AIDRA 3 MG/0.03 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

aidra 3 mg/0.03 mg film-coated tablets EFG

drospirenone/ethinylestradiol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. 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 blood clots in veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots").

Package Leaflet Contents

1. What is aidra and what is it used for
2. What you need to know before taking aidra
3. How to take aidra
4. Possible side effects
5. Storing aidra
6. Package contents and additional information

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, called drospirenone and ethinylestradiol.

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking 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.

This package leaflet describes several situations in which you should stop using aidra or in which the effect of aidra may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since 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

Do 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 blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need 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 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 stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with blood vessel 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) liver disease and your liver function has not yet returned to normal.
• If your kidneys do not work well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to the active substances or to any of the other components of this medication (listed 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

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

In some situations, you should be extra careful while using aidra or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically. If the condition develops or worsens while you are using aidra, you should also inform your doctor:

• If a close relative has or has ever had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease 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 long time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking aidra after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see "Taking aidra with other medicines").
• 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 previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (gestational herpes), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (a skin discoloration, especially on the face or neck, known as "pregnancy spots"). In that case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, 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.

Psychiatric disorders:

Some women who use hormonal contraceptives like aidra have reported depression or a depressed mood. Depression can be severe and sometimes can 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 a blood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.

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 attention if 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 the 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of 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 take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive again (the same medication or a different one) after an interruption 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 within 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.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as aidra, between 9 and 12 women will have a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50).
• If you need surgery or spend a long time without getting up due to an injury or illness, or if you have a leg in a cast. You may need to stop using aidra several weeks before surgery or while you have reduced mobility. If you need to stop using aidra, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have recently given birth.

The risk of a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using aidra.

If any of the above conditions change while you are using aidra, for example, a close relative experiences a thrombosis 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 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 can increase:

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like aidra, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using aidra, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

aidraand cancer

Breast cancer has been observed slightly more often in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts examined regularly, and you should see your doctor if you notice any lump.

Rarely, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you experience severe unusual abdominal pain.

Irregular bleeding

During the first few months that you are taking aidra, you may have unexpected bleeding (bleeding outside of the withdrawal week). If this bleeding persists for more than a few months or starts after a few months, your doctor will investigate what is wrong.

What to do if you do not have your period during the withdrawal week

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

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

Takingaidrawith other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those bought without a prescription or herbal preparations that you are taking. Also, inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking aidra. They may tell you if you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or if you should modify the use of another medicine that you need.

Some medicines

• may affect aidra levels in the blood
• may make aidra less effective in preventing pregnancy
• may cause irregular bleeding

This can occur with:

• medicines used to treat
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin, ketoconazol)
  • arthritis, arthrosis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations containing St. John's Wort

aidra may affect the effectof other medicines, for example:

• medicines containing cyclosporin
• the antiepileptic lamotrigine (may lead to an increased frequency of seizures)
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or spasms)

Do not takeaidraif you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir,glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver test results (increase in liver enzyme ALT). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.aidra can 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 medicine.

Takingaidrawith food and drinks

aidra can be taken with or without food, and with some water if necessary.

Lab tests

If you need a blood test, tell 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 wish to become pregnant, you can stop taking aidra at any time (see "If you stop treatment with aidra").

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

Generally, it is not recommended to take aidra during the breastfeeding period (when you are giving your baby breast milk). If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

aidracontains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

aidracontains sodium

3. How to take aidra

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

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

After that, you should not take any tablets for 7 days. During these 7 days when you do not take tablets (a period called the withdrawal week), menstruation should occur. Menstruation, which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the withdrawal week.

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

If you use aidra in this way, you are also protected against pregnancy during the 7 days when you do not take any tablets.

When can you start with the first blister pack

• If you have not used any hormonal contraceptive in the previous 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) during the first 7 days.

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

You can start taking aidra preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the withdrawal week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

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

You can switch from the progestin-only pill at any time (if it's an implant or intrauterine system, on the same day it is removed; if it's an injectable, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet-taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

You can start taking aidra between 21 and 28 days after having a child. If you start later, use a barrier method (e.g., a condom) during the first 7 days of aidra use.

If, after having a child, you have had sexual intercourse before starting aidra 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 again after having a child

Read the section "Breastfeeding".

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

If you take moreaidrathan you should

No cases have been reported in which an overdose of aidra has caused serious harm.

The symptoms that may appear if you take many tablets at once may include 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 have accidentally taken this medication.

If you have taken too many aidra tablets, or 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take aidra

• If you are less than 12 hourslate in taking a tablet, protection against pregnancy will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.

• If you are more than 12 hourslate in taking a tablet, 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 greatest if you forget to take a tablet at the beginning or end of the blister pack. Therefore, you should follow the following recommendations (see the diagram below):

• Forgetfulness of more than one tablet from the blister pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional precautions, such as a condom, during the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetfulness of a tablet in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. Protection against pregnancy will not decrease, and you do not need to take additional precautions.

• Forgetfulness of a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of starting the withdrawal week, start the next blister pack.

You will likely have your period at the end of the second blister pack, although you may also experience light bleeding or spotting during the second blister pack.

1. You can also stop taking tablets and go directly to the 7-day withdrawal week (noting the day you forgot to take the tablet). If you want to start a new blister pack on the day you always start, your withdrawal week should last less 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 withdrawal week, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a tablet or have severe 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 reserve blister pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take aidra".

Delay of your period: what you should know

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

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

Change of 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 withdrawal week. If you need to change that day, reduce the number of withdrawal days (but never increase them - 7 at most!). For example, if your withdrawal 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 withdrawal week very short (e.g., 3 days or less), you may not have bleeding during these days. Then you may experience light bleeding or spotting.

If you are not sure 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 more easily calculate the estimated date of delivery.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to aidra, consult your doctor.

Severe side effects

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

All women who take 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 taking aidra".

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

Common 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

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

• breast enlargement, changes in libido
• 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) or erythema multiforme (characterized by a skin rash with target-like lesions 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 those of a stroke, called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk 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 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage 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 "EXP:". The expiration date is the last day of the month indicated.

Medications should not be disposed of in wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of aidra

• The active ingredients are drospirenone and ethinylestradiol.

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

• The other ingredients are:

Tablet core: lactose monohydrate, hydroxypropylcellulose, potassium polacrylate, 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 package contents

• The aidra tablets are film-coated tablets. The tablets are cylindrical, biconvex, and pale yellow in color

• Aidra is available in boxes of 1 or 3 blister packs, each containing 21 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Manufacturer

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla

Av. De Ágreda 31

42110 Ólvega (Soria)

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Date of the last revision of this leaflet:April 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83762/P_83762.html

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