CECILIANA 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ceciliana 2 mg/0.03 mg film-coated tablets EFG

dienogest/ethinylestradiol

Important things 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 having 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 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 to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Ceciliana is and what it is used for
2. What you need to know before you start taking Ceciliana
3. How to take Ceciliana
4. Possible side effects
5. Storage of Ceciliana

1. Package contents and additional information

1. What Ceciliana is and what it is used for

This medication is used to:

• prevent pregnancy (contraceptive pill),
• treat moderate to severe acne in women who accept taking a contraceptive pill after the failure of adequate oral or local antibiotic treatment.

It contains a small amount of female hormones, called progesterone (dienogest) and an estrogen (ethinylestradiol).

Contraceptive pills that contain two hormones are called "combined" pills or combined oral contraceptives.

Oral contraceptive pills (taken by mouth) are a very effective method of family planning. If taken regularly (without missing pills), the chance of becoming pregnant is very low.

In women with a higher male hormonal effect, the "androgenic effect" results in the development of acne; these symptoms improved with the application of Ceciliana.

2. What you need to know before starting to take Ceciliana

General considerations

Before starting to use Ceciliana, you should 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 Ceciliana, 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 Ceciliana, or in which the effectiveness of Ceciliana is reduced. 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 the rhythm or temperature methods. These methods are unreliable because oral contraceptive pills alter the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Ceciliana, like other hormonal oral contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

If you have acne, it will normally start to improve between 3 to 6 months after treatment, and may continue to improve even after 6 months. You should consult your doctor about the need to continue your treatment 3 or 6 months after starting and then have regular check-ups to assess the need to extend treatment.

Do not takeCeciliana

You should not use Ceciliana 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 are allergic to ethinylestradiol, dienogest, or any of the other components of this medicine (included in section 6). The allergy may manifest itself, for example, by itching, rash, or swelling.
• 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 an operation or spend a lot of time without getting up (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 that causes severe chest pain and can be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that can increase your risk of forming a clot in the arteries:

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you smoke.
• If you have, have had, or have had cancer that can be affected by your sex hormones (such as breast cancer or cancer in the genital organs).
• If you have or have had a liver tumor (benign or malignant).
• If you have or have had liver disease, if your liver values in the blood are not normalized (also in case of Rotor syndrome and Dubin-Johnson syndrome).
• If you have any type of vaginal bleeding of unknown cause.
• If you are pregnant or suspect you may be pregnant.
• 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 "Other medicines and Ceciliana").

If any of the situations mentioned above occur while you are taking Ceciliana for the first time, you should stop taking this medicine immediately and inform your doctor. In the meantime, you should use a non-hormonal contraceptive method. For more information, see the section "Warnings and precautions".

Additional information on other user groups

Children and adolescents

Ceciliana is not intended for women (girls) who are not yet menstruating.

Use in older women

Ceciliana is not intended for postmenopausal women.

Liver failure

Do not take Ceciliana if you have liver disease. Also, consult "Do not take Ceciliana" and "Warnings and precautions".

Kidney failure

Consult a doctor. The available data do not indicate the need to change the use of Ceciliana.

Warnings and precautions

When you should be particularly careful with Ceciliana

If a woman uses the combined pill and is experiencing any of the conditions listed below, she may need to be closely monitored.

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

If the condition develops or worsens while you are using Ceciliana, you should also inform your doctor:

• if you smoke,
• if you have diabetes mellitus,
• if you are overweight,
• if you have high blood pressure,
• 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 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 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 an operation 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 blood clots. You should ask your doctor when you can start taking Ceciliana after childbirth,
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if you have heart valve problems or heart rhythm disorders,
• if any of your close relatives have had a blood clot (thrombosis in the lower limb, in the lung - pulmonary embolism, or in any other location), a heart attack, or a stroke at a young age;
• if you have migraines,
• if you have epilepsy (see "Other medicines and Ceciliana"),
• if a close relative has had breast cancer,
• if you have a liver or gallbladder disease
• if you have or have had conditions that appeared for the first time or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy called herpes gestationalis, a nerve disease called Sydenham's chorea),
• if you have brownish-yellow spots on the skin, especially on the face (chloasma), if so, avoid sun exposure or ultraviolet radiation,
• if you have hereditary angioedema: administered estrogens can cause symptoms of angioedema. You should consult your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, and/or pharynx and/or difficulty swallowing or urticaria along with difficulty breathing.
• you should consult your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria, along with difficulty breathing. If you have hereditary angioedema, medications containing estrogens can induce or worsen the symptoms of angioedema.

If any of these conditions or diseases appear for the first time, reappear, or worsen while you are taking the pill, you should contact your doctor.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Ceciliana increases your risk of having 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 Ceciliana 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 thromboembolism). 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 having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive. The risk may also be higher if you start 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 is always slightly higher than if you were not taking a combined hormonal contraceptive.

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

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with Ceciliana is small.

• Out of 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.
• Out of 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.
• Out of 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, such as Ceciliana, between approximately 8 and 11 women will have a blood clot in a year.
• The risk of having 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 having a blood clot with Ceciliana 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 an operation 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 Ceciliana several weeks before surgery or while you have less mobility. If you need to stop using Ceciliana, ask your doctor when you can start using it again.
• As you get older (especially over 35 years).
• If you have given birth in the past few weeks.

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

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

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

If any of the above conditions change while you are using Ceciliana, 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 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 Ceciliana is very small, but it can increase:

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

Of these, the risk of presenting a blood clot can be further increased.

If any of the above conditions change while you are using Ceciliana, 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.

The "pill" and cancer

Cases of breast cancerhave been observed with a slightly higher frequency in women taking oral contraceptives, but it is unknown if this is caused by the treatment.

The findings may be due to the fact that women taking the combined pill were examined by the doctor much more frequently. The risk of breast cancer decreases gradually after stopping the combined hormonal contraceptive. It is essential that you check your breasts regularly and inform your doctor if you notice any lump.

In rare cases, benign liver tumors and, in fewer cases, malignant liver tumorshave been reported in users of the pill. These tumors can occasionally cause potentially fatal internal bleeding. Inform your doctor immediately if you have severe abdominal pain.

The most important risk factor for cervical canceris persistent infection with the human papillomavirus (HPV).

Some studies suggest that prolonged use of hormonal contraceptives is a risk factor for developing cervical cancer in women. However, it is not clear to what extent this risk increases due to sexual behavior or other factors such as the human papillomavirus.

The tumors mentioned above can cause a potentially fatal condition or death.

Psychiatric disorders

• Some women using hormonal contraceptives like Ceciliana 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.

Bleeding between periods

During the first few months while taking Ceciliana, you may have unexpected bleeding or spotting between regular periods. You may also need to use hygiene products and take the pills as usual. Irregular bleeding usually disappears as soon as your body gets used to the pill (generally after 3 months of use).

Inform your doctor if this bleeding occurs for more than a few months or if it reappears after disappearing.

What to do if bleeding does not occur during the pill-free interval

If you have taken the pills correctly, have not had vomiting or severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant. Continue taking Ceciliana as usual.

If you did not take the pills correctly before the first missed withdrawal bleeding or if you do not have withdrawal bleeding twice in a row, you might be pregnant. Inform your doctor immediately. Start the next blister pack only if you are sure you are not pregnant. Meanwhile, use non-hormonal contraceptives (See "General considerations").

Other medications and Ceciliana

Always inform your doctor about the medications or herbal products you are using. Also, inform any other doctor or dentist who prescribes you another medication (or the pharmacist) that you use Ceciliana. They may tell you if you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long or if you should change the use of another medication that you need.

Some medications

• may affect the blood levels of Ceciliana,
• may make it less effective in preventing pregnancy,
• may cause unexpected bleeding.

These include medications used to treat:

• epilepsy (e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate),
• tuberculosis (e.g., rifampicin),
• some medications used to treat HIV and Hepatitis C infections (such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors like ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, azole antifungals like itraconazole, voriconazole, fluconazole),
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin),
• certain heart conditions, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem),
• joint diseases: arthritis, arthrosis (etoricoxib),
• certain herbal supplements containing St. John's Wort (Hypericum perforatum),
• grapefruit juice.

Ceciliana may affect the efficacy of other medications, e.g.,

• lamotrigine,
• cyclosporine,
• melatonin,
• midazolam,
• theophylline,
• tizanidine.

Do not use Ceciliana if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications 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 medications.

Ceciliana can be taken approximately 2 weeks after completing this treatment. See section "Do not take Ceciliana"

Consult your doctor or pharmacist before taking any medication. Consult your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medication. They may advise you on additional protective measures while taking other medications with Ceciliana.

Laboratory tests

If you need to have a blood test, inform your doctor or laboratory personnel that you are taking a contraceptive because this medication may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not use Ceciliana during pregnancy. Before starting to take Ceciliana, ensure you are not pregnant. If you become pregnant while taking this medication, stop taking Ceciliana and consult your doctor immediately.

Breastfeeding

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

Driving and using machines

No studies have been conducted on the effect on the ability to drive or use machines.

Ceciliana contains lactose

This medication 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 Ceciliana

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

Each blister of Ceciliana contains 21 film-coated tablets. The day of the week on which each tablet should be taken is printed on the blister. Take the tablet approximately at the same time every day; if necessary, with a little liquid. Follow the direction of the arrows every day until you finish the 21 tablets. You will not take any tablets during the next 7 days. Menstruation (withdrawal bleeding) should occur during these 7 days. This usually starts 2 to 3 days after taking the last tablet of Ceciliana.

Start a new blister on the eighth day, whether you have stopped bleeding or not. This means you should start each blister on the same day of the week and that withdrawal bleeding should occur approximately on the same day every month.

With the proper use of combined oral contraceptives, failure is around 1% per year. If you forget a tablet or take it incorrectly, the failure rate may increase.

When to Start Taking Ceciliana

If You Have Not Used Any "Pill" Contraceptive in the Previous Month

Start on the first day of your menstrual cycle (the first day of menstruation as Day 1), taking the tablet marked with the correct day of the week on the blister. Continue with the following days in the correct order. This is how Ceciliana acts immediately, and no other contraceptive method is necessary.

If you start taking Ceciliana between days 2 and 5, use an additional barrier contraceptive method during the first 7 days of taking the "pill".

Switching from a Combined Hormonal Contraceptive or a Vaginal Ring/ Patch Contraceptive

You can start taking Ceciliana the day after taking the last tablet of your previous contraceptive blister (meaning there will be no interval without taking tablets). If your previous package also contained inactive tablets (placebo tablets), you can start taking Ceciliana the day after taking the last active tablet (if you are unsure if the tablets are active, consult your doctor or pharmacist). You can start taking it later, but no later than the day after the tablet-free days of your previous contraceptive that ended (or after taking the last inactive tablet of your previous contraceptive). In the case of a patch or vaginal ring, you should start taking Ceciliana preferably on the day they are removed and, at the latest, on the day they should be reapplied.

If you follow these instructions, you do not need to use any other contraceptive method.

Switching from a Progestogen-Only Method (Progestogen-Only Pill, Injection, Intrauterine System Releasing Progestogen)

You can stop taking the mini-pill at any time and start taking Ceciliana the next day at the usual time. However, if you have had sexual intercourse, use an additional barrier contraceptive method (barrier method) during the first 7 days of use.

From an injectable, an implant, or an IUS, start taking Ceciliana on the day you would normally have received the next injection or the day the implant or IUS is removed. However, if you have had sexual intercourse, use an additional barrier contraceptive method (barrier method) during the first 7 days of taking the tablets.

After Having a Baby

If you have just had a baby, your doctor may recommend that you start taking Ceciliana after your first period. However, in some cases, you may start hormonal contraception earlier; consult your doctor. If, after having a baby, you have had sexual intercourse before starting Ceciliana, you should first ensure you are not pregnant or wait until your next menstrual period.

If you are breastfeeding and want to start taking Ceciliana, talk to your doctor.

After an Abortion or Miscarriage

Talk to your doctor about the possibility of taking Ceciliana.

If You Take More Ceciliana Than You Should

No serious reactions have been reported from taking too many Ceciliana tablets.

If you take several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even girls who have not yet menstruated but have taken this medication without realizing it may experience this bleeding.

If you discover that a child has taken Ceciliana, consult your doctor.

If you have taken more Ceciliana than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Ceciliana

Depending on the day of your cycle when you missed a tablet, you may need additional contraceptive measures, such as a barrier method, like a condom. Take the tablets as described below. Consult the diagram below for more details. In case of doubt, contact your doctor.

• If it has been less than 12 hourssince you missed a tablet, the contraceptive effect of Ceciliana is not reduced. Take the tablet as soon as you remember and then continue taking the following tablets at the usual time.
• If it has been more than 12 hourssince you missed a tablet, pregnancy protection is not guaranteed. The more consecutive tablets you miss, the higher the risk of becoming pregnant. There is a particularly high risk of becoming pregnant if you miss a tablet at the beginning or end of the blister. Therefore, you should follow the rules below (also consult the diagram for missed tablets below).
• If You Missed More Than One Tablet

Contact your doctor.

Do Not Take More Than 2 Tablets in One Day to Make Up for Missed Doses.

If you have missed taking some tablets and then do not have withdrawal bleeding during the first normal tablet-free interval, you should consider the possibility of pregnancy. In this case, you should talk to your doctor before starting the next blister.

Follow the instructions below if you missed a tablet:

If You Missed a Tablet in Week 1:

If you forget to start a new blister or miss a tablet within the first 7 days, there is a risk that you may be pregnant (if you have had sexual intercourse within the 7 days before missing a tablet). Inform your doctor before taking a new package. Also, consult the diagram below.

If you have not had sexual intercourse before missing the tablet, take the missed tablet as soon as you remember (even if this means taking two tablets at once) and take the next tablet at the usual time. Take additional contraceptive precautions (barrier method: condom) for the next 7 days.

If You Missed a Tablet in Week 2:

Take the missed tablet as soon as you remember (even if this means taking two tablets at once) and take the next tablet at the usual time. The reliability of the pill is maintained, and no additional contraceptives are necessary.

If You Missed a Tablet in Week 3:

If you follow one of the two options explained below, no additional contraceptive measures are necessary:

Option 1: Take the missed tablet as soon as possible (even if this means taking two tablets at once). Then, continue taking the tablets at the usual time. You should start the next blister immediately after taking the last tablet of the current blister, i.e., without the tablet-free interval between blisters.It is unlikely that withdrawal bleeding will occur until the end of the second blister, but you may experience spotting or intermenstrual bleeding on the days you are taking the tablets.

or

Option 2: You should stop taking the tablets from the current blister immediately. In this case, you should have a tablet-free interval of up to 7 days, including the day you missed the tablet, and then continue with the tablets from the next blister.

Diagram for Missed Doses

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

Each blister of Ceciliana contains 21 film-coated tablets. The day of the week on which each tablet should be taken is printed on the blister. Take the tablet approximately at the same time every day; if necessary, with a little liquid. Follow the direction of the arrows every day until you finish the 21 tablets. You will not take any tablets during the next 7 days. Menstruation (withdrawal bleeding) should occur during these 7 days. This usually starts 2 to 3 days after taking the last tablet of Ceciliana.

Start a new blister on the eighth day, whether you have stopped bleeding or not. This means you should start each blister on the same day of the week and that withdrawal bleeding should occur approximately on the same day every month.

With the proper use of combined oral contraceptives, failure is around 1% per year. If you forget a tablet or take it incorrectly, the failure rate may increase.

When to Start Taking Ceciliana

If You Have Not Used Any "Pill" Contraceptive in the Previous Month

Start on the first day of your menstrual cycle (the first day of menstruation as Day 1), taking the tablet marked with the correct day of the week on the blister. Continue with the following days in the correct order. This is how Ceciliana acts immediately, and no other contraceptive method is necessary.

If you start taking Ceciliana between days 2 and 5, use an additional barrier contraceptive method during the first 7 days of taking the "pill".

Switching from a Combined Hormonal Contraceptive or a Vaginal Ring/ Patch Contraceptive

You can start taking Ceciliana the day after taking the last tablet of your previous contraceptive blister (meaning there will be no interval without taking tablets). If your previous package also contained inactive tablets (placebo tablets), you can start taking Ceciliana the day after taking the last active tablet (if you are unsure if the tablets are active, consult your doctor or pharmacist). You can start taking it later, but no later than the day after the tablet-free days of your previous contraceptive that ended (or after taking the last inactive tablet of your previous contraceptive). In the case of a patch or vaginal ring, you should start taking Ceciliana preferably on the day they are removed and, at the latest, on the day they should be reapplied.

If you follow these instructions, you do not need to use any other contraceptive method.

Switching from a Progestogen-Only Method (Progestogen-Only Pill, Injection, Intrauterine System Releasing Progestogen)

You can stop taking the mini-pill at any time and start taking Ceciliana the next day at the usual time. However, if you have had sexual intercourse, use an additional barrier contraceptive method (barrier method) during the first 7 days of use.

From an injectable, an implant, or an IUS, start taking Ceciliana on the day you would normally have received the next injection or the day the implant or IUS is removed. However, if you have had sexual intercourse, use an additional barrier contraceptive method (barrier method) during the first 7 days of taking the tablets.

After Having a Baby

If you have just had a baby, your doctor may recommend that you start taking Ceciliana after your first period. However, in some cases, you may start hormonal contraception earlier; consult your doctor. If, after having a baby, you have had sexual intercourse before starting Ceciliana, you should first ensure you are not pregnant or wait until your next menstrual period.

If you are breastfeeding and want to start taking Ceciliana, talk to your doctor.

After an Abortion or Miscarriage

Talk to your doctor about the possibility of taking Ceciliana.

If You Take More Ceciliana Than You Should

No serious reactions have been reported from taking too many Ceciliana tablets.

If you take several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even girls who have not yet menstruated but have taken this medication without realizing it may experience this bleeding.

If you discover that a child has taken Ceciliana, consult your doctor.

If you have taken more Ceciliana than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Ceciliana

Depending on the day of your cycle when you missed a tablet, you may need additional contraceptive measures, such as a barrier method, like a condom. Take the tablets as described below. Consult the diagram below for more details. In case of doubt, contact your doctor.

• If it has been less than 12 hourssince you missed a tablet, the contraceptive effect of Ceciliana is not reduced. Take the tablet as soon as you remember and then continue taking the following tablets at the usual time.
• If it has been more than 12 hourssince you missed a tablet, pregnancy protection is not guaranteed. The more consecutive tablets you miss, the higher the risk of becoming pregnant. There is a particularly high risk of becoming pregnant if you miss a tablet at the beginning or end of the blister. Therefore, you should follow the rules below (also consult the diagram for missed tablets below).
• If You Missed More Than One Tablet

Contact your doctor.

Do Not Take More Than 2 Tablets in One Day to Make Up for Missed Doses.

If you have missed taking some tablets and then do not have withdrawal bleeding during the first normal tablet-free interval, you should consider the possibility of pregnancy. In this case, you should talk to your doctor before starting the next blister.

Follow the instructions below if you missed a tablet:

If You Missed a Tablet in Week 1:

If you forget to start a new blister or miss a tablet within the first 7 days, there is a risk that you may be pregnant (if you have had sexual intercourse within the 7 days before missing a tablet). Inform your doctor before taking a new package. Also, consult the diagram below.

If you have not had sexual intercourse before missing the tablet, take the missed tablet as soon as you remember (even if this means taking two tablets at once) and take the next tablet at the usual time. Take additional contraceptive precautions (barrier method: condom) for the next 7 days.

If You Missed a Tablet in Week 2:

Take the missed tablet as soon as you remember (even if this means taking two tablets at once) and take the next tablet at the usual time. The reliability of the pill is maintained, and no additional contraceptives are necessary.

If You Missed a Tablet in Week 3:

If you follow one of the two options explained below, no additional contraceptive measures are necessary:

Option 1: Take the missed tablet as soon as possible (even if this means taking two tablets at once). Then, continue taking the tablets at the usual time. You should start the next blister immediately after taking the last tablet of the current blister, i.e., without the tablet-free interval between blisters.It is unlikely that withdrawal bleeding will occur until the end of the second blister, but you may experience spotting or intermenstrual bleeding on the days you are taking the tablets.

or

Option 2: You should stop taking the tablets from the current blister immediately. In this case, you should have a tablet-free interval of up to 7 days, including the day you missed the tablet, and then continue with the tablets from the next blister.

Diagram for Missed Doses

If You Vomit or Have Severe Diarrhea

If you have gastrointestinal disorders, such as vomiting or diarrhea, within 4 hours after taking a tablet, it is possible that the active ingredient may not be fully absorbed into your body. In these cases, follow the instructions that apply to missing a tablet within 12 hours of your usual time. If you do not want to deviate from your usual time, take a replacement tablet from another blister. If gastrointestinal symptoms persist for several days or are recurrent, use a barrier contraceptive method (e.g., condom) and inform your doctor.

If You Interrupt Treatment with Ceciliana

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

If you stop taking Ceciliana because you want to become pregnant, it is generally recommended that you wait until you have had a natural period before trying to become pregnant. This way, you can calculate the expected date of delivery more easily.

If You Want to Delay Withdrawal Bleeding (Your Period)

If you want to delay your period, you should continue with the next blister of Ceciliana immediately after taking the last tablet of the current blister. You can take as many tablets from the next blister as you want, until the end of the second blister. If you want to start your period, simply stop taking them. While taking the second blister, you may experience intermenstrual bleeding or spotting. The usual intake of Ceciliana resumes after the usual 7-day tablet-free interval.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effect worsens, or if one appears that is not mentioned in this leaflet, 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 information, see section 2 "What you need to know before you start taking Ceciliana".

Serious side effects

Serious adverse reactions associated with the use of the pill, as well as the associated symptoms, are described in the sections: "What you need to know before you start taking Ceciliana", "Blood clots", and "Pill and cancer".

Read these sections of the leaflet for detailed information and contact your doctor if necessary.

Contact a doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria, along with difficulty breathing (see also the section "Warnings and precautions").

Other possible side effects

The following side effects may occur with the use of dienogest/ethinylestradiol:

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

• headache,
• chest pain, including chest discomfort and breast tenderness.

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

• inflammation of the genitals (vaginitis/vulvovaginitis), vaginal infections caused by fungi (candidiasis, vulvovaginal infections),
• increased appetite,
• depressive mood,
• dizziness,
• migraine,
• increased or decreased blood pressure, in rare cases increased diastolic blood pressure (decreased value),
• abdominal pain (including upper and lower abdominal pain, discomfort/bloating),
• nausea, vomiting, and diarrhea,
• acne,
• hair loss (alopecia),
• itching of the skin (including erythema with spots on the skin),
• itching (in some cases all over the body),
• irregular menstrual bleeding including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea),
• spotting (vaginal bleeding and metrorrhagia),
• painful menstruation (dysmenorrhea), pelvic pain,
• increased swelling of the breast size, breast edema,
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue including weakness, fatigue, and general malaise,
• weight changes (increase, decrease, or fluctuation).

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

• inflammation in the fallopian tubes or ovaries,
• inflammation of the cervix (cervicitis),
• urinary tract infection, bladder infection (cystitis),
• breast infection (mastitis),
• fungal infections (such as Candida), viral infections, cold sores,
• flu, bronchitis, respiratory tract infections, sinusitis,
• asthma,
• rapid breathing (hyperventilation),
• benign tumors in the uterus (fibroma),
• benign tumors in the breast tissue (breast lipoma),
• anemia,
• allergic reactions (hypersensitivity),
• development of male characteristics (virilization),
• severe loss of appetite (anorexia),
• depression,
• mental disorders,
• insomnia,
• sleep disturbances,
• aggression,
• ischemic stroke (decreased or interrupted blood flow to the brain),
• stroke (vascular disorders in the brain),
• change in muscle tension - dystonia (muscle disorder that can cause an unusual posture or movement),
• dryness or irritation of the eyes,
• visual disturbances,
• oscillopsia (visual disturbance where objects appear to be moving) or other vision disorders
• sudden hearing loss,
• tinnitus,
• vertigo,
• deafness,
• cardiovascular disorders (disorders of blood flow to the heart),
• rapid heart rate (tachycardia),
• 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,
• symptoms of a mini-stroke or temporary stroke, known as a transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eyes
• increased diastolic blood pressure (the lowest blood pressure value reached between two heartbeats),
• orthostatic hypotension (dizziness or fainting when standing up after sitting or lying down),
• hot flashes,
• varicose veins,
• venous disorders, vein pain,
• asthma,
• deep breathing,
• gastritis,
• inflammation of the intestines,
• indigestion (dyspepsia)
• skin reactions,
• skin disorders including allergic skin reaction, neurodermatitis/atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (brown or yellowish spots on the skin),
• disorders of pigmentation/increased pigmentation,
• seborrhea (oily skin),
• dandruff,
• hirsutism (male hair growth),
• orange peel skin,
• spider veins (blood vessels in a network with a central red spot on the skin),
• back pain,
• discomfort of bones and muscles,
• muscle pain,
• pain in arms and legs,
• abnormal growth of cells on the surface of the cervix (cervical dysplasia),
• pain or cysts in the uterine appendages (fallopian tubes and ovaries),
• breast cysts,
• fibrocystic breast disease (benign growths in the breast),
• pain during sexual intercourse (dyspareunia),
• secretion from the breast (galactorrhea),
• menstrual disorders,
• chest pain,
• peripheral edema (fluid retention in the body),
• flu-like illness,
• inflammation.

Adverse reactions that have been reported with the use of the pill and for which the exact frequency is unknown are: mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, urticaria, skin disorders such as erythema nodosum or multiforme, breast secretion, fluid retention.

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

Description of selected adverse reactions

The following are very rare or delayed adverse reactions that may occur or worsen with the use of combined oral contraceptives (see sections "Do not take Ceciliana" and "What you need to know before you start taking Ceciliana").

Tumors

• The frequency of breast cancer diagnosis among users of combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40, this increase is low in relation to the overall risk of breast cancer. The causality related to the use of combined oral contraceptives is unknown.
• Liver tumors (benign and malignant).

Other disorders

• Women with hypertriglyceridemia (increased fat in the blood resulting in an increased risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Appearance or worsening of disorders whose association with the use of combined oral contraceptives is not conclusive: jaundice and/or itching related to cholestasis (bile flow blocked); formation of bile stones; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a disease with the formation of blood clots); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin disorder that occurs during pregnancy); hearing loss related to otosclerosis.
• In women with congenital angioedema (which manifests as sudden swelling of the eyes, mouth, throat, etc.), externally administered estrogens may cause or worsen the symptoms of angioedema.
• Liver function disorders.
• Changes in glucose tolerance or effect on peripheral insulin resistance.
• Crohn's disease, ulcerative colitis.
• Chloasma (brown or yellowish spots on the skin).

Interactions

Unexpected bleeding and/or lack of contraceptive efficacy may be due to interactions with other medications and oral contraceptives (e.g., St. John's Wort, medications for treating epilepsy, tuberculosis, HIV infection, and other infections). See also "Other medicines and Ceciliana".

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

More about the contraceptive pill

The combined pill may also have non-contraceptive health benefits.

Your menstrual bleeding may be lighter and shorter. This may result in a lower risk of anemia. The pain associated with menstruation may be less or disappear completely.

Additionally, it has been reported that users of pills containing 50 micrograms of ethinylestradiol (high-dose pill) have a lower incidence of certain serious diseases. These include benign breast diseases, ovarian cysts, pelvic infections (inflammatory diseases of the small organs of the pelvis), ectopic pregnancy (the fetus develops outside the uterus), and endometrial and ovarian cancer. This may also apply to the use of a low-dose pill, but so far it has only been confirmed for endometrial and ovarian cancer.

5. Storage of Ceciliana

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

Do not use this medicine after the expiry date that appears on the outer packaging and on the blister pack after CAD/EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Keep the blister pack in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Ceciliana

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

• Core of the tablet: lactose monohydrate, magnesium stearate, cornstarch, and povidone.
• Coating of the tablet: (which contains an Aquarius coating system):hypromellose 2910, macrogol 400 (PEG), and titanium dioxide.

Appearance of the product and package contents

Ceciliana is a white, round, and biconvex film-coated tablet.

Ceciliana is available in packs containing 21, 3x21, and 6x21 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

La Vallina s/n

Polígono Industrial Navatejera

24193 Villaquilambre, León

Spain

Local representative

SHIONOGI, S.L.

C/ Serrano 45, 3rd floor

28001 Madrid

Spain

Date of the last revision of thisleaflet:December 2021

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