Antin 0.03 mg/3 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antin 0.03 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

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

• Keep this leaflet. 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 they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 of use 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 Antin is and what it is used for
2. What you need to know before taking Antin

• When you must not use Antin
• When you should be cautious with Antin
• Blood clots
• Antin and cancer
• Using Antin with other medicines
• Taking Antin with food and drink
• Laboratory tests
• Pregnancy and breastfeeding
• Driving and using machines
• Important information about some of the ingredients of Antin

3. How to take Antin

• When can you start the first pack?
• If you take more Antin than you should
• If you forget to take Antin
• What to do in case of vomiting or severe diarrhoea
• Bleeding between menstrual periods
• What to do if you do not have your period during the break 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 Antin
• Stop treatment if

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

1. What Antin is and what it is used for

Antin is a contraceptive used to prevent pregnancy.

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

Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting Antin

General considerations

Before starting Antin, 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 Antin, or in which the effect of Antin may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or another barrier method.

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

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

When you must not use Antin

Do not use Antin 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 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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you need surgery or will be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of forming 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) liver disease and your liver function has not yet returned to normal.
  • If your kidneys do not work properly (renal failure).
  • If you have (or have ever had) a liver tumour.
  • If you have (or have ever had), or if you 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 Antin. 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 Antin with other medicines”).

When you should be especially careful with Antin

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot, which may indicate you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood clot (thrombosis)” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

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

In certain situations, you should take special care when using Antin 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 Antin, 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 Antin after delivery.
• 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 characterized by 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 radiation.
  • 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 throat, difficulty swallowing, or hives accompanied by breathing difficulties.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Antin 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 can form:

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

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

It is important to remember that the overall risk of a harmful blood clot due to Antin 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., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Pain, discomfort, pressure, heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or beneath the sternum. 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 a 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 abdominal 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 of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking Antin, 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 Antin is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Antin, between about 9 and 12 women will develop a blood clot in one year.
• Your individual risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/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 Antin	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 Antin 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 has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for long periods due to injury or illness, or if your leg is in a cast. You may need to stop taking Antin several weeks before surgery or while you are less mobile. If you need to stop taking Antin, 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 need to stop taking Antin.

If any of the conditions listed above change while you are using Antin, for example, if a close relative experiences a thrombosis without a known cause or if 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?

Just like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or 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 Antin is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Antin, 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 a young age (under about 50 years). In this case, you may also have an increased risk of 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 suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

Antin 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, more tumors may be 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 lump.

Benign liver tumors have rarely been reported in users of contraceptives, and malignant liver tumors even more rarely. 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 taking HRT, about 2 cases of ovarian cancer have been observed per 2,000 women over a 5-year period. In women taking HRT for 5 years, about 3 cases per 2,000 women have been observed (i.e., about 1 additional case).

Antin and psychiatric disorders

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

Use of Antin with other medicines

Always inform the doctor who prescribed Antin 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 Antin. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long.

• Some medicines may cause Antin 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 Antin, you should consult your doctor first.
• Antin may affect 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 Antin 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.

Antin can be taken again approximately 2 weeks after completion of this treatment. See section "When not to use Antin."

Consult your doctor or pharmacist before starting to take Antin.

Use of Antin with food and drinks

Take one tablet of Antin 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 Antin. If you become pregnant while taking Antin, stop treatment immediately and contact your doctor.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

In general, Antin is not recommended during the breastfeeding period. 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 use of machines

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

Important information about some of the components of Antin

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

3. How to take Antin

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

One 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 marked "WED" on the side. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Next, you must not take any tablets for 7 days. During these 7 days when you do not take tablets (called the tablet-free interval), you should experience your menstrual period.

Usually, menstruation—also referred to as withdrawal bleeding—starts on the second or third day of the tablet-free interval.

On the eighth day after taking the last Antin tablet (i.e., after the 7-day tablet-free interval), start the next pack, even if your menstrual bleeding has not finished. This means you should start the next pack on the same day of the week as you started the previous one, and your menstrual period should occur on the same days every month.

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

When can you start the first pack?

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

Start taking Antin on the first day of your cycle (i.e., the first day of your menstruation). If you start Antin on the first day of your period, you will be protected against pregnancy immediately. You may also start between days 2–5 of your cycle, but in this case 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 patch.

You may start taking Antin the day after the end of the break period of your previous contraceptive (or after taking the last inactive tablet). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's advice.

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

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

• After an abortion.

Follow your doctor's advice.

• After giving birth.

After giving birth, you may start taking Antin 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 Antin.

If, after giving birth, you have already had sexual intercourse before starting Antin (again), you must first ensure that 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 (or restart) taking Antin after giving birth.

Read the section "Breastfeeding".

If you take more Antin than you should

No serious harmful effects have been reported following overdose of ethinylestradiol/drospirenone.

Symptoms that may occur if you take several 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 Antin

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and take the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk that contraceptive protection 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 week 3 (3rd row of the pack). Therefore, you should follow the measures below (see also the diagram below):

• Missing more than one tablet from 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 in 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 starting the tablet-free interval, begin the next pack immediately.

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

2. You may also stop taking tablets. In this case, begin a 7-day tablet-free interval (noting the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, the tablet-free interval must be less than 7 days.

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

• If you have missed taking any tablets and do not have your period during the tablet-free interval, this may indicate that you are pregnant. In this case, you must see 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 a yellow 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 what happens when you miss 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 Antin".

Bleeding between menstrual periods

During the first few months of using Antin, unexpected bleeding (bleeding outside the tablet-free interval) 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 tablet-free phase?

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

If you miss two consecutive menstrual periods, you may be pregnant. In this case, see 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 continuing to take a second pack of Antin instead of starting the tablet-free interval. You may experience spotting (drops or stains of blood) or bleeding during the second pack. After the usual 7-day tablet-free interval, 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 you should know

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

If you are unsure about what to do, consult your doctor.

If you stop taking Antin

You may stop taking Antin 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 will experience them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Antin, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Antin”.

The following list of adverse effects has been associated with the use of Ethinylestradiol/drospirenone 0.03 mg/3 mg:

• Frequent adverse effects (may affect up to 1 in 10 women): menstrual disorders, intermenstrual bleeding, breast pain, headache, depression, migraine, nausea, lethargy, whitish vaginal discharge, and fungal vaginal infection.

• Uncommon adverse effects (may affect up to 1 in 100 women): changes in libido (sex drive), high blood pressure, low blood pressure, vomiting, acne, skin rash (eczema), severe itching, vaginal infection, fluid retention, and changes in body weight.

• Rare adverse effects (may affect up to 1 in 1,000 women): asthma, breast discharge, hearing problems, 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, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Antin

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 drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Antin

The active substances are 0.03 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

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

Appearance of the product and contents of the container

Film-coated tablets, round, yellow in colour.

Antin is available in packs of 1 and 3 dispensers (blister packs), 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 most recent review of this leaflet: November 2022

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