Prospect: information for the user

Ceciliana 2 mg/0.03 mg film-coated tablets EFG

dienogest/etinilestradiol

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

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

Read this prospect thoroughly before starting to take this medicine, because it contains important information for you.

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

6. Contents of the pack andadditional information

This medication is used for:

• preventing pregnancy (birth control pill),
• treatment of moderately severe acne in women who accept taking a birth control pill after failure of adequate oral or local antibiotic treatment.

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

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

Oral contraceptives (administered orally) are a very effective method of family planning. If taken regularly (without missing pills), the likelihood 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.

General Considerations

If you have acne, it will usually 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 treatment 3 or 6 months after starting and then have regular checks to evaluate the need to extend treatment.

Do not take

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

Additional Information on Other Groups of Users

Children and Adolescents

Ceciliana is not intended for girls who have not yet started menstruating.

Use in Older Women

Ceciliana is not intended for postmenopausal women.

Liver Disease

Do not take Ceciliana if you have liver disease. See also “Do not take Ceciliana” and “Warnings and Precautions”.

Renal Insufficiency

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

Warnings and Precautions

When to be particularly careful with Ceciliana

If a woman uses the combined pill and is experiencing any of the conditions listed below, it may be necessary to have close monitoring.

Inform 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 inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• 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 disorder 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 surgery or spend a lot of time without standing up (see section “Blood Clots”),
• If you recently gave birth, you are at greater risk of blood clots. Ask your doctor when you can start taking Ceciliana after delivery
• If you have superficial thrombophlebitis,
• If you have varicose veins,
• If you have heart valve disorders or arrhythmias,
• 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 organ), a heart attack, or a stroke at a younger age;
• If you have migraines,
• If you have epilepsy (see “Other Medications and Ceciliana”),
• If a close relative has had breast cancer,
• If you have liver or gallbladder disease
• If you have any conditions that appeared for the first time or worsened during pregnancy or previous use of sex hormones (such as hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy called herpes gestational, a nerve disorder called Sydenham's chorea),
• If you have brownish-yellow spots on the skin, especially on the face (melasma), if so, avoid exposure to the sun or ultraviolet radiation,
• If you have hereditary angioedema: the administered estrogens may cause symptoms of angioedema. You should consult your doctor immediately if you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria accompanied by difficulty breathing.
• You should consult your doctor immediately if you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria, accompanied by difficulty breathing. If you have hereditary angioedema, medications containing estrogens may induce or worsen angioedema symptoms.

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

BLOOD CLOTS

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

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

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

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

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.

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

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

What is the risk of a blood clot?

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

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimate, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol like Ceciliana, approximately 8-11 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

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

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

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

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

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Ceciliana.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (over about 35 years old).
• If you smoke.
• 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 younger age (i.e., before about 50 years old). You may also be at higher risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation).
• If you have diabetes.

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

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

The pill and cancer

There have been cases ofbreast cancerwith a slightly higher frequency in women taking the pill, but it is unclear whether this is caused by the treatment.

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

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

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

Some studies suggest that long-term use of hormonal contraceptives may be a risk factor for developing cervical cancer in women. However, it is unclear to what extent this risk is increased by sexual behavior or other factors such as HPV.

The mentioned tumors can cause potentially fatal or fatal conditions.

Mental Health Disorders

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

Spotting between periods

During the first few months of taking Ceciliana, you may experience unexpected bleeding or spotting between regular periods. You may also need to use products for hygiene and take the pills as usual. Irregular bleeding usually disappears as soon as your body gets used to the pill (usually 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 no bleeding occurs during the pill-free interval

If you have taken the pills correctly, have not had severe vomiting or 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 period or if you have not had two consecutive periods of withdrawal bleeding, you may be pregnant. Inform your doctor immediately. Start the next pack only if you are sure you are not pregnant. In the meantime, use non-hormonal contraceptives (see “General Considerations”).

Other Medications and Ceciliana

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

Some medications

• may affect the blood levels of Ceciliana,
• may make itless 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 (such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors like ritonavir, nevirapine, efavirenz),
• infections caused by fungi (e.g., griseofulvin, azole antifungals like itraconazole, voriconazole, fluconazole),
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin),
• heart conditions: high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem),
• joint diseases: arthritis, osteoarthritis (etoricoxib),
• some herbal medicinal supplements containing St. John's Wort (Hypericum perforatum),
• orange juice.

Ceciliana mayaffect the effectiveness of other medications, e.g.,

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

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

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 taken recently, or may need to take any other medication. You may be advised 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 staff that you are taking a contraceptive because this medication may affect the results of some tests.

Pregnancy, Lactation, and Fertility

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

Pregnancy

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

Lactation

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 Operating Machines

No studies have been conducted on the effect on the abilityto drive or operate machines.

Ceciliana contains lactose

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

Follow exactly the administration instructions of this medication as 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 blister is printed with the day of the week on which each tablet should be taken. Take the tablet approximately at the same time every day; if necessary, with a little liquid. Follow the arrow direction every day until you finish with the 21 tablets. You will not take any tablets for 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 or not you have stopped bleeding. This means that 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 proper use of combined oral contraceptives, failure is around 1% per year. If you forget a tablet or take it incorrectly, the frequency of failure may increase.

When to start taking Ceciliana

If you have not used any "pill" contraceptive the previous month

Start on the first day of the 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 the following days in the correct order. This is how Ceciliana acts immediately and no other contraceptive method is needed.

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

Change from a combined hormonal contraceptive or a vaginal ring or patch contraceptive

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

If you follow these instructions, no other contraceptive method is needed.

Change from a progestin-only method (progestin-only pill, injection, intrauterine system releasing progestin)

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 sex, use an additional barrier contraceptive method (barrier method) for the first 7 days of use.

From an injectable, an implant, or an IUD, start taking Ceciliana on the day you would normally receive the next injection or the day the implant or IUD is removed. However, if you have sex, use an additional barrier contraceptive method (barrier method) for 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 can start hormonal contraception before, consult your doctor. If, after having a baby, you have had sex before starting with Ceciliana, you must first ensure that you are not pregnant or wait until the next menstrual bleeding.

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

After an abortion or spontaneous abortion

Talk to your doctor about the possibility of taking Ceciliana.

If you take more Ceciliana than you should

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

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 immediately, your pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Ceciliana

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

• If you makeless than 12 hoursof the forgotten tablet, the contraceptive effect ofCecilianais not reduced. Take the tablet as soon as you remember it and then continue taking the next tablets at the usual time.
• If you makemore than 12 hoursof the forgotten tablet, the protection against pregnancy is not guaranteed. The more consecutive tablets you omit, the higher the risk of becoming pregnant. There is a particularly high risk of becoming pregnant if you forget to take a tablet at the beginning or end of the blister. Therefore, you must follow the following rules (also see the diagram of forgotten tablets below).
• You forgot more than one tablet

Contact your doctor.

Do not take more than 2 tablets in a day to compensate for the missed doses.

If you have forgotten to take some tablets and then do not present withdrawal bleeding in the first normal interval without tablets, you should consider the possibility of pregnancy. In this case, you should talk to your doctor before starting with the next blister.

Follow the instructions below if you forgot to take a tablet:

If you forgot to take a tablet in week 1:

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

If you have not had sex before forgetting the tablet, take the forgotten tablet as soon as you remember it (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 forgot to take a tablet in week 2:

Take the forgotten tablet as soon as you remember it (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 needed.

If you forgot to take a tablet in week 3:

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

Option 1: take the forgotten tablet as soon as possible (even if this means having to take two tablets at once). Then, continue taking the tablets at the usual time. You should start the next package immediately after taking the last tablet of the current package, e.g.,without the interval without tablets between blisters.You are unlikely to experience withdrawal bleeding until the end of the second package, but you may experience spotting or intermenstrual bleeding while taking the tablets.

or

Option 2: you must stop taking the tablets from the current package immediately. In this case, you must maintain a tablet-free period of up to 7 days, including the day you forgot the tablet, and then continue with the tablets from the next package.

Diagram for forgotten tablets

If you vomit or have intense 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 will not be fully absorbed by your body. In these cases, follow the instructions that apply to if you forgot to take 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 package. 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 usually recommended that you wait until you have had a natural period before trying to become pregnant. This way, you can calculate your expected delivery date more easily.

If you want to delay withdrawal bleeding (period)

If you want to delay your period, you must continue with the next package of Ceciliana immediately after taking the last tablet of the current package. You can take as many tablets from the next package as you want, up to the end of the second package. If you want to start your period, simply stop taking them. While taking the second package, you may experience spotting or intermenstrual bleeding. The usual intake of Ceciliana is resumed after the usual 7-day interval without tablets.

If you want to change the first day of your period

If you take the tablets according to the instructions, you will always have your menstrual period approximately the same days every four weeks. If you need to change this day, you can shorten (but never lengthen) the next tablet-free interval by as many days as you want. For example, if your menstrual period usually starts on Friday and you want it to start on Tuesday (i.e., 3 days earlier), you must start the next package 3 days earlier than usual. The shorter the tablet-free interval (i.e., 3 days or less), the greater the likelihood that you will not experience withdrawal bleeding and may experience spotting or bleeding during the next package.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.If any side effect worsens, or if any not mentioned in this leaflet appears, consult your doctor

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

Severe side effects

Severe side effects associated with the use of the pill, as well as symptoms associated with them, are described in the sections: “What you need to know before starting to take Ceciliana”, “Blood clots” and “The pill and cancer”.

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

Contact a doctorimmediately 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:

Common(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, vaginal infections),
• increased appetite,
• depressed mood,
• dizziness,
• migraine,
• increase or decrease in blood pressure, in rare cases increase in diastolic blood pressure (decrease in value),
• abdominal pain (including upper and lower abdominal pain, discomfort/swelling),
• nausea, vomiting and diarrhea,
• acne,
• hair loss (alopecia),
• pruritus on the skin (including erythema with skin spots),
• itching (in some cases throughout 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),
• menstrual pain (dysmenorrhea), pelvic pain,
• enlargement and swelling of the breasts, 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 in the cervix,
• urinary tract infection, bladder infection (cystitis),
• breast infection (mastitis),
• fungal infections (such asCandida), viral infections, herpes labialis,
• flu, bronchitis, respiratory tract infections, sinusitis,
• asthma,
• accelerated breathing (hyperventilation),
• benign tumors in the uterus (fibroma),
• benign tumors in the breast tissue (mammary lipoma),
• anemia,
• allergic reactions (hypersensitivity),
• development of male characteristics(virilization),
• severe loss of appetite (anorexia),
• depression,
• mental disorders,
• insomnia,
• sleep disturbances,
• aggressiveness,
• ischemic stroke (decrease or interruption of blood flow to the brain),
• cerebrovascular accident (vascular alterations in the brain),
• muscle dystonia (muscular alteration that can cause an unusual posture or movement),
• dryness or irritation of the eyes,
• visual disturbances,
• oscillopsia (visual disturbance where objects appear to move) or other visual disorders
• sudden loss of hearing,
• tinnitus,
• dizziness,
• deafness,
• cardiovascular disorders (blood flow disorders 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,
• cerebrovascular accident,
• mini-stroke or transient ischemic attack (TIA) symptoms, known as transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys or eyes
• increase in diastolic blood pressure (lower value),
• orthostatic hypotension (dizziness or fainting when standing up after sitting or lying down),
• angina,
• varicose veins,
• venous disorders, pain in the veins,
• asthma,
• deep breathing,
• gastritis,
• inflammation of the intestines,
• indigestion (dyspepsia)
• skin reactions,
• skin disorders that include allergic skin reaction, neurodermatitis/atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• melasma (brown or yellowish skin spots, especially on the face),
• skin pigmentation changes / increased pigmentation,
• seborrhea (greasy skin),
• dandruff,
• hirsutism (male hair growth),
• orange skin,
• vascular spiders (blood vessels in a red spot on the skin),
• back pain,
• bone and muscle discomfort,
• muscle pain,
• arm and leg pain,
• abnormal cell growth on the surface of the cervix (cervical dysplasia),
• pelvic pain or cysts in the fallopian tubes and ovaries,
• breast cysts,
• benign breast disease (fibrocystic disease),
• pelvic pain during sex (dyspareunia),
• breast secretion (galactorrhea),
• menstrual disorders,
• chest pain,
• peripheral edema (fluid retention in the body),
• illness similar to the flu,
• inflammation.

The side effects that have been reported with the use of the pill and for which the exact frequency is unknown are: changes in mood, increase or decrease in libido (sex drive), intolerance to contact lenses, urticaria, skin disorders such as erythema nodosum or multiforme, breast secretion, fluid retention.

The likelihood 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 symptoms of a blood clot).

Selected adverse reaction descriptions

The following are rare side effects or delayed symptom appearance that may occur or worsen with the group of combined oral contraceptives (see sections “Do not take Ceciliana” and “What you need to know before starting to take 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 compared to the overall risk of breast cancer. The causal relationship with the use of combined oral contraceptives is unknown.
• Liver tumors (benign and malignant).

Other alterations

• Women with hypertriglyceridemia (increase in blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives).
• Hypertension.
• Aparition or worsening of alterations whose association with the use of AOC is not conclusive: jaundice and/or pruritus related to cholestasis (bile flow blocked); formation of gallstones; a metabolic alteration called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a disease with blood clot formation); a neurological alteration called Sydenham's chorea; gestational herpes (a type of skin alteration that occurs during pregnancy); hearing loss related to otosclerosis.
• In women with congenital angioedema (who manifest sudden swelling of the eyes, mouth, throat, etc.), the administered estrogens can cause or worsen the symptoms of angioedema.
• Alterations in liver function.
• Changes in glucose tolerance or effect on peripheral insulin resistance.
• Crohn's disease, ulcerative colitis.
• Cloasma (brown or yellowish skin spots).

Interactions

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

Reporting of adverse reactions

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

More about the contraceptive pill

The combined pill may also produce 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 also applies to the use of a low-dose pill, but has only been confirmed for endometrial and ovarian cancer so far.

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

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

Do not store at a temperature above30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ceciliana

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

• Tablet core: lactose monohydrate, magnesium stearate, cornstarch and povidone.
• Tablet coating: (which contains an Aquarius coating system):hypromellose 2910, macrogol 400 (PEG) and titanium dioxide.

Appearance of the product and contents of the packaging

Ceciliana are white, round, biconvex film-coated tablets.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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, floor 3

28001 Madrid

Spain

Last review date of this prospectus:December 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/