Drosbela Diario 3 mg/0.03 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Drosbela Diario 3mg/0.03mg 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 have 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Drosbela Diario is a contraceptive 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 any active ingredients and are referred to as placebo tablets.

Contraceptives containing two hormones are called "combined" tablets.

2. What you need to know before starting to take Drosbela Diario

General considerations

Before starting to use Drosbela 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 starting to take Drosbela 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 Drosbela Diario, or in which the effect of Drosbela 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 temperature method. These methods may not be reliable because Drosbela Diario alters the monthly changes in body temperature and cervical mucus.

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

Do not use Drosbela Diario

You must not use Drosbela 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 if you are immobile for long periods (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 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 medicines containing ombitasvir, paritaprevir, ritonavir and dasabuvir or glecaprevir / pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Drosbela Diario with other medicines”).

When you should be especially careful with Drosbela 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 Drosbela 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 (a hereditary 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 are immobile for long periods (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 Drosbela Diario after delivery.
• If you have inflammation of the 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 Drosbela 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 Drosbela 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., if it becomes pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe stomach 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 such as 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).
Pain, discomfort, pressure, or heaviness in the chest. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading 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 difficulty 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. 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 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 blood clots in veins (venous thrombosis). However, these adverse events are rare. 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 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 of taking a combined hormonal contraceptive for the first time. The risk may also be increased 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drosbela 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 on 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 Drosbela Diario is low.

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

• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will experience a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone such as [brand name], between about 9 and 12 women will experience a blood clot in 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/vaginal 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 Drosbela 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 Drosbela 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 or illness, or if your leg is in a cast. You may need to stop taking Drosbela Diario several weeks before surgery or while you are less mobile. If you need to stop taking Drosbela Diario, ask your doctor when you can start taking it again.
• With increasing age (especially over about 35 years).
• If you have given birth less than a few weeks ago.

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 should stop taking Drosbela Diario.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

With age (especially over about 35 years).

• If you smoke. When using a combined hormonal contraceptive like Drosbela 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 a close relative has 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 a close relative 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 disorder called 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 Drosbela Diario—for example, you start smoking, a close relative experiences thrombosis without a known cause, or you gain significant weight—inform your doctor.

Drosbela Diario and cancer

Women who use combined contraceptives have a slightly higher 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. See your doctor if you experience sudden severe abdominal pain.

Psychiatric disorders:

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

Bleeding between menstrual periods

During the first months of using Drosbela 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 a few months, 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 yellow tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medication, 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 are sure you are not pregnant.

Other medicines and Drosbela Diario

Always inform the doctor who prescribed Drosbela Diario about any medicines or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Drosbela 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 blood levels of Drosbela 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 such as HIV and Hepatitis C (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • other infections (griseofulvin/ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • drugs for the treatment of high blood pressure in blood vessels and lungs (bosentan)

• The herbal remedy St. John's wort.

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

• Medicines containing cyclosporine (a medicine used to treat infections).
• The antiepileptic lamotrigine (this may lead to an increase in seizure frequency).
• Theophylline (used to treat breathing problems)
• Tizanidine (used to treat pain and/or muscle cramps)

Do not take Drosbela 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 tests measuring liver function (increase in liver enzyme ALT).

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

Drosbela Diario can be restarted approximately 2 weeks after completing this treatment. See section “Do not use Drosbela Diario”.

Taking Drosbela 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 Drosbela Diario. If you become pregnant while taking Drosbela Diario, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Drosbela Diario at any time (see also: "Stopping Drosbela Diario treatment").

Consult your doctor or pharmacist before using any medicine.

In general, Drosbela 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 Drosbela Diario has any effect on the ability to drive or use machines.

Important information about some of the components of Drosbela Diario

Drosbela 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 Drosbela Diario

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

The two different colored tablets in Drosbela Diario are arranged in order. One pack contains 28 tablets.

Take one Drosbela Diario tablet every day 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 confuse the tablets: take one yellow tablet daily for the first 21 days, then one white tablet daily for the following 7 days. After that, start a new pack (21 yellow and 7 white tablets). Therefore, there is no tablet-free interval 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 daily in sequence. To maintain the correct order, follow the direction of the arrows on the blister pack.

Pack preparation

To help you keep track of your daily contraceptive intake, each Drosbela Diario pack (blister) includes seven adhesive strips with days of the week printed on them. You should know which day of the week you will take the 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, use the strip marked “WED” as your starting tablet. Then, attach this strip to the upper-left corner of the pack, in the “Start” position. This way, each tablet will have a day of the week marked above it, allowing you to visually confirm whether you have taken a specific tablet. The arrows indicate the order in which the tablets should be taken.

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

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

When can you start the first pack?

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

Start taking Drosbela Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosbela 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, vaginal contraceptive ring, or contraceptive patch.

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

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

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

• After an abortion.

Follow your doctor’s recommendations.

• After giving birth.

After childbirth, you may start taking Drosbela 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 Drosbela Diario.

If, after childbirth, you have already had sexual intercourse before starting Drosbela 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 Drosbela Diario after childbirth.

See the “Breastfeeding” section.

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

If you take more Drosbela 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 several tablets at once include nausea and vomiting. Adolescent women may experience vaginal bleeding.

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

If you forget to take Drosbela Diario

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

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

• If you are less than 12 hours late in taking an active tablet, contraceptive protection 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, contraceptive protection 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, follow these instructions (see also the diagram below):

• Missing more than one tablet in 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 have your period (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. Alternatively, you may stop taking the yellow active tablets and go directly to the 7 white placebo tablets (you must note the day you missed the tablet). If you wish to start the next 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 missed any tablets and do not have your period during the placebo week, this may indicate 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 yellow active tablet or have severe diarrhea, there is a risk that the active ingredients are not fully absorbed by your body. This is similar to missing a tablet. After vomiting or diarrhea, take a tablet from a backup 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 Drosbela Diario.”

Delaying your period: what you should know

Although not recommended, it is possible to delay your 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 Drosbela Diario. You may experience spotting (drops or blood stains) or bleeding during the second pack. After the usual 7-day placebo week (taking the 7 white tablets), start the next pack.

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

Changing the day of your period: what you should know

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

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

If you stop taking Drosbela Diario

You may stop taking Drosbela Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective contraceptive methods. If you wish to become pregnant, stop taking Drosbela Diario and wait for one menstrual cycle before trying to conceive. This will help you calculate your probable due date more easily.

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

4. Possible side effects

Like all medicines, Drosbela Diario may cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes you think may be due to Drosbela 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 Drosbela 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).

Below is a list of side effects associated with the use of Drosbela Diario.

Common side effects (may affect up to 1 in 10 women):

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

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

• Candidiasis (vaginal infection)
• Herpes simplex (cold sores)
• Allergic reactions
• Increased appetite
• Depression, nervousness, sleep disorders, loss of interest in sex
• Tingling and pricking 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, seborrhoeic dermatitis
• Neck pain, limb pain, muscle cramps
• Bladder infection
• Breast lumps (benign and cancerous), milky discharge from 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, excessive thirst, increased sweating
• Weight loss.

Rare side 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 side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect 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 side effects, you can help provide more information on the safety of this medicine.

5. Storage of Drosbela Diario

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not take Drosbela Diario after the expiry date which appears on the packaging after the phrase “Do not use after:” or “EXP:”.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, 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 Drosbela Diario

One Drosbela Diario blister contains 21 yellow 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 0.03 mg of ethinylestradiol and 3 mg of drospirenone.

The other components are:

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

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

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of Drosbela Diario and contents of the pack

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

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

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

Only certain pack sizes may be commercially available.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Marketing Authorization Holder and Manufacturer

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.

Pol. Ind. Navatejera

La Vallina s/n

24193-Villaquilambre, León

Spain

Date of the most recent revision of this package 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/