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.
Important things you should know about combined hormonal contraceptives (CHCs):
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.
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.
- Severe diabetes with vascular damage.
- Very high blood pressure.
- Very high levels of fat in the blood (cholesterol or triglycerides).
- A condition called hyperhomocysteinemia.
When to have special care with Antin
When to consult your doctor? Seek immediate medical attention
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.
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:
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?
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.
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:
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:
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.
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
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.
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?
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.
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.
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.
Follow your doctor's recommendations.
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.
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
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):
Consult your doctor.
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.
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.
You can choose between two options:
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.
If you follow one of these two recommendations, you will remain protected against pregnancy.
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.
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:
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.
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.
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/”
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