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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

ethinylestradiol/drospirenone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 blood clots in the veins and arteries, especially during the first year of use 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”).

Contents of this leaflet:

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

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

Drosiane Diario is a contraceptive used to prevent pregnancy.

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

The 7 white tablets do not contain any 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 Drosiane Diario

General considerations Before starting to take Drosiane Diario, you must 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 Drosiane 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 taking Drosiane Diario, or in which the effectiveness of Drosiane Diario may be reduced. In such situations, you should not have sexual intercourse or you must use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm (or calendar) method or the temperature method. These methods may not be reliable because Drosiane Diario alters the monthly changes in body temperature and cervical mucus. Drosiane Diario, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Drosiane Diario

You should not take Drosiane 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 alternative method of contraception would be more suitable:

• if you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the 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 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 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 hyperhomocysteinaemia,

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

• if you have (or have had in the past) liver disease and your liver function has not returned to normal,

• if your kidneys are not working properly (renal failure),

• if you have (or have had in the past) a liver tumour,

• if you have (or have had in the past), or suspect you 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 present as itching, rash, or swelling.

• if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Drosiane Diario”).

Additional information on special populations

Use in children

Drosiane Diario is not intended for use in women who have not yet started menstruating.

Warnings and precautions

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

When should you consult your doctor? Seek urgent medical attention If you notice possible signs of a blood clot, which may indicate 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 side effects, see “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 required when using Drosiane Diario or any other combined oral contraceptive pill. Your doctor may need to examine you regularly. If any of these conditions develop or worsen while you are using Drosiane Diario, 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 prolonged periods (see section 2 “Blood clots”),
• if you have recently given birth, as you are at increased risk of blood clots. Ask your doctor when you may start taking Drosiane Diario after delivery,
• if you have inflammation of veins beneath the skin (superficial thrombophlebitis),
• if you have varicose veins,
• if you have epilepsy (see “Other medicines and Drosiane Diario”),
• if you have ever had a condition that first occurred during pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous system 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 “melasma” or “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. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Drosiane 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 long-lasting serious effects, and very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you experience 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 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, 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 radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe 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 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 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 Drosiane 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 Drosiane 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 in 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 in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drosiane Diario, between about 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot in a vein” 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 Drosiane 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 Drosiane 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 has 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 plaster cast on your leg. You may need to stop using Drosiane Diario several weeks before surgery or while you are less mobile. If you need to stop using Drosiane Diario, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you gave birth recently (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 unsure. Your doctor may decide that you need to stop using Drosiane Diario.

If any of the above conditions change while you are using Drosiane Diario—for example, a close relative experiences a 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 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 Drosiane 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 Drosiane 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 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 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, the risk of developing a blood clot may be further increased.

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

Drosiane Diario and cancer

Cervical cancer has been detected more frequently in women taking 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 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. Consult your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as Drosiane 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 periods

During the first few months of taking Drosiane Diario, you may experience unexpected bleeding (bleeding outside the placebo tablet days). If this bleeding persists beyond a few months or starts 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 yellow active tablets correctly, have not had vomiting or severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If your expected period does not occur during two consecutive cycles, 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 Drosiane Diario

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Also inform any other doctor or dentist who prescribes another medicine for you (or your pharmacist) about your use of Drosiane Diario. This way, they can 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 require.

• Some medicines may affect the blood levels of Drosiane Diario and cause it to lose its contraceptive effect, or may cause unexpected bleeding. This may occur with medicines used to treat:

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

• tuberculosis (e.g., rifampicin),

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

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

• arthritis, osteoarthritis (etoricoxib),

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

• herbal preparations containing St. John’s wort.

• Drosiane Diario may influence the effect of other medicines, for example:

• medicines containing cyclosporine,

• the antiepileptic lamotrigine (which 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 Drosiane Diario 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.

Drosiane Diario may be restarted approximately 2 weeks after completion of this treatment. See section “Do not take Drosiane Diario”.

Taking Drosiane Diario with food and drink

Drosiane Diario can 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 may be pregnant, or are planning 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 Drosiane Diario, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Drosiane Diario at any time (see “If you want to stop taking Drosiane Diario”).

Breastfeeding

In general, Drosiane Diario 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 Drosiane Diario has any effect on the ability to drive or operate machinery.

Drosiane Diario 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; essentially “sodium-free”.

3. How to take Drosiane 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 yellow active tablets and 7 white placebo tablets.

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

Take one Drosiane 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 yellow tablet daily for the first 21 days, followed by one white tablet daily for the last 7 days. Then immediately start a new blister (21 yellow 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 upper 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.

Blister preparation

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

Depending on the day of the week you start taking the tablets, select the corresponding adhesive strip. For example, if you start on Wednesday, use the strip indicating “WED” as the first tablet. Then attach the corresponding strip to the upper 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 specific 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), menstruation (also called withdrawal bleeding) usually begins. Menstruation typically starts on the second or third day after taking the last yellow active tablet of Drosiane 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 begin the next pack on exactly the same day of the week as you started the previous one, and your period should occur on the same days each month.

If you take Drosiane 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 Drosiane Diario on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosiane 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 ring, or contraceptive patch.

You may start taking Drosiane 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 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 it is an implant or IUD, on the same day of removal; if it is 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 tablet intake.

• After an abortion.

Follow your doctor’s recommendations.

• After giving birth.

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

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

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

Read the section “Breast-feeding.”

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

If you take more Drosiane Diario than you should

No serious harm has been reported from overdosing on Drosiane Diario.

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 Drosiane Diario tablets than you should, or if you find that a child has taken them, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Drosiane 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 Drosiane Diario is not lost. Discard the forgotten placebo tablet.

If you forget a yellow 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 your 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):

• Missed more than one tablet in the pack

Consult your doctor.

• Missed one 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 your usual time and use additional precautions, e.g., 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.

• Missed one 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 your usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• Missed one 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 your usual time. Instead of continuing with the white placebo tablets, discard them and immediately start the next 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. Alternatively, you may stop taking the yellow 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 regular 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 tablet 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 to 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 of 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 Drosiane Diario.”

Delayed menstruation: what you should know

Although not recommended, it is possible to delay your period by not taking the white placebo tablets in the 4th row and instead starting directly with the tablets from a new blister of Drosiane Diario, continuing until the end of this new blister. You may experience spotting (drops or blood stains) 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 period: what you should 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 shortening the placebo days—the days when you take the white tablets—(never extend them; 7 days is the maximum!). For example, if you usually start the placebo days on Friday and want to change it to Tuesday (3 days earlier), you should start the new blister 3 days earlier than usual. It is possible that bleeding will not occur during these days. You may then experience spotting or bleeding.

If you are unsure about what to do, consult your doctor.

If you stop taking Drosiane Diario

You may stop taking Drosiane Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, it is advisable to stop taking Drosiane Diario and wait until your next menstrual 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 Drosiane 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 Drosiane 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 potentially accompanied by difficulty breathing (see also section “Warnings and precautions”).

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

Common: may affect up to 1 in 10 people

• menstrual disorders, bleeding between periods, breast pain, breast tenderness, whitish vaginal discharge and vaginal fungal infection,
• headache, changes in mood,
• migraine,
• nausea.

Uncommon: may affect up to 1 in 100 people

• breast enlargement, changes in libido (interest in sex),
• high blood pressure, low blood pressure,
• vomiting, diarrhea,
• acne, itching, skin rash, hair loss (alopecia),
• vaginal infection,
• fluid retention and changes in body weight.

Rare: may affect up to 1 in 1,000 people

• allergic reactions (hypersensitivity), asthma,
• hearing problems,
• skin disorders: erythema nodosum (a skin disease characterized by the formation of painful reddish nodules) or erythema multiforme (characterized by the appearance of a rash or skin eruption with target-shaped red spots or ulcers),
• breast discharge,
• 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).

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 it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drosiane Diario

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 CAD/EXP: 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 packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Pack contents and additional information

Composition of Drosiane Diario

One Drosiane Diario blister pack contains 21 yellow active tablets in rows 1, 2 and 3, and 7 white placebo tablets in row 4.

Active tablets:

• The active substances are ethinylestradiol 0.03 mg and drospirenone 3 mg.
• The other components are:

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

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

White placebo tablets

Tablet core: anhydrous lactose, povidone, magnesium stearate.

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

Appearance of the product and contents of the pack

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

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

Drosiane 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 commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina s/n
Navatejera Industrial Estate
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:

Estonia: Marionelle 0.03 mg/3 mg õhukese polümeerikattega tabletid
Finland: Rubira 0.03 mg/3 mg kalvopäällysteiset tabletit
Norway: Rubira 3 mg/0.03 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 Medical Devices (AEMPS) http://www.aemps.gob.es.