Patient Information Leaflet

Drosbelalleflex 3mg /0.02mg Film-Coated Tablets

Drospirenone/Ethinylestradiol

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 CHC after a pause of 4 or more weeks
• Please be aware and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section2, «Blood Clots»)

1. What is Drosbelalleflex and what it is used for

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

3. How to take Drosbelalleflex

4. Possible side effects

5. Storage of Drosbelalleflex

6. Contents of the pack and additional information

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

Do not take Drosbelalleflex:

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

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), a blood clot in the lungs (pulmonary embolism, PE), or other organs;
• If you know that you have a condition 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 are not able to stand for long periods (see section "Blood Clots");
• If you have (or have ever had) a heart attack or stroke;
• If you have (or have ever had) angina pectoris (a condition that causes intense 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, which may increase the risk of developing a blood clot in the arteries:
• • severe diabetes with damage to blood vessels
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a known disease called hyperhomocysteinemia
• If you have (or have ever had) a type of migraine called "migraine with aura";
• If you have (or have ever had) a liver disease and your liver function has not yet normalized;
• If your kidneys do not function well (renal insufficiency);
• If you have (or have ever had) a liver tumor;
• If you have (or have ever had) or are suspected of having breast cancer or cancer of the reproductive organs;
• If you have unexplained vaginal bleeding;
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medication (including in section 6). This may manifest as itching, skin rash, or swelling.
• Do not take Drosbelalleflex 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 Drosbelalleflex with other medications").

Additional information on special populations

Children and adolescents

Drosbelalleflex is not indicated for use after menopause.

Women in 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 dysfunction or acute renal failure. See sections "Do not use Drosbelalleflex" and "Warnings and precautions".

Warnings and precautions

Inform your doctor if you have any of these conditions.

• In some situations, you should take special care while using Drosbelalleflex or any other combined hormonal contraceptive, and your doctor may need 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 disease or gallbladder disease;
• If you are diabetic;
• If you suffer from depression;
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• 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 coagulation that causes renal 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 a positive family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• If you need surgery or are not able to stand for long periods (see section 2 "Blood Clots");
• If you have recently given birth, you have a higher risk of developing blood clots. Ask your doctor how long you can start taking Drosbelalleflex after giving birth;
• If you have superficial thrombophlebitis;
• If you have varicose veins;
• If you have epilepsy (see the section "Other medications 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, skin rash with blisters during pregnancy (herpes gestational), a nervous disorder that causes spasmodic movements of the body (Sydenham's chorea);
• If you have or have ever had brownish-yellow patches (chloasma), also known as "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.

BLOOD CLOTS

The use of 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 "deep vein thrombosis", "thromboembolism", or DVT)
• in arteries (known as "arterial thrombosis", "thromboembolism", or TEA)

The recovery from blood clots is not always complete. In rare cases, chronic effects or, very rarely, fatal effects may occur.

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

HOW TO RECOGNIZE A BLOOD CLOT

Solicite atención médica urgenteif 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?

• It has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. More frequently, they occur during the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause a deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lungs, it can cause a pulmonary embolism (PE).
• Rarely, a blood clot can 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 highest during the first year after starting a combined hormonal contraceptive for the first time. The risk may also be higher after restarting a combined hormonal contraceptive (the same or another product) after a pause of 4 weeks or more.

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

After stopping Drosbelalleflex, the risk of developing 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 TEV and the type of combined hormonal contraceptives taken.

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

• Of 10,000 women who do not take combined hormonal contraceptives and are not pregnant, about 2 may develop a blood clot in a year.
• Of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, noretisterone, or norgestimato, between 5 and 7 may develop a blood clot in a year.
• Of 10,000 women taking combined hormonal contraceptives containing drospirenone like Drosbelalleflex, between 9 and 12 may develop a blood clot in a year.
• The risk of blood clot varies depending on 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 (BMI) above 30 kg/m²);
• if any of your close relatives have had a blood clot in the leg, lungs, or any other organ at a young age (before the age of 50). If this is the case, you may have an inherited disorder of coagulation;
• if you need surgery or are unable to stand for long periods due to an injury or disease, or have your leg immobilized. You may need to interrupt taking Drosbelalleflex for several weeks before surgery or while you have reduced mobility. If you need to interrupt taking Drosbelalleflex, ask your doctor to tell you when you can start taking it again.
• with age (especially from around 35 years old);
• if you have recently given birth;

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

Long flights (over 4 hours) may temporarily increase the risk of blood clot, especially if you already have one of the above factors.

It is essential to inform your doctor if you meet any of these criteria, even if you are unsure. Your doctor may decide to interrupt taking Drosbelalleflex.

If any of these criteria change while taking Drosbelalleflex, for example, if a close relative develops a blood clot for unknown reasons, or if 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 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 around 35 years old);
• if you are a smoker. When taking a combined hormonal contraceptive like Drosbelalleflex, you are advised to quit smoking. If you cannot quit 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 an increased risk of heart attack or stroke;
• if you 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, abnormal heart rhythm known as atrial fibrillation);
• if you are diabetic.

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 criteria change while taking Drosbelalleflex, for example, if you start smoking, a close relative develops a blood clot for unknown reasons, or if you gain a lot of weight, inform your doctor.

Drosbelalleflex and cancer

Cases of breast cancer have been observed with a slightly higher frequency in women using combined hormonal contraceptives, but it is unknown whether the treatment is the cause. For example, it may be that more tumors are detected in women using 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 regularly examine your breasts and to contact your doctor if you notice any lump.

In rare cases, benign tumors in the liver and, more rarely, malignant tumors in users of contraceptives have been reported. If you experience unusual abdominal pain, consult your doctor.

Mental health 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.

Spotting between periods

During the first few months of taking Drosbelalleflex, you may experience unexpected bleeding (bleeding outside the 4-day 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 had severe vomiting or diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

However, if the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately.

If you receive treatment with Drosbelalleflex to delay your periods, you will usually not experience withdrawal bleeding every 4 weeks but with a reduced frequency, with intervals of up to 120 days. An unexpected pregnancy may be difficult to recognize. If you suspect you may be pregnant for any reason, you should have a pregnancy test. If the result is positive, or if you are still unsure, contact your doctor.

Do not start the next pack 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 the blood levels of Drosbelalleflex

- may make this less effective in preventing pregnancy

- may cause unexpected bleeding.

Examples include:

• medications used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (e.g., rifampicin)
• VIH and hepatitis C infections (inhibitors of protease and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapina, efivarenz)
• fungal infections (griseofulvina, ketoconazol)
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the pulmonary vessels (bosentán)

• and herbal preparations of St. John's Wort

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

• medications containing ciclosporina
• the antiepileptic lamotrigina (may lead to an increase in seizure frequency)
• 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 that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated 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 completing 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.

Blood tests

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

Pregnancy

If you are pregnant, do not take Drosbelalleflex. If you become pregnant while taking Drosbelalleflex, stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosbelalleflex at any time (see also "If you interrupt treatment with Drosbelalleflex").

Consult your doctor or pharmacist before using any medication.

Lactation

In general, it is not recommended to take Drosbelalleflex during the lactation period. If you want to take contraceptives 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 Drosbelalleflex has any effect on your ability to drive or operate 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 (1 mmol) per tablet; this is, essentially "sodium-free".

Follow the exact administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Each strip contains 24tablets.

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 at approximately the same time every day.

Tablet-taking

General dosing rules:

• Only a 4day interval without tablets can be initiated if the tablets have been taken uninterruptedly for a minimum of 24days, i.e. after completing the compulsory phase.
• After a 4day interval without tablets, a new compulsory phase will begin, so the tablets must be taken uninterruptedly for a minimum of 24days before a new interruption can be programmed.

Preparation of the strips in the blister

To keep track of daily tablet-taking, 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 for the week that starts with the day on which you will take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with «MIE».

Next, you must stick the weekly strip to 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 will be able to check visually if you have taken the tablet. The arrows indicate the order in which the tablets should be taken.

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

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

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

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

When can you start with the first strip in the blister?

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

Start taking Drosbelalleflex on the first day of the cycle (i.e. the first day of your menstruation). If you start Drosbelalleflex on the first day of your menstruation, you will be protected immediately against pregnancy. You can also start on days2-5 of the cycle, but in that case you must use additional contraceptive methods (e.g. a condom) during the first 7days.

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

You can start taking Drosbelalleflex preferably on the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, and at the latest on 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 method based exclusively on progestogens (progestogen-only pill, injection, implant or progestogen-releasing intrauterine system (PPIUS))

You can switch from the progestogen-only pill on any day. If it is an implant or a PPIUS, on the same day as its removal; if it is an injection, 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 7days of tablet-taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

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

If, after having a child, you have already had sexual relations, before starting to take Drosbelalleflex, you must be sure 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

See the section «Breastfeeding».

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

If you take more Drosbelalleflex than you should

No serious cases of overdose of Drosbelalleflex have been reported.

If you take several tablets at once, you may feel unwell, have vomiting or 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 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 24tablets in the strip), do the following:

• If more than 24 hours have passed since you took a tablet, the protection against pregnancy may be reduced. The more 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 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 during days 1-7

Take the forgotten tablet as soon as you remember it, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time and useadditional contraceptive precautionsfor the next 7days, e.g. condoms. If you have had sexual relations 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

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

• Forgetting a tablet during days 15-24

You can choose between two options, without needing to take additional precautions:

2.Leaveoff taking the tablets, initiate a 4day interval without tablets (counting the day you forgot to take the tablet) and start a new cycle of Drosbelalleflex tablet-taking.

• If you have forgotten to take a tablet from a strip and do not have your period during the 4day interval without tablets, this may mean you are pregnant. In that case, you should see your doctor before continuing with the next blister.

What to do in case of vomiting or intense diarrhea

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

If you interrupt treatment with Drosbelalleflex

You can stop taking Drosbelalleflex whenever you want. 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 recommended that you stop taking Drosbelalleflex and wait until your menstruation before trying to become pregnant. This way, you will be able to calculate your estimated delivery date more easily.

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

Like all medications, Drosbelalleflex may 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 notice 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 section2 "What you need to know before starting Drosbelalleflex".

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 (also see section "Warnings and precautions")

The following are side effects related to the use of Drosbelalleflex:

• Frequent side effects(affect between 1 and 10users out of every 100):
• • Mood changes
  • Headache
  • Nausea
  • Mammary pain, menstrual problems such as irregular periods, absence of menstruation
  • Emotional lability, depression, decreased libido

• Infrequent side effects(affect between 1 and 10 users out of every 1,000):
• • Depression, nervousness, drowsiness
  • Dizziness,tingling
  • Migraine, varicose veins, increased blood pressure
  • Abdominal pain, vomiting, indigestion, gas, intestinal inflammation, diarrhea
  • Acne, itching, skin rash
  • Muscle and joint pain, such as back pain, limb pain, muscle cramps
  • Vaginal yeast infection, lower abdominal pain (pelvic), breast enlargement, benign breast lumps, uterine or vaginal bleeding (usually resolves during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful menstruation, shorter or heavier periods, vaginal dryness, abnormal vaginal cytology, loss of interest in sex
  • Lack of energy, increased sweating, fluid retention
  • Weight gain

Depression, decreased libido, and migrainesare frequent side effects associated with the use of Drosbelalleflex in a flexible regimen of up to 120days.

• Rare side effects(affect between 1 and 10 users out of every 10,000):
• • Candidiasis (a fungal infection)
  • Anemia, increased platelet count in the blood
  • Allergic reaction
  • Endocrine disorder
  • Increased appetite, loss of appetite, abnormally elevated 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
  • Abnormally fast heart rate
  • Vein inflammation, nasal bleeding, fainting
  • Abdominal enlargement, intestinal disorder, feeling of flatulence, hernia of the stomach, fungal infection of the mouth, constipation, dry mouth
  • Biliary tract or gallbladder pain, inflammation of the gallbladder
  • Brownish-yellow skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, skin marks, skin inflammation, skin inflammation due to photosensitivity, skin nodules
  • Difficult or painful sex, vaginal inflammation (vulvovaginitis), post-coital bleeding, menstrual bleeding, breast cysts, breast enlargement, benign breast lumps, abnormal cell growth on the surface of the cervix, cervical stenosis or loss of cervical mucus, ovarian cysts, uterine enlargement
  • General malaise
  • Weight loss
  • Life-threatening 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
    • Cerebral stroke
    • Transient ischemic attack (TIA) or symptoms similar to a stroke
    • Blood clots in the liver, stomach/intestine, kidneys, or eyes.

The likelihood of experiencing a blood clot may increase if you have a condition that increases the risk (see section2 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 redness and blisters in a butterfly shape).

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the strip and on the cardboard box after «CAD».The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.

Depositthe packaging and unused medications at the SIGRE collection pointat 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 Drosbelalleflex

• The active principles are drospirenone and ethinylestradiol. Each coated tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.
• The other components are: lactose monohydrate, pregelatinized cornstarch, povidone (E1201), croscarmellose sodium, polisorbate 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 contents of the package

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

Holder of the marketing authorization

Exeltis Healthcare S.L

Avda. de Miralcampo 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares. (Guadalajara)

Spain

Responsible for manufacturing

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 with the following names:

Netherlands: Talia 0.02 mg/3 mg filmomhulde tabletten

Germany: Drosbelalleflex Langzyklus 0.02 mg/3 mg filmtabletten

Austria: Drosbelalleflex Langzyklus 0.02 mg/3 mg filmtabletten

Belgium: Pernyella 0,02 mg/3 mg comprimé pelliculé

Estonia: Talia

Spain Drosbelalleflex 0.02 mg/3 mg comprimidos recubiertos con película

Finland: Diza 0,02 mg/3 mg kalvopäällysteiset tabletit

France: Pernyella 0,02 mg/3 mg comprimé pelliculé

Italy: Perliq

Hungary: Jangee flexibilis 3 mg/0,02 mg

Latvia: Talia 0,02 mg/3 mg apvalkotas tabletes

Luxembourg: Pernyella 0,02 mg/3 mg comprimé pelliculé

Poland: Naraya Flex

Portugal: Drosbelalleflex 0,02 mg/3 mg comprimido revestido

Sweden: Diza

Last review date of this leaflet: November 2024

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