Package Leaflet: Information for the User

Aidra Daily 3 mg/0.03 mg Film-Coated Tablets EFG

Drospirenone/Ethinylestradiol

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. 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”).

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

Each of the 21 yellowish-colored active film-coated tablets contains a small amount of two different female hormones, known as drospirenona and etinilestradiol.

The 7 white film-coated 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, 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 personal situation, may perform some other tests.

This leaflet describes several situations in which you should interrupt the use of this 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, for example, 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 this medication alters the monthly changes in body temperature and cervical mucus.

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

Do not takeaidra Diario

Do not takeaidra Diarioif 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 an operation or if you spend a lot of time without getting up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, 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 yet normalized.
• If your kidneys do not function well (renal failure).
• If you have (or have ever had) or a tumor in the liver.
• 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 the active ingredients or to any of the other components of this medication (including in section 6). This may cause itching, rash, or inflammation.

Do not use aidra Diario

Do not takeaidra 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 aidra Diario”).

Additional Information on Special Populations

Children and Adolescents:

aidra Diariois not indicated for use in women who have not yet had their first menstrual period.

Women of Advanced Age

aidra Diariois not indicated for use after menopause.

Women with Liver Insufficiency

Do not takeaidra Diarioif you suffer from liver disease. See sections “Do not take aidra Diario” and “Warnings and Precautions”.

Women with Renal Insufficiency

Do not takeaidra Diarioif you are suffering from kidney failure or acute renal failure. See sections “Do not take aidra Diario” and “Warnings and Precautions”.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take aidra Diario.

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 any close relative has had or has 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 hereditary 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 an operation 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 this medication 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 aidra Diario”).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have a disease that 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 melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, 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 drospirenona/etinilestradiol 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 long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to aidra Diario 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 thromboembolism). 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 of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (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 this medication 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 like 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

Your risk of a blood clot is small, but some conditions increase it. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• If any close relative has 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 blood clotting disorder.
• If you need surgery or spend a lot of time without getting up due to an injury or disease, or if you have your leg immobilized. You may need to interrupt the use of this medication for several weeks before the operation or while you have less mobility. If you need to interrupt the use of this medication, consult your doctor about when you can start using it again.
• With increasing age (especially above about 35 years).
• If you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase your 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 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, for example, 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 the use of this medication is very small, but it may increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like this medication, 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 close relative has 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 or any 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, arrhythmia 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 this medication, 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.

aidra Diario and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, 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, more rarely, malignant tumors have been reported in users of combined hormonal contraceptives. Consult your doctor if you experience severe abdominal pain.

Mental Disorders

Some women who use combined hormonal contraceptives like aidra 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 of placebo pills). If these bleeding persists beyond a few months or starts after a few months, your doctor will investigate what is wrong.

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

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

If your expected period does not come in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other Medications and aidra 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 drospirenona/etinilestradiol. They may advise you to take additional contraceptive precautions and, if so, for how long, or to modify the use of another medication that you need.

Some medications can affect the levels of drospirenona/etinilestradiol in the blood, making itless effective in preventing pregnancymay cause unexpected bleeding.

This may occur with:

• medications used in the treatment of

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• infections with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungus infections (e.g., griseofulvin, ketoconazole)
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)

• herbal preparations of St. John's Wort

aidra Diario may affect the effect of other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or cramps)

Do not take aidra 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 test results (elevated ALT levels).

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

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

Consult your doctor or pharmacist before taking any medication.

Taking aidra 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 can 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 during treatment with drospirenona/etinilestradiol, stop treatment 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 aidra Diario”).

Breastfeeding

Generally, it is not recommended to take this medication during the breastfeeding period (while you are 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.

aidra Diario contains Lactose

Thismedication 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 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 pale yellow color and 7 inactive film-coated tablets of white color (placebo).

The two different types of colored tablets of aidra Diario are arranged in order.

One blister contains 28 tablets.

Take one aidra Diario tablet every day, with some 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 pale yellow tablet every day for the first 21 days, and then one white tablet for the last 7 days. Then you should start taking a new blister (21 pale yellow 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 taking order, each aidra Diario blister contains 7 self-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 aidra Diario blister, where it is indicated “Place the adhesive strip that matches 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 (the placebo days), you usually start your period (also called withdrawal bleeding). Usually, your period starts the second or third day after taking the last active tablet, of pale yellow color, of aidra 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 that you started the previous one, and your period should occur on the same days every month.

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

When can you start with the first blister

If you have not used 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 period).

If you start on the first day of your period, 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 a combined hormonal contraceptive, combined vaginal 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 week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

Switching from a progestin-only method (progestin-only pill, injection, implant, or intrauterine system of progestin release)

You can switch from the progestin-only pill on any day (if it is an implant or an IUS, on the day of its removal; if it is an injectable, on the day of the next injection), but in all cases, 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

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

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

If you are breastfeeding and want to start taking aidra Diario (again) after giving birth

See the section “Pregnancy and Lactation”.

Ask your doctor if you are unsure when to start.

If you take more aidra Diario than you should

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

The symptoms that may appear if you take many tablets can be feeling unwell or vomiting or vaginal bleeding. This bleeding can 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 used.

If you forget to take aidra Diario

The tablets in the fourth row of the blister are the placebo tablets. If you forget to take one of these tablets, it will not affect the reliability of aidra Diario. Dispose of the forgotten placebo tablet.

If you forget to take an active pale yellow tablet from the first, second, or third row, 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 greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a pale yellow tablet at the beginning (first row) or at the end of the blister (third row). 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 this means taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, for example, a condom, during the next 7 days. If you have had sex in the week before forgetting the tablet, you may be pregnant. 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 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:

• Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this blister, dispose of them and start the next blister.
• You may experience bleeding during the use of the second blister, which may be light or similar to menstruation. You can also interrupt the taking of active yellow tablets and pass directly to the 7 white placebo tablets(before taking the placebo tablets, note the day you forgot to take the tablet). If you want to start a new blister on the day you always start, take the placebo tablets forless than 7 days.

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 bleeding during the placebo days, you may be pregnant. Contact your doctor before starting the next blister.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3-4 hours after taking an active yellow tablet, or if you 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, take a pale yellow tablet from a spare blister as soon as possible. If possible, take itwithin 12 hoursafter the usual time when you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forgot to take aidra Diario”.

Delay of your menstrual period: what you should know

Although not recommended, you can delay your menstrual period if you do not take the placebo tablets, take a new blister of aidra Diario 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 from the fourth row. Then start the next blister.

You should ask your doctor for advice before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your menstrual period will startduring the placebo week. If you need to change that day, reduce the number of days of placebo - when you take the white placebo tablets - (but never increase it - 7 at most!). For example, if you usually start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), start a new blister 3 days earlier than usual. If you make the interval of taking placebo very short (e.g., 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 unsure how to proceed, consult your doctor.

If you interrupt the treatment with aidra Diario

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

If you want to become pregnant, stop taking this medication and wait until your menstrual period before trying to become pregnant. This way, you can calculate your estimated due 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 notice any changes in your health that you think may be due to this medicine, consult your doctor.

Contact your 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 aidra 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 10 people)

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• headache, depressive mood,
• migraine,
• nausea,
• thick, white vaginal discharge and vaginal yeast infection.

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

• breast enlargement, changes in sex drive,
• high blood pressure, low blood pressure,
• vomiting, diarrhea,
• acne, skin rash, intense itching, hair loss (alopecia),
• vaginal infection,
• fluid retention and changes in body weight.

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

• allergic reactions (hypersensitivity), asthma,
• breast secretion,
• hearing problems,
• skin disorders such as erythema nodosum (characterized by painful nodules on the skin with a reddish color) or erythema multiforme (characterized by skin rash with target-shaped redness 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,
• mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of 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 to the Spanish System for the Pharmacovigilance of Medicinal Products 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.

This medication does not require special storage conditions.

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 the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of aidra Diario

• The active principles are drospirenone and ethinylestradiol. Each film-coated tablet of color pale yellow contains 3 milligrams of drospirenone and 0.03 milligrams of ethinylestradiol.
• The film-coated tablets of color white do not contain active principles.
• The other components (excipients) are:

Film-coated active tablets of color pale yellow:

Tablet core: lactose monohydrate, hydroxypropylcellulose, potassium polacrilex, sodium lauryl sulfate, magnesium stearate (E-470b).

Coating: Opadry II yellow containing: macrogol 3350, poly (vinyl alcohol), titanium dioxide (E-171), talc (E-553b), yellow iron oxide (E-172).

Film-coated inactive tablets of color white (placebo tablets):

Tablet core: lactose monohydrate, potassium polacrilex, anhydrous colloidal silica, povidone K30, magnesium stearate (E-470b).

Coating: Opadry II white containing: macrogol 3350, poly (vinyl alcohol), titanium dioxide (E-171), talc (E-553b).

Appearance of the product and contents of the package

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

aidra 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 aidra Diario are cylindrical, biconvex, of pale yellow color, and approximately 6 mm in diameter.

The placebo tablets are cylindrical, biconvex, of white color, and approximately 6 mm in diameter.

Each carton contains a pouch to store the blister pack.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cyndea Pharma, S.L

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31

42110 Ólvega (Soria) Spain

Last review date of this leaflet: July 2024

The 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/.

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79439/P_79439.html

QR code to: https://cima.aemps.es/cima/dochtml/p/79439/P_79439.html