Aidra 3 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

aidra 3 mg/0.03 mg film-coated tablets EFG

drospirenone/ethinylestradiol

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this 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 developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet contents

1. What aidra is and what it is used for
2. What you need to know before taking aidra
3. How to take aidra
4. Possible side effects
5. How to store aidra
6. Contents of the pack and other information

1. What aidra is and what it is used for

aidra is a contraceptive 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 known as combined contraceptives.

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

General considerations

Before starting to use aidra, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before you start taking aidra, your doctor will ask you questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some additional tests.

This leaflet describes several situations in which you should stop using aidra, or in which the effectiveness of aidra may be reduced. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, such as a condom or another barrier method. Do not use the rhythm method or the 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) infection or any other sexually transmitted disease.

When you must not 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 which other form of contraception would be most 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), in your lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you require surgery or if you are going to be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms).
• If you have any of the following conditions that may increase your risk of developing 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 returned to normal.
• If your kidneys do not work properly (renal insufficiency).
• If you have (or have ever had) a liver tumour.
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding of unknown cause.
• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6). This may cause itching, rash, or swelling.
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking aidra with other medicines”).

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 should you consult your doctor? Seek urgent medical attention: if you notice possible signs of a blood clot which may indicate that you are experiencing 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). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

In certain situations, you should take special care when using aidra or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using aidra, you must also inform your doctor:

• If any 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 causing kidney failure).
• If you have sickle cell anemia (an inherited red blood cell disorder).
• 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 require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking aidra after childbirth.
• If you have inflammation of the veins beneath 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 affecting your body’s natural defense system).
• If you have a condition that first occurred during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous system disorder involving involuntary movements (Sydenham’s chorea)).
• If you have or have ever had chloasma (skin discoloration, especially on the face or neck, known as “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet radiation.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders:

Some women using hormonal contraceptives such as aidra have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for additional medical advice as soon as possible.

BLOOD CLOTS

Using a combined hormonal contraceptive such as aidra increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects or, very rarely, they may be fatal.

It is important 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.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one 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 or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly producing blood. Sharp chest pain that may worsen when taking a deep breath. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms 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 a limb. Severe stomach pain (acute abdomen).	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 thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also 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 remains slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking aidra, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with aidra is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as aidra, between 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 in 10,000 women
Women who use cyproterone	About 9–12 in 10,000 women

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if you have a plaster cast on your leg. You may need to stop using aidra several weeks before surgery or while you are less mobile. If you need to stop using aidra, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

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 above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop using aidra.

If any of the conditions listed above change while you are using aidra—for example, a close relative experiences a thrombosis without a known cause, or you gain a significant amount 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 stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using 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 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder 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 developing a blood clot may be even higher.

If any of the conditions listed above 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 significant amount of weight—inform your doctor.

aidra and cancer

Slightly more cases of breast cancer have been observed in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

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

Bleeding between periods

During the first few months of taking aidra, you may experience unexpected bleeding (bleeding outside the pill-free week). If this bleeding persists beyond a few months or starts after several months, your doctor will investigate the cause.

What to do if you do not have your period during the pill-free week

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

If you miss two consecutive expected periods, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking aidra with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including over-the-counter medicines or herbal preparations. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking aidra. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of another medicine.

Some medicines:

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

This may occur with:

• medicines used to treat
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g., rifampicin)
  • HIV and Hepatitis C infections (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)
• St. John’s wort herbal preparations

aidra may affect the action of other medicines, for example:

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

Do not take aidra if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (increase in liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. aidra can be restarted approximately 2 weeks after completing this treatment. See the section "Do not take aidra".

Consult your doctor or pharmacist before taking any medicine.

Taking aidra with food and drink

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

Laboratory tests

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should not take aidra. If you become pregnant while taking aidra, 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 taking aidra").

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

In general, aidra is not recommended during the breastfeeding period (while you are breastfeeding). If you wish to use a 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 suggesting that the use of aidra has any effect on the ability to drive or use machinery.

aidra contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

aidra contains sodium

This medicine 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 some water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

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

Afterwards, you should not take any tablets for 7 days. During these 7 days without tablets (called the "rest week"), your menstrual period should occur. The menstruation, also known as withdrawal bleeding, usually begins on the 2nd or 3rd day of the rest week.

On the 8th day after taking the last aidra tablet (i.e., after the 7-day rest period), you must start the next blister pack, even if bleeding has not yet finished. This means you should begin each new blister pack on the same day of the week, and your period should occur during 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 to start the first blister pack

• If you have not used any hormonal contraception 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 against pregnancy immediately. You may also start on days 2–5 of your cycle, but in this case, you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You may preferably start taking aidra 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 the last inactive tablet of your previous contraceptive). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system [IUS])

You may switch from the progestogen-only pill on any day (if it is an implant or IUS, on the same day of removal; if it is an injectable, at the time the next injection would be due), but in all cases, you must use additional contraceptive measures (e.g., a condom) during the first 7 days of taking aidra tablets.

• After a miscarriage

Follow your doctor's advice.

• After giving birth

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

If, after giving birth, you have already had sexual intercourse before starting aidra (again), you must be sure you are not pregnant or wait until your next menstrual period.

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

Please read the section "Breastfeeding".

Ask your doctor if you are unsure about when to start.

If you take more aidra than you should

No serious harmful effects have been reported following overdose of aidra.

Symptoms that may occur if you take several tablets at once include feeling unwell, vomiting, or vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine.

If you have taken too many aidra tablets, or if you find that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take aidra

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and continue taking the following tablets at your usual time.

• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a tablet at the beginning or end of the pack. Therefore, follow the recommendations below (see the diagram below):

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 1

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

• Missing one tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of starting the rest week, start the next blister pack immediately.

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

2. You may also stop taking tablets and go directly into the 7-day rest period (noting the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period should last less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any tablets and do not have bleeding during the first rest period, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhoea, there is a risk that the active ingredients of the contraceptive may not be fully absorbed by your body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhoea, take a tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the 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".

Delaying your period: what you should know

Although not recommended, you may delay your period by starting a new aidra blister pack instead of taking the usual 7-day rest week, and completing it. During the second pack, you may experience light bleeding or spotting. After the usual 7-day rest week, start the next blister pack.

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

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

If you take the tablets as instructed, your period will start during the rest week. If you wish to change that day, reduce the number of rest days (but never extend them – maximum 7 days!). 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 period very short (e.g., 3 days or fewer), bleeding may not occur during these days. In this case, you may experience light bleeding or spotting later.

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

If you stop taking aidra

You may stop taking aidra at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking aidra and wait until your next period before trying to conceive. This will make it easier to calculate your estimated due date.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. If you experience 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 aidra, consult your doctor.

Serious adverse 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

All women who take combined hormonal contraceptives have an increased 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 associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take aidra”.

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

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

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depressed mood
• migraine
• nausea
• thick, whitish vaginal discharge and fungal vaginal infection

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

• increase in breast size, changes in sexual interest
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• 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 discharge

• hearing problems

• skin disorders such as nodular erythema (characterized by painful reddish skin nodules) or erythema multiforme (characterized by skin eruptions with target-shaped redness or ulcers)

• harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT).

• In a lung (i.e., PE).

• Heart attack.

• Stroke.

• Mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA).

• Blood clots in the liver, stomach/intestine, kidneys or eye.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of aidra

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of aidra

• The active substances are drospirenone and ethinylestradiol.

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

• The other components are:

Tablet core: lactose monohydrate, hydroxypropyl cellulose, potassium polacrilin, sodium lauryl sulfate, and magnesium stearate.

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

Appearance of the product and contents of the pack

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

• aidra is available in packs of 1 or 3 blisters, each containing 21 tablets.

Only certain 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 most recent review of this leaflet: April 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

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

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