Package Leaflet: Information for the User

Aidrana 3 mg/ 0.02 mg Film-Coated Tablets

Drospirenone/Ethinylestradiol

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are 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 blood clots in veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

1.What is Aidrana and what it is used for

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

3.How to take Aidrana

4.Possible side effects

1. Storage of Aidrana

6. Contents of the pack and additional information

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

Contraceptives that contain two hormones are known as combined contraceptives.

When Not to UseAidrana

You should 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 what other form of contraception would be more suitable.

Do Not Take Aidrana:

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without 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, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Diabetes with severe vascular damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have had in the past) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function well (renal insufficiency).
• If you have (or have had in the past) a liver tumor.
• If you have (or have had in the past), or are suspected to have breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic todrospirenona or etinilestradiolor to any of the other components of this medication (including in section 6).This may manifest as itching, rash, or inflammation.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Use of Aidrana with Other Medications”).

Inform Your Doctor If You Suffer Any of the Following Conditions.

In some situations, you should take special care while using drospirenona/etinilestradiol or any other combined hormonal contraceptive, and may need to be examined periodically by your doctor. If the condition develops or worsens while you are using drospirenona/etinilestradiol, you should also inform your doctor

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency).
• 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 a higher risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without getting up (see section 2 “Blood Clots”).
• If you are at higher risk of blood clots after giving birth. You should ask your doctor when you can start taking aidrana after delivery.
• If you have superficial vein inflammation under the skin (thrombophlebitis) or varicose veins.
• If you have epilepsy (see “Use of Aidrana with Other Medications”).
• If you have some diseases that appeared for the first time during pregnancy or in a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)). If you have or have had any brownish-yellow patches (melasma), also called “pregnancy patches”, especially on the face. In this case, avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria, with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Consult your doctor or pharmacist before starting to takeaidrana.

Mental Disorders:

Some women who use hormonal contraceptives like aidrana have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood alterations and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

BLOOD CLOTS

The use of a combined hormonal contraceptive like aidrana increases your risk of suffering ablood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek Urgent Medical Assistanceif 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 veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot may form in a vein in another organ, such as the eye (retinal vein thrombosis).

When Is the Risk of a Blood Clot in a Vein Higher?

The risk of a blood clot in a vein is higher during the first year of using a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop taking aidrana, your risk of a blood clot returns to normal in a few weeks.

What Is the Risk of a Blood Clot?

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

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenona, such as drospirenona/etinilestradiol, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors That Increase Your Risk of a Blood Clot” below).

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

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

• If you are overweight (body mass index (BMI) of 30 kg/m2or higher).
• If 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). You may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without getting up due to an injury or illness, or if you have your leg immobilized. You may need to stop using aidrana for several weeks before surgery or while you have limited mobility. If you need to stop using aidrana, ask your doctor when you can start using it again.
• As you get older (especially over the age of about 35).
• If you have given birth recently.

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

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

It is essential to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you should stop using aidrana.

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

• With age (over the age of about 35).
• If you smoke.You are advised to quit smoking. If you are unable to quit smoking and are over 35, your doctor may recommend that you 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 (i.e., before the age of about 50). You may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm 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 a blood clot may be increased even further.

If any of the above conditions change while you are using aidrana, 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.

Drospirenona/Ethinylestradiol and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women using combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations, and you should consult your doctor if you notice any lump.

In rare cases, benign tumors in the liver and, more rarely, malignant tumors have been reported in users of combined hormonal contraceptives. Consult your doctor if you experience any unusual abdominal pain.

Bleeding Between Periods

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

What to Do If You Do Not Have a Period During Placebo Days

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

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

Use of Aidrana with Other Medications

Some medications

• may affect the levels of aidrana in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding

This may occur with

• medications used in the treatment of:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g. rifampicin)
• infections with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)

• herbal preparations of St. John's Wort

Drospirenona/ethinylestradiol mayinfluence the effectof other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat pain and/or muscle cramps)

Do Not Take Aidranaif you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver test results (elevated ALT levels).

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

Aidranacan be restarted approximately 2 weeks after the completion of this treatment. See the section"Do Not Take Aidrana").

Consult your doctor or pharmacist before using any medication

Use of Aidrana with Food and Drinks

Drospirenona/ethinylestradiol can be taken with or without food, and with a little water if necessary.

Laboratory Tests

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

Pregnancy and Breastfeeding

Pregnancy

If you are pregnant, you should not take aidrana. If you become pregnant while taking aidrana, stop taking it immediately and consult your doctor. If you want to become pregnant, you can stop taking aidrana at any time (see “If You Stop Taking Aidrana”).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

In general, it is not recommended to take aidrana during breastfeeding. If you want to take the contraceptive while breastfeeding, consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

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

Aidrana Contains Lactose

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

Each blister contains 24 active pink tablets and 4 white placebo tablets. The tablets ofaidranaof different colors are ordered. A blister contains 28 tablets.

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

Do not confuse the tablets: take a pink tablet for the first 24 days and then a white tablet for the last 4 days. After that, you must start another blister immediately (24 pink tablets and then 4 white tablets). There is no interval between two blisters.

Since the composition of the tablets is different, you must start the blister with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.

Preparation of the blister

To help you follow the taking order, each aidrana package contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with “WED”.

Stick the adhesive strip of the week on the top of the aidrana blister, where it is indicated “Stick the adhesive strip here!”, so that the first day is placed above the tablet marked with “1”.

Now you will have a day marked above each tablet and you can check visually if you have taken your tablet. The arrows indicate the taking order of the tablets.

During the 4 days when you take the placebo tablets (the placebo days), you should have menstruation (the so-called withdrawal bleeding). Usually it starts on the 2nd or 3rd day after taking the last active pink tablet of aidrana. After taking the last white tablet, start the next blister, even if menstruation has not finished. This means that you must start the next blister on the same day of the week that you started the previous one and menstruation by withdrawal should take place during the same days every month.

Since the composition of the tablets is different, you must start the blister with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.

When to start with the first blister

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

Start taking aidrana on the first day of the cycle (i.e. the first day of your menstruation). If you start aidrana on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2–5 of the cycle, but in that case you must use additional contraceptive methods (e.g. a condom) during the first 7 days.

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

You can start taking aidrana preferably on the day after taking the last active tablet (the last tablet containing active principles) of your previous contraceptive, but no later than the day after the days without tablets (or after the last inactive tablet) of your previous contraceptive. When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

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

You can switch from progestin-only pills on any day. If it is an implant or an IUS, on the same day of its removal; if it is an injectable, on the day of the next injection. In all cases, it is recommended to use additional contraceptive methods (e.g. a condom) during the first 7 days of taking tablets.

• After an abortion

Follow your doctor's recommendations.

• After having a child

After having a child, you can start taking aidrana between 21 and 28 days. If you start later, you must use one of the barrier methods (e.g. a condom) during the first 7 days of aidrana use.

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

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

Read the section “Breastfeeding”.

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

If you take moreaidranathan you should

No serious cases of overdose of aidrana have been reported.

If you take many tablets at once, you may feel unwell, vomit or have vaginal bleeding.

This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

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

If you forgot to takeaidrana

The last 4 tablets of the 4th row of the blister are placebo tablets. If you forgot to take one of these tablets, there is no loss of aidrana's contraceptive effect. You must discard the forgotten placebo tablet.

If you forgot to take an active pink tablet (tablets 1–24 of the blister), follow these guidelines:

• If you are lateless than 24 hoursin taking some tablets, there is no decrease in protection against pregnancy. Take the tablet as soon as you remember and the subsequent tablets at the usual time.

• If you are latemore than 24 hoursin taking some tablets, there may be a decrease in protection against pregnancy. The greater the number of tablets you have forgotten, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is maximum if you forget to take a pink tablet at the beginning or end of the blister. The following recommendations should be followed in this situation (see also the diagram below):

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet duringdays 1–7 (first row)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time and useadditional precautions, for example, condoms, during the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In that 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 once. Continue taking the subsequent tablets at the usual time. There is no decrease in protection against pregnancy and you do not need to take additional precautions.

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

You can choose between two options:

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

Probably, you will have bleeding at the end of the second blister – during the taking of the second blister – although you may experience spotting or bleeding similar to menstruation during the taking of the second blister.

1. You can also interrupt the taking of active pink tablets and pass directly to the 4 white placebo tablets (before taking the placebo tablets, note the day you forgot to take your tablet). If you want to start a new blister on your scheduled start day, take the placebo tablets forless than 4 days.

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

If you have forgotten to take a tablet from a blister and you do not have menstruation during the placebo days, this may mean that you are pregnant. In this case, you should consult your doctor before continuing with the next blister.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3–4 hours after taking an active pink tablet or if you have intense diarrhea, there is a risk that the active principles of the tablet will not be fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you should take a pink tablet from a reserve package as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If this is not possible or more than 24 hours have passed, follow the guidelines in the section “If you forgot to take aidrana”.

Delay of menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period if you do not take the white placebo tablets of the 4th row and start taking aidrana tablets until the end of this new blister. You may experience spotting (drops or spots of blood) or bleeding similar to menstruation during the use of the second blister. After finishing this second blister taking the 4 white placebo tablets, start the next blister.

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

Change of first day of menstrual period: what you should know

If you take the tablets according to the instructions, your menstrual period will startduring the placebo days. If you need to change this day, you can do so by reducing theplacebo days(the days when you take the white placebo tablets) – but never extending – 4 days is the maximum! For example, if you start the placebo days on a Friday and want to change it to a Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. It is possible that there will be no bleeding during these placebo days. Then you may experience spotting or bleeding similar to menstruation.

If you are not sure how to proceed, consult your doctor.

If you interrupt the treatment withaidrana

You can stop taking aidrana whenever you want. If you do not want to get pregnant, consult your doctor about other effective methods of birth control. If you want to get pregnant, stop taking aidrana and wait until your menstrual period before trying to get pregnant. This way you can calculate your estimated due date more easily.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related toaidrana, consult your doctor.

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

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before starting to takeaidrana."

The following describes side effects related to the use ofaidrana:

Frequent side effects: can affect up to 1 in 10 people

• Mood changes
• Headaches
• Nausea
• Mammary pain, problems with periods such as irregular periods, absence of periods

Less frequent side effects: can affect up to 1 in 100 people

• Depression, nervousness, drowsiness
• Dizziness, tingling and pins and needles
• Migraine, varicose veins, increased blood pressure
• Abdominal pain, vomiting, indigestion, gas, intestinal inflammation, diarrhea
• Acne, itching, skin rash
• Discomfort and pain, such as back pain, limb pain, muscle cramps
• Vaginal yeast infection, lower abdominal pain (pelvic), breast enlargement, benign breast lumps, uterine/vaginal bleeding (usually resolves during treatment), vaginal discharge, hot flashes, 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 side effects: can affect up to 1 in 1,000 people

• Candida (a fungal infection)
• Anemia, increased platelet count in the blood
• Allergic reaction
• Endocrine disorder
• Increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood
• Lack of orgasm, insomnia
• Dizziness, tremors
• Eye disorders, such as eyelid inflammation, dry eyes
• Unusually fast heart rate
• Vein inflammation, nasal bleeding, fainting
• Abdominal enlargement, intestinal disorder, feeling of flatulence, gastric hernia, fungal infection of the mouth, constipation, dry mouth
• Biliary duct pain or gallbladder, inflammation of the gallbladder
• Brownish-yellow skin spots, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, skin tension marks, skin inflammation, skin inflammation due to photosensitivity, skin nodules
• Difficult or painful sex, vaginal inflammation (vulvovaginitis), post-coital bleeding, amenorrhea, breast cysts, breast enlargement, abnormal cell growth in the breast tissue, malignant breast lumps, abnormal surface mucosa growth of the cervix, cervical atrophy or loss of the uterine lining, fluid-filled sacs in an ovary, uterine enlargement
• Malaise
• Weight loss
• Deleterious blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild or transient stroke-like symptoms, known as transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye

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

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with circular red patches or ulcers).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

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

Do not store at a temperature above 30 °C.

Do not dispose of medications through drains or trash.Depositunused packaging and medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of aidrana

• The active principlesaredrospirenone and ethinylestradiol.

Each film-coated tablet of color pink contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.

The film-coated tablets of color white do not contain active principle.

• The othercomponentsare:

Film-coated active tablets of color pink

Core of the tablet:lactose monohydrate, potassium polacrilex, povidone K-30, magnesium stearate.

Coating of the tablet film:macrogol 3350,titania dioxide (E171), poly (vinyl alcohol), talc, iron oxide red (E172) and iron oxide yellow (E172).

Film-coated inactive white tablets:

Core of the tablet:lactose monohydrate, potassium polacrilex, povidone K-30, magnesium stearate, anhydrous colloidal silica

Coating of the tablet film:macrogol 3350, titania dioxide (E171), poly (vinyl alcohol), talc.

Appearance of the product and contents of the package

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

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

• The active tablet is cylindrical with a diameter of approximately 6 mm, biconvex and of pink color.

• The placebo tablet is cylindrical with a diameter of approximately 6 mm, biconvex and of white color.

Aidrana is available in packages of 1 and 3 blisters, each containing 28 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cyndea Pharma, S.L.

Emiliano Revilla Industrial Estate

Av. De Ágreda 31

42110 Ólvega (Soria)- Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:july 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information about this medicine by scanning with your 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