverse effects

Serious reactions associated with the use of dienogest/ethinylestradiol tablets are described in the section “Warnings and precautions”. More information can be found there. Contact 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 hives with possible breathing difficulties (see also section “Warnings and precautions”).

Other possible adverse effects

The following adverse effects have been reported by users of the dienogest/ethinylestradiol tablet:

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

• Headache
• Breast pain, including breast discomfort and breast tenderness

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

• Genital inflammation (vaginitis/vulvovaginitis), vaginal fungal infections (candidiasis, vulvovaginal infections)
• Increased appetite
• Depressed mood
• Migraine
• Dizziness
• High (hypertension) or low (hypotension) blood pressure
• Abdominal pain (including upper and lower abdominal pain, abdominal discomfort, flatulence)
• Nausea, vomiting, diarrhoea
• Acne
• Skin rash (including rash)
• Pruritus (sometimes generalized)
• Hair loss (alopecia)
• Irregular withdrawal bleeding [including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), infrequent bleeding (oligomenorrhoea), and absence of bleeding (amenorrhoea)]
• Bleeding between periods (intermenstrual bleeding, including vaginal bleeding and metrorrhagia)
• Breast enlargement (including swelling and edema of the breast)
• Painful menstruation (dysmenorrhoea)
• Vaginal discharge
• Ovarian cysts
• Pelvic 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)
• Breast infection (mastitis)
• Cervical inflammation (cervicitis)
• Fungal infections (e.g., Candida), viral infections, cold sores
• Influenza, bronchitis, upper respiratory tract infection, sinus inflammation (sinusitis)
• Benign neoplasms in the uterus (fibroids)
• Benign neoplasms in the fatty tissue of the breast (breast lipoma)
• Anaemia
• Allergic reactions (hypersensitivity)
• Development of male characteristics (virilism)
• Loss of appetite (anorexia)
• Depression, mental disorders, irritability, aggression
• Insomnia, sleep disturbances
• Circulatory disorders of the brain and heart, stroke
• Dystonia (muscle disorder that may cause, for example, abnormal posture)
• Dryness or irritation of the eyes
• Blurred vision
• Sudden hearing loss, hearing impairment
• Tinnitus
• Balance problems
• Rapid heartbeat
• Thrombosis, blood clot in a lung vein (pulmonary embolism)
• Inflammation of veins (thrombophlebitis)
• Varicose veins (varicose veins), venous disorders, vein pain
• Dizziness or fainting upon standing from a sitting or lying position (orthostatic hypotension)
• Hot flushes
• Asthma
• Increased respiratory rate (hyperventilation)
• Inflammation of the stomach lining (gastritis), inflammation of the intestine (enteritis)
• Indigestion (dyspepsia)
• Skin reactions/disorders, including allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis
• Increased sweating
• Golden-brown pigmented spots (so-called pregnancy spots), especially on the face (chloasma), disorders/increased pigmentation
• Oily skin (seborrhoea)
• Dandruff
• Growth of male-pattern hair (hirsutism)
• Orange-peel skin (cellulite)
• Spider naevus (reticular blood vessels with a central red spot on the skin)
• Back pain, chest pain
• Bone and muscle discomfort, muscle pain (myalgia), pain in arms and legs
• Abnormal cell growth on the surface of the cervix (cervical dysplasia)
• Pain or cysts in uterine appendages (ovaries and fallopian tubes)
• Breast cysts, benign breast neoplasms (fibrocystic mastopathy), asymptomatic accessory breast manifestation
• Spontaneous milk flow (galactorrhoea)
• Pain during intercourse (dyspareunia)
• Menstrual disorders
• Fluid accumulation in the body (peripheral oedema)
• Pseudo-influenza-like disorders, inflammation, pyrexia (fever)
• Increased blood triglyceride and cholesterol levels (hypertriglyceridaemia, hypercholesterolaemia)
• Harmful blood clots in a vein or artery, for example:
  • In a leg or foot (i.e., deep vein thrombosis)
  • In a lung (i.e., pulmonary embolism)
  • Heart attack
  • Stroke
  • Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  • Blood clot in the liver, stomach/intestine, kidneys or eye

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

Other side effects observed in users of this medicine, but whose frequency is unknown, 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 nodosum or multiforme); breast secretion, fluid retention (oedema)

Tumours

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

Other conditions

• Women with hypertriglyceridaemia (elevated blood fat levels resulting in an increased risk of pancreatitis when taking combined oral contraceptives)
• High blood pressure
• Onset or worsening of conditions definitively linked to combined oral contraceptives: jaundice or pruritus related to cholestasis (impaired bile flow); gallstones; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uraemic syndrome (a blood clotting disorder); a neurological condition called Sydenham's chorea; herpes gestationis (a type of skin condition occurring during pregnancy), and hearing loss-related hypoacusis.
• Impaired 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 medicines and oral contraceptives (e.g. products containing St. John’s wort, medicines for epilepsy, tuberculosis, HIV infection, and other infections). See section “Effect of other medicines on Oedien”.

Reporting of adverse effects

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

5. Storage of Dienacne

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

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

Do not store above 30°C.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of containers or unused medicines, please consult your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Oedien

• The active substances are ethinylestradiol and dienogest. Each white film-coated active tablet contains: 2 mg of dienogest and 0.03 mg of ethinylestradiol.

• The pink film-coated tablets do not contain any active substances.

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

• Components of the placebo tablets: Povidone K30, corn starch, 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 pack

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

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

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

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

Pack sizes:

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

84 film-coated tablets (3 blisters of 28 tablets each).

168 film-coated tablets (6 blisters of 28 tablets each).

Only certain pack 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 under the following names:

Germany:	Dienacne 2 mg / 0.03 mg film-coated tablets
Belgium:	Oedien 2 mg/0.03 mg film-coated tablets
Spain:	Oedien 2 mg/0.03 mg film-coated tablets EFG
France:	Oedien 2 mg/0.03 mg, film-coated tablet
Italy:	Aglae 2 mg/0.03 mg film-coated tablets
Luxembourg:	Oedien 2 mg/0.03 mg, film-coated tablet
Netherlands:	Dienelle 0.03 mg / 2 mg film-coated tablets
Portugal:	Amelye 2 mg/ 0.03 mg film-coated tablets

Date of the most recent review of this leaflet: November 2024

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