Package Insert: Information for the User

Aidraelle Diario 3 mg/0.02 mg Film-Coated Tablets

Drospirenone/Ethinylestradiol

Read this package insert carefully before starting to take this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it 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 package insert. 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 alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

• Do not take Aidraelle Diario
• Warnings and Precautions
• Blood Clots
• Aidraelle Diario and Cancer
• Intermenstrual Bleeding
• What to do if you do not have a menstrual period during the placebo days?
• Other Medicines and Aidraelle Diario
• Taking Aidraelle Diario with Food and Drinks
• Laboratory Tests
• Pregnancy and Breastfeeding
• Driving and Operating Machines
• Aidraelle Diario contains Lactose

1. How to Take Aidraelle Diario

• When can you start with the first pack?
• If you take more Aidraelle Diario than you should
• If you forgot to take Aidraelle Diario
• What to do in case of severe vomiting or diarrhea?
• Delayed Menstrual Period: What to Know?
• Change in the First Day of Your Menstrual Period: What to Know?
• If you interrupt the treatment with Aidraelle Diario

1. Possible Adverse Effects
2. Storage of Aidraelle Diario
3. Contents of the Package and Additional Information

aidraelle Diariois a contraceptive and is used to prevent pregnancy.

Each of the 21 film-coated active tablets of pink color, contains a small amount of two different female hormones, called drospirenona and etinilestradiol.

The 7 film-coated white color tablets without active ingredients are called placebo tablets.

Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

Before starting to take this medication, 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. The 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 drospirenona/etinilestradiol, or in which its effect may be reduced.

In these situations, you should not have sexual intercourse or should 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 drospirenona/etinilestradiol alters the monthly changes in body temperature and cervical mucus.

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

Do not takeaidraelle Diario

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

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without 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, 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) 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 that you have breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to etinilestradiol or drospirenona, or to any of the other components of this medication (including in section 6). This may manifest as itching, rash or inflammation.

Do not takeaidraelle Diarioif you have hepatitis C and are taking medications that contain ombitasvir / paritaprevir / ritonavir and dasabuvir, glecaprevir / pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other Medications and aidraelle Diario”).

Additional Information on Special Populations

Children and Adolescents

Drospirenona/etinilestradiol is not indicated for use in women who have not yet had their first menstrual period.

Women of Advanced Age

Drospirenona/etinilestradiol is not indicated for use after menopause.

Women with Liver Disease

Do not take drospirenona/etinilestradiol if you suffer from liver disease. See sections “Do not take aidraelle Diario” and “Warnings and Precautions”.

Women with Renal Disease

Do not take drospirenona/etinilestradiol if you are suffering from kidney dysfunction or acute renal failure. See sections “Do not take aidraelle Diario” and “Warnings and Precautions”.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

Inform Your Doctor if You Suffer from Any of the Following Conditions

In some situations, you should take special care while taking this medication or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor.

If the condition develops or worsens while you are taking this medication, 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 hemolytic-uremic syndrome (HUS, a blood clotting disorder 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 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 getting up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking aidraelle Diario again after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have epilepsy (see section “Other Medications and aidraelle Diario”).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have a disease that may have appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)). If you have or have had any of these conditions, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms such as facial swelling, tongue, and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like aidraelle 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 (which is called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek Immediate 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 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 lungs, it may cause a pulmonary embolism (PE).
• 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 of 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 one) 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 this medication, 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 aidraelle Diario is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 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, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenona, such as this medication, 9-12 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 is small, but some conditions increase the risk. Your risk is higher:

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

The risk of a blood clot 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 listed above, even if you are unsure. Your doctor may decide that you should stop taking this medication.

If any of the conditions listed above change while you are using this medication, 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, such as 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 this medication is very small, but it may increase:

• With age (over about 35 years old).
• If you smoke.
• When using a combined hormonal contraceptive like aidraelle 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 a close relative has had a heart attack or stroke at a young age (less than about 50 years old). In this case, you may also be at higher risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, abnormal heart rhythm called atrial fibrillation).
• If you have diabetes.

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

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

Aidraelle Diario and Cancer

Women who use combined hormonal contraceptives have a slightly higher risk 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 taking combined hormonal contraceptives because they are examined by the 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 in the liver and, even more rarely, malignant tumors have been reported in users of combined hormonal contraceptives. If you experience severe abdominal pain, consult your doctor.

Mental Health Disorders

Some women who use combined hormonal contraceptives like aidraelle Diario 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.

Intermenstrual Bleeding

During the first few months of taking this medication, you may experience unexpected bleeding (bleeding outside the week when you are taking the white pills). If you experience these bleeding episodes for more than a few months or if they start after a few months, your doctor should investigate the cause.

What to Do if You Do Not Have Your Period During the Placebo Days

If you have taken all the active pills correctly, are not vomiting, and have not had severe diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances, 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.

Other Medications and aidraelle Diario

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication or herbal preparations. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking aidraelle Diario. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or if you need to modify the use of another medication that you need.

Some medications may affect the levels of aidraelle Diario in the blood, making it less effective in preventing pregnancy or causing unexpected bleeding. This can occur with:

• Medications used to treat:
• • Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • Tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • Fungal infections (e.g., griseofulvin, ketoconazole)
  • Arthritis, osteoarthritis (etoricoxib)
  • Pulmonary hypertension (bosentan)
  • St. John's Wort.

Drospirenona/etinilestradiol may affect the effect of other medications, for example:

• Cyclosporin-containing medications
• Lamotrigine (an antiepileptic medication that may increase the frequency of seizures)
• Theophylline (used to treat respiratory problems)
• Tizanidine (used to treat muscle pain and/or cramps).

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

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

Drospirenona/etinilestradiol can be used again approximately 2 weeks after the end of this treatment (see section “Do not take aidraelle Diario”).

Consult your doctor or pharmacist before taking any medication.

Taking aidraelle Diario with Food and Drinks

You can take the pills with or without food, with a glass of water if necessary.

Laboratory Tests

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

Pregnancy and Breastfeeding

Pregnancy

If you are pregnant or suspect that you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, do not take this medication. If you become pregnant while taking aidraelle Diario, stop taking the medication immediately and contact your doctor. If you want to become pregnant, you can stop taking this medication at any time (see section “If you interrupt treatment with aidraelle Diario”).

Breastfeeding

Generally, it is not recommended to take this medication during breastfeeding. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and Operating Machines

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

Aidraelle Diario contains Lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each blister contains 21 active film-coated tablets of pink color and 7 inactive film-coated tablets of white color (placebo).

The two different colored tablets of aidraelle Diario are arranged in order. A blister contains 28 tablets.

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

Do not confuse the tablets:take one pink tablet every day for the first 21 days, and then one white tablet for the last 7 days. You should then start taking a new blister (21 pink tablets and 7 white tablets). In this way, there is no week of rest between two blisters.

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

Preparation of the blister:

To help you follow the order of taking, each blister of aidraelle Diario contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with “WED”.

Stick the adhesive strip of the week on the top of the aidraelle Diario blister, where it is indicated “Place the adhesive strip that corresponds to the start date”, so that the first day is placed above the tablet marked with “Start”.

In this way, there is a day of the week indicated above each tablet and you can see if you have taken a specific tablet. The arrows show the order in which you should take the tablets.

During the 7 days when you take white placebo tablets (placebo days), you usually start your period (also called withdrawal bleeding). Normally, your period starts the second or third day after taking the last active tablet, of pink color, of aidraelle Diario. Once you have taken the last white tablet, you should start the next blister, even if you have not finished your period. This means that you should start each blister on the same day of the week as the previous one, and your period should occur on the same days every month.

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

When can you start with the first blister?

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

Start taking this medication on the first day of your cycle (i.e., the first day of your menstruation).

If you start aidraelle Diario 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 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 this medication preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, or at the latest on the day after the break of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill on any day. If it is an implant or an SLI, on the same day of its removal; if it is an injectable, on the corresponding next injection. 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 having a child.

You can start taking this medication between 21 and 28 days after. If you start later, you should use one of the so-called barrier methods (e.g., a condom) during the first 7 days of taking this medication.

If, after having a child, you have already had sex before starting to take this medication (again), you should first be sure that you are not pregnant or wait for your next menstrual period.

If you are breastfeeding and want to start takingdrospirenona etinilestradiolagain after having a child.

See the section “Pregnancy and Lactation”.

Ask your doctor if you are not sure when to start.

If you take moreaidraelle Diariothan you should

No serious cases of overdose with this medication have been reported.

The symptoms that may appear if you take many tablets at once may be feeling unwell, vomiting, or vaginal bleeding. This bleeding may occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

If you have taken too many tablets of this medication, or if you discover that a child has taken them, consult your doctor or pharmacist.

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

If you forget to takeaidraelle Diario

The tablets of thefourthrow of the blister are the placebo tablets. If you forget to take one of those tablets, it will have no effect on the reliability of aidraelle Diario. Dispose of the forgotten placebo tablet.

If you forget to take an active pink tablet of the1st, 2nd, or 3rdrow, do the following:

• If you are lateless than 12 hoursin taking some tablets, 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 some tablets, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of pregnancy.

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

Forgetting more than one tablet from the blister

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 once. Continue taking the tablets at the usual time and useadditional precautions, such as a condom, during the next 7 days. If you have had sex in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In that case, consult your doctor.

Forgetting a tablet in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced and you do not need to take additional precautions.

Forgetting a tablet in week 3

You can choose between two options:

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 a period during the placebo days, you may be pregnant. In that case, you should consult your doctor before continuing with the next blister.

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

If you have vomiting in the 3-4 hours after taking an active tablet, of pink color, or have intense diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, you should take a pink tablet from a reserve blister as soon as possible. If possible, take it within the12 hours after the usual timeyou take your contraceptive. If it is not possible or more than 12 hours have passed, follow the advice in the section “If you forgot to take aidraelle Diario”.

Delay of menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period if you do not take the placebo tablets, of white color, of the fourth row and start taking a new blister of drospirenona/etinilestradiol and finish it. You may experience bleeding during the use of the second blister, which may be light or similar to menstruation. Finish this second blister by taking the 7 white placebo tablets of the 4th row. Then start a new blister.

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

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

If you take the tablets as indicated, your menstrual period will startduring the placebo days. If you have to change that day, reduce the number of days of taking placebo tablets, of white color (but never increase – 7 at most!). For example, if you normally start taking placebo tablets on Friday and want to change it to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. If you make the placebo periodvery short (for example, 3 days or less), you may not experience bleeding during these days. Then you may experience light or similar to menstruation bleeding.

If you are not sure how to proceed, consult your doctor.

If you interrupt the treatment with aidraelle Diario

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

If you want to get pregnant, stop taking this medication and wait until your menstrual period before trying to get pregnant. This way, you can calculate your estimated delivery date more easily.

If you have any other questions about the use of this medication, 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 this medicine, consult your doctor.

Contact a doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also the "Warnings and Precautions" section).

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 aidraelle Diario".

The following list of side effects has been associated with the use of this medicine.

Frequent side effects(may affect up to 1 in 10people)

• mood changes.
• headache.
• abdominal pain (stomach pain).
• acne.
• breast pain, breast enlargement,breast tenderness, painful or irregular periods.
• weight gain.

Infrequent side effects(may affect up to 1 in 100people)

• candidiasis (a fungal infection).
• herpes labialis (simple herpes).
• allergic reactions.
• increased appetite.
• depression, nervousness, sleep disorders.
• tingling and pins and needles, dizziness.
• vision problems.
• irregular or unusually fast heart rate.
• blood clots (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins.
• throat pain.
• nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation.
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or urticaria with difficulty breathing (angioedema), hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis.
• neck pain, limb pain, muscle cramps.
• urinary tract infection.
• breast lumps (benign or cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic), abnormal cervical smears (Papanicolau or Papanicolau staining), decreased interest in sex.
• fluid retention, lack of energy, excessive thirst, increased sweating.
• weight loss.

Rare side effects(may affect up to 1 in 1,000people):

• asthma.
• hearing problems.
• erythema nodosum (characterized by painful red nodules on the skin).
• erythema multiforme (skin rash with red spots in the shape of a target or ulcers).
• 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), which is a temporary condition similar to a stroke.
  • 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use https://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.

Do not use this medicationafter the expiration date that appears on the packaging after CAD.Theexpirationdateisthelastdayofthemonththatisindicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAidraelle Diario

• The active principles are drospirenone and ethinylestradiol. Each film-coated tablet of color pink contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.
• The film-coated tablets of color white do not contain active principles.
• The other components are:

Film-coated active tablets of color pink:

Tablet core: lactose monohydrate, potassium polacrilex, povidone, magnesium stearate.

Coating: Opadry II pink containing: macrogol, poly (vinyl alcohol), titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172) and red iron oxide (E-172).

Film-coated inactive tablets of color white:

Tablet core: lactose monohydrate, potassium polacrilex, povidone, anhydrous colloidal silica, magnesium stearate.

Coating: Opadry II white containing: macrogol, poly (vinyl alcohol), titanium dioxide (E-171) and talc (E-553b).

Appearance of the product and packaging content

Each blister pack of Aidraelle Diario contains 21 film-coated active tablets of color pink in the 1st, 2nd and 3rd row of the blister pack and 7 inactive (placebo) tablets of color white in the 4th row.

Aidraelle Diario is available in cartons of 1 and 3 blister packs, which contain a PVC/PVDC/Aluminum blister pack with 28 film-coated tablets.

The active tablets of Aidraelle Diario are cylindrical, biconvex, of pink color and with an approximate diameter of 6 mm.

The placebo tablets are cylindrical, biconvex, of white color and with an approximate diameter of 6 mm.

There is a pouch in each carton box to store the blister pack.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible manufacturer

Cyndea Pharma, S.L

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31

42110 Ólvega (Soria) Spain

Last review date of this leaflet:November 2024

The detailed informationof this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78878/P_78878.html

QR code to:https://cima.aemps.es/cima/dochtml/p/78878/P_78878.html