Introduction

Label: Information for the User

Aidra 3 mg/0.03 mg Film-Coated Tablets EFG

Drospirenone/Ethinylestradiol

Read this label carefully before starting to take this medicine, as it contains important information for you.

Keep this label, 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 must 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 label. 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”).

1. What is aidra and what is it used for

aidra is a contraceptive and is used to prevent pregnancy.

Each of the 21 tablets contains a small amount of two different female hormones, known as drospirenona and etinilestradiol.

Contraceptives that contain two hormones are known as combined contraceptives.

2. What you need to know before starting to take Aidra

General Considerations

Before starting to use aidra, 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 aidra, 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.

In this prospectus, several situations are described in which you should interrupt the use of aidra, or in which the effect of aidra 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 another barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable because aidra alters the monthly changes in body temperature and cervical mucus.

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

When Not to Use Aidra

You should not use aidra 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.

Do Not Take Aidra

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 standing up (see section “Blood Clots”).
If you have ever had a heart attack or a stroke.
If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).
If you have any of the following diseases that may increase your risk of forming a blood clot in 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 insufficiency).
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 the active ingredients or to any of the other components of this medication (including in section 6). This may cause 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 “Taking Aidra with Other Medications”).

Additional Information on Special Populations

Use in Children

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

Warnings and Precautions

When to Consult a Doctor

Seek Urgent Medical Attention:

-If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section “Blood Clots” below).

To obtain a description of the symptoms of these serious adverse effects, see “How to Recognize a Blood Clot”.

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

In some situations, you should take special care while using aidra or any other combined contraceptive, and you may need to have regular check-ups with your doctor. If the condition develops or worsens while you are using aidra, 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 standing up (see section 2 “Blood Clots”).
If you are at increased risk of blood clots after childbirth. You should ask your doctor when you can start taking aidra 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 “Taking Aidra with Other Medications”).
If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
If you have a disease that first appeared during pregnancy or during a previous use of sex hormones (e.g., 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 symptoms of hereditary and acquired angioedema.

Psychiatric Disorders:

Some women who use hormonal contraceptives like aidra 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.

BLOOD CLOTS

The use of a combined hormonal contraceptive like aidra increases your risk of suffering ablood clotcompared 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 ATE).

The recovery from 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 is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek Urgent Medical Attentionif you notice any of the following signs or symptoms.

Do You Experience Any of These Signs?	What You May Be Suffering From?
Swelling of a leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing up or walking. Increased temperature in the affected leg. Change in skin color of the leg, e.g., if it becomes pale, red, or blue.	Deep Vein Thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden coughing without a clear cause, which may bring up blood. Severe chest pain that may worsen with deep breathing. Intense dizziness or fainting. Irregular or rapid heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a milder condition like a common cold.	Pulmonary Embolism
Symptoms that occur more frequently in one eye: Sudden loss of vision. Or Blurred vision without pain, which may progress to loss of vision.	Retinal Vein Thrombosis (Blood Clot in the Eye)
Chest pain, discomfort, or pressure. Feeling of oppression or fullness in the chest, arm, or under the sternum. Feeling of fullness, indigestion, or choking. Upper body discomfort that radiates to the back, jaw, neck, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Irregular or rapid heartbeat.	Heart Attack
Sudden weakness or numbness in one side of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking, or understanding. Sudden difficulty seeing in one eye or both eyes. Sudden difficulty walking, dizziness, loss of balance, or coordination. Sudden severe headache, without a known cause. Sudden loss of consciousness or fainting, with or without convulsions. Sometimes, the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of an extremity. Severe stomach pain (abdominal pain).	Blood Clots Blocking Other Blood Vessels

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 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 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 aidra, 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 aidra is small.

Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like aidra, about 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).

	Risk of a Blood Clot in a Year
Women whodo not usea combined hormonal contraceptive and who are not pregnant	About 2 of every 10,000 women
Women who use a combined hormonal contraceptive containinglevonorgestrel, noretisterone, or norgestimato	About 5-7 of every 10,000 women
Women who useaidra	About 9-12 of every 10,000 women

Factors That Increase Your Risk of a Blood Clot in a Vein

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

If you are overweight (body mass index (BMI) of 30 kg/m2or higher).
If a 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 a hereditary blood clotting disorder.
If you need surgery or spend a lot of time without standing up due to an injury or illness, or if you have your leg immobilized. You may need to stop using aidra for several weeks before the surgery or while you have less mobility. If you need to stop using aidra, 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 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 above, even if you are unsure. Your doctor may decide that you should stop using aidra.

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

With age (over about 35 years).
If you smoke.When using a combined hormonal contraceptive like aidra, you are advised to quit smoking. If you cannot 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). 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 problem (valve disorder, irregular heart rhythm called atrial fibrillation).
If you have diabetes.

If you have more than one 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 above change while you are using aidra, 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 and Cancer

Cancer of the breast has been observed slightly more frequently in women who use 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 who take 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 contraceptives. You should consult your doctor if you experience severe abdominal pain.

Menstrual Bleeding

During the first few months while you are taking aidra, you may experience unexpected bleeding (bleeding outside of the menstrual period). If these bleeding persist beyond a few months, or start after a few months, your doctor will investigate what is wrong.

What to Do If You Do Not Have a Period During the Menstrual Period

If you have taken all the tablets correctly, have not had severe vomiting or 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 occasions, you may be pregnant. You should consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Aidra with Other Medications

Inform your doctor or pharmacist if you are using or have used other medications, even those acquired without a prescription or herbal preparations that you are taking. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking aidra. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or to modify the use of another medication that you need.

Some medications

may affect the levels of aidra in the blood
may make itless effective in preventing pregnancy
may 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)
- fungal 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

Aidramay affect the effectof 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 Aidraif 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 (ALT). Your Doctor Will Prescribe Another Type of Contraceptive Before Starting Treatment with These Medications.AidraCan Be Used Again Approximately 2 Weeks After the End of This Treatment. See the Section"Do Not Take Aidra").

Consult Your Doctor or Pharmacist Before Taking Any Medication.

Taking Aidra with Food and Drinks

Aidra can be taken with or without food, and with some 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, you should not take aidra. If you become pregnant during treatment with aidra, you should stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking aidra at any time (see “If You Interrupt Treatment with Aidra”).

Consult Your Doctor or Pharmacist Before Taking Any Medication.

Breastfeeding

In general, it is not recommended to take aidraduring the breastfeeding period (when you are breastfeeding). If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult Your Doctor or Pharmacist Before Taking Any Medication.

Driving and Operating Machines

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

Aidra Contains Lactose

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

Aidra Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Aidra

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

The blister pack contains 21 tablets. Next to each tablet, the day of the week is printed on which it should be taken. If, for example, you start on a Wednesday, take a tablet marked with the letters "MIE". Follow the direction of the arrow on the blister pack until you have taken all 21 tablets.

Do not take any tablets for 7 days after that. During these 7 days, when no tablets are taken (called the rest week), menstruation should occur. Menstruation, also known as withdrawal bleeding, usually starts on the 2nd or 3rd day of the rest week.

At the 8th day after taking the last aidra tablet (i.e., after the 7-day rest period), start with the next blister pack, even if the bleeding has not stopped yet. This means that you should start each blister pack on the same day of the week and that menstruation should occur on the same days every month.

If you use aidra in this way, you are also protected against pregnancy during the 7 days when no tablets are taken.

When can you start with the first blister pack

If you have not used any hormonal contraceptives in the past month

Start taking aidra on the first day of your cycle (i.e., the first day of your period). If you start aidra 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 must use additional contraceptive methods (e.g., a condom) for the first 7 days.

Switching from a combined hormonal contraceptive, vaginal combined contraceptive ring, or patch

You can start taking aidra preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest week 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 pills, injection, implant, or intrauterine system releasing progestin)

You can switch from progestin-only pills at any time (if it's an implant or an IUS, on the day of its removal; if it's an injection, when the next injection is due), but in all cases, use additional contraceptive methods (e.g., a condom) for the first 7 days of taking tablets.

After an abortion

Follow your doctor's recommendations.

After giving birth

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

If, after giving birth, you have already had sex before starting aidra (again), make sure you are not pregnant or wait for your next menstrual period.

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

Read the section "Breastfeeding".

Ask your doctor if you are unsure when to start.

If you take moreaidrathan you should

No serious cases of overdose have been reported.

The symptoms that may appear if you take many tablets at once can be feeling unwell, 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 aidra tablets, or if 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take aidra

If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.

If you are latemore than 12 hoursin taking a tablet, the protection against pregnancy may decrease. 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 tablet at the beginning or end of the blister pack. Therefore, follow the following recommendations (see the diagram later):

Forgetting more than one tablet from the blister 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 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 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 does not decrease, 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 starting the rest week, start the next blister pack.

You may experience bleeding during the use of the second blister pack, which may be light or similar to menstruation. After the usual 7-day rest week,startthe next blister pack.

You can also interrupt taking tablets and go directly to the 7-day rest week (marking the day you forgot to take the tablet). If you want to start a new blister pack on the day you always start, your rest week should lastless 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 first rest week, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or intense diarrhea

If you have vomiting within 3-4 hours after taking a tablet 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, take a tablet from a spare blister pack 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".

Delayed period: what you should know

Although not recommended, you can delay your period if you start taking a new aidra blister pack instead of continuing with the usual 7-day rest week and finish it. You may experience bleeding during the use of the second blister pack, which may be light or similar to menstruation. After the usual 7-day rest week,startthe next blister pack.

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

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

If you take the tablets according to the instructions, your period will start during the rest week. If you need to change that day, reduce the number of rest days (but never increase – 7 at most!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the rest week very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience light bleeding or similar to menstruation.

If you are unsure how to proceed, consult your doctor.

If you interrupt treatment withaidra

You can stop taking aidra whenever 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 aidra and wait until your 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.

4. Possible Adverse Effects

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 aidra, consult your doctor.

Severe side effects

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

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”.

The following list of side effects has been associated with the use of aidra:

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
Auditory problems
Dermatological disorders such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by skin rash with target-shaped redness or ulcers)
Deleterious 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.

5. Preservation of aidra

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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of aidra

The active principles are drospirenone and ethinylestradiol.

Each coated tablet contains 3 milligrams of drospirenone and 0.03 milligrams of ethinylestradiol.

The other components are:

Tablet core : lactose monohydrate, hydroxypropylcellulose, potassium polacrilex, sodium lauryl sulfate, and magnesium stearate.

Tablet coating : macrogol 3350, titanium dioxide (E171), poly(vinyl alcohol), talc, and yellow iron oxide (E172)

Appearance of the product and contents of the packaging

Aidra tablets are coated tablets. The tablets are cylindrical, biconvex, and pale yellow in color.

Aidra is available in boxes of 1 or 3 blisters, each containing 21 tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Responsible manufacturer

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla

Av. De Ágreda 31

42110 Ólvega (Soria)

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Last review date of this leaflet: April 2024

The detailed information on 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 on this medicine 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/83762/P_83762.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83762/P_83762.html