Prospect: information for the user

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

Dienogest/Ethinylestradiol

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

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

Read this prospect thoroughly before starting to take this medication, as it contains important information for you.

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

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

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

3. How to take Serísima Diario

4. Possible adverse effects

5. Storage of Serísima Diario

6. Contents of the package and additional information

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

• Each of the21 white tabletscontains a small amount of two different female hormones, a progestogen (dienogest) and an estrogen (etinilestradiol);
• the7 green tabletsdo not contain active ingredients and are also known as placebo tablets.

The clinical trials that have been conducted have shown that, in those women in whom a pronounced effect of male hormones (designated as “androgens”) causes acne, Serísima Diario alleviates this condition.

Serísima Diario is used for:

• preventing pregnancy,

the treatment of women with acne who accept receiving a contraceptive treatment after the failure of an appropriate local treatment or antibiotic treatment.

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 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 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.

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

Warnings and Precautions

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

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

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

If the condition develops or worsens while 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 that affects your natural defense system),
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure),
• if you have sickle cell anemia (a hereditary disease of red blood cells),
• if you have high levels of fat in your blood (hypertriglyceridemia) or have a known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas),
• if you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”),

• if you recently gave birth, you are at a higher risk of developing blood clots. Ask your doctor when you can start taking Serísima Diario after delivery,

• if you have superficial thrombophlebitis (inflammation of the veins under the skin),
• if you have varicose veins.

BLOOD CLOTS

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

Blood clots can form:

• in veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical assistanceif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

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

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

The risk of a blood clot in a vein is higher during the first year when you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4weeks 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 in 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 developing a blood clot in your leg or lung (DVT or PE) with Serísima Diario is small.

• Of every 10,000women who are not using a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000women who are using a combined hormonal contraceptive that contains levonorgestrel or noretisterone or norgestimato, 5‑7will develop a blood clot in a year.
• Of every 10,000 women who are using a combined hormonal contraceptive that contains dienogest and etinilestradiol like Serísima Diario, between 8 and 11 women will develop a blood clot in a year.
• The risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

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

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

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

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

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

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• with age (over about 35years).
• 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 35years, your doctor may advise you to use a different type of contraceptive.
• if you are overweight.
• if you have high blood pressure.
• if any of your close relatives have had a heart attack or stroke at a young age (less than about 50years). You may also be at a higher risk of having a heart attack or stroke.
• if you or any of your close relatives have high levels of fat in your blood (cholesterol or triglycerides).
• if you have migraines, especially migraines with aura.
• if you have a heart problem (valve disorder, 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 increased even further.

If any of the conditions above change while you are using Serísima Diario, for example, you start smoking, a close relative experiences a clot without a known cause, or you gain a lot of 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 increases constantly to reach values of 140/90 mmHg (your doctor should tell you to start taking “the pill” again as soon as your blood pressure has normalized with appropriate treatment),
• if you are planning surgery (you should stop taking “the pill” at least 4 weeks before the operation) or are immobile for a long time (see “The Pill and Vascular Diseases”),
• if you have migraines for the first time or if they worsen,
• if you have severe and unusual headache or persistent headache that starts suddenly with aura symptoms (problems with sensations, 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 yellow, your urine turns brown, and your stools turn very pale (jaundice), or if your skin itches all over,
• if you are diabetic (diabetes mellitus) and your blood sugar levels increase suddenly,
• if you have porphyria (a disorder that affects the production of heme) and it recurs while you are taking Serísima Diario.

Your doctor will perform regular check-ups:

• if you have a heart disease or kidney disease,
• if you have a tendency to develop inflammation of the veins (phlebitis) or severe varicose veins,
• if you have circulation problems in your hands/feet,
• if your blood pressure is above 140/90 mmHg,
• if you have a history of problems with how your body processes fats (lipid metabolism disorders),
• if you have sickle cell anemia (a hereditary disease that affects your red blood cells),
• if you have a history of 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. 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 seizures while taking Serísima Diario, you may want to consider using other non-hormonal contraceptives,
• if you have a disorder that affects your movement, causing rapid, jerky movements that mainly affect your face, feet, hands, and is also known as “Saint Vitus' Dance” (Sydenham's chorea),
• if you have a chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis),
• if you have a disorder that causes damage to your kidneys (hemolytic uremic syndrome),
• if you have a benign tumor in the muscular layer of the uterus (uterine fibroid),
• if you have otosclerosis (a type of hearing loss),
• if you are immobile for a long time (see “The Pill and Vascular Diseases”),
• if you are overweight,
• if you have a systemic immune 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 the pill, compared to women of similar age who are not taking the pill. Once the woman stops taking the pill, the risk gradually decreases and after 10 years, the difference is no longer detectable between women who have used the pill and 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 currently taking the pill or who have taken it is relatively small compared to the general 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, it is not yet clear to what extent this result is influenced by other factors (such as differences in the number of sexual partners or the use of mechanical contraceptive methods).

In very rare cases, benign tumors (non-cancerous but potentially life-threatening) have been described. These tumors can cause internal bleeding that can be life-threatening. Seek immediate medical attention if you experience severe abdominal pain. Studies have shown an increased risk of developing liver cancer in women who take the pill for a long 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 long-term 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 have certain kidney diseases (in this case, consult your doctor, and also see the section “Do not take Serísima Diario”, “Stop taking Serísima Diario immediately” and “Your doctor will perform regular check-ups”).

Age Spots

Occasionally, brown-yellow spots (melasma) may appear on the skin, especially in women who have had them during pregnancy. Therefore, women who are prone to this condition should avoid exposure to sunlight or ultraviolet light (such as tanning) while taking the pill.

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

Mental Health Disorders:

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

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 recurs after your regular cycle has ended.

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

Reduced Efficacy

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

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

Medical Exams/Consultations

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

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

Other Medications and Serísima Diario

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

Some medications reduce 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 used to treat epilepsy, such as phenytoin, barbiturates, barbexaclone, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate,
• medications used to treat high blood pressure in the blood vessels of the lungs (bosentan),
• some antibiotics used to treat tuberculosis (such as rifampicin) or fungal infections (such as griseofulvin). Certain medications used to treat HIV and hepatitis C (the so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz).
• some herbal supplements containing St. John's Wort (Hypericum perforatum).

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

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

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

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

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

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

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

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 cause increases in liver function test results (elevated ALT levels).

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 advise you to take additional contraceptive precautions and, if so, for how long.

Diabetes

If you are diabetic, your doctor may need to adjust the dose of medication you take to control your blood sugar levels.

Laboratory Tests

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

Pregnancy and Breastfeeding

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

Pregnancy

Do not use Serísima Diario during pregnancy. Before starting to take Serísima Diario, you should 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.

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3. How to Take Serísima Daily

4. Possible Adverse Effects

5. Conservation of Serious Diary

6. Content of the container and additional information