Ceciliana Diario 2 mg/0.03 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: 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 developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read this entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Ceciliana Diario is and what it is used for
What you need to know before taking Ceciliana Diario
How to take Ceciliana Diario
Possible side effects
How to store Ceciliana Diario
Contents of the pack and other information

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

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

Each of the 21 white tablets contains a small amount of two different female hormones: a progestogen (dienogest) and an estrogen (ethinylestradiol);
the 7 green tablets contain no active ingredients and are also known as placebo tablets.

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

Ceciliana Diario is a medicine:

to prevent pregnancy,
for the treatment of women with moderate acne who are willing to receive an oral contraceptive pill after failure of appropriate topical treatments or oral antibiotics.

2. What you need to know before starting Ceciliana Diario

General considerations

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

Acne will usually improve after 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 it, and periodically thereafter.

Do not take Ceciliana Diario

You must 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 which other form of contraception would be most suitable.

if you are allergic to ethinylestradiol, dienogest, or any of the other components of this medicine (listed in section 6),
if you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs,
if you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies,
if you require surgery or will be immobile for a long time (see section “Blood clots”),
if you have ever had a heart attack or stroke,
if you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms),
if you have any of the following conditions that may increase your risk of forming a blood clot in the arteries:
- severe diabetes with blood vessel damage,
- very high blood pressure,
- very high levels of fat in the blood (cholesterol or triglycerides),
- a condition called hyperhomocysteinemia,
if you have (or have ever had) a type of migraine called “migraine with aura”,
if you smoke (see section “Blood clots”),
if you have or have had inflammation of the pancreas associated with elevated serum triglyceride levels (lipid metabolism disorder),
if you have or have had liver disease, or if your liver blood values are not normalized (also in case of Rotor syndrome and Dubin-Johnson syndrome),
if you have or have had a liver tumour (benign or malignant),
if you have, have had, or suspect you may have cancer (such as breast cancer or endometrial cancer) that may be influenced by sex hormones,
if you have any type of vaginal bleeding of unknown cause,
if you do not have withdrawal bleeding (period) and the cause is unknown,
if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Ceciliana Diario”).

Warnings and precautions

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

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

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot, which may indicate you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below).

For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

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

If any of these conditions develop or worsen while you are using Ceciliana Diario, you must 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 affecting your body's natural defense system),
if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure),
if you have sickle cell anemia (a hereditary red blood cell disorder),
if you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas),
if you require surgery or will be immobile for prolonged periods (see section 2 "Blood clots"),
if you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you may start taking Ceciliana Diario after childbirth,
if you have inflammation of veins beneath the skin (superficial thrombophlebitis),
if you have varicose veins,
you must 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 hives, together with difficulty breathing. If you have hereditary angioedema, products containing estrogens may induce or worsen angioedema symptoms.

BLOOD CLOTS

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

Blood clots may form:

In the veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
In the arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be long-lasting serious effects, and very rarely, they may be fatal.

It is important 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.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable when standing or walking, increased warmth in the affected leg, change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing, sudden cough without clear cause, which may produce blood, sudden sharp pain that may worsen upon deep breathing, severe chest pain or dizziness, rapid or irregular heartbeat, severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision, or painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, heaviness, feeling of tightness or fullness in the chest, arm, or below the sternum, sensation of fullness, indigestion, or suffocation, upper body discomfort radiating to the back, jaw, throat, arm, or stomach, sweating, nausea, vomiting, or dizziness, extreme weakness, anxiety, or shortness of breath, rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body, sudden confusion, difficulty speaking or understanding speech, sudden vision problems in one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, sudden, severe, or prolonged headache without known cause, loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb, severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN

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

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

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

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

After the first year, the risk decreases, but it is still 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 venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.

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

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, between 5 and 7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Ceciliana Diario, approximately 8 to 11 women will develop a blood clot in one year.
Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

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

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

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

If you are overweight (body mass index or BMI above 30 kg/m²).
If any of your close relatives have had a blood clot in the leg, lung, or another organ at an early age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Ceciliana Diario several weeks before surgery or while you are less mobile. If you need to stop taking Ceciliana Diario, ask your doctor when you can start taking it again.
As you get older (especially over about 35 years of age).
If you have given birth within the last few weeks.

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

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

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

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

With age (over 35 years).
If you 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 are overweight.
If you have high blood pressure.
If a close relative has had a heart attack or stroke at an early age (before approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke.
If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
If you suffer from migraines, especially migraines with aura.
If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
If you have diabetes.

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

If any of the above conditions change while you are using Ceciliana Diario, for example, if you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant 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 consistently increases to values of 140/90 mmHg (your doctor should advise you when to restart the “pill” once your blood pressure has normalized with appropriate treatment),
if you are scheduled for surgery (you must stop taking the “pill” at least 4 weeks before surgery) or in case of prolonged immobilization (see section 2 “Blood clots”),
if you experience migraine for the first time or if it worsens,
if you have unusually frequent severe or persistent headaches that start suddenly with signs of so-called aura (problems with sensation, perception, and/or mobility),
if you have severe pain in the upper abdomen (see also “The pill and cancer”),
if your skin or the whites of your eyes turn yellowish, your urine becomes brown, your stools become very pale (jaundice), or if your skin itches all over,
if you are diabetic (diabetes mellitus) and your blood sugar levels suddenly increase,
if you have a disorder in blood pigment formation (porphyria) and it recurs while taking Ceciliana Diario.

Your doctor will perform periodic check-ups:

if you have a heart or kidney disease,
if you are prone to vein inflammation (phlebitis) or severe varicose veins,
if you suffer from circulation disorders in your hands/feet,
if your blood pressure levels are above 140/90 mmHg,
if you have a history of problems with how your body processes fats (lipid metabolism disorders),
if you have sickle cell anemia (a hereditary disease affecting your red blood cells),
if you have had previous liver disease,
if you have a history of gallbladder disease,
if you have migraines,
if you have depression,
if you are diabetic (diabetes mellitus) or have limited ability to metabolize glucose (reduced glucose tolerance). The dose of medication needed to treat diabetes may change while taking Ceciliana Diario,
if you smoke (see section 2 “Blood clots”),
if you have epilepsy. If you experience an increase in the number of epileptic seizures while taking Ceciliana Diario, consider using other contraceptive methods,
if you have a movement disorder causing rapid, jerky movements mainly affecting the face, feet, and hands, also known as “St. Vitus’ dance” (Sydenham’s chorea),
if you have chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis),
if you suffer from a blood disorder causing 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 (see section 2 “Blood clots”),
if you are overweight,
if you have a certain immune system disorder (systemic lupus erythematosus),
if you are 40 years of age or older.

Psychiatric disorders:

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

The “pill” and cancer

A slightly higher frequency of breast cancer has been observed in women taking contraceptive pills compared to women of similar age not taking the “pill.” Once a woman stops taking the “pill,” the risk gradually decreases, and after 10 years, no detectable difference remains between women who have used the “pill” and other women of similar age.

Since breast cancer is rare in women under 40 years of age, the number of additional cases of breast cancer in women currently taking or who have taken the “pill” is quite low 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, to date, it is unclear to what extent this result is influenced by other factors (such as differences in the number of sexual partners or use of mechanical contraceptive methods).

In very rare cases, benign (non-cancerous) but dangerous liver tumors have been reported. These tumors can cause life-threatening internal bleeding. 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 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 refer to the sections “Do not take Ceciliana Diario,” “Stop taking Ceciliana Diario immediately,” and “Your doctor will perform periodic check-ups”).

Pigmentation spots

Occasionally, yellowish-brown pigmentation spots (chloasma) may appear on the skin, especially in women who have had them during pregnancy. Therefore, women with this predisposition should avoid exposure to sunlight or ultraviolet light (such as tanning) while taking the “pill.”

Irregular bleeding (bleeding between periods)

During the first 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 bleeding reappears after your regular cycle has ended.

It is possible that withdrawal bleeding may not occur during the placebo tablet days. 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 bleed, or if you miss withdrawal bleeding twice in a row, you may be pregnant. Pregnancy must be definitively ruled out before continuing to take Ceciliana Diario.

Reduced effectiveness

The effectiveness of the “pill” may be reduced if you forget to take it, vomit, have intestinal diseases, severe diarrhea, or are taking other medications simultaneously.

If you are taking Ceciliana Diario together with other medications containing St. John’s wort, you must use another additional contraceptive method (such as a condom) (see “Other medicines and Ceciliana Diario”).

Medical examinations/consultations

Before using Ceciliana Diario, your doctor will ask about your medical history and that of your close relatives. They will perform a basic general medical examination and a gynecological check-up, including a breast examination and a cervical smear test. Pregnancy must be ruled out. 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 infection or other sexually transmitted diseases.

Other medicines and Ceciliana Diario

Do not use Ceciliana Diario if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in blood parameters measuring liver function (elevated 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 effectiveness of Ceciliana Diario or may cause unexpected bleeding.

The following medications may reduce the effectiveness 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),
some antibiotics used to treat tuberculosis (such as rifampicin) or those used to treat fungal infections (such as griseofulvin),
some medications used to treat HIV infection and hepatitis C (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, a barrier contraceptive method (condom) should be used in addition to Ceciliana Diario. With some of these medications listed above, additional contraceptive measures should be taken both during treatment with the medication and for 7 to 28 days afterward, depending on the type of medication used. Consult your doctor or pharmacist if you are unsure.

If the barrier method needs to be used for a long period exceeding the blister pack content, you should start taking tablets from the next Ceciliana Diario blister pack without taking the 7 placebo tablets. If long-term treatment with any of the medications listed above is required, consult your doctor about switching 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 blood fat levels),
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 function:

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

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

Diabetes

If you are diabetic, your need for medications to lower blood sugar (such as insulin) may change.

Laboratory tests

If you need 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, adrenal cortex, kidney, and thyroid function values, as well as the levels of certain proteins in the blood, such as those affecting lipid (fat) metabolism, carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes generally remain within normal ranges.

Pregnancy and breastfeeding

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 Ceciliana Diario, ensure you are not pregnant. If you become pregnant while taking this medication, 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 use of machines

Ceciliana Diario does not affect the ability to drive or operate machinery.

Ceciliana Diario contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Ceciliana Diario

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

Unless otherwise advised by your doctor, the usual dose is 1 tablet of Ceciliana Diario per day.

How to take Ceciliana Diario

Each blister contains 28 tablets: 21 active white tablets and 7 green placebo tablets.

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

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

Do not confuse the tablets: take one white tablet daily for the first 21 days, then take one green tablet daily for the last 7 days. After that, start a new blister (21 white tablets and 7 green tablets). In this way, there is no tablet-free interval between two blisters.

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

Blister preparation

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

Apply the adhesive strip to the blister over the phrase "Stick strip here".

Now each tablet has a day of the week indicated above it, so you can see whether you have taken a particular 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), withdrawal bleeding (so-called withdrawal bleeding) should occur. This usually starts on day 2 or 3 after taking the last white active tablet. Once you have taken the last green tablet, you must start a new blister, regardless of whether your bleeding has stopped or not. This means you should start each new blister on the same day of the week, and withdrawal bleeding should occur on the same days every month.

If you use Ceciliana Diario in this way, you will be protected against pregnancy even during the 7 days when you are taking 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 taken correctly, contraceptive protection begins on the first day of tablet intake.

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

If switching to Ceciliana Diario from another combined oral contraceptive pill, vaginal ring, or patch:

If you previously used a pill (where the tablet-free interval follows the day you take the last active tablet), start taking Ceciliana Diario the day after the tablet-free interval.
If you previously used a pill whose blister contains inactive tablets (also known as placebo tablets) in addition to active tablets, such that there is no tablet-free interval, start taking Ceciliana Diario the day after taking the last inactive tablet. If you are unsure which was the last inactive tablet, consult your doctor or pharmacist.
If you previously used a vaginal ring or patch, start taking Ceciliana Diario the day after your usual ring- or patch-free interval.

If switching from a progestogen-only pill (also called a "mini-pill")

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

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

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

If you have given birth and are not breastfeeding

Do not start taking the pill until 21 to 28 days after childbirth. For the first 7 days, use an additional barrier contraceptive method (such as a condom). If you have already had sexual intercourse before starting Ceciliana Diario, you must ensure you are not pregnant, or wait until your next menstruation before taking this medicine.

If you are breastfeeding

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

If you have had a miscarriage or fetal loss

Inform your doctor of your intention to take Ceciliana Diario.

Duration of treatment

You may take Ceciliana Diario for as long as you wish to use a hormonal contraceptive method and no health risks arise (see section "Do not take Ceciliana Diario" and "Stop taking Ceciliana Diario immediately"). Periodic medical check-ups are strongly recommended (see section "Medical examinations/consultations").

If you take more Ceciliana Diario than you should

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

Possible signs of overdose include: nausea, vomiting (usually after 12 to 24 hours, possibly lasting several days), breast tenderness, dizziness, stomach pain, drowsiness/tiredness, and vaginal bleeding in women and adolescents. Consult your doctor if relatively large quantities have been taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine 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 placebo tablets, it will not affect the reliability of this medicine. Discard the forgotten placebo tablet.

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

If less than 12 hours have passed since you missed the tablet, the contraceptive effect of Ceciliana Diario is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
If more than 12 hours have passed since you missed the tablet, protection against pregnancy is not guaranteed. If during the first days of taking the green placebo tablets (the first placebo days) your period does not occur, you may be pregnant. In that case, see your doctor before starting a new blister.

In general, consider the following:

The intake of active tablets should not be interrupted for more than 7 days.
For adequate contraceptive protection after missing a tablet, active tablets must be taken continuously for 7 days.

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

If you forget a tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. However, for the next 7 days, use an additional barrier contraceptive method (such as a condom). If you had sexual intercourse in the week before missing the tablet, there may be a risk of pregnancy. The closer this situation is to the usual placebo tablet interval, the higher the chance of pregnancy.

If you forget a tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. If you took Ceciliana Diario correctly during the 7 days before missing the tablet, the contraceptive effect is not affected and you do not need to use any additional contraceptive method. If this is not the case, or if you missed more than one tablet, use an additional barrier contraceptive method (such as a condom) for the next 7 days.

If you forget a tablet in week 3

Contraceptive protection is not fully guaranteed. By adjusting the 7-day placebo tablet interval, you may still maintain contraceptive effectiveness. If you follow either of the two options described below, you do not need to use any additional contraceptive method, but only if you took the tablets correctly during the 7 days before missing the tablet. If this is not the case, follow Option 1. Additionally, use an additional barrier contraceptive method (such as a condom) for the next 7 days.

Option 1: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the green placebo tablets, start taking the tablets from the next blister. Withdrawal bleeding is unlikely until you finish the second blister, but you may experience bleeding or spotting.

Option 2: Immediately stop taking the white tablets in the current blister and start taking the green placebo tablets (from the day you missed your tablet); then continue with the white tablets from the next blister. If you wish to start the new blister on your usual day of the week, take the placebo tablets for fewer than 7 days.

If you forget more than one tablet from the same blister

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

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

If you vomit or have diarrhea

If you experience gastrointestinal disturbances such as vomiting or diarrhea within 4 hours after taking the tablet, the active ingredient may not be completely absorbed into your body. In such cases, follow the instructions applicable to a missed tablet if you remember within the next 12 hours. If you do not wish to deviate from your usual tablet-taking routine, take a replacement tablet from another blister. If gastrointestinal disturbances persist for several days or are recurrent, use an additional barrier contraceptive method (such as a condom) and inform your doctor.

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

If you wish to delay your withdrawal bleeding, continue directly with the tablets from the next blister of Ceciliana Diario, without taking the placebo tablets. Withdrawal bleeding can be delayed as long as desired, but only until you finish the second blister. During this time, you may experience bleeding or spotting. After the usual placebo tablet interval, you may continue taking Ceciliana Diario as before.

If you stop treatment with Ceciliana Diario

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

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

4. Possible adverse effects

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

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you need to know before starting to take 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". There you can find detailed information about them. 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 hives, together with difficulty breathing (see also the section "Warnings and precautions").

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

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

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

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

genital inflammation (vaginitis/vulvovaginitis), fungal vaginal infections (candidiasis, vulvovaginal 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/bloating),
nausea, vomiting and diarrhoea,
acne,
hair loss (alopecia),
skin itching (including erythema with skin spots),
pruritus (sometimes affecting the whole body),
irregular menstrual bleeding including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), irregular bleeding (oligomenorrhoea) and absence of bleeding (amenorrhoea),
spotting (vaginal haemorrhage and metrorrhagia),
painful menstruation (dysmenorrhoea), pelvic pain,
breast enlargement, including swelling, breast oedema,
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,
accelerated breathing (hyperventilation),
benign neoplasms in the uterus (fibroma),
benign neoplasms in the fatty tissue of the breasts (mammary lipoma),
anaemia,
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,
dystonia (muscle disorder that may cause abnormal posture or movement),
dryness or irritation of the eye,
visual disturbances,
sudden loss of hearing, deafness,
tinnitus,
balance disorders,
rapid heartbeat,
thrombosis, pulmonary embolism,
inflammation of the veins (phlebitis, thrombophlebitis),
varicose veins (varicosities), vein pain,
dizziness or fainting when standing up from a sitting or lying position (orthostatic hypotension),
hot flushes,
inflammation of the stomach wall (gastritis), inflammation of the intestine (enteritis),
indigestion (dyspepsia),
skin reactions/skin disorders including allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, redness and irritation of the skin (psoriasis),
excessive sweating,
brownish-gold pigmentation spots (called chloasma), especially on the face (melasma), pigmentary disorders/increased pigmentation,
oily skin (seborrhoea),
dandruff,
masculinized hair growth (hirsutism),
orange-peel skin (cellulitis),
varicose veins (blood vessels appearing like spider webs with a central red spot),
back pain, chest pain,
aches in bones and muscles, muscle pain (myalgia), pain in arms and legs,
cervical dysplasia (abnormal growth of cells on the surface of the cervix),
pain or cysts in the uterine appendages (fallopian tubes and ovaries),
breast cysts, benign neoplasms in the breasts (fibrocystic breast disease), swelling of tissue near the breasts (supernumerary breasts),
pain during sexual intercourse,
secretion from the mammary gland, mammary secretions,
menstrual disorders,
peripheral oedema (fluid retention),
flu-like illness, inflammation, pyrexia (fever),
increased levels of triglycerides and cholesterol in the blood (hypertriglyceridaemia, hypercholesterolaemia),
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,
- transient ischaemic attack or temporary stroke-like symptoms, known as transient ischaemic attack (TIA),
- blood clots in the liver, stomach/intestine, kidneys or eye.

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

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

increase or decrease in sexual desire (libido),
intolerance to contact lenses,
hives (urticaria),
red, painful lumps under the skin (erythema multiforme nodosum).

Reporting of adverse effects

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

5. Storage of Ceciliana Diario

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

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after CAD/EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceciliana Diario

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

Active tablets

The active substances are dienogest and ethinylestradiol. One white active tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
Other components are:

Tablet core: lactose monohydrate, magnesium stearate, corn starch 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, corn starch and povidone K-30.

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

Appearance of the product and contents of the pack

The active film-coated tablets are white and round.

The placebo film-coated tablets are green and round.

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

Only certain pack sizes may be marketed.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
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 latest review of the package leaflet: August 2021

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