Drosiane 3 mg/0.03 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: Information for the patient

Drosiane 3 mg/0.03 mg film-coated tablets EFG

drospirenone/ethinylestradiol

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they 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 blood clots in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Leaflet Contents

1. What Drosiane is and what it is used for

2. What you need to know before taking Drosiane

3. How to take Drosiane

4. Possible side effects

5. How to store Drosiane

6. Contents of the pack and other information

1. What Drosiane is and what it is used for

Drosiane is a contraceptive used to prevent pregnancy.

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

Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting to take Drosiane

General considerations Before starting to use Drosiane, you should read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2, “Blood clots”). Before you start taking Drosiane, 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 patient information leaflet describes several situations in which you should stop using Drosiane, or in which the effect of Drosiane may be reduced. In such situations, you should not have sexual intercourse or must use additional non-hormonal contraceptive precautions, such as 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 alters the monthly changes in body temperature and cervical mucus. Drosiane, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted infections.

Do not take Drosiane

You must not use Drosiane 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 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 need surgery or will be immobile for a long time (see section “Blood clots”),

• if you have ever had a heart attack or stroke,

• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and 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 hyperhomocysteinaemia,

• if you have (or have had in the past) 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 do not work properly (renal insufficiency),

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

• if you have (or have had in the past), or 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 medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Drosiane”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drosiane.

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 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 have any of the following conditions

In certain situations, you should take special care when using Drosiane or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are taking Drosiane, you must also inform your doctor.

• if a close relative has or has had breast cancer,
• if you have any 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 immune system),
• if you have hemolytic uremic syndrome (HUS—a blood clotting disorder causing kidney failure),
• if you have sickle cell anemia (a hereditary 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 Drosiane after childbirth,
• 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”),
• if you have any condition that first appeared during pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin 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”). In such cases, avoid direct exposure to sunlight or ultraviolet rays,
• 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 Drosiane 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 long-lasting serious effects or, very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Drosiane 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 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 upon deep breathing. 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 like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or, Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
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 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 effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.

• If a blood clot forms in a vein 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 (PE).
• Very rarely, a clot may form in a vein of another organ such as the eye (retinal venous 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 slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drosiane, 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 Drosiane is small.

• 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 Drosiane, between 9 and 12 women will experience a blood clot in one year.
• Your individual risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5–7 out of 10,000 women
Women who use Drosiane	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 is small, but certain conditions 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 the age of approximately 50). In this case, you might have an inherited blood clotting disorder.
• If you require surgery or if you are immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Drosiane several weeks before surgery or while you are less mobile. If you need to stop taking Drosiane, ask your doctor when you can start again.
• As you get older (especially over about 35 years of age).
• If you have recently given birth within the past 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 conditions listed above, even if you are uncertain. Your doctor may decide that you need to stop taking Drosiane.

If any of the conditions listed above change while you are using Drosiane—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 may 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 is very small, but it may increase:

• With age (over 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Drosiane, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If a close family member 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 has 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 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 conditions listed above change while you are using Drosiane—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Drosiane 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 increased 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.

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

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Drosiane, you may experience unexpected bleeding (bleeding outside the tablet-free 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 tablet-free interval

If you have taken all 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 in 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor at all times about any medications or herbal preparations you are taking. Also inform any other doctor or dentist who prescribes you a new medication (or your pharmacist) that you are using Drosiane. This will allow them to advise you whether you need to take additional contraceptive precautions (e.g., condoms), and if so, for how long, or whether you should modify the use of any other medication you may require.

Some medicines may affect the blood levels of Drosiane and may make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include:

• Medicines used to treat:

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

• Tuberculosis (e.g.: rifampicin),

• HIV and hepatitis C infections (so-called 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 blood vessels of the lungs (bosentan),

• Herbal preparations containing St. John’s wort.

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

• Medicines containing cyclosporine,
• The antiepileptic lamotrigine (this could 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 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 the liver enzyme ALT).

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

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

Taking Drosiane with food and drink

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

Laboratory tests

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

Pregnancy and breastfeeding

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

Breastfeeding

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

Driving and using machines

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

Drosiane contains lactose

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

3. How to take Drosiane

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

One pack (blister) contains 21 tablets. The day of the week on which you should take the tablet is printed next to each tablet. For example, if you start on a Wednesday, you should take a tablet marked "WED" on the side. Follow the direction of the arrow on the blister pack until you have taken all 21 tablets.

Afterwards, do not take any tablets for 7 days. During these 7 days when no tablets are taken (called the tablet-free interval), you should experience menstruation. Usually, the menstrual bleeding, which may also be referred to as withdrawal bleeding, begins on the second or third day of the tablet-free interval.

On the eighth day after taking the last Drosiane tablet (i.e., after the 7-day tablet-free interval), start the next pack, even if you have not finished menstruating. This means you should start the next pack on the same day of the week as you started the previous one, and menstruation should occur on the same days every month.

If you use Drosiane in this way, you will also be protected against pregnancy during the 7 days when you do not take any tablets.

When can you start the first blister pack?

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

Start taking Drosiane on the first day of your cycle (i.e., the first day of your menstruation). If you start Drosiane on the first day of your menstruation, 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 patch.

You may preferably start taking Drosiane 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 patch, follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or 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 that you use additional contraceptive measures (e.g., a condom) during the first 7 days of taking Drosiane tablets.

• After an abortion.

Follow your doctor's recommendations.

• After giving birth.

After giving birth, you may start taking Drosiane 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.

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

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

Please read the section “Breast-feeding”.

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

If you take more Drosiane than you should

No cases have been reported in which an overdose of Drosiane 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 Drosiane tablets than you should, or if you discover that a child has taken them, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Drosiane

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

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

• Forgetting more than one tablet from the blister pack

Consult your doctor.

• Forgetting one tablet in week 1

Take the forgotten 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, for example, a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should be aware that there is a risk of pregnancy. In this case, consult your doctor.

• Forgetting one tablet in week 2

Take the forgotten 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.

• Forgetting one tablet in week 3

You have two options:

1. Take the forgotten 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 starting the tablet-free interval, start taking the next pack immediately.

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

2. You may also stop taking tablets. You must begin a 7-day tablet-free interval (noting the day on which you forgot to take the tablet). If you wish to start a new pack on your usual starting day, the tablet-free interval must be less than 7 days.

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

If you have forgotten to take any tablets from a pack and do not have your period during the tablet-free days, this may indicate that you are pregnant. In this case, you must see your doctor before starting the next pack.

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

If you vomit within 3 or 4 hours after taking a tablet or suffer from severe diarrhoea, there is a risk that the active substances are not fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhoea, 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 Drosiane”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack by continuing to take a second pack of Drosiane instead of starting the tablet-free interval. You may experience spotting (drops or stains of blood) or bleeding during the use of the second pack. After the usual 7-day tablet-free interval, continue with the next pack.

Before deciding to delay your menstrual period, ask your doctor.

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

If you take the tablets as instructed, your menstrual period (withdrawal bleeding) will begin during the tablet-free interval. If you wish to change that day, you may do so by shortening (but never extending—7 days is the maximum!) the tablet-free interval. For example, if your tablet-free interval starts on Friday and you wish to change it to Tuesday (3 days earlier), you should start a new pack 3 days earlier than usual.

If you make the tablet-free interval very short (e.g., 3 days or less), withdrawal bleeding may not occur during this interval. In this case, you may experience spotting or bleeding.

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

If you stop treatment with Drosiane

You may stop taking Drosiane 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 and wait until your menstrual period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

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

4. Possible adverse effects

Like all medicines, this medicine can 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 Drosiane, 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 Drosiane”.

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

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 with difficulty breathing (see also section “Warnings and precautions”).

Frequent: may affect up to 1 in 10 people

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• headache, mood changes,
• migraine,
• nausea,
• thick, whitish vaginal discharge and vaginal yeast infection.

Uncommon: may affect up to 1 in 100 people

• breast enlargement, changes in sex drive,
• high blood pressure, low blood pressure,
• vomiting, diarrhoea,
• 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,

• breast discharge,

• hearing problems,

• erythema nodosum (a skin disease characterized by the formation of painful red nodules), or erythema multiforme (characterized by the appearance of a rash or skin eruption with target-like red spots or ulcers),

• 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/intestine, 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, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Drosiane

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Drosiane

• The active substances are drospirenone and ethinylestradiol. Each film-coated tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol.
• The other components are: lactose monohydrate, corn starch, pregelatinized corn starch, crospovidone, povidone, polysorbate 80, magnesium stearate in the core; partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172) in the coating.

Appearance of the product and contents of the container

Film-coated, round, yellow tablets.

The tablets are packaged in Alu/PVC/PVDC blisters within cardboard boxes.

Pack sizes: 1x21, 2x21, 3x21, 6x21 and 13x21 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
Calle Serano Galvache, 56
28033 Madrid
Spain

Manufacturer

Laboratorios León Farma, S.A.
Calle La Vallina s/n
Navatejera Industrial Estate
24193 Villaquilambre, León
Spain

or

Lek Pharmaceutical d.d.
Verovskova 57
Ljubljana 1546
Slovenia

or

Salutas Pharma GmbH
Otto von Guericke Alle 1
Barleben D-39179
Germany

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

Czech Republic: Rhonya 3 mg/0.03 mg potahované tablety
Denmark: Finminette filmovertrukne tabletter
Estonia: Marionelle 0.03 mg/3 mg õhukese polümeerikattega tabletid
Finland: Tasminetta 0.03 mg/3 mg kalvopäällysteiset tabletit
Hungary: Deciora 3 mg/0.03 mg filmtabletta
Ireland: Freedo 0.03 mg/3 mg Film-Coated Tablets
Norway: Finminette 3 mg/0.03 mg filmdrasjerte tabletter
Portugal: Drosianne Drospirenone + Ethinylestradiol 3 mg + 0.03 mg Film-Coated Tablet

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