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

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

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

ethinylestradiol/drospirenone

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, consult your doctor, pharmacist, or nurse.
• 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 are effects not listed in this leaflet. See section 4.

Important things you should 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 the 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”).

Leaflet Contents

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

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

Drosianelle Diario is a contraceptive used to prevent pregnancy.

Each of the 21 pink tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

The 7 white tablets do not contain active ingredients and are also referred to as placebo tablets.

Contraceptives containing two hormones are known as combined contraceptives.

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

General considerations Before starting Drosianelle Daily, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 “Blood clots”). Before you start taking Drosianelle Daily, 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 Drosianelle Daily, or in which the effectiveness of Drosianelle Daily may be reduced. In such situations, you should not have sexual intercourse or you must use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use the rhythm (or calendar) method or the temperature method. These methods may not be reliable because Drosianelle Daily alters the monthly changes in body temperature and cervical mucus. Drosianelle Daily, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted diseases.

When not to take Drosianelle Diario

Do not take Drosianelle Diario if you have any of the following 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.

Do not take Drosianelle Diario

• if you have (or have ever had) 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 require 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 ever had) angina pectoris (a condition causing severe chest pain and which may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms),
• if you have any of the following diseases that may increase your risk of forming 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 (or have ever had) liver disease and your liver function has not returned to normal,
• if your kidneys do not work properly (renal failure),
• if you have (or have ever had) a liver tumour,
• if you have (or have had in the past), or suspect you may have breast cancer or cancer of the genital organs,
• if you have vaginal bleeding of unknown cause,
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, rash, or swelling.
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Drosianelle Diario”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drosianelle Diario.

When should you consult your doctor? Seek urgent medical assistance 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 the section “Blood clots” below). For a description of the symptoms of these serious adverse effects, please refer to the section “How to recognize a blood clot”.

Inform your doctor if you are affected by any of the following conditions

In certain situations, special care is needed when using Drosianelle Daily or any other combined pill, and your doctor may need to examine you regularly. If any of these conditions develop or worsen while you are using Drosianelle Daily, you must also inform your doctor.

• if a close relative has or has had breast cancer,
• if you have liver or gallbladder disease,
• if you have diabetes,
• if you have depression,
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease),
• if you have systemic lupus erythematosus (SLE – a disease affecting your natural defense system),
• if you have hemolytic uremic syndrome (HUS – a blood 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 known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas),
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”),
• if you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Drosianelle Daily after childbirth,
• if you have inflammation of the veins beneath the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if you have epilepsy (see “Other medicines and Drosianelle Daily”),
• if you have any condition that first occurred during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder involving involuntary movements (Sydenham's chorea)),
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light,
• 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. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Drosianelle Daily 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 may 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 Drosianelle Daily 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 along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable 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 known cause or rapid breathing, sudden cough without clear cause, possibly bringing up blood, sharp chest pain that may worsen when taking a deep breath, 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—can be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms that may occur 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).
Pain, discomfort, pressure, or heaviness in the chest, feeling of tightness or fullness in the chest, arm, or below the sternum, 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 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. 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 the veins (venous thrombosis). However, these adverse effects 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 first-time use of a combined hormonal contraceptive. 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 remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drosianelle 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 Drosianelle Diario is small.

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

	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 -Drosianelle Daily	About 9-12 out of 10,000 women

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

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

The risk of developing a blood clot with Drosianelle Diario is small, but certain conditions can increase this 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 remain immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Drosianelle Diario several weeks before surgery or while you are less mobile. If you need to stop taking Drosianelle Diario, consult your doctor about when you can start taking it again,
• as you get older (especially over about 35 years of age),
• if you have recently given birth (within the last few weeks).

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

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

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

If any of the above conditions change while you are using Drosianelle Diario—for example, a close relative experiences a thrombosis without a known cause, or if you gain significant 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 blood clot in an artery can cause serious problems. For example, it may lead to a heart attack (myocardial infarction) or a stroke.

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

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

• with age (over about 35 years),
• if you smoke. When using a combined hormonal contraceptive such as Drosianelle Diario, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend that you 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 have migraines, especially migraines with aura,
• if you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation),
• if you have diabetes.

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

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

Drosianelle Diario and cancer

Cervical cancer has been detected more frequently in women who take combined hormonal contraceptives. However, this may be due to other causes, including sexually transmitted infections.

A slightly higher rate of breast cancer has been observed in women using combined contraceptives, 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 doctors 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 unusually severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as Drosianelle 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 symptoms of depression, contact your doctor for medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Drosianelle Diario, you may experience unexpected bleeding (bleeding outside the days when placebo tablets are taken). If this bleeding persists beyond a few months or begins after several months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

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

If you miss two consecutive expected periods, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and Drosianelle Diario

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. You should also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) about your use of Drosianelle Diario. This will allow them to advise you whether you need to take additional contraceptive precautions (for example, condoms), and if so, for how long, or whether you should change the use of any other medicine you may need.

Some medicines may affect the blood levels of Drosianelle Daily, causing it to lose its contraceptive effect, or may cause

• unexpected bleeding. This may occur with medicines used in the treatment of:

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

• tuberculosis (e.g., rifampicin),

• HIV and hepatitis C infections (called protease inhibitors and reverse transcriptase inhibitors, non-nucleoside analogues such as ritonavir, nevirapine, efavirenz),

• fungal infections (e.g., griseofulvin, ketoconazole),

• arthritis, osteoarthritis (etoricoxib),

• high blood pressure in the pulmonary blood vessels (bosentan),

• herbal preparations containing St. John's wort.

• Drosianelle Daily may influence the effect 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 Drosianelle Daily if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in blood parameters measuring liver function (elevation of liver enzyme ALT).

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

Drosianelle Daily may be restarted approximately 2 weeks after completing this treatment. See section “Do not take Drosianelle Daily”.

Taking Drosianelle Daily with food and drink

Drosianelle Daily may be taken with or without food and should be taken 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 hormonal contraceptives may influence the results of certain tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

In general, Drosianelle Daily is not recommended during breastfeeding. If you wish to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and use of machines

There is no information suggesting that the use of Drosianelle Daily has any effect on the ability to drive or operate machinery.

Drosianelle Daily 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 1 mmol of sodium (23 mg) per film-coated tablet; thus, it is essentially “sodium-free”.

3. How to take Drosianelle Diario

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The Drosianelle Diario tablets of different colors are arranged in order. One blister contains 28 tablets.

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

Do not confuse the tablets: take one pink tablet for the first 21 days, then one white tablet for the following 7 days. After that, start a new blister immediately (21 pink tablets followed by 7 white tablets). Therefore, there is no break between two blisters.

Because the composition of the tablets differs, you must start the blister with the tablet in the top left corner and take the tablets every day in sequence. Follow the direction of the arrows on the blister to take the tablets in the correct order.

Preparing the blister

To help you keep track of the dosing schedule, each Drosianelle Diario package contains 7 adhesive strips with the days of the week. Choose the strip starting with the day on which you take your first tablet.

Depending on the day of the week you start taking the tablets, you should select the corresponding adhesive strip. For example, if you start on Wednesday, apply the strip indicating “WED” as the first tablet. Then, stick the corresponding strip onto the top left part of the package, 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 particular tablet. The arrows show the order in which the tablets should be taken.

During the 7 days when you take the placebo tablets (placebo days), your period usually begins (also called withdrawal bleeding). Your period usually starts on the second or third day after taking the last pink active tablet of Drosianelle Diario. After taking the last white tablet, you must immediately start the next pack, 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 period should occur on the same days every month.

If you take Drosianelle 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 blister?

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

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

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

You may start taking Drosianelle Diario preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but 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 contraceptive patch, follow your doctor’s recommendations.

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

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 Drosianelle Diario tablets.

• After an abortion.

Follow your doctor’s recommendations.

• After giving birth.

After giving birth, you may start taking Drosianelle Diario between 21 and 28 days later. If you start later than 28 days after giving birth, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Drosianelle Diario.

If, after giving birth, you have already had sexual intercourse before starting to take Drosianelle Diario (again), you must be sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking Drosianelle Diario (again) after giving birth.

Read the section “Breast-feeding.”

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

If you take more Drosianelle Diario than you should

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

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 more Drosianelle Diario tablets than you should, or if you find that a child has taken them, contact your doctor or pharmacist immediately or call the Spanish Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Drosianelle Diario

The last tablets in the 4th row of the blister are placebo tablets. If you forget one of these tablets, the contraceptive effect of Drosianelle Diario is not lost. Discard the forgotten placebo tablet.

If you forget a pink active tablet (tablets in the 1st, 2nd, or 3rd row), follow these steps:

• if you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and take the following tablets at the usual time;
• if you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk that protection against pregnancy will decrease.

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

• Missing more than one tablet in the blister

Consult your doctor.

• Missing a tablet during 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 the usual time and use additional precautions, e.g., a condom, for the next 7 days. 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 a tablet during 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 the usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• Missing a tablet during 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 the usual time. Instead of continuing with the white placebo tablets, discard them and immediately start a new blister (the day you take the first tablet will be different).

You will likely have your period at the end of the second blister, during the intake of the white placebo tablets, although you may experience spotting or bleeding during the second blister.

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

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

If you have missed taking any tablets from a blister and do not have your period during the placebo days, this may indicate that you are pregnant. In this case, you must see your doctor before starting the next blister.

What should you do in case of vomiting or severe diarrhea?

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhea, there is a risk that the active ingredients are not fully absorbed by the 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 Drosianelle Diario”.

Delayed menstrual period: what should you know?

Although not recommended, it is possible to delay your period by skipping the white placebo tablets in the 4th row and immediately starting a new blister of Drosianelle Diario, continuing until the end of this new blister. You may experience spotting (drops or spots of blood) or bleeding during the use of the second blister. Finish this second blister by taking the 7 white tablets in the 4th row. Then start the next blister.

Before deciding to delay your period, consult your doctor.

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

If you take the tablets as instructed, your period will begin during the placebo week. If you wish to change that day, you may do so by reducing the number of placebo days—the days when you take the white tablets—(but never extending them—7 days is the maximum!). For example, if you usually start the placebo days on Friday and wish to change it to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. Bleeding may not occur during these days. You may then experience spotting or bleeding.

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

If you stop treatment with Drosianelle Diario

You may stop taking Drosianelle Diario whenever you wish. If you do not want 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 Drosianelle Diario and wait until your next period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, this medicine 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 may be due to Drosianelle Diario, consult your doctor.

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

Serious adverse effects

Contact your 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, possibly accompanied by difficulty breathing (see also section "Warnings and precautions").

The following are adverse effects associated with the use of Drosianelle Diario:

Common (may affect up to 1 in 10 patients)

• mood changes,
• headache,
• abdominal pain (stomach ache),
• acne,
• breast pain, menstrual problems such as irregular periods, absence of periods, breast tenderness,
• weight gain.

Uncommon (may affect up to 1 in 100 patients)

• candidiasis (fungal infection),
• cold sores (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disturbances,
• tingling sensation, dizziness (vertigo),
• vision problems,
• irregular or unusually rapid heartbeat,
• blood clot (thrombosis) in a blood vessel of the legs or lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, inflammation of the stomach and/or intestines, diarrhoea, constipation,
• sudden swelling of the skin or mucous membranes (tongue or throat) and/or difficulty swallowing along with difficulty breathing (angioedema), hair loss (alopecia), eczema, rash, itching, dry skin, oily skin (seborrheic dermatitis),
• neck pain, limb pain and muscle cramps,
• bladder infection,
• breast lumps (benign or cancerous), milk secretion from the breasts without being pregnant (galactorrhea), ovarian cysts, hot flushes, absence of periods, very heavy periods, vaginal bleeding, vaginal dryness, lower abdominal (pelvic) pain, abnormal Pap smear, loss of interest in sex,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

Rare (may affect up to 1 in 1,000 patients)

• asthma,
• hearing loss,
• blockage of a blood vessel by a clot formed elsewhere in the body,
• erythema nodosum (characterized by painful reddish nodules on the skin),
• erythema multiforme (characterized by a skin rash with target-like red spots or ulcers),
• dangerous blood clots in a vein or artery, such as:
  • in a leg or foot (i.e., DVT),
  • in the lung (i.e., PE),
  • myocardial infarction,
  • stroke,
  • minor stroke or temporary stroke symptoms, known as transient ischaemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys or eye.

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

Not known: the following adverse effects have also been reported, but their frequency cannot be estimated from the available data:

• worsening of symptoms of hereditary and acquired angioedema.

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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drosianelle Daily

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP/CAD: "The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

6. Package contents and other information

Composition of Drosianelle Diario

One blister of Drosianelle Diario contains 21 pink active tablets in rows 1, 2 and 3, and 7 white placebo tablets in row 4.

Active tablets:

• The active ingredients are ethinylestradiol 0.02 mg and drospirenone 3 mg.
• The other components (excipients) are:

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

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Placebo tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the product and contents of the pack

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n

Polígono Industrial de Navatejera

24193 Villaquilambre, León

Spain

or

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto von Guericke Alle 1

39179 Barleben

Germany

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

Finland: Rubira 0.02 mg/3 mg kalvopäällysteiset tabletit

Norway: Rubira 3 mg/0.02 mg filmdrasjerte tabletter

Date of the most recent review of this leaflet: December 2022

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