ANTIN DAILY 0.03 mg/3 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antin Daily 0.03 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

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

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

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

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

• When not to use Antin Daily
• When to take special care with Antin Daily
• Blood clots
• Antin Daily and cancer
• Using Antin Daily with other medicines
• Using Antin Daily with food and drink
• Laboratory tests
• Pregnancy and breast-feeding
• Driving and using machines
• Important information about some of the ingredients of Antin Daily

1. How to take Antin Daily

• When can you start with the first pack?
• If you take more Antin Daily than you should
• If you forget to take Antin Daily
• What to do in case of vomiting or severe diarrhea?
• Bleeding between menstrual periods
• What to do if you do not have your period during the rest phase?
• Delayed menstrual period: what you should know?
• Change of the first day of your menstrual period: what you should know?
• If you stop treatment with Antin Daily
• Stop treatment if

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

1. What is Antin Daily and what is it used for

Antin Daily is a contraceptive and is used to prevent pregnancy.

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

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

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Antin Daily

General considerations

Before starting to take Antin Daily, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take this medication, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your state of health, may perform other tests.

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

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

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

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

When you should not use Antin Daily

You should not use Antin Daily if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

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

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have ever had) inflammation of the pancreas (pancreatitis).
• If you have (or have ever had) a liver disease and your liver function has not yet normalized.
• If your kidneys do not work well (renal failure).
• If you have (or have ever had) a tumor in the liver.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the sex organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of Antin Daily. This may manifest with 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 Daily with other medications").

When you should be careful with Antin Daily

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

In some situations, you will need to be careful while using Antin Daily or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using Antin Daily, you should also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking Antin Daily after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Use of other medications").
• If you have any disease that appeared for the first time during pregnancy or during previous use of sex hormones; for example, hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous disease in which involuntary movements appear).
• If you have or have ever had chloasma (brownish spots, also called "pregnancy spots", especially on the face). In that case, you should avoid direct exposure to the sun or ultraviolet rays.
• • If you have hereditary angioedema, products containing estrogens may induce or worsen the symptoms of angioedema. You should go to your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, or pharynx, difficulty swallowing, or hives, along with difficulty breathing.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (which is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be lasting effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

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

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Antin Daily, your risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Antin Daily is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Antin Daily, about 9-12 will have a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

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

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

Long-distance flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Antin Daily.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

It is essential to note that the risk of a heart attack or stroke due to Antin Daily is very small, but it may increase:

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

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

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

Antin Daily and cancer

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

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

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

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

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

Antin Daily and psychiatric disorders

Some women who use hormonal contraceptives like Antin Daily have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for advice.

3. How to take Antin Diario

If you were taking another contraceptive before starting Antin Diario, you will know that most contraceptives contain 21 tablets. With these contraceptives, you take one tablet for 21 days and then have a one-week period during which you do not take any (tablet-free period).

The procedure to follow when taking Antin Diario is different. After the 21 yellow tablets, you must continue taking the 7 placebo tablets; therefore, there is no tablet-free period, but a "placebo" week (the week during which you take the placebo tablets from row 4). Since you must take one tablet every day and there is no tablet-free period between packs, taking them becomes a routine, and consequently, the risk of forgetting a tablet is lower.

The two different types of colored tablets in Antin Diario are placed in order. One pack contains 28 tablets.

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

Do not get confused about the tablet: take a yellow tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you must start taking a new pack (21 yellow tablets and 7 white tablets). Therefore, there is no tablet-free period between packs.

Due to the different composition of the tablets, it is necessary to start with the first tablet located in the top left corner and then take one tablet every day. To maintain the order, follow the direction of the arrows on the pack.

Preparing the pack

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

According to the day of the week on which you will start taking the tablets, you should choose the corresponding adhesive strip, for example, if you start on Wednesday, stick the one that indicates "WED" as the initial tablet.

Then, you must stick the corresponding strip on the top left of the pack, in the "Start" position. This way, there is a day of the week indicated above each tablet, and you can visually check if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

During the 7 days when you take placebo tablets (placebo week), menstruation usually begins (also called withdrawal bleeding). Usually, menstruation starts on the second or third day after taking the last active yellow tablet containing ethinylestradiol/drospirenone. Once you have taken the last white tablet, you must start the next pack, even if you have not finished bleeding. This means that you should start the next pack on the same day of the week as the previous one, and that menstruation should occur during the same days every month.

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

When can you start with the first pack?

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

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

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

You can start taking Antin Diario the day after the tablet-free week of your previous contraceptive (or after taking the last inactive tablet). When switching from a combined vaginal 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 a progestin-only pill at any time (if it is an implant or an IUD, on the day of its removal; if it is an injectable, when the next injection is due), but in all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

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

If, after having a child, you have had sexual intercourse before starting to take Antin Diario again, you must first ensure that 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 Diario again after having a child.

Read the section "Breastfeeding".

If you take more Antin Diario than you should

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

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

In case of overdose or accidental ingestion, consult 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 Diario

The tablets in the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, the effect of Antin Diario will not be affected. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could have a negative effect on the efficacy of the Antin Diario tablets.

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

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

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

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

• Forgetting a tablet in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time. The contraceptive protection will 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 it means taking two tablets at the same time. Continue taking the following tablets at the usual time. Instead of taking the 7 white placebo tablets, start taking the next pack.

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

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 placebo week (tablet-free period), this may mean that you are pregnant. In this case, you must consult your doctor before continuing with the next pack.

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

If you vomit within 3-4 hours after taking an active yellow tablet or experience severe diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take a tablet from a reserve pack as soon as possible. If possible, take it before 12 hours have 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 "If you forget to take Antin Diario" section.

Bleeding between menstrual periods

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

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

If you have taken all the yellow tablets correctly, have not vomited, 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 may be pregnant. In this case, consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Delayed menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you do not take the white placebo tablets from the fourth row and start taking a second pack of Antin Diario. You may experience spotting (drops or spots of blood) or bleeding during the use of the second pack. After the usual placebo week, during which you take the 7 white tablets, start the next pack.

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

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

If you take the tablets as instructed, your menstrual period (withdrawal bleeding) will start during the placebo period. If you need to change this day, you can do so by shortening (but never lengthening!) the placebo period. For example, if your placebo period starts on Friday and you want to change it to Tuesday (3 days earlier), you must start a new pack 3 days earlier than usual. If you make the placebo 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 stop treatment with Antin Diario

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

If you have any other 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 all people suffer from them. If you suffer from any adverse effect, especially if it is severe and persistent, or have any health change that you believe may be due to Antin Daily, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Antin Daily".

The following list of adverse effects has been related to 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, white vaginal discharge, and fungal vaginal infection.

• Uncommon Adverse Effects(may affect up to 1 in 100 women): changes in 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 Adverse Effects(may affect up to 1 in 1,000 women): asthma, breast secretion, 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 those of a stroke, called a 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).

Adverse Effect Reporting:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Antin Daily

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

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

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Antin Daily:

Active Tablets:

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

The other components are:

Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, crospovidone, povidone, 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).

Placebo Tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Product Appearance and Package Contents

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

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

Antin Daily is available in boxes of 1 and 3 packages (blisters), each with 28 tablets (21 active tablets and 7 placebo tablets).

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

C/ La Vallina s/n

24193 - Villaquilambre, León

Spain

Date of the Last Revision of this Prospectus:November 2022

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