PROSPECTO: INFORMATION FOR THE USER

Antinelle 0.02 mg/3mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Read this prospectus carefully before starting to take this medication, 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 medication has been prescribed only to 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 Antinelle
• When to have special care with Antinelle
• Blood clots
• Antinelle and cancer
• Antinelle use with other medications
• Antinelle use with food and beverages
• Laboratory tests
• Pregnancy and breastfeeding
• Driving and operating machines
• Important information about some of the components of Antinelle

1. How to take Antinelle

• When can you start with the first package?

• If you take more Antinelle than you should
• If you forgot to take Antinelle
• 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 Antinelle
• Stop treatment if

1. Possible adverse effects
2. Storage of Antinelle
3. Contents of the package and additional information

Antinelle is a contraceptive and is used to prevent pregnancy.

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

Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

Before starting to take Antinelle, 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 Antinelle, or in which the effect of Antinelle 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 basal body temperature method. These methods may not be reliable since Antinelle alters the monthly changes in body temperature and cervical mucus.

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

When not to use Antinelle

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

• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your 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, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:

- Severe diabetes with vascular damage.

- Very high blood pressure.

- Very high levels of fat in your 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) a liver disease and your liver function has not yet normalized.
• If your kidneys do not function properly (renal failure).
• If you have (or have ever had) a liver tumor.
• 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 Antinelle. This may manifest itself 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 Antinelle with other medicines”).

When to have special care with Antinelle

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

In some situations, you should have special care while using Antinelle or any other combined hormonal contraceptive, and you may need to have regular check-ups. If the condition develops or worsens while you are using Antinelle, you should also inform your doctor.

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have 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 genetic disorder of red blood cells).
• If you have high levels of fat in your 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 surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you are at greater risk of blood clots after childbirth. You should ask your doctor when you can start taking Antinelle 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 medicines”).
• 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 in which involuntary movements occur).
• If you have or have had melasma (brown or yellowish patches, also called “pregnancy mask”, especially on the face). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you have hereditary angioedema, the 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, along with difficulty breathing.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Antinelle increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistanceif 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 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 your leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your 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 you start taking a combined hormonal contraceptive 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 Antinelle, 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 Antinelle 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 Antinelle, 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).

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

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

• If you are overweight (body mass index or BMI greater than 30 kg/m²).
• If any of your close relatives have had a blood clot in their leg, lung or other organ at a young age (i.e. before the age of about 50). 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 your leg immobilized. You may need to interrupt the use of Antinelle for several weeks before the operation or while you have less mobility. If you need to interrupt the use of Antinelle, ask your doctor when you can start using it again.
• As you get older (especially over the age of about 35).
• If you have given birth recently.

The risk of a blood clot increases the more 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should interrupt the use of Antinelle.

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

• With age (over the age of about 35).
• If you smoke.When using a combined hormonal contraceptive like Antinelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35, 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 a stroke at a young age (less than about 50). In this case, you may also be at higher risk of a heart attack or a stroke.
• If you have or any of your close relatives have high levels of fat in your 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, the risk of a blood clot may be increased even further.

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

Antinelle 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, it may be that more tumors are detected in women who take 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 have regular breast examinations and you should consult your doctor if you notice any lump.

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

Antinelle and psychiatric disorders

Some women who use combined hormonal contraceptives like Antinelle 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, contact your doctor for additional medical advice as soon as possible.

Use of Antinelle with other medicines

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

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

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

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

Antinelle can be restarted approximately 2 weeks after the end of this treatment. See the section “When not to use Antinelle”.

Consult your doctor or pharmacist or nurse before starting to take Antinelle.

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medicine.

Use of Antinelle with food and drinks

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

Pregnancy

If you are pregnant, do not take Antinelle. If you become pregnant while taking Antinelle, stop taking the medication immediately and consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Important information about some of the components of Antinelle

Antinelle contains lactose. If your doctor has told you that you have a lactose intolerance, consult him before taking the medication.

Take one Antinelle tablet every day with a glass of water if needed. 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 break), your menstruation should occur. Normally, menstruation, also known as withdrawal bleeding, starts on the second or third day of the tablet-free break.

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

If you use Antinelle 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 Antinelle on the first day of your cycle (i.e., the first day of your menstruation). If you start taking Antinelle 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 Antinelle 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 on any day (if it's an implant or IUD, the same day of its removal; if it's an injection, when the next injection is due), but in all cases, it's recommended to use additional contraceptive methods (e.g., a condom) during the first 7 days of tablet-taking.

• After an abortion.

Follow your doctor's recommendations.

• After giving birth.

After giving birth, you can start taking Antinelle 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 Antinelle use.

If, after giving birth, you have had sex again before starting Antinelle (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 Antinelle (again) after giving birth.

Read the "Breastfeeding" section.

If you take more Antinelle than you should

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

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

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

If you forgot to take Antinelle

• If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy is not reduced. 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 be reduced. The more tablets you have forgotten, the higher the risk of reduced 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, such as a condom, for 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 is not reduced, and you do not need to take additional precautions.

• Forgetting a tablet in week 3

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.

• If you have forgotten to take a tablet and do not have your period during the break, this may 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 within 3-4 hours after taking a 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 not possible or more than 12 hours have passed, follow the advice in the "If you forgot to take Antinelle" section.

Spotting between menstrual periods

During the first months of using Antinelle, unexpected bleeding (spotting outside the break) 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 break?

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 may 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 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 break. You may experience spotting (drops or spots of blood) or bleeding during the use of the second pack. After the usual 7-day break, 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 break. If you need to change that day, you can do so by shortening (but never lengthening) the break. For example, if your break 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 break too short (e.g., 3 days or less), you may not experience withdrawal bleeding during this break. 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 Antinelle

You can stop taking Antinelle 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 may 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 due to Antinelle, 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 Antinelle”.

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

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

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

• Rare side effects(may affect up to 1 in 1,000 women): harmful blood clots in a vein or artery, for example:
• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Transient ischemic attack (TIA) or mild stroke-like symptoms.
• 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 the 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 Pharmacovigilance of Medicines 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 shown on the packaging after “CAD”: The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Antinelle

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

The other components are:

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

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

Appearance of the product and contents of the packaging

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

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

Marketing authorization holder

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

Last review date 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/”