AIDRA DIARIO 3 mg/0.03 mg FILM-COATED TABLETS

Introduction

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Important things to 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 having a blood clot in the veins and arteries, especially in the first year or when you restart a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet

1. What is aidra Daily and what is it used for
2. What you need to know before you start taking aidra Daily
   • Do not take aidra Daily
   • Warnings and precautions
   • Blood clots
   • aidra Daily and cancer
   • Bleeding between menstrual periods
   • What to do if you do not have your menstrual period during the placebo days
   • Other medicines and aidra Daily
   • Taking aidra Daily with food and drink
   • Laboratory tests
   • Pregnancy and breastfeeding
   • Driving and using machines
   • aidra Daily contains lactose
3. How to take aidra Daily
   • When you can start with the first blister
   • If you take more aidra Daily than you should
   • If you forget to take aidra Daily
   • What to do in case of vomiting or severe diarrhea
   • Delayed menstrual period: what you should know
   • Change of your menstrual period's first day: what you should know
   • If you stop taking aidra Daily
4. Possible side effects
5. Storing aidra Daily
6. Package contents and further information

1. What is aidra Daily and what is it used for

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

Each of the 21 active pale yellow film-coated tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

The 7 white film-coated tablets do not contain active ingredients and are called placebo tablets.

Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking aidra Daily

General considerations

Before starting to take this medication, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before starting to take this medication, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may perform some other tests.

This prospectus describes several situations in which you should interrupt the use of this drospirenone/ethinylestradiol, or in which its effect may decrease.

In such 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 temperature method. These methods may not be reliable since this medication alters the monthly changes in body temperature and cervical mucus.

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

Do not takeaidra Daily

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

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need 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, 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) a liver disease and your liver function has not yet normalized.
• If your kidneys do not work well (renal failure).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had) or suspect you have breast cancer or cancer of the sex 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 (included in section 6). This can cause itching, rash, or inflammation.

Do not use aidra Daily

Do not take aidra Daily 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 "Other medications and aidra Daily").

Additional information on special populations

Children and adolescents:

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

Older women

aidra Daily is not indicated for use after menopause.

Women with liver insufficiency

Do not take aidra Daily if you suffer from liver disease. See sections "Do not take aidra Daily" and "Warnings and precautions".

Women with renal insufficiency

Do not take aidra Daily if you are suffering from kidney malfunction or acute renal failure. See sections "Do not take aidra Daily" and "Warnings and precautions".

Warnings and precautions

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

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

In some situations, you will need to be particularly careful while taking this medication 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 taking this medication, 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 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 have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking this medication 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 section "Other medications and aidra Daily").
• 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 (herpes gestationalis), 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 patches"). In this 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 may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like drospirenone/ethinylestradiol increases your risk of having 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 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 long-term 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 Daily 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 side 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 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 having 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 this medication, your risk of having 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 having a blood clot in the leg or lung (DVT or PE) with this medication 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, like this medication, between 9 and 12 women will have a blood clot in a year.
• The risk of having 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 having a blood clot with this medication 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 about 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a lot of 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 this medication several weeks before surgery or while you have reduced mobility. If you need to stop using this medication, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have recently given birth.

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

Long-distance air travel (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 this medication.

If any of the above conditions 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, 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 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 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 about 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 a high level 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 disorder called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions 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 Daily and cancer

It has been observed that breast cancer is slightly more common 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.

In rare cases, 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.

Psychiatric disorders

3. How to take aidra Daily

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

Each blister pack contains 21 active yellow pills and 7 inactive white pills.

The two different types of colored pills in aidra Daily are arranged in order.

A blister pack contains 28 pills.

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

Do not get confused with the pills:take one yellow pill every day for the first 21 days, and then one white pill for the last 7 days. Then, start a new blister pack (21 yellow pills and 7 white pills). This way, there is no week of rest between two blister packs.

Due to the different composition of the pills, it is necessary to start with the first pill located in the upper left corner and then take one pill every day. To maintain the order, follow the direction of the arrows on the blister pack.

Preparing the blister pack

To help you follow the order of intake, each aidra Daily blister pack contains 7 self-adhesive strips with the 7 days of the week. Choose the strip that starts with the day you take the first pill. For example, if you take your first pill on a Wednesday, use the strip that starts with "WED".

Stick the self-adhesive strip on the top of the aidra Daily blister pack, where it says "Place the strip that matches the start date here", so that the first day is placed above the pill marked "Start".

This way, there is a day of the week indicated above each pill, and you can see if you have taken a particular pill. The arrows show the order in which you should take the pills.

During the 7 days when you take the white inactive pills (the placebo days), you usually start your period (also called withdrawal bleeding). Normally, your period starts on the second or third day after taking the last active yellow pill of aidra Daily. Once you have taken the last white pill, you should start the next blister pack, even if you have not finished your period. This means that you should start each blister pack on the same day of the week that you started the previous one, and that your menstruation should take place during the same days every month.

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

When can you start with the first blister pack

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 immediately protected 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.

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

You can start taking this medication preferably the day after taking the last active pill (the last pill that contains active ingredients) of your previous contraceptive, or at the latest on the day after the rest week of your previous contraceptive (or after taking the last inactive pill of your previous contraceptive). When changing from a vaginal ring or patch, follow your doctor's recommendations.

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

You can change from the progestin-only pill at any time (if it is an implant or an intrauterine system, on the day of its removal; if it is 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 pill taking.

After an abortion

Follow your doctor's recommendations.

After having a child

You can start taking this medication 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 using this medication.

If, after having a child, you have had sexual intercourse before starting to take this medication again, you must be sure that you are not pregnant or wait until your next menstrual period.

If you are breastfeeding and want to start taking aidra Daily again after having a child

See the section "Pregnancy and Breastfeeding".

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

If you take more aidra Daily than you should

No cases have been reported in which an overdose with this medication has caused serious harm.

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

If you have taken too many pills of this medication, 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 used.

If you forget to take aidra Daily

The pills in the fourth row of the blister pack are the placebo pills. If you forget to take one of these pills, it will have no effect on the reliability of aidra Daily. Discard the forgotten placebo pill.

If you forget to take an active yellow pill from row 1, 2, or 3, do the following:

• If you are less than 12 hourslate in taking a pill, the protection against pregnancy is not reduced. Take the pill as soon as you remember and the following pills at the usual time.

• If you are more than 12 hourslate in taking a pill, the protection against pregnancy may be reduced. The more pills you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you forget to take a yellow pill at the beginning (row 1) or end (row 3) of the blister pack. Therefore, you should follow the following recommendations (see the diagram below).

Forgetting more than one pill in the blister pack

Consult your doctor.

Forgetting a pill in week 1

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

Forgetting a pill in week 2

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

Forgetting a pill in week 3

You can choose between two options:

• Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Instead of taking the white placebo pills from this blister pack, discard them and start the next blister pack.
• You will probably have your period at the end of the second blister pack, while taking the white placebo pills, although you may experience light bleeding or spotting during the second blister pack. You can also stop taking the active yellow pills and go directly to the 7 white placebo pills (before taking the placebo pills, you must note the day you forgot to take the pill). If you want to start a new blister pack on the day you always start, take the placebo pills for 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 pill and do not have bleeding during the placebo days, 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 an active yellow pill, or suffer from 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 pill. After vomiting or diarrhea, take a yellow pill 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 Daily".

Delayed menstrual period: what you should know

Although it is not recommended, you can delay your menstrual period if you do not take the white placebo pills from the fourth row and start a new aidra Daily blister pack and finish it. You may experience light bleeding or spotting during the use of the second blister pack. Finish this second blister pack by taking the 7 white pills from the 4th row. Then, start the next blister pack.

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

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

If you take the pills as instructed, your menstrual period will start during the placebo week. If you need to change this day, reduce the number of placebo days - when you take the white placebo pills - (but never increase them - 7 at most!). For example, if you usually start taking the placebo pills on Fridays and want to change it to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the placebo interval 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 with aidra Daily

You can stop taking this medication 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 this medication and wait until your menstrual 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you suffer from any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to this medicine, consult your doctor.

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 the 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 you start taking aidra Daily".

The following list of adverse effects has been associated with the use of this medicine:

Frequent Adverse 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 fungal infection.

Uncommon Adverse 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 Adverse 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 of a reddish color) or erythema multiforme (characterized by a skin rash with target-like 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 those of a stroke, known as a transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood 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 Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of aidra Daily

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of aidra Daily

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

Active yellow pale-colored film-coated tablets:

Tablet core: lactose monohydrate, hydroxypropylcellulose, potassium polacrylate, 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).

Inactive white film-coated tablets (placebo tablets):

Tablet core: lactose monohydrate, potassium polacrylate, 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 Package Contents

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

aidra Daily is available in cardboard boxes of 1 and 3 blister packs, each containing a PVC/PVDC/Aluminum blister pack with 28 film-coated tablets.

The active aidra Daily tablets are cylindrical, biconvex, yellow pale-colored, and have an approximate diameter of 6 mm.

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

Each cardboard box contains an envelope to store the blister pack.

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.

Pol. Ind. Emiliano Revilla Sanz

Avenida de Ágreda, 31

42110 Ólvega (Soria) Spain

Date of the Last Revision of this Prospectus: July 2024

Detailed and updated information on this medicine 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 on this medicine by scanning the QR code included in the prospectus 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/79439/P_79439.html

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