Drosbelalle Diario 3 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Drosbelalle Diario 3mg /0.02mg film-coated tablets EFG

Drospirenone/Ethinylestradiol

Important things you need to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to 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 these effects are not listed in this leaflet. See section 4. >

Leaflet contents

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

1. What Drosbelalle Diario is and what it is used for

Drosbelalle Diario is a contraceptive and is used to prevent pregnancy.

Each pink tablet contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.

The 7 white tablets do not contain active ingredients and are called placebo tablets.

Contraceptives containing two hormones are known as "combined" tablets.

2. What you need to know before starting Drosbelalle Diario

General considerations

Before starting to use Drosbelalle Diario, you should read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before you start taking Drosbelalle Diario, 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 health status, may carry out other tests.

This leaflet describes several situations in which you should stop using Drosbelalle Diario, or in which the effectiveness of Drosbelalle Diario may be reduced.

In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method.

Do not use the rhythm method or the temperature method. These methods may not be reliable because Drosbelalle Diario alters the monthly changes in body temperature and cervical mucus.

Drosbelalle Diario, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not use Drosbelalle Diario

You must not use Drosbelalle Diario if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

• if you have (or have had in the past) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs

• if you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• if you need surgery or will be immobile for a long time (see section “Blood clots”).

• if you have ever had a heart attack or stroke

• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your 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 condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

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

When to be especially careful with Drosbelalle Diario

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot which may mean you are experiencing a

blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see section

“Blood clot (thrombosis)” below).

For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

If the condition develops or worsens while you are using Drosbelalle Diario, you should also inform your doctor.

• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
• If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure).
• If you have sickle cell anaemia (an inherited red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or will be immobile for a long time (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Drosbelalle Diario after childbirth.
• If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive such as Drosbelalle Diario increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

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

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 might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticed when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly bringing up blood. Sharp chest pain that may worsen upon deep breathing. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision, or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance or coordination. Sudden, severe, or prolonged headache without a known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

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

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

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

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

When you stop taking Drosbelalle Diario, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

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

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

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.

• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drosbelalle Diario, between about 9 and 12 women will develop a blood clot within one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

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

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

The risk of having a blood clot with Drosbelalle Diario is small, but certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives have had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Drosbelalle Diario several weeks before surgery or while you are less mobile. If you need to stop taking Drosbelalle Diario, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the above conditions, even if you are uncertain. Your doctor may decide that you need to stop taking Drosbelalle Diario.

If any of the above conditions change while you are using Drosbelalle Diario—for example, a close relative experiences a thrombosis without a known cause or 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?

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

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke while using Drosbelalle Diario is very small, but it may increase:

With age (over about 35 years of age).

• If you smoke. When using a combined hormonal contraceptive like Drosbelalle Diario, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorders, heart rhythm disorders such as atrial fibrillation).
• If you have diabetes.

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

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

Drosbelalle Diario and cancer

Women who use combined contraceptives have a slightly increased rate of breast cancer, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of hormonal contraceptives. Contact your doctor if you experience sudden severe abdominal pain.

Psychiatric disorders:

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

Bleeding between menstrual periods

During the first few months of using Drosbelalle Diario, unexpected bleeding (bleeding outside the placebo period) may occur. If you experience such bleeding for more than a few months, or if it starts after several months of use, your doctor should investigate the cause.

What should you do if you do not have your period during the placebo phase?

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

If you miss two consecutive periods, you may be pregnant. In this case, see your doctor immediately. Do not start the next pack until you have confirmed that you are not pregnant.

Taking Drosbelalle Diario with other medicines

Always inform the doctor who prescribed Drosbelalle Diario about any medicines or herbal remedies you are taking. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Drosbelalle Diario. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

Some medicines may affect the blood levels of Drosbelalle Diario and may cause it to be less effective in preventing pregnancy, or may cause unexpected bleeding. This applies to:

• Medicines used to treat:

  • Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • Tuberculosis (e.g., rifampicin)
  • Viral infections with HIV and Hepatitis C virus (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • High blood pressure in the lungs (bosentan)
  • Fungal infections (e.g., griseofulvin, ketoconazole)
  • Arthritis and osteoarthritis (etoricoxib)

• The herbal remedy St. John’s wort.

Drosbelalle Diario may influence the effect of other medicines, e.g.:

• Medicines containing cyclosporine
• The antiepileptic lamotrigine (this may lead to an increased frequency of seizures)
• Theophylline (used to treat respiratory problems)
• Tizanidine (used to treat pain and/or muscle cramps)

Do not take Drosbelalle Diario 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.

Drosbelalle Diario can be restarted approximately 2 weeks after completion of this treatment. See the section “Do not use Drosbelalle Diario.”

Taking Drosbelalle Diario with food, drinks, and alcohol

You may take the tablets with or without food, with a glass of water if needed.

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, you must not take Drosbelalle Diario. If you become pregnant while being treated with Drosbelalle Diario, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Drosbelalle Diario at any time (see also: "Discontinuing treatment with Drosbelalle Diario").

Consult your doctor or pharmacist before using any medicine.

In general, Drosbelalle Diario is not recommended during breastfeeding. If you wish to take the contraceptive while breastfeeding, 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 Drosbelalle Diario has any effect on the ability to drive or use machines.

Important information about some of the components of Drosbelalle Diario

Drosbelalle Diario contains lactose.

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

3. How to take Drosbelalle Diario

Each blister contains 21 pink active tablets and 7 white placebo tablets.

The two differently colored tablets in Drosbelalle Diario are arranged in order. One pack contains 28 tablets.

Take one tablet of Drosbelalle Diario daily with a glass of water, if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

Do not take the wrong tablet: Take one pink tablet for the first 21 days, followed by one white tablet for the last 7 days. Then start a new pack (21 pink tablets and 7 white tablets). Therefore, there is no tablet-free break between packs.

Due to the different composition of the tablets, you must start with the first tablet located in the upper left corner and then take one tablet each day. To maintain the correct order, follow the direction of the arrows on the pack.

Pack preparation

To help you keep track of your daily contraceptive intake, each pack (blister) of Drosbelalle Diario includes seven adhesive strips with printed days of the week. You should know the day of the week on which you will take your first tablet.

Depending on the day of the week you plan to start taking the tablets, select the corresponding adhesive strip. For example, if you start on Wednesday, attach the strip marked “WED” as your starting tablet. Then, stick the corresponding strip onto the upper left corner of the pack, in the “Start” position. This way, each tablet will have a day of the week indicated above it, allowing you to visually check whether you have taken a specific tablet. The arrows show the order in which the tablets should be taken.

During the 7 days when you take the white placebo tablets (placebo week), menstruation (also called withdrawal bleeding) usually begins. Menstruation typically starts on the second or third day after taking the last pink active tablet containing ethinylestradiol/drospirenone. After taking the last white tablet, you must start the next pack immediately, even if bleeding has not yet stopped. This means you should start the next pack on the same day of the week as you started the previous one, and your menstruation should occur on the same days every month.

If you take Drosbelalle Diario as directed, you will also be protected against pregnancy during the 7 days when you are taking the white placebo tablets.

When can you start the first pack?

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

Start taking Drosbelalle Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosbelalle Diario on the first day of your period, you will be protected against pregnancy immediately. You may also start on days 2–5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You may start taking Drosbelalle Diario the day after the end of the tablet-free interval of your previous contraceptive (or after taking the last inactive tablet). When switching from a combined vaginal contraceptive ring or contraceptive patch, follow your doctor’s recommendations.

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

You may switch from a progestogen-only pill on any day (if switching from an implant or IUD, on the same day of removal; if switching from an injectable, at the time the next injection would be due), but in all cases it is recommended to use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Drosbelalle Diario.

• After an abortion.

Follow your doctor’s recommendations.

• After giving birth.

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

If, after giving birth, you have already had sexual intercourse before starting Drosbelalle Diario (again), you must first ensure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking Drosbelalle Diario after giving birth.

Read the section “Breast-feeding”.

Consult your doctor if you are unsure about when to start.

If you take more Drosbelalle Diario than you should

There have been no reports of serious harm caused by overdose of ethinylestradiol/drospirenone.

Symptoms that may occur if you take many tablets at once include nausea and vomiting. Adolescent women may experience vaginal bleeding.

If you have taken too many Drosbelalle Diario tablets, or if you find that a child has taken them, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount taken.

If you forget to take Drosbelalle Diario

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, the effectiveness of Drosbelalle Diario will not be affected. You should discard the forgotten placebo tablet to avoid prolonging the placebo week, which could negatively affect the efficacy of Drosbelalle Diario.

If you forget to take a tablet from rows 1st, 2nd, or 3rd, follow these recommendations:

• If you are less than 12 hours late in taking an active tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking an active tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk of reduced contraceptive protection.

The risk of incomplete protection against pregnancy is highest if you miss a tablet at the beginning of the pack (1st row) or at the end of week 3 (3rd row of the pack). Therefore, you should take the following measures (see also the diagram below):

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 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 and use additional precautions, such as a condom, for the next 7 days. If you 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 in week 2

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. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

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. Instead of taking the 7 white placebo tablets (tablet-free interval), start the next pack immediately.

You will likely experience menstruation (withdrawal bleeding) at the end of the second pack, during the placebo tablet week, although you may experience spotting or bleeding during the second pack.

2. You may also stop taking the pink active tablets and go directly to the 7 white placebo tablets (you must note the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, take fewer than 7 placebo tablets.

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

• If you have missed tablets and do not have your period during the placebo week, this may indicate that you are pregnant. In this case, consult your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea?

If you vomit within 3–4 hours after taking a pink active tablet or experience severe diarrhea, there is a risk that the active ingredients will not be fully absorbed by your body. This is similar to missing a tablet. After vomiting or diarrhea, take a tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Drosbelalle Diario”.

Delaying your menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack by skipping the white placebo tablets in the fourth row and starting a second pack of Drosbelalle Diario. You may experience spotting (drops or blood stains) or bleeding during the second pack. After the usual placebo week (taking the 7 white tablets), start the next pack.

You must consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets as instructed, your menstrual period (withdrawal bleeding) will occur during the placebo week. If you wish to change this day, you may do so by shortening (but never lengthening! – 7 is the maximum) the placebo period. For example, if your placebo week starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), menstruation (withdrawal bleeding) may not occur during this period. In this case, you may experience spotting or bleeding.

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

If you stop taking Drosbelalle Diario

You may stop taking Drosbelalle Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking Drosbelalle Diario and wait for a menstrual period before trying to conceive. This will help you calculate the expected date of delivery more easily.

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

4. Possible adverse effects

Like all medicines, Drosbelalle Diario may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think could be due to Drosbelalle Diario, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Drosbelalle Diario”.

Harmful blood clots in a vein or artery, for example:

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

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

The following is a list of adverse effects associated with the use of Drosbelalle Diario.

Frequent adverse effects (may affect up to 1 in 10 women):

• Emotional instability
• Headache
• Abdominal pain (stomach ache)
• Acne
• Breast tenderness, breast enlargement, painful or irregular menstruation, weight gain.

Uncommon adverse effects (may affect up to 1 in 100 women):

• Candidiasis (vaginal infection)
• Herpes simplex (on the lips)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders, loss of interest in sex
• Tingling and prickling sensations, dizziness
• Vision problems
• Irregular or unusually fast heartbeat
• Blood clots (thrombosis) in a blood vessel of the legs or lungs (pulmonary embolism), increased blood pressure, migraine, varicose veins
• Sore throat
• Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhoea, constipation
• Sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or hives along with difficulty breathing (angioedema), hair loss (alopecia), itching, skin rash, dry skin, seborrheic dermatitis
• Neck pain, limb pain, muscle cramps
• Bladder infection
• Lumps in the breasts (benign and cancerous), milky discharge from the nipples (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, pelvic pain, abnormal cervical smears
• Fluid retention, lack of energy, feeling excessively thirsty, increased sweating
• Weight loss.

Rare adverse effects (may affect up to 1 in 1,000 women):

• Asthma
• Hearing problems
• Blockage of a blood vessel due to a clot formed elsewhere in the body
• Erythema nodosum (characterized by painful reddish nodules on the skin)
• Erythema multiforme (characterized by skin rash with target-shaped redness or sores).

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”).

Reporting of adverse effects

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

5. Storage of Drosbelalle Diario

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not take Drosbelalle Diario after the expiry date stated on the packaging after the phrases “No use after:” or “EXP:”.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Drosbelalle Diario

One Drosbelalle Diario blister contains 21 pink active tablets in rows 1st, 2nd and 3rd of the blister and 7 white placebo tablets in row 4.

Active tablets:

The active substances are 0.02 mg ethinylestradiol and 3 mg drospirenone.

The other components are:

Tablet core: monohydrate lactose, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80, magnesium stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance of Drosbelalle Diario and contents of the pack

The active tablets are film-coated, round, pink tablets.

The placebo tablets are film-coated, round, white tablets.

• Drosbelalle Diario is available in packs of 1, 2, 3, 6 and 13 packages (blister packs), each containing 28 tablets (21 active tablets plus 7 placebo tablets).

Only certain pack sizes may be marketed.

This medicinal product is authorised in the European Economic Area member states under the following names:

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Exeltis Healthcare S.L.

Avda. de Miralcampo 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares (Guadalajara), Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera;

La Vallina s/n;

24193-Villaquilambre, León

Spain

Date of the most recent revision of this leaflet: September 2022

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