DROSBELALLEFLEX 3 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Drosbelalleflex 3mg /0.02mg Film-Coated Tablets

Drospirenone / Ethinylestradiol

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

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

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
• Please be alert and consult your doctor if you think you might have symptoms of a blood clot (see section 2, «Blood clots»)

Contents of the package leaflet

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

1. What is Drosbelalleflex and what is it used for

• Drosbelalleflex is a contraceptive pill used to prevent pregnancy.
• Each of the 24 tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Drosbelalleflex

Do not take Drosbelalleflex:

You should not use Drosbelalleflex if you have any of the following conditions. If you have any of the following conditions, you should inform your doctor. Your doctor will tell you which alternative contraceptive method would be most suitable for you.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• If you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If you need surgery or will be unable to walk for a long time (see section "Blood clots");
• If you have (or have had in the past) a heart attack or stroke;
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke-like symptoms);
• If you have any of the following diseases, which may increase the 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 disease known as hyperhomocysteinemia
• If you have (or have had in the past) 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 yet returned to normal;
• If your kidneys do not work well (renal insufficiency);
• If you have (or have had in the past) a tumor in the liver;
• If you have (or have had in the past) or are suspected to have breast cancer or cancer of the genital organs;
• If you have vaginal bleeding of unknown cause;
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (listed in section 6). This may be manifested by itching, rash, or swelling.
• Do not take Drosbelalleflex if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Using Drosbelalleflex with other medicines").

Additional information on special populations

Children and adolescents

Drosbelalleflex is not indicated for use after menopause.

Women of advanced age

Drosbelalleflex is not indicated for use after menopause.

Women with liver insufficiency

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

Women with renal insufficiency

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

Warnings and precautions

Tell your doctor if you have any of these conditions.

• In some situations, you will need to be particularly careful while using Drosbelalleflex or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically.

You should also inform your doctor if the condition develops or worsens while you are using Drosbelalleflex, if a close relative has or has had breast cancer;

• if you have any liver or gallbladder disease;
• if you are diabetic;
• if you suffer from depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects the natural defense system);
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this disorder. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you need surgery or will be unable to walk for a long time (see section 2 "Blood clots");
• if you have just given birth, you have a higher risk of developing blood clots. You should ask your doctor how long after giving birth you can start taking Drosbelalleflex;
• If you have inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see section "Other medicines and Drosbelalleflex")
• if you have a disease that has appeared for the first time during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationalis), a nervous disease that causes spasmodic movements of the body (Sydenham's chorea);
• if you have or have had brownish discolorations (chloasma), also known as "pregnancy spots", especially on the face. In this case, avoid direct exposure to the sun or ultraviolet rays;
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives like Drosbelalleflex increases the risk of developing blood clots compared to not taking them. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

• 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. In rare cases, they can cause long-term effects or, very rarely, be fatal.

It is important to note that the overall risk of a harmful blood clot caused by Drosbelalleflex is low.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• Taking combined hormonal contraceptives has been linked to an increased risk of blood clots in veins (venous thrombosis). However, these side effects are rare. More often, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a blood clot can form in a vein in 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 highest during the first year after starting to take a combined hormonal contraceptive for the first time. The risk may also be higher after restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than when not using combined hormonal contraceptives.

When you stop using Drosbelalleflex, the risk of having a blood clot decreases to normal levels within a few weeks.

What is the risk of developing a blood clot?

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

The overall risk of having a blood clot in the leg or lung (DVT or PE) with Drosbelalleflex is low.

• Out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant, about 2 may have a blood clot in a year.
• Out of 10,000 women who take combined hormonal contraceptives that contain levonorgestrel, norethisterone, or norgestimate, between 5 and 7 may have a blood clot in a year.
• Out of 10,000 women who take combined hormonal contraceptives that contain drospirenone, such as Drosbelalleflex, between 9 and 12 may have a blood clot in a year.
• The risk of blood clot varies according to your personal medical history (see "Factors that increase the risk of blood clot" below)

Factors that increase the risk of blood clot in a vein

The risk of blood clot with Drosbelalleflex is low, but some conditions increase the risk. The risk increases:

• if you are overweight (body mass index or BMI over 30 kg/m²);
• if any of your close relatives have had a blood clot in the leg, lung, or any other organ at a young age (e.g., before the age of 50). If so, you may have a hereditary disorder of blood clotting;
• if you need surgery or will be unable to walk for a long time due to injury or illness, or have your leg in a cast. You may need to stop taking Drosbelalleflex for several weeks before surgery or while you have reduced mobility. If you need to stop taking Drosbelalleflex, ask your doctor when you can restart taking it.
• with age (especially above approximately 35 years);
• if you have recently given birth;

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

Long-distance flights (more than 4 hours) may temporarily increase the risk of blood clots, especially if you already have any of the above conditions.

It is essential that you inform your doctor if you meet any of these conditions, even if you are unsure. Your doctor may decide to stop you from taking Drosbelalleflex

If any of these conditions change while you are taking Drosbelalleflex, e.g., if a close relative suffers a thrombosis for unknown reasons or if you gain much 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 the risk of blood clot in an artery

It is essential to note that the risk of heart attack or stroke due to taking Drosbelalleflex is very low but may increase:

• with age (from approximately 35 years onwards);
• if you smoke.When taking a combined hormonal contraceptive like Drosbelalleflex, you are advised to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraception;
• 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 (before the age of 50). In this case, you may also have a higher 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 suffer from migraines, especially migraines with aura;
• if you have heart problems (valve disorders, heart rhythm disturbances known as atrial fibrillation);
• if you have diabetes.

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

If any of these conditions change while you are taking Drosbelalleflex, e.g., if you start smoking, a close relative suffers a thrombosis for unknown reasons, or if you gain much weight, inform your doctor.

Drosbelalleflex and cancer

There have been reports of breast cancer with a slightly higher frequency in women using combined pills, but it is not known if the cause is the treatment. For example, it may be that more tumors are detected in women using combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential that you have your breasts checked regularly and contact your doctor if you notice any lump.

In rare cases, benign liver tumors, and more rarely, malignant liver tumors have been reported in users of hormonal contraceptives. Consult your doctor if you suffer from

An unusually strong abdominal pain.

Psychiatric disorders

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

Intermenstrual bleeding

During the first few months you are taking Drosbelalleflex, you may have unexpected bleeding (bleeding outside of the pill-free interval). If this bleeding persists after a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the 4-day pill-free interval

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

In the event that the expected bleeding does not occur twice in a row, you might be pregnant. See your doctor immediately.

If you are receiving treatment with Drosbelalleflex to delay your periods, withdrawal bleeding normally does not occur every 4 weeks but with a reduced frequency, with intervals of up to 120 days. An unexpected pregnancy may be difficult to recognize. If for any reason you think you might be pregnant, you should have a pregnancy test. If the result is positive, or you still have doubts, contact your doctor.

Do not start with the next strip until you are sure you are not pregnant.

Children and adolescents

Drosbelalleflex is only indicated after menarche.

Other medications and Drosbelalleflex

Some medications:

• may affect Drosbelalleflex blood levels
• may make Drosbelalleflex less effective in preventing pregnancy
• may cause unexpected bleeding.

These include:

• medications used to treat:

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

• and St. John's Wort herbal preparations

Drosbelalleflex may affect the efficacy of other medications, for example:

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

Do not take Drosbelalleflex if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in blood parameters that measure liver function (increase in liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications. Drosbelalleflex can be taken again approximately 2 weeks after the end of this treatment. See section “Do not use Drosbelalleflex”

Consult your doctor or pharmacist before using any medication.

Taking Drosbelalleflex with food and drinks

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

Lab tests

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

Pregnancy

If you are pregnant, you should not take Drosbelalleflex. If you become pregnant while taking Drosbelalleflex, you should stop treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking Drosbelalleflex at any time (see also “If you stop taking Drosbelalleflex”).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

In general, it is not recommended to take Drosbelalleflex during breastfeeding. If you want to take contraceptives while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Drosbelalleflex contains lactose and sodium.

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

This medication contains less than 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

3. How to take Drosbelalleflex

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Each strip contains 24 tablets.

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

Tablet intake

Mandatory phase (day 1 to day 24)

Start with the tablet marked with the day of the week that applies. When starting Drosbelalleflex, the tablets must be taken uninterruptedly for a minimum of 24 days, after which you can:

• stop taking tablets during a 4-day interval, during which your menstrual period will begin,
• or continue taking the tablets up to a maximum of 120 days (see the flexible phase), which will delay the start of your period.

Flexible phase (day 25 to day 120)

Between days 25 and 120, the tablets can be taken uninterruptedly for a maximum of 120 days (at which point all the strips included in this package will have been finished). Within this period, you can decide whether you want to delay your period or start the 4-day interval without tablets.

If you have decided to continue taking the tablets for 120 days, go directly to the 4 days without tablets, completing the 120 days of tablet intake.

Your period will begin during the 4-day interval without tablets. Normally, this will cause bleeding.

If continuous bleeding (three consecutive days) occurs during the flexible phase (days 25-120), it is recommended to start a 4-day interval without tablets, which will induce the period. This 4-day interval without tablets will reduce the total number of days with bleeding.

Interval without tablets

The interval without tablets should never exceed 4 days in duration and should only be started if the tablets have been taken uninterruptedly for 24 days.

During the 4-day interval without tablets, bleeding usually occurs and may not have finished before starting the next cycle of tablets.

After each 4-day interval without tablets, a new cycle of tablet intake begins, with a minimum duration of 24 days and a maximum of 120 days. After the mandatory phase of 24 days of uninterrupted tablet intake, you can decide whether or not to start a 4-day interval without tablets between days 25 and 120.

It is recommended to start a new strip, which contains 24 tablets, for each mandatory phase and after a 4-day interval without tablets, to facilitate correct administration of the product.

General dosing rules:

• A 4-day interval without tablets can only be started if the tablets have been taken uninterruptedly for a minimum of 24 days, i.e., after completing the mandatory phase.
• After a 4-day interval without tablets, a new mandatory phase will begin, so the tablets must be taken uninterruptedly for a minimum of 24 days before a new interruption can be scheduled.

Preparation of the blister strips

To keep track of daily intake of the contraceptive, each package of Drosbelalleflex includes 35 (5x7) adhesive strips with the days of the week printed on them. You must know the day of the week on which you will take the first tablet.

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".

Then, you need to stick the weekly strip on the top of the blister strip, where it says "Place the label here". Now you will have a day marked above each tablet and you can visually check if you have taken the tablet. The arrows indicate the order of tablet intake.

If you use Drosbelalleflex in this way, you are also protected against pregnancy during the 4 days when you do not take tablets.

If you have unfinished blister strips, you can take the remaining tablets during the flexible phase. Choose a new weekly strip with the day of the week on which you start taking the remaining tablets and place it on top of the first remaining tablet you will take. Stick the new weekly strip on top of the previous one. See Preparation of the blister strips.

The new package should be prescribed with sufficient notice, i.e., before using the last strip of the package, to ensure that you do not run out of tablet supplies.

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

When can you start with the first blister strip?

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

Start taking Drosbelalleflex on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosbelalleflex on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of your 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 Drosbelalleflex preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, and at the latest the day after the tablet-free days (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 pill, injection, implant, or intrauterine system (IUS) of progestin)

You can switch from the progestin-only pill at any time. If it's an implant or an IUS, on the same day of its removal; if it's an injectable, when the next injection is due. In all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After an abortion

Follow your doctor's recommendations.

• After having a baby

You can start taking Drosbelalleflex between 21 and 28 days after giving birth. If you start more than 28 days after, you must use one of the barrier methods (e.g., condoms) during the first 7 days of using Drosbelalleflex.

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

• If you are breastfeeding and want to start taking Drosbelalleflex (again) after having a baby

Read the section "Breastfeeding".

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

If you take more Drosbelalleflex than you should

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

If you take several tablets at once, you may feel unwell or have vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication. If you have taken too many Drosbelalleflex tablets, or if a child has taken them, consult your doctor or pharmacist. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Drosbelalleflex

If you forget a tablet (one of the 24 tablets of the strip), you should do the following:

• If less than 24 hourshave passed since you took a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets at the usual time.
• If more than 24 hourshave passed since you took a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

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

• Forgetfulness of more than one tablet from the blister pack

Consult your doctor.

• Forgetfulness of a tablet during days 1-7

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

• Forgetfulness of a tablet during days 8-14

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

• Forgetfulness of a tablet during days 15-24

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the following tablets at the usual time until you finish the 24 tablets. Avoid the 4-day interval without tablets and start a new blister pack (the start day will be different from the previous one).

You will likely have your period at the end of the second blister pack (during the 4-day interval without tablets), although you may experience spotting or bleeding during the intake of the second blister pack.

1. You can also stop taking the tablets and go directly to the 4-day interval without tablets (before starting this interval without tablets, note the day on which you forgot to take the tablet).If you want to start a new blister pack on the same day as you normally do, reduce the interval without tablets to less than 4days.

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

• Forgetfulness of a tablet during days 25-120

You can choose between the following options, without needing to take additional contraceptive precautions.

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time, and take the following tablets at the usual time until you have taken at least 7 tablets without interruption.
2. Stop taking the tablets, start a 4-day interval without tablets (counting the day you forgot to take the tablet), and then start a new cycle of Drosbelalleflex intake.
   • If you have forgotten to take any tablets from a strip and do not have your period during the 4-day interval without tablets, this may mean that you are pregnant. In this case, you must consult your doctor before continuing with the next blister pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a tablet or if you have severe diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed by your body. It is similar to what happens when you forget to take a tablet. After vomiting or diarrhea, you should take a tablet from a reserve blister pack as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If it is not possible or more than 24 hours have passed, follow the advice in the section "If you forget to take Drosbelalleflex".

If you interrupt treatment with Drosbelalleflex

You can stop taking Drosbelalleflex at any time. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, it is advisable to stop taking Drosbelalleflex and wait until your menstruation before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

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

4. Possible Adverse Effects

Like all medicines, Drosbelalleflex can cause adverse effects, although not all people suffer from them.

If you experience any adverse effect, especially if it is severe and persistent, or if you feel any change in your health that you think may be caused by Drosbelalleflex, consult your doctor.

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

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 "Warnings and Precautions" section)

The following adverse effects related to the use of Drosbelalleflex are described:

• Frequent Adverse Effects(affect 1 to 10 users out of 100):
• • mood changes
  • headache
  • nausea
  • breast pain, menstrual problems such as irregular periods, absence of menstruation
  • emotional lability, depression, decreased libido

• Uncommon Adverse Effects(affect 1 to 10 users out of 1,000):
• • depression, nervousness, somnolence
  • dizziness, tingling
  • migraine, varicose veins, increased blood pressure
  • stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea
  • acne, itching, skin rash
  • discomfort and pain, such as back pain, pain in the limbs, muscle cramps
  • vaginal yeast infection, pain in the lower abdominal region (pelvic), breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful menstruation, shorter menstruation, heavy menstruation, vaginal dryness, abnormal vaginal cytology, loss of interest in sex
  • lack of energy, increased sweating, fluid retention
  • weight gain

Depression, decreased sexual interest, and migraines are frequent adverse effects associated with the use of Drosbelalleflex in a flexible regimen of up to 120 days.

• Rare Adverse Effects(affect 1 to 10 users out of 10,000):
• • candidiasis (a fungal infection)
  • anemia, increased platelet count in the blood
  • allergic reaction
  • hormonal disorder (endocrine)
  • increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood
  • absence of orgasm, insomnia
  • vertigo, tremors
  • eye disorders, such as eyelid inflammation, dry eyes
  • abnormally fast heartbeat
  • vein inflammation, nosebleeds, fainting
  • abdominal enlargement, intestinal disorder, feeling of flatulence, stomach hernia, oral thrush, constipation, dry mouth
  • bile duct or gallbladder pain, gallbladder inflammation
  • brownish-yellow 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, skin inflammation due to photosensitivity, skin nodules
  • difficult or painful intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, withdrawal bleeding, breast cysts, breast cell growth (hyperplasia), malignant breast lumps, abnormal growth of the uterine cervix mucous membrane, uterine shrinkage or loss of lining, ovarian cysts, uterine enlargement
  • general 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)
    • myocardial infarction
    • stroke
    • mini-stroke or temporary symptoms similar to a stroke, known as a transient ischemic attack (TIA)
    • blood clots in the liver, stomach/intestine, kidneys, or eyes

The likelihood of suffering a blood clot may increase if you have a disorder that increases the risk (see section 2 for more information on disorders 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 (skin rash with redness and blisters in a target-like pattern).

Reporting Adverse Effects:

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

5. Storage of Drosbelalleflex

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

Store below 30°C.

Do not use this medicine after the expiration date that appears on the strip and on the cardboard box after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste.

Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Drosbelalleflex

• The active ingredients are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, povidone (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the Product and Package Contents

• Each strip of Drosbelalleflex contains 24 film-coated tablets
• Drosbelalleflex is available in boxes of 5 blister strips; each box contains 120 tablets in total.
• Each Drosbelalleflex package includes 35 (5 x 7) adhesive stickers with the days of the week printed on them.

Marketing Authorization Holder

Exeltis Healthcare S.L

Avda. de Miralcampo 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. (Guadalajara)

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina, s/n,

Polígono Industrial Navatejera,

Villaquilambre 24193 (León),

Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Netherlands: Talia 0.02 mg/3 mg film-coated tablets

Germany: Drosbelalleflex Langzyklus 0.02 mg/3 mg film-coated tablets

Austria: Drosbelalleflex Langzyklus 0.02 mg/3 mg film-coated tablets

Belgium: Pernyella 0.02 mg/3 mg film-coated tablets

Estonia: Talia

Spain: Drosbelalleflex 0.02 mg/3 mg film-coated tablets

Finland: Diza 0.02 mg/3 mg film-coated tablets

France: Pernyella 0.02 mg/3 mg film-coated tablets

Italy: Perliq

Hungary: Jangee flexibilis 3 mg/0.02 mg

Latvia: Talia 0.02 mg/3 mg film-coated tablets

Luxembourg: Pernyella 0.02 mg/3 mg film-coated tablets

Poland: Naraya Flex

Portugal: Drosbelalleflex 0.02 mg/3 mg film-coated tablets

Sweden: Diza

Date of the last revision of this prospectus: November 2024

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