Antinelle Diario 0.02 mg/3 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antinelle Diario 0.02 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing blood clots 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 be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

1. What Antinelle Diario is and what it is used for
2. What you need to know before taking Antinelle Diario

• When you must not use Antinelle Diario
• When you should take special care with Antinelle Diario
• Blood clots
• Antinelle Diario and cancer
• Taking Antinelle Diario with other medicines
• Taking Antinelle Diario with food and drink
• Laboratory tests
• Pregnancy and breastfeeding
• Driving and using machines
• Important information about some of the ingredients of Antinelle Diario

3. How to take Antinelle Diario

• When can you start with the first pack?
• If you take more Antinelle Diario than you should
• If you forget to take Antinelle Diario
• What to do if you are unwell or have severe diarrhoea
• Bleeding between menstrual periods
• What to do if you do not have a withdrawal bleed during the placebo phase
• Delayed menstrual period: what you should know
• Change in the first day of your menstrual period: what you should know
• If you stop treatment with Antinelle Diario
• Stop treatment if

4. Possible side effects
5. How to store Antinelle Diario
6. Contents of the pack and other information

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

Antinelle Diario is a contraceptive used to prevent pregnancy.

Each pink tablet contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.

The white tablets do not contain any active ingredients and are called placebo tablets.

Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting Antinelle Daily

General considerations

Before starting to take Antinelle Daily, 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”).

Before starting this medicine, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health status, may carry out other tests.

This leaflet describes several situations in which you should stop using Antinelle Daily, or in which the effect of Antinelle Daily may be reduced.

In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

Do not use rhythm or temperature methods. These methods may not be reliable since Antinelle Daily alters the monthly changes in body temperature and cervical mucus.

Antinelle Daily, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When you must not use Antinelle Daily

Do not use Antinelle Daily 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 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 are due to have surgery or if you will be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a blood clot in the arteries:

  • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
  • If you have (or have ever had) a type of migraine called “migraine with aura”.
  • If you have (or have ever had) inflammation of the pancreas (pancreatitis).
  • If you have (or have ever had) a liver disease and your liver function has not yet returned to normal.
  • If your kidneys do not function properly (renal failure).
  • If you have (or have ever had) a tumour in the liver.
  • If you have (or have ever had), or suspect you have breast cancer or cancer of the genital organs.
  • If you have vaginal bleeding of unknown cause.
  • If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of Antinelle Daily. This may manifest as itching, rash, or swelling.
  • If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Antinelle Daily with other medicines”).

When you must be especially careful with Antinelle Daily

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot, which may mean 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 adverse effects, see “How to recognize a blood clot”.

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

In certain situations, you should take special care when using Antinelle Diario or any other combined hormonal contraceptive, and your doctor may need to perform periodic check-ups. If any of these conditions develop or worsen while you are using Antinelle Diario, you must also inform your doctor.

• If any close family member has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anemia (a hereditary red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Antinelle Diario after childbirth.
• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Use of other medicines”).
• If you have any condition that first occurred during pregnancy or during a previous use of sex hormones; for example, hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous disorder causing involuntary movements).
• If you have or have ever had chloasma (golden-brown patches, also known as “pregnancy mask,” especially on the face). In such cases, avoid direct exposure to sunlight or ultraviolet rays.
  • If you have hereditary angioedema, products containing estrogens may trigger or worsen angioedema symptoms. You should contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or difficulty breathing.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Antinelle 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 health problems.

Blood clots may form:

• In veins (called “venous thrombosis,” “venous thromboembolism,” or VTE).
• In arteries (called “arterial thrombosis,” “arterial thromboembolism,” or ATE).

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

It is important to remember that the overall risk of a harmful blood clot due to Antinelle 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 without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, 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 almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

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

When is the risk of 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 medicine 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 Antinelle 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 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 Antinelle 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 within 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 within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Antinelle Diario, between 9 and 12 women will develop a blood clot within one year.
• Your risk of developing a blood clot depends 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/vaginal 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 Antinelle Diario	About 9-12 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 Antinelle Daily 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 if you remain immobile for long periods due to injury, illness, or a plaster cast on your leg. You may need to stop using Antinelle Daily several weeks before surgery or while you are less mobile. If you need to stop using Antinelle Daily, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

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

It is important to inform your doctor if you have any of the conditions listed above, even if you are uncertain. Your doctor may decide that you should stop using Antinelle Daily.

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

BLOOD CLOTS IN AN ARTERY

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

Just 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 while using Antinelle Daily is very small, but it may increase:

• With age (especially over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Antinelle Daily, 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 have 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 disorders, heart rhythm disorders such as 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 Antinelle Daily—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Antinelle Daily and cancer

Women who use combined contraceptives have a slightly higher rate of breast cancer, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives.

It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

Rarely, benign liver tumors have been reported in users of contraceptives, and even more rarely, malignant liver tumors. See your doctor if you experience sudden severe abdominal pain.

Ovarian cancer occurs less frequently than breast cancer. The use of hormone replacement therapy (HRT) with estrogen alone or with a combination of estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years who are not using HRT, about 2 cases of ovarian cancer are observed per 2,000 women over a 5-year period. In women receiving HRT for 5 years, about 3 cases per 2,000 women are observed (i.e., about 1 additional case).

Antinelle Daily and psychiatric disorders

Some women using hormonal contraceptives such as Antinelle Daily 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 medical advice as soon as possible.

Use of Antinelle Daily with other medicines

Always inform the doctor who prescribed Antinelle Daily about any medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Antinelle Daily. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

• Some medicines may cause Antinelle Daily to lose its contraceptive effect or may cause unexpected bleeding.
• This applies to medicines used to treat epilepsy (primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g., rifampicin), or HIV infection (ritonavir), or other infectious diseases (griseofulvin, ampicillin, tetracycline), and to the herbal remedy St. John's wort.
• If you wish to use herbal preparations containing St. John's wort while taking Antinelle Daily, you should consult your doctor first.
• Antinelle Daily may influence the effect of other medicines, for example, those containing cyclosporine or the antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

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

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

Antinelle Daily can be restarted approximately 2 weeks after completing this treatment. See the section "When you must not use Antinelle Daily."

Consult your doctor or pharmacist or nurse before starting to take Antinelle Daily.

Inform your doctor or pharmacist that you are currently using, have recently used, or might need to use any other medicines.

Use of Antinelle Daily with food and drinks

Take one tablet of Antinelle Daily every day with a glass of water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

Laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are taking a contraceptive, as oral contraceptives may influence the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you must not take Antinelle Daily. If you become pregnant while taking Antinelle Daily, stop treatment immediately and contact your doctor.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

In general, Antinelle Daily is not recommended during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no information suggesting that the use of Antinelle Daily has any effect on the ability to drive or use machinery.

Important information about some of the components of Antinelle Daily

Antinelle Daily contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Antinelle Diario

If you were previously taking another contraceptive, you may know that most contraceptives contain 21 tablets. With these contraceptives, you take one tablet daily for 21 days, followed by a one-week break during which no tablets are taken (tablet-free break).

The procedure for taking Antinelle Diario is different. After the 21 pink tablets, you must continue taking the 7 placebo tablets; therefore, there is no tablet-free break, but rather a week of "placebo" (the week when you take the white placebo tablets in row 4). Since you must take a tablet every day and there is no tablet-free interval between packs, taking them becomes a routine, thus reducing the risk of forgetting a tablet.

The two different colored tablets in Antinelle Diario are arranged in order. One pack contains 28 tablets.

Take one tablet of Antinelle Diario daily with a glass of water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

Do not confuse the tablets: take one pink tablet daily for the first 21 days, then one white tablet daily for the following 7 days. After that, you must start a new pack (21 pink and 7 white tablets). Therefore, there is no tablet-free break between packs.

Due to the different composition of the tablets, it is essential to start with the first tablet located in the upper-left corner and then take one tablet daily in sequence. To maintain the correct order, follow the direction of the arrows on the blister pack.

Pack preparation

To help you keep track of your daily contraceptive intake, each Antinelle Diario pack (blister) includes seven adhesive strips printed with the days of the week. You should know the day of the week on which you will take your first tablet.

Depending on the day of the week you plan to start taking the tablets, select the corresponding adhesive strip. For example, if you start on Wednesday, apply the strip marked “WED” as your starting tablet.

Then, apply the corresponding strip to the upper-left corner of the pack, in the “Start” position. This way, each tablet is marked with a day of the week above it, allowing you to visually confirm whether you have taken a specific tablet. The arrows indicate the order in which the tablets should be taken.

During the 7 days when you take the placebo tablets (placebo week), menstruation (also called withdrawal bleeding) usually begins. Typically, menstruation starts on the second or third day after taking the last active pink tablet containing ethinylestradiol/drospirenone. Once you have taken the last white tablet, you must start the next pack, even if bleeding has not yet stopped. This means you should begin the next pack on exactly the same day of the week as the previous one, so that your menstruation occurs on the same days every month.

If you take Antinelle Diario as directed, you will also be protected against pregnancy during the 7 days when you are taking the placebo tablets.

When can you start the first pack?

• If you have not used any hormonal contraceptive in the previous month.

Start taking Antinelle Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start Antinelle Diario on the first day of your period, you will be protected against pregnancy immediately. You may also start on days 2–5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive, combined vaginal contraceptive ring, or contraceptive patch.

You may start taking Antinelle Diario the day after the tablet-free break of your previous contraceptive (or after taking the last inactive tablet). When switching from a combined vaginal contraceptive ring or contraceptive patch, follow your doctor’s recommendations.

• Switching from a progestogen-only method (pill, injection, implant, or intrauterine device releasing progestogen).

You may switch from a progestogen-only pill on any day (if switching from an implant or IUD, on the same day of removal; if switching from an injectable, at the time of the next scheduled injection), but in all cases, it is recommended to use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After an abortion.

Follow your doctor’s recommendations.

• After childbirth.

After childbirth, you may start taking Antinelle Diario between 21 and 28 days postpartum. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Antinelle Diario.

If, after childbirth, you have already had sexual intercourse before starting Antinelle Diario (again), you must first ensure you are not pregnant or wait until your next menstrual period.

Let your doctor advise you if you are unsure about when to start.

• If you are breastfeeding and wish to start taking Antinelle Diario (again) after childbirth.

Read the “Breast-feeding” section.

If you take more Antinelle Diario than you should

No serious harm has been reported from overdoses of ethinylestradiol/drospirenone.

Symptoms that may occur if you take many tablets at once include nausea and vomiting. Adolescent women may experience vaginal bleeding.

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

If you forget to take Antinelle Diario

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, the effectiveness of Antinelle Diario is not affected. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could negatively affect the efficacy of Antinelle Diario.

If you forget to take a tablet from rows 1st, 2nd, or 3rd, follow these recommendations:

• If you are less than 12 hours late in taking an active tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking an active tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of reduced contraceptive protection.

The risk of incomplete protection against pregnancy is highest if you miss a tablet at the beginning of the pack (1st row) or at the end of week 3 (3rd row of the pack). Therefore, you should take the following measures (see also the diagram below):

• Missing more than one tablet in the pack

Consult your doctor.

• Missing one tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time and use additional precautions, such as a condom, for the next 7 days. If you had sexual intercourse during the week before missing the tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• Missing one tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Instead of taking the 7 white placebo tablets (tablet-free break), start the next pack immediately.

You will likely have your menstruation (withdrawal bleeding) at the end of the second pack, during the placebo tablet week, although you may experience spotting or bleeding during the second pack.

2. Alternatively, you may stop taking the active pink tablets and go directly to the 7 white placebo tablets (you should note the day on which you missed the tablet). If you wish to start the next pack on your usual starting day, take fewer than 7 placebo tablets.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed tablets and do not have your period during the placebo week, this may indicate pregnancy. In this case, consult your doctor before starting the next pack.

What should you do in case of vomiting or severe diarrhea?

If you vomit within 3–4 hours after taking an active pink tablet or suffer from severe diarrhea, there is a risk that the active ingredients will not be fully absorbed by your body. This is similar to missing a tablet. After vomiting or diarrhea, take a tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Antinelle Diario.”

Bleeding between menstrual periods

During the first few months of using Antinelle Diario, unexpected bleeding (bleeding outside the placebo period) may occur. If you experience such bleeding for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What should you do if you do not have your period during the placebo phase?

If you have taken all the pink tablets correctly, have not vomited or suffered severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

If you miss two consecutive menstrual periods, you may be pregnant. In this case, consult your doctor immediately. Do not start the next pack until you have confirmed that you are not pregnant.

Delaying your menstrual period: what you should know?

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack by skipping the white placebo tablets in the fourth row and starting a second pack of Antinelle Diario immediately. You may experience spotting (drops or stains of blood) or bleeding during the second pack. After the usual placebo week (taking the 7 white tablets), start the next pack.

You must consult your doctor before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know?

If you take the tablets as instructed, your menstrual period (withdrawal bleeding) will begin during the placebo week. If you wish to change this day, you may do so by shortening (but never lengthening) the placebo period. For example, if your placebo week starts on Friday and you wish to change it to Tuesday (3 days earlier), start a new pack 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), withdrawal bleeding may not occur during this period. In this case, you may experience spotting or bleeding.

If you are unsure about how to proceed, consult your doctor.

If you stop taking Antinelle Diario

You may stop taking Antinelle Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception.

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

4. Possible adverse effects

Like all medicines, this medicine can 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 believe may be due to Antinelle 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, TEA). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, “What you need to know before starting to take Antinelle Diario”.

The following list of adverse effects has been associated with the use of Ethinylestradiol/drospirenone 0.02mg/3mg Daily.

• Frequent adverse effects (may affect up to 1 in 10 women): emotional instability, headache, abdominal pain (stomach ache), acne, breast pain, breast enlargement, painful or irregular menstruation, weight gain.

• Uncommon adverse effects (may affect up to 1 in 100 women): vaginal infection, oral herpes simplex, allergic reactions which may occasionally be severe (angioedema) with skin and/or mucous membrane swelling, increased appetite, depression, nervousness, sleep disorders, loss of interest in sex, tingling and pricking sensations, dizziness, vision problems, irregular or unusually fast heartbeat, blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, migraine, varicose veins, sore throat, inflammation of the stomach and/or intestine, nausea, vomiting, diarrhoea, constipation, hair loss, itching, skin rash, dry skin, seborrheic dermatitis, neck pain, limb pain, muscle cramps, bladder infection, breast lumps, milky discharge from the nipples, ovarian cysts, hot flushes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, abdominal pain, abnormal cervical smears, fluid retention, lack of energy, excessive thirst, increased sweating, weight loss.

• Rare adverse effects (may affect up to 1 in 1,000 women): 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).

Reporting of adverse effects

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

5. Storage of Antinelle Diario

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP": The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Antinelle Diario

Active tablets:

The active substances are 0.02 mg ethinylestradiol and 3 mg drospirenone.

The other components are:

Tablet core: monohydrate lactose, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80 (E433), magnesium stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350 (E1521), talc (E553b).

Appearance of the product and contents of the pack

The active tablets are round, film-coated, pink tablets.

The placebo tablets are round, film-coated, white tablets.

Antinelle Diario is available in packs of 1 and 3 (blister packs), each containing 28 tablets (21 active tablets plus 7 placebo tablets).

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

C/ La Vallina s/n

24193 - Villaquilambre, León

Spain

Date of the most recent revision of this leaflet: November 2022

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”