Prospect: information for the user

Ceciliana Diario 2 mg/0.03 mg film-coated tablets EFG

Dienogest/Ethinylestradiol

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 medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

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

• Each of the21 white tabletscontains a small amount of two different female hormones, a progestogen (dienogest) and an estrogen (etinilestradiol);
• The7 green tabletsdo not contain active ingredients and are also known as placebo tablets.

Clinical trials have shown that, in women in whom a pronounced effect of male hormones (designated as “androgens”) causes acne, dienogest/etinilestradiol alleviates this condition.

Ceciliana Diario is a medication:

-for preventing pregnancy,

-for the treatment of women with moderate acne who accept receiving a contraceptive pill after the failure of local treatments or oral antibiotics.

General Considerations

Before starting to use Ceciliana Diario, 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”).

The 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.

• If you are allergic to ethinylestradiol, dienogest, or any of the other components of this medication (listed in section 6),
• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs,
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies,
• If you need surgery or if you spend a lot of time without standing up (see section 2 “Blood Clots”),
• If you have ever had a heart attack or a stroke,
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA),
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:
• • Severe diabetes with vascular damage,
  • Very high blood pressure,
  • Very high levels of fat in your 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 (see section 2 “Blood Clots”),
• If you have or have had pancreatitis associated with high levels of triglycerides in your blood (lipid metabolism disorder),
• If you have or have had liver disease, if your liver function tests in blood are not normalized (also in the case of Rotor syndrome and Dubin-Johnson syndrome),
• If you have or have had liver cancer (benign or malignant),
• If you have, have had, or suspect that you have cancer (such as breast cancer or endometrial cancer) that may be affected by your sex hormones,
• If you have any type of vaginal bleeding of unknown cause,
• If you do not have menstrual bleeding and the cause is unknown,
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Ceciliana Diario”).

Warnings and Precautions

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

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

Inform your doctor if you experience any of the following conditions.

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

• 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 disorder of blood clotting 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 your blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas),
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”),
• If you recently gave birth, you are at a higher risk of developing blood clots. Ask your doctor when you can start taking Ceciliana Diario after childbirth,
• If you have superficial thrombophlebitis (inflammation of the veins under the skin),
• If you have varicose veins,
• 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, estrogen-containing products can induce or worsen angioedema symptoms.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Ceciliana Diario increases your risk of developing 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 ATE).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

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

The risk of developing a blood clot in a vein is higher during the first year when taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a 4-week or longer interruption.

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 developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

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

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

• Of every 10,000women who are not using a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000women who are using a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimate, 5 to 7will develop a blood clot in a year.
• Of every 10,000 women who are using a combined hormonal contraceptive containing dienogest and ethinylestradiol like Ceciliana Diario, approximately 8 to 11 women will develop a blood clot in a year.
• The risk of developing 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

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

• If you are overweight (body mass index (BMI) of 30kg/m2or higher).
• If one of your close relatives has had a blood clot in their leg, lung, or other organ at a young age (i.e., before the age of 50years approximately). You may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to stop using Ceciliana Diario for several weeks before the surgery or while you have limited mobility. If you need to stop using Ceciliana Diario, ask your doctor when you can start using it again.
• As you get older (especially above the age of 35years).
• If you have recently given birth.

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

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

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

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (above the age of 35years).
• If you smoke. When using a combined hormonal contraceptive like Ceciliana Diario, you are advised to quit smoking. If you are unable to quit smoking and are over 35years old, your doctor may advise you to use a different type of contraception.
• If you are overweight.
• If you have high blood pressure.
• If one of your close relatives has had a heart attack or stroke at a young age (before the age of 50years approximately). You may also be at a higher risk of a heart attack or stroke.
• If you or one of your close relatives has high levels of fat in your blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (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, your risk of developing a blood clot may be increased even further.

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

Stop taking Ceciliana Diario immediately:

• If you are pregnant or think you may be pregnant,
• If you have signs of phlebitis or blood clots (see section 2 “Blood Clots”),
• If your blood pressure increases constantly to reach values of 140/90 mmHg (your doctor should tell you to start taking “the pill” again as soon as your blood pressure has normalized with appropriate treatment),
• If you are planning surgery (you should stop taking “the pill” at least 4 weeks before the operation) or if you are immobile for a long time (see section 2 “Blood Clots”),
• If you have migraines for the first time or if they worsen,
• If you have severe, frequent, or persistent headaches that start suddenly with aura symptoms (problems with sensations, perception, and/or movement),
• If you have severe abdominal pain (see also “The Pill and Cancer”),
• If your skin or the whites of your eyes turn yellow, your urine turns brown, and your stools turn very pale (jaundice), or if your skin itches all over,
• If you are diabetic (diabetes mellitus) and your blood sugar levels increase suddenly,
• If you have porphyria (a disorder that affects the formation of hemoglobin in your blood) and it recurs while you are taking Ceciliana Diario.

Your doctor will perform regular check-ups:

• If you have a heart or kidney disease,
• If you have a tendency to develop inflammation of the veins (phlebitis) or severe varicose veins,
• If you have circulation problems in your hands/feet,
• If your blood pressure is above 140/90 mmHg,
• If you have a history of lipid metabolism disorders,
• If you have sickle cell anemia (a hereditary disease of red blood cells),
• If you have a history of liver disease, if your liver function tests in blood are not normalized (also in the case of Rotor syndrome and Dubin-Johnson syndrome),
• If you have a history of gallbladder disease,
• If you have migraines,
• If you have depression,
• If you are diabetic (diabetes mellitus) or if you have impaired glucose tolerance. The dose of medication needed to treat diabetes may change if you are taking Ceciliana Diario,
• If you smoke (see section 2 “Blood Clots”),
• If you have epilepsy. If you experience an increase in the frequency of seizures while taking Ceciliana Diario, you may want to consider using a different type of contraception,
• If you have a movement disorder that causes rapid, jerky movements that primarily affect your face, feet, hands, and is also known as “Saint Vitus' dance” (Sydenham's chorea),
• If you have a chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis),
• If you have a disorder that affects your blood and causes kidney damage (hemolytic uremic syndrome),
• If you have a benign tumor in the muscular layer of your uterus (uterine fibroid),
• If you have otosclerosis (a type of hearing loss),
• If you are immobile for a long time (see section 2 “Blood Clots”),
• If you are overweight,
• If you have a systemic immune disorder (systemic lupus erythematosus),
• If you are 40 years old or older.

Mental health disorders:

Some women who use hormonal contraceptives like Ceciliana Diario have reported depression or a depressed mood. Depression can be severe and sometimes may lead to 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 are not taking the pill. Once the woman stops taking the pill, the risk gradually decreases and after 10 years, the difference is no longer detectable between women who have used the pill and women of similar age.

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

Some studies suggest that long-term use of hormonal contraceptives may be a risk factor for developing cervical cancer in women whose cervix is infected with a certain type of sexually transmitted virus (human papillomavirus). However, it is not yet 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).

Invery rare cases, benign tumors (non-cancerous but potentially life-threatening) have been describedin the liver. These tumors can cause internal bleeding that may 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 time, although this is extremely rare.

Other diseases

High blood pressure

Cases of high blood pressure have been reported in women taking oral contraceptives. This occurs more frequently in older women and with long-term use. The frequency of high blood pressure increases with the progesterone content. Use another type of contraceptive if you already have a disease caused by high blood pressure or if you have certain kidney diseases (see also section “Do not take Ceciliana Diario”, “Stop taking Ceciliana Diario immediately”, and “Your doctor will perform regular check-ups”).

Age spots

Occasionally, brown-yellow spots (melasma) may appear on the skin, especially in women who have had them during pregnancy. Therefore, women who are prone to this condition should not expose themselves to sunlight or ultraviolet light (such as tanning) while taking the pill.

Irregular bleeding (spotting)

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

You may not experience menstrual bleeding during the days you take the placebo. If you have taken Ceciliana Diario correctly, it is unlikely that you are pregnant. However, if you have not taken the pill correctly before your first missed period or if you do not have menstrual bleeding for two consecutive times, you may be pregnant. You should rule out pregnancy with certainty before continuing to take Ceciliana Diario.

Reduced efficacy

The efficacy of the pill may be reduced if you forget to take it, vomit, have severe gastrointestinal disorders, or take other medications at the same time.

If you are taking Ceciliana Diario 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”).

Medical examinations/consultations

Before using Ceciliana Diario, your doctor will ask you about your medical history and the medical history of your close relatives. They will perform a basic physical examination and a gynecological examination, including a breast examination and a cervical smear. You should rule out pregnancy. If you are taking the pill, these examinations should be repeated regularly. Inform your doctor if you smoke or are taking other medications.

Ceciliana Diario does not protect against HIV 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 liver function tests in blood (elevated ALT levels).

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 can reduce the effectiveness of Ceciliana Diario or cause unexpected bleeding.

The following medications can reduce the effectiveness of Ceciliana Diario:

• Medications that increase intestinal motility (such as metoclopramide),
• Medications used to treat epilepsy, such as phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate,
• Medications used to treat high blood pressure in blood vessels and lungs (bosentan),
• Some antibiotics used to treat tuberculosis (such as rifampicin) or fungal infections (such as griseofulvin),
• Some medications used to treat HIV and hepatitis C (the so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, and efavirenz),
• Some herbal supplements containing 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, additional contraceptive measures should be taken at the same time as taking this medication and for 7 to 28 days thereafter, depending on the type of medication used. Consult your doctor or pharmacist if you are unsure.

If you need to use a barrier method for a long time, which exceeds the contents of the blister pack, you should start taking the next blister pack of Ceciliana Diario without taking the 7 placebo tablets. If long-term treatment with any of the medications listed above is required, 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 for pain and fever),
• Ascorbic acid (vitamin C),
• Atorvastatin (used to reduce the amount of fat in the blood),
• Troleandomycin (an antibiotic),
• Imidazole antifungals (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:

• Ciclosporin (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 the amount of fat in the blood),
• Paracetamol (used for pain and fever),
• Morphine (used for severe pain),
• Lamotrigine (used to treat epilepsy).

Please also read the leaflets of the other medications you are taking.

Diabetes

If you are diabetic, your medication needs may change.

Laboratory tests

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 should ensure that you are not pregnant. If you become pregnant while taking this medication, you should 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 operating machinery

Ceciliana Diariodoes not affect your ability to drive or operate machinery.

Ceciliana Diario contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult 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.

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

How to take Ceciliana Diario

Each blister contains 28 tablets: 21 active tablets ofwhitecolorand 7 placebo tablets ofgreencolor.

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 the same time approximately every day.

Do not confuse the tablets:take onewhitetablet once a day for the first 21 days, and then take onegreentablet per day for the last 7 days. After that, you should start a new blister (21whitetablets and 7greentablets). In this way, there will be no interval without tablets (no periods without tablets) between two blisters.

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

Preparation of the blister

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

Place the adhesive strip on the blister over the phrase that says "Stick 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 placebo tablets ofgreencolor (the placebo days), you should have a withdrawal bleeding (withdrawal bleeding). This usually starts on day 2 or 3 after taking the last active tablet ofwhitecolor. Once you have taken the last tablet ofgreencolor, you should start a new blister, regardless of whether your withdrawal bleeding has stopped or not. This means that you should start each new blisteron the same day of the week, and that the withdrawal bleeding should take place on the same days of each month.

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

When to start taking Ceciliana Diario

If you have not used any "pill" in the previous month:

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

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

If you change to Ceciliana Diario from another "pill" (with two active hormone principles), a vaginal ring or a patch:

• If you have been taking a "pill" (in which the interval without tablets comes after the day you take the last "pill" that contains active principle), start taking Ceciliana Diario on the day after the interval without tablets.
• If you have been taking a "pill" whose blister contains tablets without active principles (also known as placebo tablets) in addition to the tablets with active principle, so that there is no interval without tablets. Start taking Ceciliana Diario on the day after taking the last "pill" without active principles. If you do not know exactly which was the last tablet without active principles, consult your doctor or pharmacist.
• If you have been using a vaginal ring or a patch, start taking Ceciliana Diario on the day after the usual interval without ring or patch.

If you change from a "pill" that contains only progesterone (also called "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 barrier contraceptive method (such as a condom).

If you change from an injectable (also called "the three-month injection"), an implant or an intrauterine system (IUS)

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

If you have had a child and are not breastfeeding

Do not start taking the "pill" until 21 to 28 days after giving birth. During the first 7 days, use an additional barrier contraceptive method (such as a condom). If you have already had sex 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 fetal loss

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 there is no risk to your health (see section "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/drowsiness, 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 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 you makeless than 12 hoursof the forgotten tablet, the contraceptive effect ofCeciliana Diariois not reduced. Take the tablet as soon as you remember and then continue taking the next tablets at the usual time.

• If you makemore than 12 hoursof the forgotten tablet, the contraceptive protection is not guaranteed. If in the first days when you are taking the placebo tablets ofgreencolor (the placebo days) you do not have your period, you may be pregnant. In that case, consult your doctor before starting a new blister.

In general, you should consider two things:

• The intake of the active tablet should not be interrupted for more than 7 days,
• To have adequate contraceptive protection after forgetting to take a tablet, the active tablets should be taken without interruption for 7 days.

Follow the instructions below 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, in the following 7 days, use an additional barrier contraceptive method (such as a condom). If you have had sex in the week before the oversight, there may be a risk of pregnancy.As both of these situations are closer to the usual interval of placebo tablets, there is a greater chance that you are 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 next tablets can be taken at the usual time. If you have taken 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 barrier 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) for the next 7 days.

If you forget to take a tablet in week 3

The contraceptive protection is not completely guaranteed. By adjusting the 7 days of the placebo tablet interval, you can still have the contraceptive effect. If you follow either of the two options below, you do not need to use any additional barrier contraceptive method, but only if you have taken correctly in the 7 days before forgetting the tablet. If this is not the case, proceed with option 1. Additionally, in 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 next tablets can be taken at the usual time. Instead of taking the placebo tablets ofgreencolor, start taking the tablets from the next blister. It is very likely that you will not have withdrawal bleeding until you finish taking the second blister, but you may experience bleeding or spotting.

or

Option 2:stop taking the white tablets from the current blister immediately and start taking the placebo tablets ofgreencolor(from the day you forgot to take your tablet); then continue taking the white tablets from the next blister. If you want to start using the new blister 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

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

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

If you have vomiting or diarrhea

If you have digestive problems, such as vomiting or diarrhea within 4 hours after taking the tablet, the active principle may not be fully absorbed by your body. In these cases, follow the instructions for forgetting a tablet if you remembered within 12 hours. If you do not want to deviate from your usual routine of taking tablets, take a replacement tablet from another blister. If the digestive problems 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 of Ceciliana Diario, without taking the placebo tablets. The withdrawal bleeding can be delayed as long as you want, but only until you finish taking the second blister. During this time, you may experience bleeding or spotting. After the usual interval of placebo tablets, you can continue taking Ceciliana Diario as before.

If you interrupt the 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Ceciliana Diario, consult your doctor.

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

Severe side effects associated with the use of the pill are listed in section 2 “What you need to know before starting Ceciliana Diario”. You can find more detailed information there.If necessary, consult your doctor immediately.

Contact your doctorimmediately if you experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling and/or difficulty swallowing or urticaria, along with difficulty breathing(see also the section “Warnings and precautions”).

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

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 in 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 cramps (dysmenorrhea), pelvic pain,
• breast enlargement, including swelling, mammary 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 in the fallopian tubes or ovaries,
• inflammation in the cervix,
• urinary tract infection, bladder infection (cystitis),
• breast infection (mastitis),
• fungal infections, viral infections, herpes labialis,
• flu, bronchitis, respiratory tract infections, sinusitis,
• asthma,
• rapid breathing (hyperventilation),
• benign tumors in the uterus (fibroma),
• benign tumors in the breast tissue (mammary lipoma),
• anemia,
• allergic reactions (hypersensitivity),
• masculinization (virilization),
• loss of appetite (anorexia),
• depression, mood changes, irritability, aggression,
• insomnia, sleep disturbances,
• vascular changes in the brain or heart, stroke,
• dystonia (muscle alteration 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), pain in the veins,
• dizziness or fainting when standing up after sitting or lying down (orthostatic hypotension),
• seizures,
• inflammation of the stomach wall (gastritis), inflammation of the intestine (enteritis),
• indigestion (dyspepsia),
• skin reactions/dolences in the skin including allergic reactions in the skin, neurodermatitis/atopic dermatitis, eczema, redness and irritation in the skin (psoriasis),
• excessive sweating,
• brown-orange skin spots (called pregnancy spots), especially on the face (melasma), changes in pigmentation/increase in pigmentation,
• oily skin (seborrhea),
• dandruff,
• masculinized hair growth (hirsutism),
• orange skin (cellulitis),
• varicose veins (vascular structures with a central red spot),
• back pain, chest pain,
• bone and muscle aches, 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),
• cysts in the breasts, benign tumors in the breasts (fibrocystic disease of the breasts), breast tissue swelling (supernumerary breasts),
• pain during sexual intercourse,
• breast gland secretion, breast secretions,
• menstrual changes,
• peripheral edema (fluid retention),
• illness similar to the flu, inflammation, pyrexia (fever),
• increase in triglycerides and cholesterol levels 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 a stroke, called transient ischemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Unknown frequency(cannot be estimated from available data):

• increase or decrease in libido,
• intolerance to contact lenses,
• hives,
• red, painful bumps under the skin (erythema multiforme).

Reporting of side effects

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

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 above 30°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 the containers and medicines you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ceciliana Diario

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

Active Tablets

• The active principles are dienogest and etinilestradiol. One active tablet of white color contains 2 mg of dienogest and 0.03 mg of etinilestradiol.
• 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, anhydrous colloidal silica, cornstarch, and povidone K-30.

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

Appearance of the Product and Contents of the Package

The coated active tablets are white and round in color.

The coated placebo tablets are green and round in color.

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

Only some package sizes may be marketed.

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

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for Manufacturing

Laboratorios León Farma, S.A.

C/ La Vallina s/n, Industrial Park Navatejera

24193 Villaquilambre, León,

Spain

Local Representative

SHIONOGI, S.L.

C/ Serrano 45, 3rd floor

28001 Madrid

Spain

Last Review Date of thisProspect:August 2021

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