Фоновый узор

Antin 0,03 mg/3 mg comprimidos recubiertos con pelicula efg

О препарате

Introduction

PROSPECTO: INFORMATION FOR THE USER

Antin 0.03 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

  • Keep this prospectus, as you may need to read it again.
  • If you have any doubts, consult your doctor or pharmacist.
  • This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a pause of 4 weeks or more.
  • Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).
  • When not to use Antin
  • When to have special care with Antin
  • Blood clots
  • Antin and cancer
  • Antin use with other medicines
  • Antin use with food and drinks
  • Laboratory tests
  • Pregnancy and breastfeeding
  • Driving and operating machines
  • Important information about some of the components of Antin
  1. How to take Antin
  • When can you start with the first pack?
  • If you take more Antin than you should
  • If you forgot to take Antin
  • What to do in case of severe vomiting or diarrhea?
  • Intermenstrual bleeding
  • What to do if you do not have your period during the break?
  • Delayed menstrual period: what you should know?
  • Change in the first day of your menstrual period: what you should know?
  • If you interrupt the treatment with Antin
  • Stop treatment if
  1. Possible adverse effects
  2. Storage of Antin
  3. Contents of the pack and additional information

1. What is Antin and how is it used

Antin is a contraceptive and is used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones, known as ethinyl estradiol and drospirenone.

Contraceptives that contain two hormones are known as combined contraceptives.

2. What you need to know before starting Antin

General Considerations

Before starting to take Antin, 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 health status, perform other tests.

This leaflet describes several situations in which you should interrupt the use of Antin, or in which the effect of Antin may be reduced. In these situations, you should not have sexual intercourse or take additional non-hormonal contraceptive precautions, such as the use of a condom or other barrier method.

Do not use the rhythm or temperature method. 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 (AIDS) or any other sexually transmitted disease.

When not to use Antin

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

  • If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
  • If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
  • If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
  • If you have ever had a heart attack or a stroke.
  • If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
  • If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

- Severe diabetes with vascular 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) pancreatitis (inflammation of the pancreas).
  • If you have (or have ever had) liver disease and your liver function has not yet normalized.
  • If your kidneys do not function 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 that you have breast cancer or cancer of the reproductive organs.
  • If you have vaginal bleeding, the cause of which is unknown.
  • If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of Antin. 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 Antin with other medications”).

When to have special care with Antin

When to consult your doctor?

Seek immediate medical attention

  • If you notice possible signs of a blood clot that may indicate that you are suffering from 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 Clots” below).

For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

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

In some situations, you will need to take special care while using Antin or any other combined hormonal contraceptive, and your doctor may need to perform regular check-ups. If the condition develops or worsens while you are using Antin, 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 inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
  • If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
  • If you have sickle cell anemia (a hereditary disorder of red blood cells).
  • If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
  • If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
  • If you recently gave birth, you are at higher risk of developing blood clots. Ask your doctor when you can start taking Antin after childbirth.
  • If you have superficial thrombophlebitis (inflammation of the veins under the skin).
  • 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 a previous use of sex hormones; for example, hearing loss, porphyria (a blood disorder), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disorder characterized by involuntary movements).
  • If you have or have had melasma (brown or yellowish patches, also known as “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 estrogen may induce or worsen the symptoms of angioedema. You should seek medical attention immediately if you experience symptoms of angioedema such as swelling of the face, tongue, or pharynx, difficulty swallowing, or urticaria, accompanied by difficulty breathing.

BLOOD CLOTS

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

Blood clots can form:

  • In the veins (known as “deep vein thrombosis”, “venous thromboembolism”, or VTE).
  • In the arteries (known as “arterial thrombosis”, “arterial thromboembolism”, or ATE).

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

It is essential to remember that the overall risk of a serious blood clot due to Antin is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Do you experience any of these symptoms?

What may you be suffering from?

• Swelling of a 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 up or walking.

• Increased temperature 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 a known cause or rapid breathing.

• Sudden coughing without a clear cause, which may bring up blood.

• Severe chest pain that may worsen with deep breathing.

• Intense dizziness or fainting.

• Rapid or irregular heartbeat.

• Severe stomach pain.

If you are unsure, consult a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a milder condition like a common cold.

Pulmonary embolism

Symptoms that occur more frequently in one eye:

• Sudden loss of vision, or

• Blurred vision without pain, which may progress to loss of vision.

Retinal vein thrombosis (blood clot in the eye).

• Chest pain, discomfort, pressure, or heaviness.

• Feeling of oppression or fullness in the chest, arm, or under the sternum.

• Feeling of fullness, indigestion, or choking.

• Upper body discomfort that radiates 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 in one side of the face, arm, or leg.

• Sudden confusion, difficulty speaking, or understanding.

• Difficulty seeing in one eye or both eyes.

• Difficulty walking, dizziness, loss of balance, or coordination.

• Sudden severe headache, intense or prolonged.

• Loss of consciousness or fainting, with or without convulsions.

Sometimes the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek medical attention as you may be at risk of another stroke.

Stroke

• Swelling and slight blue discoloration of an extremity.

• Severe stomach pain (abdominal pain).

Blood clots that block 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 the veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
  • If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
  • If a blood clot breaks loose from the leg and lodges in the lung, it may 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 a combined hormonal contraceptive is taken for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) 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 Antin, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of 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 Antin is small.

  • Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
  • Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
  • Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Antin, between 9 and 12 women will develop a blood clot in a year.
  • The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

Risk of developing a blood clot in a year

Women whodo not usea combined hormonal contraceptive and who are not pregnant

About 2 per 10,000 women

Women who use a combined hormonal contraceptive containinglevonorgestrel, noretisterone, or norgestimato

About 5-7 per 10,000 women

Women who useAntin

About 9-12 per 10,000 women

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

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

  • If you are overweight (body mass index or BMI greater than 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 about 50 years). In this case, you may have an inherited disorder of blood clotting.
  • If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to interrupt the use of Antin for several weeks before the surgery or while you have limited mobility. If you need to interrupt the use of Antin, ask your doctor when you can start using it again.
  • As you get older (especially over about 35 years).
  • If you have given birth recently.

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

Long 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Antin.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

It is essential to note that the risk of a heart attack or stroke due to 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 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 about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
  • If you have 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 problem (valve disorder, abnormal heart rhythm 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 a blood clot may be increased even further.

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

Antin and cancer

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

It is essential to undergo regular breast examinations, and you should consult your doctor if you notice any lump.

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

Cancer of the ovaries 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 higher risk of ovarian cancer.

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

Antin and psychiatric disorders

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

Use of Antin with other medications

Inform your doctor who prescribed Antin about any medications or herbal preparations you are taking. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Antin. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

  • Some medications may reduce the effectiveness of Antin or cause unexpected bleeding.
  • This applies to medications used to treat epilepsy (phenytoin, carbamazepine, barbiturates, primidone, oxcarbazepine) and tuberculosis (e.g., rifampicin), or HIV infection (ritonavir) or other infectious diseases (griseofulvin, ampicillin, tetracycline), and the medicinal herb St. John's Wort.
  • If you want to use herbal preparations containing St. John's Wort while taking Antin, you should consult your doctor first.
  • Antin may affect the efficacy of other medications, for example, those containing ciclosporin or the antiepileptic lamotrigine (this may lead to an increase in seizure frequency).

Do not take Antin if you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver enzyme levels (ALT).

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

Antin can be restarted approximately 2 weeks after the completion of this treatment. See the 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 Antin tablet every day with a glass of water if necessary. You can take the tablets with or without food, but every day approximately at the same time.

Laboratory tests

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

Pregnancy and lactation

Pregnancy

If you are pregnant, you should not take Antin. If you become pregnant while taking Antin, you should stop taking it immediately and consult your doctor.

Consult your doctor or pharmacist before using any medication.

Lactation

In general, it is not recommended to take Antin during lactation. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Important information about some of the components of Antin

Antin contains lactose.If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Antin

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

One pack (blister) contains 21 tablets. The day of the week when 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 "MIE" on the side. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Do not take any tablets for 7 days after that. During those 7 days when you should not take tablets (called a tablet-free period), your menstruation should occur. Normally, menstruation, also known as withdrawal bleeding, starts on the second or third day of the tablet-free period.

On the eighth day after taking the last Antin tablet (i.e., after a 7-day tablet-free period), start the next pack, even if your menstruation has not finished. This means that you should start the next pack on the same day of the week that you started the previous one, and your menstruation 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 with the first pack?

  • If you have not taken any hormonal contraceptives in the past month.

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

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

You can start taking Antin the day after your previous contraceptive's break week (or after taking the last inactive tablet). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill at any time (if it's an implant or IUD, on the day of removal; if it's an injection, on the next scheduled injection), but in all cases, it's recommended that you use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

  • After an abortion.

Follow your doctor's recommendations.

  • After giving birth.

After giving birth, you can start taking Antin between 21 and 28 days. If you start later, you should use one of the barrier methods (e.g., a condom) during the first 7 days of taking Antin.

If, after giving birth, you have had sex again before starting Antin (again), you should first make sure you are not pregnant or wait for your next menstrual period.

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

  • If you are breastfeeding and want to start taking Antin (again) after giving birth.

Read the section "Breastfeeding".

If you take more Antin than you should

No serious harm has been reported in cases of overdose of etinilestradiol/drospirenona.

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

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

If you forgot to take Antin

  • If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
  • If you are latemore than 12 hoursin taking a tablet, the protection against pregnancy may decrease. The more tablets you have forgotten, the higher the risk of decreased protection against pregnancy.

The risk of incomplete protection against pregnancy is maximum if you forget to take the 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):

  • Forgetting more than one tablet from the pack

Consult your doctor.

  • Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the following tablets at the usual time and useadditional precautions, for example, a condom, during the next 7 days. If you have had sex in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In that case, consult your doctor.

  • Forgetting a tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the following tablets at the usual time. The contraceptive protection does not decrease, and you do not need to take additional precautions.

  • Forgetting a tablet in week 3

You can choose between two options:

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

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

  1. You can also interrupt taking tablets. You should start a 7-day tablet-free period (noting the day you forgot to take the tablet). If you want to start a new pack on your scheduled start day, the tablet-free period should be less than 7 days.

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

  • If you have forgotten to take a tablet and do not have your period during the tablet-free period, this could mean you are pregnant. In that case, you should go to your doctor before continuing with the next pack.

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

If you have vomiting in the 3-4 hours after taking a yellow tablet or experience intense diarrhea, there is a risk that the active principles will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take a tablet from a spare pack as soon as possible. If possible, take itbefore 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 forgot to take Antin".

Spotting between menstrual periods

During the first months of using Antin, unexpected bleeding (spotting outside the tablet-free period) may occur. If you experience these bleedings for more than a month, or if they start after a month, 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, have not had intense diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

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

Delaying menstruation: what should you know?

Although it is not recommended, it is possible to delay your menstruation (withdrawal bleeding) until the end of a new pack if you continue taking a second pack 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 menstruation.

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

If you take the tablets as instructed, your menstruation (withdrawal bleeding) will start during the tablet-free period. If you need to change that day, you can do so by shortening (but never lengthening) the tablet-free period. For example, if your tablet-free period starts on Friday and you want to change it to 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 experience 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 interrupt treatment with Antin

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be related to Antin, consult your doctor.

All women taking 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 starting to take Antin”.

The following list of side effects has been associated with the use of Etinilestradiol/drospirenona 0.03 mg/3 mg:

  • Frequent side effects(may affect up to 1 in 10 women): menstrual disorders, intermenstrual bleeding, breast pain, headache, depression, migraine, nausea, drowsiness, white vaginal discharge and vaginal yeast infection.
  • Infrequent side effects(may affect up to 1 in 100 women): altered libido (sex interest), high blood pressure, low blood pressure, vomiting, acne, skin rash (eczema), intense itching, vaginal infection, fluid retention and changes in body weight.
  • Rare side effects(may affect up to 1 in 1,000 women): asthma, nipple 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.
    • Mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA).
    • Blood clots in the liver, stomach/intestine, kidneys or eye.

The chances 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 type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Antin

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”: The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point.Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will be helping to protect the environment.

6. Contents of the packaging and additional information

Composition of Antin

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

The other components are:

Core of the tablet: lactose monohydrate, cornstarch, pregelatinized cornstarch, povidone, crospovidone, polisorbate 80 (E433), magnesium stearate.

Covering: 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 packaging

Coated tablets, round, yellow in color.

Antin is available in boxes of 1 and 3 packs (blister packs), each containing 21 tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

C/ La Vallina s/n

24193 - Villaquilambre, León

Spain

Date of the last review of this leaflet:November 2022

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

Страна регистрации
Активное вещество
Требуется рецепт
Да
Производитель
Состав
Lactosa monohidrato (62,00 mg mg)
Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента.

Общайтесь с врачом онлайн

Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода.

5.01 отзыв
Doctor

Анна Морет

Дерматологія18 лет опыта

Анна Морет — лікарка-дерматолог і дерматовенеролог із міжнародною сертифікацією. Спеціалізується на дерматології дорослих і дітей, венерології, естетичному догляді за шкірою та загальній медицині. Проводить онлайн-консультації, базуючись на доказовій медицині та індивідуальних потребах кожного пацієнта.

Сфера допомоги охоплює: • захворювання шкіри: екзема, акне, розацеа, дерматити, псоріаз • проблеми з волоссям і шкірою голови: випадіння волосся, лупа, себорейний дерматит • дитяча дерматологія — від новонароджених до підлітків • венерологія та інфекції, що передаються статевим шляхом (ІПСШ) • естетичні запити: вікові зміни шкіри, неінвазивні косметологічні процедури • алергічні реакції та підвищена чутливість шкіри • перевірка родимок, оцінка новоутворень, скринінг раку шкіри • поради щодо догляду за шкірою та підбір індивідуальної космецевтики

Поєднуючи дерматологію із загальноклінічним досвідом, Анна Морет надає всебічну допомогу, що охоплює як стан шкіри, так і супутні захворювання. Має сертифікацію Канадської ради естетичної медицини, що підтверджує міжнародний підхід до естетичної дерматології.

Записаться на онлайн-консультацию
5.01 отзыв
Doctor

Аліна Цуркан

Сімейна медицина12 лет опыта

Аліна Цуркан — ліцензована лікарка сімейної медицини в Португалії. Проводить онлайн-консультації для дорослих і дітей, допомагаючи пацієнтам у вирішенні широкого спектра щоденних медичних запитів з професійним підходом і увагою до деталей.

Звернутися можна з такими станами: • респіраторні інфекції: застуда, грип, бронхіт, пневмонія • Захворювання очей: кон’юнктивіт (інфекційний і алергічний) • ЛОР-захворювання: синусит, отит, тонзиліт • проблеми з травленням: гастрит, кислотний рефлюкс, синдром подразненого кишківника (СПК) • інфекції сечових шляхів та інші поширені інфекції • хронічні захворювання: артеріальна гіпертензія, діабет, порушення функції щитоподібної залози • головний біль і мігрень

Окрім лікування симптомів, Аліна Цуркан приділяє особливу увагу профілактиці та ранньому виявленню захворювань. Проводить планові огляди, надає медичні рекомендації, здійснює повторні консультації та виписує рецепти — з урахуванням індивідуальних потреб кожного пацієнта.

Її підхід — комплексний, уважний і адаптований до кожного етапу життя пацієнта: від гострих станів до довготривалого контролю здоров’я.

Записаться на онлайн-консультацию
5.09 отзывов
Doctor

Андрій Попов

Терапія6 лет опыта

Андрій Попов — ліцензований в Іспанії терапевт і фахівець із лікування болю. Проводить онлайн-консультації для дорослих, допомагаючи впоратися з хронічним і гострим болем, а також із широким спектром загальних медичних запитів.

Спеціалізується на діагностиці та лікуванні болю, що триває понад 3 місяці або суттєво знижує якість життя. Працює з такими станами, як: • хронічний біль будь-якого походження • мігрень і повторювані головні болі • біль у шиї, спині, попереку та суглобах • посттравматичний біль після травм, розтягнень або операцій • невропатичний біль, фіброміалгія, невралгії

Окрім знеболення, Андрій Попов допомагає пацієнтам у веденні загальних медичних станів, зокрема: • респіраторні інфекції (застуда, бронхіт, пневмонія) • артеріальна гіпертензія, порушення обміну речовин, цукровий діабет • профілактичні огляди та контроль загального стану здоров’я

Онлайн-консультація триває до 30 хвилин і включає детальний аналіз симптомів, рекомендації щодо обстежень, формування індивідуального плану лікування та подальший супровід за потреби.

Андрій Попов дотримується принципів доказової медицини, поєднуючи клінічний досвід із уважним і персоналізованим підходом до кожного пацієнта.

Записаться на онлайн-консультацию
5.01 отзыв
Doctor

Євген Яковенко

Загальна хірургія11 лет опыта

Євген Яковенко — ліцензований лікар-хірург і терапевт в Іспанії. Спеціалізується на загальній і дитячій хірургії, внутрішній медицині та лікуванні болю. Проводить онлайн-консультації для дорослих і дітей, поєднуючи хірургічну практику з терапевтичним супроводом.

Сфера медичної допомоги охоплює: • діагностику та лікування гострого й хронічного болю • перед- і післяопераційний супровід, оцінку ризиків, контроль стану • хірургічні захворювання: грижі, жовчнокам’яна хвороба, апендицит • консультації з дитячої хірургії: вроджені стани, дрібні втручання • травми: переломи, ушкодження м’яких тканин, обробка ран • онкохірургія: консультації, планування, супровід після лікування • внутрішні захворювання: патології серцево-судинної та дихальної систем • ортопедичні стани, реабілітація після травм • інтерпретація результатів візуалізації для хірургічного планування

Євген Яковенко активно займається науковою діяльністю та міжнародною співпрацею. Член Асоціації хірургів Німеччини (BDC), співпрацює з Асоціацією сімейних лікарів Лас-Пальмаса та Німецьким консульством на Канарських островах. Регулярно бере участь у міжнародних медичних конференціях і публікує наукові статті.

Поєднуючи багатопрофільний досвід із доказовою медициною, він надає точну та індивідуалізовану допомогу для пацієнтів із різними медичними запитами.

Записаться на онлайн-консультацию
Смотреть всех врачей

Следите за новостями и экономьте на услугах

Советы врачей, обновления платформы и скидки для подписчиков.

Следите за нами в соцсетях