PROSPECTO: INFORMATION FOR THE USER

Antinelle Diario 0.02 mg/3 mg 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 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 Diario
• When to have special care with Antinelle Diario
• Blood clots
• Antinelle Diario and cancer
• Antinelle Diario and other medications
• Antinelle Diario and food and beverages
• Laboratory tests
• Pregnancy and breastfeeding
• Driving and operating machinery
• Important information about some components of Antinelle Diario

1. How to take Antinelle Diario

• When can you start with the first package?
• If you take more Antinelle Diario than you should
• If you forgot to take Antinelle Diario
• What to do in case of discomfort or intense diarrhea?
• Intermenstrual bleeding
• What to do if you do not have your period during the placebo phase?
• Delayed menstrual period: what you should know?
• Change in the first day of your menstrual period: what you should know?
• If you interrupt treatment with Antinelle Diario
• Stop treatment if

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

Antinelle Diario is a contraceptive and is used to prevent pregnancy.

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

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

Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

Before starting Antinelle Diario, read the information about blood clots in section 2. It is particularly important to read the symptoms of a blood clot (see section 2 “Blood Clots”).

Before starting 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 Diario or in which the effect of Antinelle Diario may be reduced.

In these situations, you should not have sex or take additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

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

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

When not to use Antinelle Diario

Do not use Antinelle Diario 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 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) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function well (renal failure).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or if you suspect you have, breast cancer or cancer of the reproductive 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 Antinelle Diario. 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 Antinelle Diario with other medications”).

When to have special care with Antinelle Diario

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

In some situations, you should have special care while using Antinelle Diario or any other combined hormonal contraceptive, and your doctor may need to perform regular checks. If the condition develops or worsens while you are using Antinelle Diario, 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 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 are recently postpartum, you are at higher risk of blood clots. Ask your doctor when you can start taking Antinelle Diario after delivery.
• 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 with involuntary movements).
• If you have or have had melasma (brown or grayish-brown 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, estrogen-containing products may induce or worsen the symptoms of angioedema. You should seek medical attention immediately if you experience symptoms of angioedema such as facial swelling, tongue, or throat swelling, difficulty swallowing, or urticaria, along with difficulty breathing.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Antinelle Diario 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 (called “deep vein thrombosis”, “venous thromboembolism”, or VTE).
• In arteries (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 can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attentionif 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 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 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 Diario, 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 Diario is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and 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, such as Antinelle Diario, 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 Diario is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (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 Antinelle Diario for several weeks before the surgery or while you have less mobility. If you need to interrupt the use of Antinelle Diario, 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 in a vein increases the more conditions you have.

Long flights (over 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 above, even if you are unsure. Your doctor may decide that you should interrupt the use of Antinelle Diario.

If any of the conditions above change while you are using Antinelle Diario, 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 Antinelle Diario is very small, but it may increase:

• With age (over about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Antinelle Diario, 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 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, the risk of a blood clot may be increased even further.

If any of the conditions above change while you are using Antinelle Diario, 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 Diario and cancer

Women who use combined hormonal 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 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 combined hormonal 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 increased 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).

Antinelle Diario and psychiatric disorders

Some women who use combined hormonal contraceptives 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 Diario with other medications

Always inform your doctor who prescribed Antinelle Diario about the 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 Antinelle Diario. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

• Some medications may cause Antinelle Diario to lose its contraceptive effect, or may cause unexpected bleeding.
• This applies to medications 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 medicinal herb St. John's Wort.
• If you want to use herbal preparations containing St. John's Wort while taking Antinelle Diario, you should consult your doctor first.
• Antinelle Diario may affect the effect of other medications, for example, those containing ciclosporin or the antiepileptic lamotrigine (this may lead to an increase in seizure frequency).

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

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

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

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

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

Use of Antinelle Diario with food and drinks

Take one Antinelle Diario 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 oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, do not take Antinelle Diario. If you become pregnant during treatment with Antinelle Diario, stop treatment immediately and consult your doctor.

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to take Antinelle Diario during the breastfeeding period. 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 Antinelle Diario has any effect on your ability to drive or operate machinery.

Important information about some components of Antinelle Diario

Antinelle Diario contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

If you were taking another contraceptive before starting Antinelle Diario, you will know that most contraceptives contain 21 tablets. With those contraceptives, you take a tablet for 21 days and then there is a week-long break during which you do not take any (withdrawal period without tablets).

The procedure for taking Antinelle Diario is different. After the 21 pink tablets, you must continue taking the 7 placebo tablets; therefore, there is no withdrawal period without tablets, but a week of "placebo" (the week in which you take the placebo tablets from row 4). Since you must take a tablet every day and there is no withdrawal period without tablets between two packs, taking them becomes a routine, and therefore the risk of forgetting a tablet is lower.

The two different colored tablets of Antinelle Diario are placed in order. A pack contains 28 tablets.

Take one Antinelle Diario 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.

Do not confuse the tablets: take a pink tablet for the first 21 days, and then a white tablet for the last 7 days. You must then start taking a new pack (21 pink tablets and 7 white tablets). Therefore, there is no withdrawal period without tablets between packs.

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

Preparation of the pack

To keep track of daily contraceptive tablet intake, each pack (blister) of Antinelle Diario 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 strip, for example, if you start on Wednesday, stick the one that says "WED" as the initial tablet.

Then, you must stick the corresponding strip on the top left of the pack, in the "Start" position. In 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 in which you take placebo tablets (placebo week), menstruation (also called withdrawal bleeding) usually begins. Normally, menstruation begins the second or third day after taking the last active tablet, colored pink, of etinilestradiol/drospirenona. Once you have taken the last white tablet, you must start a new pack, even if you have not finished bleeding. This means that you should start the new pack on the same day of the week on which you started the previous one, and that menstruation should occur on the same days every month.

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

When can you start with the first pack?

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

Start taking Antinelle Diario on the first day of the cycle (i.e., the first day of your menstruation). If you start Antinelle Diario on the first day of your menstruation, you will be immediately protected against pregnancy. You can also start on days 2-5 of the cycle, but you must 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 Diario the day after the withdrawal period of your previous contraceptive (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 progestin-releasing intrauterine device).

You can switch from the progestin-only pill on any day (if it is an implant or IUD, on the day of its removal; if it is an injectable, on the day of the next injection), but in all cases, it is 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 Antinelle Diario between 21 and 28 days. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Antinelle Diario.

If, after giving birth, you have already had sex before starting Antinelle Diario (again), you must first be 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 Diario again after giving birth.

Read the "Breastfeeding" section.

If you take more Antinelle Diario than you should

No serious cases of overdose of etinilestradiol/drospirenona have been reported.

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 forget to take Antinelle Diario

The tablets in thefourthrow of the pack are placebo tablets. If you forget to take one of these tablets, the effect of Antinelle 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 Antinelle Diario tablets.

If you forget to take a tablet from the1st, 2nd, or 3rdrow, follow these recommendations:

• If you are lateless than 12 hoursin taking any active tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are latemore than 12 hoursin taking any active tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater 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 subsequent 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 must 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 subsequent 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:

Probably, you will have menstruation (withdrawal bleeding) at the end of the second pack, during the taking of placebo tablets, although you may experience spotting or bleeding during the taking 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, this may mean you are pregnant. In that case, you must 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 following the taking of an active pink 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 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 section "If you forget to take Antinelle Diario".

Spotting between menstrual periods

During the first months of use of Antinelle Diario, unexpected bleeding (bleeding outside the placebo period) may appear. If you experience these bleeding during a period longer than a few months, or if they begin after a few months, you must investigate the cause with your doctor.

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

If you have taken all the pink tablets correctly, have not vomited, have not experienced 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 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 Antinelle Diario. You may experience spotting (drops or spots of blood) or bleeding during the use of the second pack. After the usual placebo week in which you take the 7 white tablets, start the next pack.

You should 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 indicated, your menstrual period (withdrawal bleeding) will begin during the placebo period. If you need to change that day, you can do so by shortening (but never lengthening) the placebo period. For example, if your placebo period begins 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 shorten the placebo period too much (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 Antinelle Diario

You can stop taking Antinelle Diario 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 the use of 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 related to Antinelle Diario, 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 Antinelle Diario”.

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

• 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 the 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 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 theSpanish System for the Pharmacovigilance 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 at your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Antinelle Diario

Active tablets:

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

The other components are:

Tablet core: 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).

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of the product and content of the container

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

The placebo tablets are film-coated, round, white.

Antinelle Diario is available in boxes of 1 and 3 containers (blister packs), each containing 28 tablets (21 active tablets plus 7 placebo 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”