SERISIMA DAILY 2 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Dienogest/Ethinylestradiol

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

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

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

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

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

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

Serísima Diario is used to:

• prevent pregnancy,

treat women with acne who accept receiving contraceptive treatment after failure of local or antibiotic treatment.

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

General considerations

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

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

When not to use Serísima Diario:

You should 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 what other form of contraception would be more suitable.

• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.

Warnings and precautions

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

If, while taking Serísima Diario, any of the diseases or circumstances described in the section "When not to use Serísima Diario" occur for the first time, you must stop takingSerísimaDiario and consult your doctor immediately.

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

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

BLOOD CLOTS

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

Blood clots can form:

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

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential 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.

BLOOD CLOTS IN A VEIN

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

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

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

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

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

When you stop taking Serísima Diario, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

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

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

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, such as Serísima Diario, between 8 and 11 women will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

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

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

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

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

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

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

Stop takingSerísimaDiario immediately:

Your doctor will perform regular check-ups:

• if you have a kidney disease that causes kidney damage (Hemolytic Uremic Syndrome),
• if you have a benign tumor in the muscular layer of the uterus (uterine fibroid),
• if you suffer from certain hearing loss (otosclerosis),
• if you are immobilized for a long period of time (see "The pill and vascular diseases"),
• if you are overweight,
• if you suffer from a certain immune system disease (systemic lupus erythematosus),
• if you are 40 years or older.

The "pill" and cancer

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

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

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

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

Other diseases

High blood pressure

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

Pigmented spots

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

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

Psychiatric disorders:

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

Irregular bleeding (bleeding between periods)

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

It is possible that during the placebo days, withdrawal bleeding will not occur. 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 bleeding or if you do not have withdrawal bleeding for two consecutive times, you may be pregnant. Pregnancy must be ruled out with certainty before continuing to take dienogest/ethinylestradiol.

Reduced efficacy

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

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

Exams/medical check-ups

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

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

Other medications and Serísima Diario

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including over-the-counter medications.

Some medications decrease the contraceptive efficacy of Serísima Diario or may cause unexpected bleeding.

The following medications may reduce the efficacy of Serísima Diario:

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

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

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

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

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

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

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

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

Do not take Serisima Diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in liver enzyme ALT).

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

Serisima Diario can be used again approximately 2 weeks after the end of this treatment. See section 2. "Do not take Serisima Diario".

You should also inform any other doctor or dentist who prescribes you medications that you are taking Serisima Diario. They may indicate that you need to take additional contraceptive precautions and, if so, for how long.

Diabetes

If you are diabetic, you may need to change the dosage of medications that lower blood sugar levels (such as insulin).

Laboratory tests

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

Pregnancy and lactation

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

Pregnancy

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

Lactation

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

3. How to take Serísima Diario

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

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

How to takeSerísimaDiario

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

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

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

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

When to start takingSerísimaDiario

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

Start taking Serísima Diario on the first day of your cycle, which is the first day of your menstruation. If you take it correctly, the contraceptive protection begins on the first day of taking the dose. If you start taking Serísima Diario between days 2 to 5 of your cycle, you should use a barrier contraceptive method during the first 7 days of taking the "pill".

If you switch toSerísimaDiario from another "pill" (with two active hormonal principles), a vaginal ring, or a patch:

• if you have been taking a "pill" previously (in which the tablet-free interval comes after the day you take the last "pill" that contains an active principle), start taking Serísima Diario the day after the tablet-free interval,
• if you have been taking a "pill" previously whose blister contains tablets without active principles (also known as placebo tablets) in addition to the tablets with an active principle, so that you do not have a tablet-free interval. Start taking Serísima Diario the day after taking the last "pill" without active principles. If you are not sure which was the last "pill" without active principles, consult your doctor or pharmacist,
• if you have been using a vaginal ring or a patch previously, start taking Serísima Diario the day after the usual ring-free or patch-free interval.

If you switch from a "pill" that contains only progesterone (also called "mini-pill")

You can stop taking the "mini-pill" 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 you switch from an injectable product (also called "three-month injection"), an implant, or an intrauterine delivery system (IUS or IUD)

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

If you have had a child and are not breastfeeding

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

If you are breastfeeding

If you are breastfeeding and want to start taking Serísima Diario, consult your doctor (see the 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 can take Serísima Diario for as long as you want to use a hormonal contraceptive method and no health risks arise (see the sections "Do not take Serísima Diario" and "Stop taking Serísima Diario immediately"). It is strongly recommended that you undergo regular medical check-ups (see the section "Exams/medical consultations").

If you take moreSerísimaDiario than you should

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

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

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

If you forget to takeSerísimaDiario

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

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

• If it is less than 12 hourssince you forgot the tablet, the contraceptive effect of dienogest/ethinylestradiol is not reduced. Take the tablet as soon as you remember and then continue taking the following tablets at the usual time.

• If it is more than 12 hourssince you forgot the tablet, pregnancy protection is not guaranteed. If you do not have your period during the first days you are taking the green placebo tablets (the first placebo days), you may be pregnant. In that case, consult your doctor before starting a new blister.

In general, you should consider two things:

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

Follow these instructions if you forget to take a tablet:

If you forget to take a tablet in week 1

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

If you forget to take a tablet in week 2

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

If you forget to take a tablet in week 3

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

Option 1:take the forgotten tablet as soon as possible, even if it 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. It is likely that you will not have withdrawal bleeding until you finish taking the second blister, however, you may experience bleeding or spotting.

or

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

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

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

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

If you have vomiting or diarrhea

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

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

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

If you interrupt treatment withSerísimaDiario

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

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

4. Possible Adverse Effects

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

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

Severe 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". You can find detailed information there. 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):

• inflammation of the genitals (vaginitis/vulvovaginitis), vaginal infections caused by fungi (candidiasis, vulvovaginal infections),
• increased appetite,
• depressive mood,
• vertigo,
• migraine,
• increased or decreased blood pressure, in rare cases increased diastolic blood pressure (decreased value),
• abdominal pain (including upper and lower abdominal pain, discomfort/bloating),
• nausea, vomiting, and diarrhea,
• acne,
• hair loss (alopecia),
• itching of the skin (including erythema with spots on the skin),
• itching (in some cases all over the body),
• irregular menstrual bleeding including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea),
• spotting (vaginal hemorrhage and metrorrhagia),
• painful menstruation (dysmenorrhea), pelvic pain,
• increased and swollen breast size, breast edema,
• vaginal discharge,
• ovarian cysts,
• fatigue including weakness, fatigue, and general malaise,
• weight changes (increase, decrease, or fluctuation).

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

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

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

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

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

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

Contact your 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 urticaria with possible difficulty breathing (see also section "Warnings and precautions").

Reporting of adverse effects

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

5. Storage of Serísima Diario

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

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

Do not store at a temperature above 30°C.

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

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

6. Package contents and additional information

Composition of Serísima Diario

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

Active tablets

• The active ingredients are dienogest and ethinylestradiol. An active white tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• The other components are:

Tablet core: lactose monohydrate, magnesium stearate, cornstarch, and povidone.

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

Placebo tablets

• Tablet core: lactose monohydrate, magnesium stearate, colloidal anhydrous silica, cornstarch, and povidone.
• Tablet coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E 171), aluminum lake FD&C blue 2, and yellow iron oxide (E 172).

Appearance of Serísima Diario and package contents

The active film-coated tablets are white and round.

The placebo film-coated tablets are green and round.

Serísima Diario is available in packages 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 the last revision of this prospectus: October 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

https://www.aemps.gob.es/