ANTINELLE 0.02 mg/3 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antinelle 0.02 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

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

• When not to use Antinelle
• When to take special care with Antinelle
• Blood clots
• Antinelle and cancer
• Using Antinelle with other medicines
• Using Antinelle with food and drink
• Lab tests
• Pregnancy and breastfeeding
• Driving and using machines
• Important information about some of the ingredients of Antinelle

1. How to take Antinelle

• When can you start with the first pack?

• If you take more Antinelle than you should
• If you forget to take Antinelle
• What to do in case of vomiting or severe diarrhea?
• Bleeding between menstrual periods
• What to do if you do not have your period during the pause phase?
• Delayed menstrual period: what should you know?
• Change of the first day of your menstrual period: what should you know?
• If you stop taking Antinelle
• Stop treatment if

1. Possible side effects
2. Storage ofAntinelle
3. Contents of the pack and further information

1. What is Antinelle and what is it used for

Antinelle is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Antinelle

General considerations

Before starting to take Antinelle, you should 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").

Before starting to take this medication, 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 state of health, may perform other tests.

This prospectus describes several situations in which you should interrupt the use of Antinelle, or in which the effect of Antinelle may decrease.

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

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

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

When not to use Antinelle

You should not use Antinelle 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 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 that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting 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 can be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you 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 normalized.
• If your kidneys do not work well (renal failure).
• If you have (or have ever had) a tumor in the liver.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the sex organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of Antinelle. This may manifest as itching, rash, or inflammation.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Use of Antinelle with other medications").

When to have special care with Antinelle

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

In some situations, you will need to have special care while using Antinelle or any other combined hormonal contraceptive, and it may be necessary for your doctor to perform periodic checks. If the condition develops or worsens while you are using Antinelle, you should also inform your doctor.

• If a close relative has or has 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 that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder 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 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 need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking Antinelle after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Use of other medications").
• If you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones; for example, hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease in which involuntary movements appear).
• If you have or have ever had chloasma (brownish patches, also called "pregnancy patches", especially on the face). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you have hereditary angioedema, products containing estrogens may induce or worsen the symptoms of angioedema. You should go to your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, or pharynx, difficulty swallowing, or hives, along with difficulty breathing.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Antinelle 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 lasting effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Antinelle 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 blood 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 in which 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 an interruption 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, 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 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 Antinelle 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, 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 drospirenone, such as Antinelle, about 9-12 will have 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 Antinelle is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50).
• If you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using Antinelle several weeks before surgery or while you have reduced mobility. If you need to stop using Antinelle, ask your doctor when you can start using it again.
• As you get older (especially over 35 years).
• If you have recently given birth.

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

Long-distance 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 Antinelle.

If any of the above conditions change while you are using Antinelle, 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 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 Antinelle is very small, but it may increase:

• With age (over 35 years).
• If you smoke.When using a combined hormonal contraceptive like Antinelle, you are advised to quit smoking. If you are unable to quit 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 any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using Antinelle, 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.

Antinelle and cancer

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

It is essential to have regular breast exams, and you should go to your doctor if you notice any lump.

In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. Go to your doctor if you experience severe abdominal pain.

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

The risk of ovarian cancer varies with age. For example, in women between 50 and 54 years old who do not use HRT, about 2 cases of ovarian cancer have been observed per 2,000 women over a 5-year period. In women treated with HRT for 5 years, about 3 cases have been observed per 2,000 patients (i.e., about 1 additional case).

Antinelle and psychiatric disorders

Some women who use hormonal contraceptives like Antinelle 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.

Use of Antinelle with other medications

3. How to take Antinelle

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

A pack (blister) contains 21 tablets. The day of the week on which you should take the tablet is printed next to each tablet. For example, if you start on a Wednesday, you should take a tablet with "WED" on the side. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Then, you should not take any tablets for 7 days. During those 7 days when you do not take tablets (called a tablet-free period), you should have your period. Usually, your period, which can also be called withdrawal bleeding, starts on the second or third day of the tablet-free period.

On the eighth day after taking the last Antinelle tablet (i.e., after the 7-day tablet-free period), start the next pack, even if you have not finished your period. This means that you should start the next pack on the same day of the week that you started the previous one, and your period should take place during the same days every month.

If you use Antinelle in this way, you will also be protected from pregnancy during the 7 days when you do not take any tablets.

When can you start with the first pack?

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

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

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

You can start taking Antinelle the day after the week of rest from your previous contraceptive (or after taking the last inactive tablet). When changing from a vaginal ring or patch, follow your doctor's recommendations.

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

You can change from a progestogen-only pill at any time (if it's an implant or IUD, on the day of its removal; if it's an injectable, when the next injection is due), but in all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) for the first 7 days of tablet-taking.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Antinelle between 21 and 28 days later. If you start later, you must use a barrier method (e.g., a condom) for the first 7 days of Antinelle use.

If, after having a child, you have had sexual intercourse before starting to take Antinelle again, you must first be sure that you are not pregnant or wait for your next period.

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

• If you are breastfeeding and want to start taking Antinelle again after having a child.

Read the section "Breastfeeding".

If you take more Antinelle than you should

No cases have been reported in which an overdose of ethinylestradiol/drospirenone has caused serious harm.

The symptoms that may appear if you take many tablets at once are nausea and vomiting. Adolescent girls may experience vaginal bleeding.

If you have taken too many Antinelle tablets or discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Antinelle

• If you are less than 12 hourslate in taking a tablet, your protection against pregnancy will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, your protection against pregnancy may be reduced. The more tablets you have missed, the higher the risk that your protection against pregnancy will decrease.

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 the 3rd week (3rd row of the pack). Therefore, you should take the following measures (see also the diagram below):

• Missing more than one tablet from the pack

Consult your doctor.

• Missing a tablet in week 1

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

• Missing a tablet in week 2

Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. Your contraceptive protection will not decrease, and you do not need to take additional precautions.

• Missing a tablet in week 3

You can choose between two options:

1. Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. Instead of starting the tablet-free period, start the next pack.

You will probably have your period (withdrawal bleeding) at the end of the second pack, although you may experience spotting or bleeding during the second pack.

1. You can also stop taking tablets. You should start a 7-day tablet-free period (counting the day you missed the tablet). If you want to start a new pack on your fixed start day, the tablet-free period must be less than 7 days.

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

• If you have missed a tablet and do not have your period during the tablet-free period, this may mean that you are pregnant. In this case, you must consult your doctor before continuing with the next pack.

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

If you vomit within 3-4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you miss a tablet. After vomiting or diarrhea, you should take a tablet from a reserve pack as soon as possible. If possible, take it before 12 hourshave passed since the usual time you take your 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".

Bleeding between menstrual periods

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

What should you do if you do not have your period during the tablet-free period?

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

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

Delayed menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you continue taking a second pack of Antinelle instead of starting the tablet-free period. You may experience spotting (drops or spots of blood) or bleeding during the use of the second pack. After the usual 7-day tablet-free period, continue with the next pack.

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

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

If you take the tablets according to the instructions, your menstrual period (withdrawal bleeding) will start during the tablet-free period. If you need to change this day, you can do so by shortening (but never lengthening!) the tablet-free period. For example, if your tablet-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual. If you make the tablet-free period very short (e.g., 3 days or less), you may not have withdrawal bleeding during this period. Then, you may experience spotting (drops or spots of blood) or bleeding.

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

If you stop treatment with Antinelle

You can stop taking Antinelle whenever you want. If you do not want to become pregnant, consult your doctor about other effective methods of birth control.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect, especially if it is severe or persistent, or have any change in your health that you think may be due to Antinelle, 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 taking Antinelle".

The following list of side effects has been associated with the use of Ethinylestradiol/Drospirenone 0.02 mg/3 mg.

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

• Uncommon side effects(may affect up to 1 in 100 women): vaginal infection, cold sores (on the lips), allergic reactions that can occasionally be severe (angioedema) with skin and/or mucous membrane inflammation, increased appetite, depression, nervousness, sleep disorders, loss of interest in sex, tingling and numbness, dizziness, vision problems, irregular or unusually fast heartbeat, blood clots (thrombosis) in a blood vessel in the legs or lungs (pulmonary embolism), increased blood pressure, migraine, varicose veins, sore throat, inflammation of the stomach and/or intestine, nausea, vomiting, diarrhea, constipation, hair loss, itching, skin rash, dry skin, seborrheic dermatitis, neck pain, limb pain, muscle cramps, bladder infection, breast lumps, production of a milky liquid from the nipples, ovarian cysts, hot flashes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, abdominal pain, abnormal cervical smears, fluid retention, lack of energy, excessive thirst, increased sweating, weight loss.

• Rare side 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.
• Mild or temporary stroke-like symptoms, called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk 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).

Reporting side effects:

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

5. Storage of Antinelle

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 pack after "EXP": The expiry date is the last day of the month indicated.

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

6. Packaging Content and Additional Information

Composition of Antinelle

The active ingredients are 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80 (E433), magnesium stearate.

Coating: partially hydrolyzed 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).

Appearance of the Product and Packaging Content

The tablets are film-coated, round, and pink in color.

Antinelle is available in boxes of 1 and 3 packs (blisters), each containing 21 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 Last Revision of this Leaflet: November 2022

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"