CECILIANA DIARIO 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ceciliana Diario 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 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, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What Ceciliana Diario is and what it is used for

Ceciliana Diario is a hormonal contraceptive indicated for women (combined hormonal contraceptive, also known as "the pill").

• Each of the 21 white tabletscontains a small amount of two different female hormones, a progestogen (dienogest) and an estrogen (ethinylestradiol);
• the 7 green tabletsdo not contain active ingredients and are also known as placebo tablets.

Clinical trials have shown that, in women where a pronounced effect of male hormones (called "androgens") causes acne, dienogest/ethinylestradiol alleviates this condition.

Ceciliana Diario is a medication:

• to prevent pregnancy,
• for the treatment of women with moderate acne who accept receiving a contraceptive pill after the failure of adequate local treatments or oral antibiotics.

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

General considerations

Before starting to use Ceciliana Diario, you should read the information about blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section 2 "Blood clots").

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

Do not take Ceciliana Diario

You should not use Ceciliana Diario 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.

• • 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,

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ceciliana Diario.

If, while taking Ceciliana Diario, any of the diseases or circumstances described in the section "Do not take Ceciliana Diario" occur for the first time, you must stop taking Ceciliana Diario and consult your doctor immediately.

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

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

• 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, products containing estrogens may induce or worsen the symptoms of angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting 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 Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

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

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

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

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

When you stop taking Ceciliana Diario, your risk of 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 developing 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 Diario is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, 5 to 7 will develop 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 Diario, approximately 8 to 11 women 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 with Ceciliana Diario is small, but some conditions increase the risk. Your risk is higher:

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

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

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

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

smoke. When using a combined hormonal contraceptive like Ceciliana Diario, 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 have one or more of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased further.

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

Stop taking Ceciliana Diario immediately:

Your doctor will perform regular check-ups:

• "St. Vitus' dance" (Sydenham's chorea),
• if you have a chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis),
• if you suffer from a blood disorder that causes kidney damage (hemolytic uremic syndrome),
• if you have a benign tumor in the muscular layer of the uterus (uterine fibroid),
• if you suffer from certain hearing loss (otosclerosis),
• if you are immobilized for a long period of time (see section 2 "Blood clots"),
• if you are overweight,
• if you suffer from a certain immune system disease (systemic lupus erythematosus),
• if you are 40 years or older.

Psychiatric disorders:

Some women who use hormonal contraceptives like Ceciliana Diario 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.

"The pill" and cancer

Cases of breast cancer have been observed with a slightly higher frequency in women taking oral contraceptives, compared to women of similar age who do not take "the pill". Once the woman stops taking "the pill", the risk decreases gradually and after 10 years the difference is no longer detectable between women who have been users of "the pill" and other women of similar age.

Since breast cancer is a rare disease in women under 40 years of age, the number of additional cases of breast cancer in women who are currently taking "the pill" or who have taken it is quite small compared to the overall risk of breast cancer.

Some studies suggest that long-term use of hormonal contraceptives is a risk factor for developing cervical cancer in women whose cervix is infected with a certain type of sexually transmitted virus (human papillomavirus). However, so far, it is not clear to what extent this result is influenced by other factors (such as differences in the number of sexual partners or the use of mechanical contraceptive methods).

In very rare cases, benign (non-cancerous) but potentially life-threatening liver tumorshave been described. These tumors can cause internal bleeding that can be life-threatening. Seek immediate medical attention if you experience severe abdominal pain.Studies have shown an increased risk of developing liver cancer in women who take "the pill" for a long period of time, however, this is extremely rare.

Other diseases

High blood pressure

Cases of high blood pressure have been reported in women taking "the pill". This occurs more frequently in older women and with prolonged use. The frequency of high blood pressure increases with the progesterone content. Use another contraceptive method if you already have a disease caused by high blood pressure or if you suffer from certain kidney diseases (in this case, consult your doctor, and also consult the section "Do not take Ceciliana Diario", "Stop taking Ceciliana Diario immediately" and "Your doctor will perform regular check-ups").

Pigmentation spots

Occasionally, brown-yellowish pigmentation spots (chloasma) may appear on the skin, especially in women who have had them during pregnancy. Therefore, women who have this predisposition should not be exposed to sunlight or ultraviolet light (such as for tanning) while taking "the pill".

Irregular bleeding (bleeding between periods)

During the first few months of using "the pill", you may experience irregular bleeding (spotting or bleeding). Contact your doctor if this irregular bleeding continues for more than 3 months or if the bleeding reappears after your regular cycle has ended.

It is possible that during the placebo days, withdrawal bleeding may not occur. If you have taken Ceciliana Diario correctly, it is unlikely that you are pregnant. However, if you have not taken "the pill" correctly before the first missed withdrawal bleeding or if you do not have withdrawal bleeding for two consecutive times, you may be pregnant. Pregnancy must be ruled out with certainty before continuing to take Ceciliana Diario.

Reduced efficacy

The efficacy of "the pill" may be reduced if you forget to take it, if you vomit, if you have intestinal diseases, severe diarrhea, or if you are taking other medications at the same time.

If you are taking Ceciliana Diario along with other medications that contain St. John's Wort, you should use an additional contraceptive method (such as a condom) (see "Other medications and Ceciliana Diario").

Exams/medical consultations

Before using Ceciliana Diario, your doctor will ask you about your medical history and that of your close relatives. He will perform a basic medical examination and a gynecological examination, including a breast examination and a cervical smear. Pregnancy must be ruled out. If you are taking "the pill", these exams should be repeated regularly. Inform your doctor if you smoke or if you are taking other medications.

Ceciliana Diario does not protect against HIV infection or other sexually transmitted diseases.

Other medications and Ceciliana Diario

Do not use Ceciliana Diario 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 blood parameters that measure liver function (increase in liver enzyme ALT).

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

Ceciliana Diario can be restarted approximately two weeks after completing this treatment. See section "Do not take Ceciliana Diario".

Some medications reduce the contraceptive efficacy of Ceciliana Diario or may cause unexpected bleeding.

The following medications may reduce the efficacy of Ceciliana Diario:

• medications that increase intestinal motility (such as metoclopramide),
• medications for the treatment of epilepsy, such as phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate,
• medications used to treat high blood pressure in blood vessels and lungs (bosentan),
• certain antibiotics used to treat tuberculosis (such as rifampicin) or those used to treat fungal infections (such as griseofulvin),
• certain medications used to treat HIV and hepatitis C (protease inhibitors or non-nucleoside reverse transcriptase inhibitors (such as ritonavir, nevirapine, and efavirenz)),
• certain herbal supplements that contain St. John's Wort (Hypericum perforatum).

If you are being treated with any of the medications listed above, you should use a barrier contraceptive method (condom) in addition to Ceciliana Diario. With some of these medications listed above, you should take additional contraceptive measures at the same time you are taking this medication and for 7 to 28 days after, depending on the type of medication used. Consult your doctor or pharmacist if you are unsure.

If you need to use the barrier method for a long period of time, which lasts longer than the contents of the blister pack, you should start taking the tablets from the next blister pack of Ceciliana Diario without taking the 7 placebo tablets. If you require long-term treatment with any of the medications listed above, consult your doctor about how to switch to a non-hormonal contraceptive method.

Taking Ceciliana Diario at the same time as the following medications may increase the risk of adverse effects:

• paracetamol (used against pain and fever),
• ascorbic acid (vitamin C),
• atorvastatin (used to reduce the amount of fat in the blood),
• troleandomycin (an antibiotic),
• imidazole antimycotics (used to treat fungal infections) such as fluconazole,
• indinavir (used to treat HIV infection).

Taking Ceciliana Diario at the same time as the following medications may affect their functioning:

• cyclosporine (used to suppress the immune system),
• theophylline (used to treat asthma),
• glucocorticoids (such as cortisone),
• certain benzodiazepines (tranquilizers) such as diazepam and lorazepam,
• clofibrate (used to reduce fat in the blood),
• paracetamol (used against pain and fever),
• morphine (used against severe pain),
• lamotrigine (used to treat epilepsy).

Please also read the package inserts of the other medications you are taking.

Diabetes

If you are diabetic, you may need to adjust your medications to reduce blood sugar levels (such as insulin).

Laboratory tests

If you need to have a blood test, inform your doctor or laboratory personnel that you are taking an oral contraceptive because this medication may affect the results of some tests, including liver, adrenal, kidney, and thyroid function tests, as well as the amount of certain proteins in the blood, such as those that affect lipid metabolism, carbohydrate metabolism, blood coagulation, and fibrinolysis. However, these changes usually remain within normal values.

Pregnancy and lactation

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

Pregnancy

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

Breastfeeding

Do not use Ceciliana Diario 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

Ceciliana Diario does not affect your ability to drive or use machines.

Ceciliana Diario contains lactose

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

3. How to take Ceciliana Diario

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

If your doctor does not indicate that you should take it in another way, the usual dose is 1 tablet of Ceciliana Diario per day.

How to take Ceciliana Diario

Each blister pack contains 28 tablets: 21 active tablets of whitecolor and 7 placebo tablets of greencolor.

The two types of Ceciliana Diario tablets are placed in order.

Swallow one tablet once a day, if necessary with a little water. You should take the tablets at approximately the same time every day.

Do not confuse the tablets:take one whitetablet once a day for the first 21 days, and then take one greentablet per day for the last 7 days. Then, you should start a new blister pack (21 whitetablets and 7 greentablets). In this way, there is no interval without tablets (no tablet-free periods) between two blister packs.

Due to the different composition of the tablets, it is necessary that you start with the first tablet from the top left of the blister pack (near START) and take one tablet per day. Follow the direction of the arrows on the blister pack to take them in the correct order.

Preparation of the blister pack

To help you remember to take the tablets, each package of Ceciliana Diario contains a label per blister pack, which contains 7 adhesive strips with the days of the week printed on them. Remove the adhesive strip that starts with the day of the week that coincides with the taking of the first tablet. For example, if you start on Wednesday, use the adhesive strip that starts with "WED".

Place the adhesive strip on the blister pack over the phrase that indicates "Place the adhesive strip here".

Now there is a day of the week indicated above each tablet, and you can see if you have taken a certain tablet. The arrows indicate the order in which to take the tablets.

During the 7 days when you are taking the green placebo tablets (the placebo days), bleeding (the so-called withdrawal bleeding) should occur. This usually starts on the 2nd or 3rd day after taking the last active white tablet. Once you have taken the last green tablet, you should start a new blister pack, regardless of whether your bleeding has stopped or not. This means that you should start each new blister pack on the same day of the week, and that the withdrawal bleeding should occur on the same days of each month.

If you use Ceciliana Diario in this way, you will also be protected against pregnancy during the 7 days when you take the green placebo tablets.

When to start taking Ceciliana Diario

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

Start taking Ceciliana Diario on the first day of your cycle, which is the first day of your menstruation. If you take it correctly, the contraceptive protection begins on the first day of taking the dose.

If you start taking Ceciliana Diario between days 2 to 5 of your cycle, you should use a barrier contraceptive method during the first 7 days of taking the pill.

If you are switching to Ceciliana Diario from another contraceptive pill (with two active hormonal principles), a vaginal ring, or a patch:

• If you have been taking a contraceptive pill previously (in which the tablet-free interval comes after the day you take the last active tablet), start taking Ceciliana Diario the day after the tablet-free interval.
• If you have been taking a contraceptive pill previously that contains inactive tablets (also known as placebo tablets) in addition to the active tablets, so that you do not have a tablet-free interval, start taking Ceciliana Diario the day after taking the last inactive tablet. If you are not sure which was the last inactive tablet, consult your doctor or pharmacist.
• If you have been using a vaginal ring or a patch previously, start taking Ceciliana Diario the day after the usual ring-free or patch-free interval.

If you are switching from a progestin-only pill (also called a "mini-pill")

You can stop taking the mini-pill on any day. Start taking Ceciliana Diario the next day. During the first 7 days, use a non-hormonal contraceptive method (such as a condom).

If you are switching from an injectable product (also called a "three-month injection"), an implant, or an intrauterine delivery system (IUD)

Start taking Ceciliana Diario on the day you would normally receive your next injection or on the day the implant or IUD is removed. During the first 7 days, use a non-hormonal contraceptive method (such as a condom).

If you have had a child and are not breastfeeding

Do not start taking the pill until at least 21 to 28 days have passed after giving birth. During the first 7 days, use an additional barrier contraceptive method (such as a condom). If you have already had sexual intercourse before starting to take Ceciliana Diario, you should ensure that you are not pregnant or wait until your next menstruation before taking this medication.

If you are breastfeeding

If you are breastfeeding and want to start taking Ceciliana Diario, consult your doctor (see section "Pregnancy and Breastfeeding").

If you have had an abortion or miscarriage

Inform your doctor of your intention to take Ceciliana Diario.

Duration of treatment

You can take Ceciliana Diario for as long as you want to use a hormonal contraceptive method and no health risks are present (see sections "Do not take Ceciliana Diario" and "Stop taking Ceciliana Diario immediately"). It is strongly recommended that you have regular medical check-ups (see section "Exams/medical consultations").

If you take more Ceciliana Diario than you should

If you have taken more tablets than prescribed, consult your doctor or pharmacist.

Among the possible signs of overdose are: nausea, vomiting (usually after 12 to 24 hours, possibly lasting several days), breast tenderness, dizziness, stomach pain, drowsiness/fatigue, women and adolescents may experience vaginal bleeding. You should consult your doctor if you have taken relatively large amounts.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ceciliana Diario

The green tablets in the fourth row of the blister pack are placebo tablets. If you forget to take one of these green tablets, it will not affect the reliability of this medication. You should discard the forgotten placebo tablet.

If you forget to take an active white tablet (tablets in the 1st, 2nd, 3rd row), you should do the following:

• If it has been less than 12 hourssince you forgot the tablet, the contraceptive effect of Ceciliana Diario 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 forgot the tablet, the protection against pregnancy is not guaranteed. If you do not have your period during the first days of taking the green placebo tablets, you may be pregnant. In this case, consult your doctor before starting a new blister pack.

In general, you should consider two things:

• the taking of the active tablet should not be interrupted for more than 7 days,
• for adequate contraceptive protection after forgetting a tablet, the active tablets should be taken without interruption for 7 days.

Follow these instructions if you forget to take a tablet:

If you forget to take a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then take the tablets at the usual time. However, during the following 7 days, use an additional barrier contraceptive method (such as a condom). If you have had sexual intercourse in the week before forgetting the tablet, there is a possible risk of pregnancy. The closer these situations are to the usual tablet-free interval, the more likely you are to be pregnant.

If you forget to take a tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. The following tablets can be taken at the usual time. If you took Ceciliana Diario correctly in the 7 days before forgetting the tablet, the contraceptive effect of the pill is not affected, and you do not need to use any additional contraceptive method. If this is not the case or if you forgot to take more than 1 tablet, use an additional barrier contraceptive method (such as a condom) during the following 7 days.

If you forget to take a tablet in week 3

The contraceptive protection is not completely guaranteed. By adjusting the 7-day tablet-free interval, you can still maintain the contraceptive effect. If you follow either of the two options detailed below, you do not need to use any additional contraceptive method, but only if you have taken the tablets correctly in the 7 days before forgetting the tablet. If this is not the case, proceed according to option 1. Additionally, during the following 7 days, use an additional barrier contraceptive method (such as a condom).

Option 1:take the forgotten tablet as soon as possible, even if this means taking two tablets at the same time. The following tablets can be taken at the usual time. Instead of taking the green placebo tablets, start taking the tablets from the next blister pack. It is likely that you will not have withdrawal bleeding until you finish taking the second blister pack; however, you may experience bleeding or spotting.

or

Option 2:stop taking the white tablets from the current blister pack immediately and start taking the green placebo tablets (from the day you forgot to take your tablet); then continue taking the white tablets from the next blister pack. If you want to start using the new blister pack on your usual day of the week, take the placebo tablets for less than 7 days.

If you forget to take more than 1 tablet from the same blister pack

If you forget to take more than 1 tablet from the same blister pack, you are not protected against pregnancy.

The probability of pregnancy increases as you forget to take more tablets and as you get closer to the placebo week. Use an additional barrier contraceptive method (such as a condom) until your next withdrawal bleeding occurs. If the withdrawal bleeding does not occur when you finish taking the current blister pack, you may be pregnant. In this case, consult your doctor before starting a new blister pack.

If you have vomiting or diarrhea

If you have gastrointestinal disorders, such as vomiting or diarrhea within 4 hours after taking the tablet, the active ingredient may not be fully absorbed into your body. In these cases, follow the instructions that correspond to forgetting a tablet if you remember within 12 hours. If you do not want to deviate from your usual tablet-taking routine, take a replacement tablet from another blister pack. If the gastrointestinal disorders persist for several days or are recurrent, use an additional barrier contraceptive method (such as a condom) and inform your doctor.

If you want to delay your withdrawal bleeding (your period)

If you want to change your withdrawal bleeding, you should continue taking the tablets from the next blister pack of Ceciliana Diario directly, without taking the placebo tablets. The withdrawal bleeding can be delayed for as long as you want, but only until you have finished taking the second blister pack. During this time, you may experience bleeding or spotting. After the usual tablet-free interval, you can continue taking Ceciliana Diario as before.

If you interrupt treatment with Ceciliana Diario

You can stop taking Ceciliana Diario at any time. If you do not want to become pregnant, ask your doctor for advice on other reliable contraceptive methods.

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

4. Possible Adverse Effects

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

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

The serious adverse effects associated with the use of the "pill" are listed in section 2 "What you need to know before starting to take Ceciliana Diario". You can find detailed information there. If necessary, consult your doctor immediately.

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 "Warnings and Precautions" section).

The following adverse effects may occur with the use of Ceciliana Diario:

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 skin spots),
• 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 hemorrhage and metrorrhagia),
• painful menstruation (dysmenorrhea), pelvic pain,
• increased breast size, including swelling, breast edema,
• vaginal discharge,
• ovarian cysts,
• fatigue including weakness, fatigue, and general malaise,
• weight changes (increase, decrease, or fluctuation).

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

• inflammation of the Fallopian tubes or ovaries,
• 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 of the uterus (fibroma),
• benign tumors of the breast tissue (breast lipoma),
• anemia,
• allergic reactions (hypersensitivity),
• masculinization (virilization),
• loss of appetite (anorexia),
• depression, mood changes, irritability, aggression,
• insomnia, sleep disturbances,
• vascular disorders in the brain or heart, stroke,
• distonia (muscle disorder that can cause an abnormal posture or movement),
• dryness or irritation of the eyes,
• visual disturbances,
• sudden hearing loss, deafness,
• tinnitus,
• balance disturbances,
• rapid heart rate,
• thrombosis, pulmonary embolism,
• inflammation of the veins (phlebitis, thrombophlebitis),
• varicose veins (varicosis), vein pain,
• dizziness or fainting when standing up after sitting or lying down (orthostatic hypotension),
• hot flashes,
• inflammation of the stomach wall (gastritis), inflammation of the intestine (enteritis),
• indigestion (dyspepsia),
• skin reactions/skin conditions including allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, redness, and skin irritation (psoriasis),
• excessive sweating,
• brown-gold spots (called pregnancy spots), especially on the face (chloasma), changes in pigmentation/increased pigmentation,
• oily skin (seborrhea),
• dandruff,
• masculinized hair growth (hirsutism),
• orange peel skin (cellulitis),
• varicose veins (spider-like blood vessels with a central red spot),
• back pain, chest pain,
• aches in the bones and muscles, muscle pain (myalgia), pain in the arms and legs,
• cervical dysplasia (abnormal growth of cells on the surface of the cervix),
• pain or cysts in the uterine extremities (Fallopian tubes and ovaries),
• breast cysts, benign breast tumors (fibrocystic breast disease), swelling of the tissue near the breasts (supernumerary breasts),
• pain during sexual intercourse,
• breast secretion, breast discharge,
• menstrual disturbances,
• peripheral edema (fluid retention),
• flu-like illness, inflammation, pyrexia (fever),
• increased levels of triglycerides and cholesterol in the blood (hypertriglyceridemia, hypercholesterolemia),

• harmful blood clots in a vein or artery, for example:
• • in a leg or foot (i.e., DVT),
  • in a lung (i.e., PE),
  • heart attack,
  • stroke,
  • mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

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

Frequency not known(cannot be estimated from the available data):

• increased or decreased sexual desire (libido),
• intolerance to contact lenses,
• hives (urticaria),
• red and painful lumps under the skin (erythema multiforme).

Reporting of Adverse Effects

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

5. Storage of Ceciliana Diario

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

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

Do not store above 30°C.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ceciliana Diario

A blister of Ceciliana Diario contains 21 active white tablets in the 1st, 2nd, and 3rd rows and 7 green placebo tablets in the 4th row.

Active Tablets

• The active ingredients are dienogest and ethinylestradiol. One active white 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 K-30.

Tablet coating: hypromellose 2910, macrogol 400, and titanium dioxide (E171).

Placebo Tablets

Tablet core: lactose monohydrate, magnesium stearate, colloidal anhydrous silica, cornstarch, and povidone K-30.

Tablet coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E-171), aluminum lake FD&C blue 2, and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

The film-coated active tablets are white and round.

The film-coated placebo tablets are green and round.

Ceciliana Diario is available in packages containing 28, 3x28, 6x28, and 13x28 film-coated tablets (21 active tablets and 7 placebo tablets).

Only some package sizes may be marketed.

Each package of Ceciliana Diario contains a sticker per blister with 7 adhesive strips with the days of the week printed in a different order depending on the start of tablet intake.

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.

C/ 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 this Prospectus:August 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