Drosbelalleflex 3 mg/0.02 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Drosbelalleflex 3mg /0.02mg Film-coated tablets

Drospirenone/Ethinylestradiol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Important 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 developing a blood clot in the veins and arteries, especially during 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 are experiencing symptoms of a blood clot (see section 2, "Blood clots").

Leaflet contents

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

1. What Drosbelalleflex is and what it is 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 starting to take Drosbelalleflex

Before starting to take Drosbelalleflex, you must consult your doctor on how to use this product. Before starting to take Drosbelalleflex, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of a blood clot; see section 2, "Blood clots". Before starting to take Drosbelalleflex, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some additional tests. This leaflet describes several situations in which you should stop taking Drosbelalleflex, or in which the effectiveness of Drosbelalleflex may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm or temperature methods. These methods may not be reliable because Drosbelalleflex alters the monthly changes in body temperature and cervical mucus. Drosbelalleflex, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Drosbelalleflex:

You must not use Drosbelalleflex if you have any of the following conditions. If you have any of these conditions, you must inform your doctor. Your doctor will advise you on the most appropriate alternative contraceptive method.

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• If you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If you require surgery or will be unable to walk for a prolonged period (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 causing severe chest pain and which may be the first sign of a myocardial infarction) or transient ischaemic attack (TIA, transient stroke-like symptoms);
• If you have any of the following diseases, which may increase the risk of arterial thrombosis:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition known as hyperhomocysteinaemia
• If you have (or have ever had) a type of migraine called "migraine with aura";
• If you have (or have had in the past) liver disease and your liver function has not returned to normal;
• If your kidneys are not working properly (renal insufficiency);
• If you have (or have had in the past) a liver tumour;
• If you have (or have had in the past) or are suspected of having breast cancer or cancer of the genital organs;
• If you have vaginal bleeding of unknown cause;
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may present as itching, rash, or swelling.
• Do not take Drosbelalleflex if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Use of 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 hepatic impairment

Do not take Drosbelalleflex if you have liver disease. See sections “Do not use Drosbelalleflex” and “Warnings and precautions”.

Women with renal impairment

Do not take Drosbelalleflex if you have impaired kidney function or acute renal failure. See sections “Do not use Drosbelalleflex” and “Warnings and precautions”.

Warnings and precautions

When should you contact your doctor? Seek urgent medical attention If you notice possible signs of a blood clot which may indicate that you have a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see the section «Blood clot» below). For a description of the symptoms of these serious side effects, see the section «How to recognize a blood clot».

Inform your doctor if you have any of these conditions.

• In certain situations, you should take special care when using Drosbelalleflex or any other combined hormonal contraceptive, and your doctor may need to examine you periodically.

You must also inform your doctor if any condition develops or worsens while you are using Drosbelalleflex:

• if a close relative has or has ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• 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 affecting the body's natural defense system);
• if you have hemolytic uremic syndrome (HUS, a clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you require surgery or will be immobile for long periods (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Ask your doctor how long after childbirth 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 ever developed a condition for the first time during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder causing spasmodic movements (Sydenham's chorea));
• if you have or have ever had brownish-yellow patches (chloasma), also known as "pregnancy mask," especially on the face. In this case, avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives such as 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 may 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, chronic effects may occur, and very rarely, these may 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.

Are you experiencing any of these signs?	What could you be suffering from?
swelling in one leg or along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be felt when standing or walking increased warmth in the affected leg skin discoloration on the leg, e.g., turning pale, red, or blue	Deep vein thrombosis
sudden onset of shortness of breath or rapid breathing of unknown cause; sudden cough without a clear cause, which may be bloody; sudden sharp chest pain that may worsen with deep breathing; severe dizziness or lightheadedness; rapid or irregular heartbeat severe stomach pain; If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition, such as a respiratory tract infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision or painless blurred vision that may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, tightness sensation of pressure or fullness in the chest, arm, or beneath the sternum; feeling of fullness, indigestion, or suffocation; discomfort in the upper body radiating to the back, jaw, throat, one arm, or stomach; sweating, nausea, vomiting, or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat	Myocardial infarction
sudden weakness or numbness of the face, arm, or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding speech; sudden vision problems in one or both eyes; sudden difficulty walking, dizziness, loss of balance or coordination; sudden, severe, or prolonged headache without known cause; loss of consciousness or fainting with or without seizures. Occasionally, stroke symptoms may be brief with almost immediate and complete recovery, but urgent medical attention should still be sought because of the risk of having another stroke.	Stroke
swelling and slight bluish discoloration of a limb; severe stomach pain (acute abdomen)	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of venous blood clots (venous thrombosis). However, these adverse effects are uncommon. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in a lung, it may cause a pulmonary embolism (PE).
• Very rarely, a blood clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is highest during the first year after starting a combined hormonal contraceptive. The risk may also be increased when restarting a combined hormonal contraceptive (the same or another product) after a break of 4 weeks or more.

After the first year, the risk decreases but remains somewhat higher than in women who do not use combined hormonal contraceptives.

When you stop using Drosbelalleflex, the risk of developing a blood clot decreases and returns to normal after a few weeks.

What is the risk of developing a blood clot?

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

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

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

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

Factors that increase the risk of blood clot in a vein

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

• if you are overweight (body mass index or BMI above 30 kg/m²);
• if any of your close relatives has had a blood clot in the leg, lungs, or any other organ at a young age (e.g., before age 50). If so, you might have an inherited blood clotting disorder;
• if you require surgery or are unable to stand for long periods due to injury, illness, or have a leg in plaster. You may need to stop taking Drosbelalleflex for several weeks before surgery or while your mobility is reduced. If you need to stop taking Drosbelalleflex, ask your doctor when you can resume taking it.
• with increasing age (especially from around age 35);
• if you have given birth within the last few weeks.

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

Air travel (>4 hours) may temporarily increase the risk of blood clot, especially if you already have one or more of the above-mentioned risk factors.

It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop Drosbelalleflex treatment.

If any of these conditions change while you are taking Drosbelalleflex, for example, if a close relative suffers thrombosis for unknown reasons, or if you gain a significant amount of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Just like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to a heart attack or stroke.

Factors that increase the risk of blood clot in an artery

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

• with age (from around 35 years);
• if you smoke. When taking a combined hormonal contraceptive such as Drosbelalleflex, you are advised to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if any of your close relatives has had a heart attack or stroke at a young age (before age 50). In this case, you may also have an increased risk of heart attack or stroke;
• if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides);
• if you 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 is particularly severe, the risk of developing a blood clot may be even higher.

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

Drosbelalleflex and cancer

A slightly increased number of cases of breast cancer have been observed in women using combined oral contraceptives, but it is unknown whether the treatment is the cause. For example, more tumours may be detected in women using combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumours gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you notice any lump.

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

Psychiatric disorders

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

Bleeding between periods

During the first months of taking Drosbelalleflex, you may experience unexpected bleeding (bleeding outside the tablet-free interval). If this bleeding persists after a few months, or begins after several months of use, your doctor should investigate the cause.

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

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

If the expected bleeding does not occur twice in succession, you may be pregnant. Contact your doctor immediately.

If you are using Drosbelalleflex to delay periods, withdrawal bleeding typically does not occur every 4 weeks, but less frequently, with intervals of up to 120 days. An unexpected pregnancy may therefore be difficult to recognize. If for any reason you suspect you might be pregnant, you should perform a pregnancy test. If the result is positive, or if you still have doubts, contact your doctor.

Do not start the next pack until you are certain you are not pregnant.

Children and adolescents

Drosbelalleflex is only indicated after menarche.

Other medicines and Drosbelalleflex

Inform your doctor at all times about any medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are using Drosbelalleflex. They may advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to change the use of any other medicine you are taking.

Some medicines:

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

These include:

• medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

• tuberculosis (e.g. rifampicin)

• viral infections caused by HIV and Hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)

• fungal infections (griseofulvin, ketoconazole)

• arthritis, osteoarthritis (etoricoxib)

• high blood pressure in the blood vessels of the lungs (bosentan)

• and herbal preparations containing St. John's wort

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

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

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

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Drosbelalleflex may be restarted approximately 2 weeks after completion of such treatment. See section “Do not use Drosbelalleflex”.

Consult your doctor or pharmacist before using any medicine.

Taking Drosbelalleflex with food and drinks

Drosbelalleflex may be taken with or without food, and with some water if needed.

Laboratory tests

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

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breast-feeding

In general, Drosbelalleflex is not recommended during breast-feeding. If you wish to use contraceptives while breast-feeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Drosbelalleflex contains lactose and sodium.

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

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

3. How to take Drosbelalleflex

Follow exactly the instructions for using this medicine given 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 may take the tablets with or without food, but you should take them at approximately the same time each day.

Tablet intake

Mandatory phase (day 1 to day 24)

Start with the tablet marked with the corresponding day of the week. When starting Drosbelalleflex, the tablets must be taken continuously for at least 24 days, after which you may:

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

Flexible phase (day 25 to day 120)

Between days 25 and 120, the tablets may be taken continuously for up to 120 days (at which point all strips included in this package will have been used). During this period, you may decide whether you wish to delay your period or start the 4-day interval without tablets.

If you have decided to continue taking tablets for 120 days, proceed directly to the 4-day interval without tablets, completing the full 120 days of tablet intake.

Your period will begin during the 4-day interval without tablets. This usually causes 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 your period. This 4-day interval without tablets will reduce the total number of bleeding days.

Interval without tablets

The interval without tablets must never exceed 4 days in duration and should only be initiated after having taken tablets continuously for 24 days.

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

After each 4-day interval without tablets, a new cycle begins, lasting a minimum of 24 days and up to 120 days. After the mandatory phase of 24 days of uninterrupted tablet intake, you may 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 containing 24 tablets for each mandatory phase and after each 4-day interval without tablets, to facilitate correct administration of the product.

General dosage rules:

• A 4-day interval without tablets may only be initiated after having taken tablets continuously for at least 24 days, i.e., after completing the mandatory phase.
• After a 4-day interval without tablets, a new mandatory phase begins, so tablets must be taken continuously for at least 24 days before another interruption can be scheduled.

Preparing the blister strips

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

Choose the weekly strip starting with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with "WED".

Next, attach the weekly strip to the top of the blister strip, where it says "Place label here". You will now have a day marked above each tablet, allowing you to visually check whether you have taken your tablet. The arrows indicate the order in which to take the tablets.

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

If you have incomplete blister strips remaining, you may 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 over the first remaining tablet you will take. Attach the new weekly strip over the previous one. See Preparing the blister strips.

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

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 may also start on days 2–5 of the cycle, but in this case you must use additional contraceptive methods (e.g., a condom) for the first 7 days.

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

You may start taking Drosbelalleflex preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, and no later than the day after the tablet-free interval (or after the last inactive tablet) of your previous contraceptive. When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

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

You may switch from the progestogen-only pill on any day. If switching from an implant or IUS, do so on the same day of removal; if switching from an injectable, do so at the time of the next scheduled injection. In all cases, it is recommended to 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 giving birth

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

If, after giving birth, you have already had sexual intercourse, you must be certain you are not pregnant before starting Drosbelalleflex, or wait until your next menstruation.

• If you are breastfeeding and want to start (or restart) Drosbelalleflex after giving birth

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 serious harm has been reported from overdosing on Drosbelalleflex.

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

If you forget to take Drosbelalleflex

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

• If less than 24 hours have passed since you were supposed to take a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember and then continue taking the following tablets at your usual time.
• If more than 24 hours have passed since you were supposed to take a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a tablet at the beginning or end of the strip. The following recommendations should be followed in this situation (see also the diagram below):

• Missing more than one tablet from the strip

Consult your doctor.

• Missing one tablet during days 1–7

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

• Missing one tablet during days 8–14

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

• Missing one tablet during days 15–24

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time until you have completed the 24 tablets. Avoid the 4-day interval without tablets and start the new strip (the starting day will be different from before).

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

2. You may also stop taking tablets and go directly to the 4-day interval without tablets (before starting this tablet-free interval, note the day on which you missed the tablet). If you wish to start a new strip on the same day as usual, reduce the tablet-free interval to less than 4 days.

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

• Missing one tablet during days 25–120

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

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time, and continue taking the tablets at your usual time until you have taken at least 7 tablets without interruption.
2. Stop taking tablets, start a 4-day interval without tablets (counting the day you missed the tablet), and then start a new cycle of Drosbelalleflex.

• If you missed any tablets from a strip and do not have your period during the 4-day interval without tablets, this may indicate you are pregnant. In this case, you must see your doctor before starting the next strip.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients in the tablet are not fully absorbed by your body. This is similar to what happens when you forget to take a tablet. After vomiting or severe diarrhea, take a tablet from a spare blister strip as soon as possible. If possible, take it within 24 hours of your usual time for taking the contraceptive. If this is not possible or more than 24 hours have passed, follow the advice in the section "If you forget to take Drosbelalleflex".

If you stop treatment with Drosbelalleflex

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

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

4. Possible adverse effects

Like all medicines, Drosbelalleflex may cause adverse effects, although not everyone experiences them.

If you experience any adverse effect, especially if it is severe and persistent, or notice any change in your health you think may be due to Drosbelalleflex, consult your doctor.

Women who take combined hormonal contraceptives have an increased 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 various risks associated with taking combined hormonal contraceptives, see section 2, “What you need to know before starting to take 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 section “Warnings and precautions”).

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

• Frequent adverse effects (affect between 1 and 10 users in every 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 between 1 and 10 users in every 1,000):

  • depression, nervousness, somnolence
  • dizziness, tingling
  • migraine, varicose veins, increased blood pressure
  • stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea
  • acne, itching, skin rash
  • discomfort and pain, such as back pain, limb pain, muscle cramps
  • vaginal fungal infection, lower abdominal (pelvic) pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flushes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavy periods, 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 between 1 and 10 users in every 10,000):
  • candidiasis (a fungal infection)
  • anaemia, increased number of platelets in the blood
  • allergic reaction
  • hormonal disorder (endocrine)
  • increased appetite, loss of appetite, abnormally high potassium concentration in the blood, abnormally low sodium concentration in the blood
  • absence of orgasm, insomnia
  • vertigo, tremors
  • eye disorders, such as eyelid inflammation, dry eyes
  • unusually fast heartbeat
  • vein inflammation, nosebleed, fainting
  • abdominal enlargement, intestinal disorder, bloating sensation, stomach hernia, oral fungal infection, constipation, dry mouth
  • pain in the bile ducts or gallbladder, gallbladder inflammation
  • brownish-yellow skin spots, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitivity-related skin inflammation, skin nodules
  • painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal metrorrhagia, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the cervical mucosa, shrinking or loss of the uterine 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 stroke-like symptoms, known as transient ischaemic attack (TIA)
    • blood clots in the liver, stomach/intestines, kidneys or eyes.

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

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the strip and carton after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste.

Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drosbelalleflex

• The active substances are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 milligrams of drospirenone and 0.02 milligrams of ethinylestradiol.
• The other components are: monohydrate lactose, 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 contents of the pack

• Each strip of Drosbelalleflex contains 24 film-coated tablets.
• Drosbelalleflex is available in boxes containing 5 blister strips; each box contains a total of 120 tablets.
• Each Drosbelalleflex pack includes 35 (5 × 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 medicinal product is authorized in the Member States of the European Economic Area under 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 film-coated tablets

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 coated tablet

Sweden: Diza

Date of the most recent review of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es