Aidrana 3 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

aidrana 3 mg/ 0.02 mg film-coated tablets EFG

drospirenone/ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience 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 aidrana is and what it is used for

2. What you need to know before taking aidrana

3. How to take aidrana

4. Possible side effects

   1. Storage of aidrana

5. Contents of the pack and other information

1. What aidrana is and what it is used for

• aidrana is a contraceptive used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are also referred to as placebo tablets.

Contraceptives containing two hormones are known as combined contraceptives.

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

General considerations Before starting to use aidrana, you should 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 aidrana, your doctor will ask you some 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 patient information leaflet describes several situations in which you should stop using aidrana, or in which the reliability of aidrana may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable because drospirenone/ethinylestradiol alters the monthly changes in body temperature and cervical mucus. aidrana, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

When not to use aidrana

Do not use aidrana 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 more suitable.

Do not take aidrana:

• 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 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 had in the past) liver disease and your liver function has not yet returned to normal.

• If your kidneys are not working properly (renal failure).

• If you have (or have had in the past) a liver tumour.

• If you have (or have had in the past), or are suspected of having breast cancer or cancer of the reproductive organs.

• If you have vaginal bleeding of unknown cause.

• If you are allergic to drospirenone or ethinylestradiol or to any of the other components of this medicine (listed in section 6). This may manifest as itching, rash, or swelling.

• If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking aidrana with other medicines”).

Warnings and precautions

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may mean 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 side 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 drospirenone/ethinylestradiol or any other combined hormonal contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using drospirenone/ethinylestradiol, you must also inform your doctor.

• If any close family member 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 systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
• 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 long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking aidrana after delivery.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis). If you have varicose veins.
• If you have epilepsy (see “Taking aidrana with other medicines”).
• If you have had any conditions that first occurred during pregnancy or during previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham’s chorea)). If you have or have ever had brownish-yellow patches (chloasma), also known as “pregnancy mask,” especially on the face. In this case, 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. Medicinal products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Consult your doctor or pharmacist before starting to take aidrana.

Psychiatric disorders:

Some women using hormonal contraceptives such as aidrana have reported depression or a 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 aidrana increases your risk of developing a blood clot compared to not using it. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

It is important to remember that the overall risk of a harmful blood clot due to aidrana is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistance 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., turning 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 on deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal 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 like 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).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the sternum. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme 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 abdominal 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 the veins (venous thrombosis). However, these adverse events are rare. They occur more 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 (either the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking aidrana, 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 aidrana is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will experience a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will experience a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone such as drospirenone/ethinylestradiol, between about 9 and 12 women will experience a blood clot within 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 pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5-7 out of 10,000 women
Women who use aidrana	About 9-12 out of 10,000 women

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

The risk of having a blood clot with aidrana 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 has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). 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 leg in a cast. You may need to stop using aidrana several weeks before surgery or while you are less mobile. If you need to stop using aidrana, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• 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 mentioned above, even if you are uncertain. Your doctor may decide that you need to stop using aidrana.

If any of the conditions listed above change while you are using aidrana—for example, a close relative experiences a thrombosis without a known cause, or you gain significant 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 lead to 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 heart attack or stroke with drospirenone/ethinylestradiol is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as aidrana, 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 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 condition (valve disorders, a heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

Drospirenone/ethinylestradiol and cancer

Breast cancer has been observed slightly more frequently in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women using combined contraceptives because they are examined by a doctor more often. 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.

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

Bleeding between periods

During the first few months of taking aidrana, you may experience unexpected bleeding (bleeding outside the days when taking placebo tablets). If this bleeding persists beyond a few months, or starts after several months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo tablet days

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

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

Taking aidrana with other medicines

Inform your doctor who prescribed aidrana at all times about any medications or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking aidrana. They may advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or whether you should modify the use of any other medication you may need.

Some medicines

• may influence the blood levels of aidrana
• may make it 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 virus 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)

• herbal preparations containing St. John's wort

Drospirenone/ethinylestradiol may affect the action of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (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 aidrana 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 the liver enzyme ALT).

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

aidrana can be restarted approximately 2 weeks after completion of this treatment. See section "Do not take aidrana".

Consult your doctor or pharmacist before using any medicine

Taking aidrana with food and drinks

Drospirenone/ethinylestradiol may be taken with or without food, and with some water if needed.

Laboratory tests

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

Pregnancy and breast-feeding

Pregnancy

If you are pregnant, you must not take aidrana. If you become pregnant while taking aidrana, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking aidrana at any time (see "If you stop taking aidrana").

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

In general, aidrana is not recommended during breast-feeding. If you wish to take the contraceptive while breast-feeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no information suggesting that the use of aidrana has any effect on the ability to drive or use machines.

aidrana contains lactose

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

3. How to take aidrana

Each blister contains 24 pink active tablets and 4 white placebo tablets. The aidrana tablets of different colors are arranged in order. One blister contains 28 tablets.

Take one aidrana 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.

Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. Then start a new blister pack immediately (24 pink tablets followed by 4 white tablets). Therefore, there is no break between two blister packs.

Because the composition of the tablets differs, you must start the blister pack with the tablet in the upper left corner and take the tablets every day. Follow the direction of the arrows on the blister pack to take the tablets in the correct order.

Preparing the blister pack

To help you keep track of the dosing schedule, each aidrana package contains 7 adhesive strips labeled with the 7 days of the week. Choose the strip that starts with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with “WED”.

Attach the weekly adhesive strip to the top of the aidrana blister pack, where it indicates “Place the adhesive strip here!”, so that the first day is positioned above the tablet marked “1”.

You will now have a day marked above each tablet and will be able to visually check whether you have taken your tablet. The arrows indicate the order in which to take the tablets.

During the 4 days when you take the placebo tablets (the placebo days), you should experience menstruation (the so-called withdrawal bleeding). This usually begins on the 2nd or 3rd day after taking the last pink active tablet of aidrana. After taking the last white tablet, start the next blister pack immediately, even if your menstruation has not ended. This means you should start the next blister pack on the same day of the week as you started the previous one, and the withdrawal bleeding should occur on the same days each month.

If you use aidrana in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablets.

When to start the first blister pack

• If you have not used any hormonal contraceptive in the previous month

Start taking aidrana on the first day of your cycle (i.e., the first day of your menstruation). If you start aidrana on the first day of your period, you are protected against pregnancy immediately. You may also start on days 2–5 of the 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 aidrana 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 tablet-free interval (or after the last inactive tablet) of your previous contraceptive. When switching from a combined vaginal contraceptive ring or contraceptive patch, follow your doctor’s recommendations.

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

You may switch from the progestogen-only pill on any day. If switching from an implant or IUS, do so on the day of removal; if switching from an injectable, do so at the time the next injection would have been due. In all cases, it is advisable to use additional contraceptive measures (e.g., a condom) during the first 7 days of taking the tablets.

• After an abortion

Follow your doctor’s recommendations.

• After giving birth

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

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

• If you are breastfeeding and wish to start taking drospirenone/ethinylestradiol

Read the section “Breast-feeding”.

Consult your doctor if you have any doubts about when to start.

If you take more aidrana than you should

No cases of serious harm due to overdose of aidrana have been reported.

If you take many tablets at once, you may feel unwell or experience 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 aidrana tablets, or if you discover 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take aidrana

The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget one of these tablets, the contraceptive effect of aidrana is not lost. Discard the forgotten placebo tablet.

If you forget an active pink tablet (tablets 1–24 of the blister), follow the advice below:

• If you are less than 24 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, and continue taking the following tablets at your usual time.

• If you are more than 24 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you forget, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is highest if you forget a pink tablet at the beginning or end of the blister pack. The recommendations below apply in this situation (see also the diagram below):

• Forgetting more than one tablet in the blister pack

Consult your doctor.

• Forgetting a tablet during days 1–7 (first row)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time and use additional precautions, e.g., condoms, for the next 7 days. If you had sexual intercourse in the week before forgetting the tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• Forgetting a tablet during days 8–14 (second row)

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

• Forgetting a tablet between days 15 and 24 (third or fourth row)

You have two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Instead of continuing with the white placebo tablets, discard them and start the next blister pack (the day you take the first tablet will be different).

You will likely have your period at the end of the second blister pack—during the intake of the white placebo tablets—although you may experience spotting or menstrual-like bleeding during the second blister pack.

2. You may also stop taking the pink active tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day on which you forgot to take your tablet). If you wish to start a new blister pack on your usual starting day, take the placebo tablets for fewer than 4 days.

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

If you have forgotten to take any tablets from a blister pack and do not have your period during the placebo days, this may indicate that you are pregnant. In this case, you must see 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 pink active tablet, or if you have severe diarrhea, there is a risk that the active ingredients in the tablet may not be fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, take a pink tablet from a spare pack as soon as possible. If possible, take it within 24 hours of your usual time for taking the contraceptive. If this is not possible or more than 24 hours have passed, follow the advice in the section “If you forget to take aidrana”.

Delaying your menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period by not taking the white placebo tablets in the 4th row and instead starting directly with the tablets from a new aidrana blister pack, continuing until the end of this new blister pack. You may experience spotting (drops or blood stains) or menstrual-like bleeding during the use of the second blister pack. After completing this second blister pack by taking the 4 white tablets in the 4th row, start the next blister pack.

Before deciding to delay your menstrual period, consult your doctor.

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

If you take the tablets as instructed, your menstrual period will begin during the placebo days. If you wish to change this day, you may do so by reducing the number of placebo days (the days when you take the white tablets), but never extend them—4 days is the maximum! For example, if you usually start the placebo days on a Friday and want to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. It is possible that no bleeding will occur during these placebo days. You may then experience spotting or menstrual-like bleeding.

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

If you stop taking aidrana

You may stop taking aidrana 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 aidrana and wait for your menstrual 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 your health that you think may be due to aidrana, 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 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 aidrana”.

The following are adverse effects associated with the use of aidrana:

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

• mood changes
• headache
• nausea
• breast pain, menstrual problems such as irregular periods, absence of periods

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

• depression, nervousness, drowsiness
• dizziness, tingling and prickling sensations
• migraine, varicose veins, increased blood pressure
• stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhoea
• acne, itching, skin rash
• discomfort and pain, such as back pain, limb pain, muscle cramps
• vaginal fungal infection, lower abdominal (pelvic) pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flushes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex
• lack of energy, increased sweating, fluid retention
• weight gain

Rare adverse effects: may affect up to 1 in 1,000 people

• candidiasis (a fungal infection)

• anaemia, increased number of platelets in the blood

• allergic reaction

• hormonal disorder (endocrine)

• increased appetite, loss of appetite, abnormally high potassium concentration in the blood, abnormally low sodium concentration in the blood

• absence of orgasm, insomnia

• dizziness, tremors

• eye disorders, such as eyelid inflammation, dry eyes

• unusually rapid heart rate

• vein inflammation, nosebleeds, fainting

• abdominal swelling, intestinal disorder, sensation of bloating, gastric hernia, fungal mouth infection, constipation, dry mouth

• pain in the bile ducts or gallbladder, gallbladder inflammation

• yellowish-brown spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, photosensitivity-related skin inflammation, skin nodules

• difficult or painful sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the mucosal surface of the cervix, shrinking or loss of the uterine lining, fluid-filled sac-like structures in an ovary, uterine enlargement

• malaise

• weight loss

• 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 stroke-like symptoms, 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).

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (target-shaped skin rash or ulcers).

Reporting of adverse effects

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

5. Storage of aidrana

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

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

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers 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 aidrana

• The active substances are drospirenone and ethinylestradiol.

Each active pink film-coated tablet contains 3 mg of drospirenone and 0.02 mg of ethinylestradiol.

The white film-coated tablets do not contain any active substance.

• Other components are:

Active pink film-coated tablets

Tablet core: lactose monohydrate, potassium polacrilin, povidone K-30, magnesium stearate.

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

Inactive white film-coated tablets:

Tablet core: lactose monohydrate, potassium polacrilin, povidone K-30, magnesium stearate, anhydrous colloidal silica.

Tablet film coating: macrogol 3350, titanium dioxide (E171), poly(vinyl alcohol), talc.

Appearance of the product and contents of the pack

• Each aidrana blister contains 24 active pink film-coated tablets in the 1st, 2nd, 3rd, and 4th rows of the blister, and 4 white placebo film-coated tablets in the 4th row.

• The aidrana tablets, both pink and white, are film-coated; the tablet core is coated.

• The active tablet is cylindrical, approximately 6 mm in diameter, biconvex, and pink in colour.

• The placebo tablet is cylindrical, approximately 6 mm in diameter, biconvex, and white in colour.

aidrana is available in packs of 1 and 3 blisters, each containing 28 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) - Spain

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: July 2024

Detailed information about this medicine 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 about 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/83761/P_83761.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83761/P_83761.html