Serisima 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

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

Dienogest/Ethinylestradiol

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

They are one of the most reliable reversible contraceptive methods if used correctly.
They slightly increase the risk of 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 you start taking this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Serísima 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 oestrogen (ethinylestradiol);
the 7 green tablets do not contain any 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, Serísima Diario alleviates this condition.

Serísima Diario is used for:

preventing pregnancy,

and for the treatment of acne in women who agree to use a contraceptive method after failure of appropriate local therapy or antibiotic treatment.

2. What you need to know before starting Serísima Diario

General considerations

Before starting to use Serísima 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”).

Your acne will usually improve between three and six months after starting treatment, and may continue to improve even after six months. You should consult your doctor about the need to continue your treatment three or six months after starting, and then regularly thereafter.

When you must not use Serísima Diario:

Do not use Serísima 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 ischemic attack (TIA, temporary stroke-like symptoms),
if you have any of the following conditions that may increase your risk of developing a clot in the arteries:
- Severe diabetes with blood vessel damage,
- Very high blood pressure,
- Very high levels of fat in the blood (cholesterol or triglycerides),
- A condition called hyperhomocysteinemia,
if you have (or have ever had) a type of migraine called “migraine with aura”,
if you smoke (see section “The pill and vascular diseases”),
if you have or have had pancreatitis associated with serious problems processing fats (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 tumor (benign or malignant),
if you have, have had, or suspect you have cancer (such as breast cancer or endometrial cancer) that can be influenced by your 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, or glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section 2 “Other medicines and Serísima Diario”).

Warnings and precautions

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

If, while taking Serísima Diario, any of the diseases or conditions described under “When you must not use Serísima Diario” occurs for the first time, you must stop taking Serísima Diario and consult your doctor immediately.

When should you consult your doctor?

Seek urgent medical assistance

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 clot (thrombosis)” 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 Serísima 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 (an inherited 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 developing blood clots. You should ask your doctor when you can start taking Serísima Diario after childbirth,
if you have inflammation of the veins beneath the skin (superficial thrombophlebitis),
if you have varicose veins.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Serísima 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 (called "venous thrombosis", "venous thromboembolism" or VTE).
In the arteries (called "arterial thrombosis", "arterial thromboembolism" or TEA).

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

It is important to remember that the overall risk of a harmful blood clot due to Serísima 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, or 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 with no clear cause, possibly bringing up blood. Sharp pain that may worsen when taking a deep breath. 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 like 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, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling 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 nearly 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 the 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 (PE).
Very rarely, a blood clot may form in a vein of another organ, such as the 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 you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking Serísima 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 Serísima 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, about 5–7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Serísima Diario, between 8 and 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	About 5–7 out of 10,000 women
Women who use Serísima Diario	About 8–11 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 Serísima 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, illness, or if your leg is in a cast. You may need to stop taking Serísima Diario several weeks before surgery or while you are less mobile. If you need to stop taking Serísima Diario, ask your doctor when you can start taking it again.
As you get older (especially over about 35 years of age).
If you gave birth less than a few weeks ago.

The risk of developing a blood clot increases the more 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 uncertain. Your doctor may decide that you need to stop taking Serísima Diario.

If any of the above conditions change while you are using Serísima Diario—for example, a close relative experiences 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 lead to 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 heart attack or stroke from using Serísima Diario is very small, but it may increase:

With age (especially over about 35 years).
If you smoke. When using a combined hormonal contraceptive like Serísima 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 (under about 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 Serísima Diario—for example, you start smoking, a close relative experiences thrombosis without a known cause, or you gain significant weight—inform your doctor.

Stop taking Serísima Diario immediately:

if you are pregnant or think you may be pregnant,
if you have signs of phlebitis or blood clots (see “The pill and vascular diseases”),
if your blood pressure consistently rises to values of 140/90 mmHg (your doctor should advise you to restart the “pill” as soon as 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 “The pill and vascular diseases”),
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 aura (problems with sensation, perception, and/or movement),
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, or you experience itching all over your body (jaundice),
if you are diabetic (diabetes mellitus) and your blood sugar levels rise suddenly,
if you have a disorder affecting blood pigment formation (porphyria) and it recurs while taking Serísima Diario.

Your doctor will perform periodic check-ups:

if you have heart or kidney disease,
if you are prone to vein inflammation (phlebitis) or have severe varicose veins,
if you suffer from circulation problems in your hands/feet,
if your blood pressure is above 140/90 mmHg,
if you have a history of lipid metabolism disorders (problems with how your body processes fats),
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 impaired glucose metabolism (reduced glucose tolerance). The dose of medication needed to treat diabetes may change if you are taking Serísima Diario at the same time,
if you smoke (see “The pill and vascular diseases”),
if you have epilepsy. If you experience an increase in the number of epileptic seizures while taking Serísima Diario, you should 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 experience certain hearing loss (otosclerosis),
if you are immobilized for a long period (see “The pill and vascular diseases”),
if you are overweight,
if you suffer from a certain immune system disorder (systemic lupus erythematosus),
if you are 40 years old or older.

The “pill” and cancer

A slightly higher frequency of breast cancer has been observed in women taking oral contraceptives 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, there is no detectable difference 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 relatively 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 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 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 incidence 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 Serísima Diario,” “Stop taking Serísima Diario immediately,” and “Your doctor will perform periodic check-ups”).

Pigmentation spots

Occasionally, brownish-yellow 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 (e.g., tanning) while taking the “pill.”

Hereditary and acquired angioedema
If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives with possible breathing difficulty, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

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

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 no withdrawal bleeding occurs during the placebo days. If you have taken Serísima 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 for two consecutive cycles, you may be pregnant. Pregnancy must be definitively ruled out before continuing to take dienogest/ethinylestradiol.

Reduced effectiveness

The effectiveness of the “pill” may be reduced if you miss a dose, vomit, have intestinal disorders, severe diarrhea, or are taking other medications simultaneously.

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

Medical examinations/consultations

Before using dienogest/ethinylestradiol, 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.

Dienogest/ethinylestradiol does not protect against HIV infection or other sexually transmitted diseases.

Other medicines and Serísima Diario

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Some medicines reduce the contraceptive effectiveness of Serísima Diario or may cause unexpected bleeding.

The following medicines may reduce the effectiveness of Serísima Diario:

medicines that increase intestinal motility (e.g., metoclopramide),
medicines for treating epilepsy, such as: hydantoin or phenytoin, barbiturates, barbexaclone, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate,
medicines used to treat high blood pressure in the blood vessels of the lungs (bosentan),
certain antibiotics used to treat tuberculosis (e.g., rifampicin) or fungal infections (e.g., griseofulvin). Certain medicines for treating HIV and hepatitis C (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 medicines listed above, a barrier contraceptive method (condom) should be used in addition to dienogest/ethinylestradiol. With some of these listed medicines, additional contraceptive measures must be taken during treatment and for 7 to 28 days afterward, depending on the type of medicine used. Consult your doctor or pharmacist if you are unsure.

If the barrier method must be used for a long period exceeding the blister pack content, you should start taking tablets from the next Serísima Diario blister pack without taking the 7 placebo tablets. If long-term treatment with any of the listed medicines is required, consult your doctor about switching to a non-hormonal contraceptive method.

Taking Serísima Diario at the same time as the following medicines 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 Serísima Diario at the same time as the following medicines 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 medicines you are taking.

Do not take Serísima Diario if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated liver enzyme ALT).

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

Serísima Diario can be restarted approximately 2 weeks after completing this treatment. See section 2. “Do not take Serísima Diario.”

You should also inform any other doctor or dentist prescribing medications that you are taking Serísima Diario. They can advise you whether you need to take additional contraceptive precautions and, if so, for how long.

Diabetes

If you are diabetic, your need for blood sugar-lowering medications (e.g., 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 medicine may affect the results of certain tests, including liver, adrenal cortex, kidney, and thyroid function values, as well as the levels of certain blood proteins 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not use Serísima Diario during pregnancy. Before starting Serísima Diario, ensure you are not pregnant. If you become pregnant while taking this medicine, stop taking Serísima Diario and consult your doctor immediately.

Breastfeeding

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

Driving and using machines

Serísima Diario does not affect the ability to drive or use machines.

Serísima Diario contains lactose

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

3. How to take Serísima Diario

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

If your doctor has not instructed you otherwise, the usual dose is 1 tablet of Serísima Diario per day.

How to take Serísima Diario

Swallow the tablet whole, with a little liquid if necessary.

The "pill" must be taken every day, approximately at the same time, following the direction of the arrows, until the blister is finished. Do not confuse the tablets: take one white tablet once daily for the first 21 days, and then one green tablet daily for the last 7 days. Afterwards, you must start a new blister (21 white tablets and 7 green tablets). In this way, there is no interval without tablets (no tablet-free period) between blisters.

During the 7 days when you are taking the green placebo tablets (the placebo days), withdrawal bleeding (also known as withdrawal bleeding) should occur. This usually starts on day 2 or 3 after taking the last 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 day each month.

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

When to start taking Serísima Diario

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

Start taking Serísima 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 Serísima 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 Serísima Diario from another combined oral contraceptive pill (containing two active hormonal ingredients), a vaginal ring, or a patch:

if you have previously been taking an oral contraceptive pill (where the tablet-free interval occurs after the last active pill), start taking Serísima Diario the day after the tablet-free interval,
if you have previously been taking an oral contraceptive 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 Serísima Diario the day after taking the last inactive tablet. If you are not sure which was the last inactive tablet, consult your doctor or pharmacist,
if you have previously been using a vaginal ring or a patch, start taking Serísima Diario the day after the usual interval without the ring or patch.

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

You may stop taking the "mini-pill" on any day. Start taking Serísima Diario the next day. During 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 system (IUS or IUD)

Start taking Serísima Diario on the day you would normally receive your next injection, or on the day your implant or IUD is removed. During 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. During the first 7 days, use an additional barrier contraceptive method (such as a condom). If you have already had sexual intercourse before starting Serísima 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 Serísima Diario, consult your doctor (see section "Pregnancy and Breastfeeding").

If you have had an abortion or miscarriage

Inform your doctor of your intention to take Serísima Diario.

Duration of treatment

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

If you take more Serísima 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/fatigue; women and adolescents may experience vaginal bleeding. You should consult your doctor if relatively large amounts have been taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Serísima 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 an active white tablet (tablets in rows 1, 2, 3), do the following:

If less than 12 hours have passed since you missed the tablet, the contraceptive effect of dienogest/ethinylestradiol is not reduced. Take the tablet as soon as you remember, then continue taking the following tablets at the 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 this case, consult your doctor before starting a new blister.

In general, consider two points:

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 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 continue taking the tablets at the 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 the missed 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 to take a tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. The following tablets can be taken at the usual time. If you took Serísima Diario correctly during the 7 days before the missed tablet, the contraceptive effect of the "pill" is not affected and you do not need to use any additional contraceptive method. If this is not the case, or if you missed more than one 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

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 detailed below, you do not need to use any additional contraceptive method, but only if you took the tablets correctly during the 7 days before the missed tablet. If this is not the case, follow Option 1. Additionally, use an additional barrier contraceptive method (e.g., a condom) for the next 7 days.

Option 1: Take the forgotten tablet as soon as possible, even if this means taking two tablets at the same time. The following tablets can be taken at the usual time. Instead of taking the green placebo tablets, start taking the tablets from the next blister. 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 from the current blister and start taking the green placebo tablets (from the day you forgot to take 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 to take more than 1 tablet from the same blister

If you forget to take 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 this 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 these cases, follow the instructions applicable when a tablet is missed, if you remember within 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 change your withdrawal bleeding, continue directly with the tablets from the next blister of Serísima 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 can continue taking Serísima Diario as before.

If you stop taking Serísima Diario

You may stop taking Serísima 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 Serísima 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 use Serísima Diario”.

Serious adverse effects associated with the use of the "pill" are listed in section 2 “What you need to know before starting to take Serísima Diario”. There you will find detailed information on this topic. If necessary, consult your doctor immediately.

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

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

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

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

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),
itching (sometimes generalized over the entire 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,
increase and swelling of breast size, breast oedema,
vaginal discharge,
ovarian cysts,
fatigue including weakness, fatigue, and general malaise,
changes in weight (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 (herpes labialis),
flu, bronchitis, respiratory tract infections, sinusitis,
asthma,
rapid breathing (hyperventilation),
benign neoplasms in the uterus (fibroids),
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 veins (phlebitis, thrombophlebitis),
varicose veins (varicosities), vein pain,
dizziness or fainting upon standing up from a sitting or lying position (orthostatic hypotension),
hot flushes,
inflammation of the stomach lining (gastritis), inflammation of the intestine (enteritis),
indigestion (dyspepsia),
skin reactions/skin disorders including skin allergic reactions, neurodermatitis/atopic dermatitis, eczema, redness and irritation of the skin (psoriasis),
excessive sweating,
brownish-golden pigmentation spots (called chloasma), especially on the face (melasma), pigmentary disturbances/increased pigmentation,
oily skin (seborrhoea),
dandruff,
masculinized hair growth (hirsutism),
orange-peel skin (cellulitis),
varicose veins (blood vessels appearing as spider veins 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 adjacent to the breasts (supernumerary breasts),
pain during sexual intercourse,
secretion from the mammary gland, galactorrhea,
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.
- Mini-stroke 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 about 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).

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Serísima 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 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 a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Serísima Diario

A Serísima Diario blister 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: monohydrate lactose, magnesium stearate, maize starch and povidone.

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

Placebo tablets

Tablet core: monohydrate lactose, magnesium stearate, colloidal anhydrous silica, maize starch and povidone.
Tablet coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E 171), FD&C Blue No. 2 aluminium lake and yellow iron oxide (E 172).

Appearance of Serísima Diario and contents of the pack

The active film-coated tablets are white and round.

The placebo film-coated tablets are green and round.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Exeltis Healthcare S.L
Av. Miralcampo 7 - Polígono Ind. Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

Manufacturer

Laboratorios León Farma, S.A.
Pol. Ind. Navatejera
La Vallina s/n
24193 Villaquilambre, León
Spain

Date of latest revision of this leaflet: October 2022

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