Drosure

Package leaflet: Information for the user

DROSURE 0.03 mg / 3 mg film-coated tablets

(ethinylestradiol/drospirenone)
EQUIVALENT MEDICINE
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

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

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

1. What DROSURE is and what it is used for
DROSURE is an oral contraceptive pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are known as "combined" pills.

2. What you should know before taking DROSURE

General notes
Before starting to use DROSURE, you must read the information about blood clots in
paragraph 2. It is particularly important that you read about the symptoms of a blood clot
(see paragraph 2 “Blood clots”).
Before you start taking DROSURE, your doctor will ask you some questions about your personal health and that of your close family members. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out some additional tests.
This patient information leaflet describes various situations in which you should stop taking DROSURE or in which the reliability of DROSURE may be reduced. In these situations, you must not have sexual intercourse or you must use additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because DROSURE alters the monthly variations in body temperature and cervical mucus.
Like other hormonal contraceptives, DROSURE does not protect against HIV infections (AIDS) or other sexually transmitted diseases.
Do not take DROSURE
Do not take DROSURE if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other methods of birth control that might be more suitable for your case.

• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be bedridden for a prolonged period (see paragraph 2 “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 that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of developing clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
  • if you have (or have ever had) a type of migraine called “migraine with aura”;
  • if you have (or have ever had) a liver disease and your liver function has not yet 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 ever had) or suspect you may have a tumour of the breast or genital organs
  • if you have unexplained vaginal bleeding
  • if you are allergic to ethinylestradiol or drospirenone or any of the excipients of DROSURE (listed in paragraph 6). This may include itching, rash or swelling.

Do not take DROSURE if you have hepatitis C and are taking medicinal products containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see section “Other medicines and
DROSURE”).
Warnings and precautions
When to be particularly careful with DROSURE
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack or a stroke (see the following section "Blood clot").

For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using DROSURE, you must inform your doctor. In some situations, you must be particularly careful when using DROSURE or any other combined pill, and your doctor may need to examine you regularly.
Contact your doctor or pharmacist before taking DROSURE:

• if a close relative has or has ever had breast cancer
• if you have a tumour
• if you have a liver disease (e.g., obstruction of a bile duct which may cause jaundice and symptoms such as itching) or gallbladder disease (e.g., gallstones)
• if you have diabetes
• if you are depressed. Some women using hormonal contraceptives, including DROSURE, have reported depression or low mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be bedridden for a prolonged period (see paragraph 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after giving birth you can start taking DROSURE;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.
• if you have epilepsy (see “Other medicines and DROSURE”)
• if you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nerve disorder involving sudden, involuntary movements of the body (Sydenham's chorea).
• if during treatment you develop high blood pressure that is not controlled by medication for high blood pressure
• if you have or have ever had chloasma (skin pigmentation changes, especially on the face or neck, also known as “pregnancy mask”). In this case, you should avoid direct sunlight and ultraviolet light while taking this medicine
• if you have hereditary angioedema, products containing oestrogens may cause or worsen symptoms. You must consult your doctor immediately if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives associated with breathing difficulties.

Blood clots
Using a combined hormonal contraceptive such as DROSURE increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
or in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).
Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with DROSURE is low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

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 developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur 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, the clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year
of first-time use of a combined hormonal contraceptive. The risk may
also be higher when restarting a combined hormonal contraceptive
(the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking DROSURE, the risk of developing a blood clot
returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your individual baseline 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 DROSURE is low.
Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, approximately 2 will develop a blood clot over one year. Among 10,000 women who
use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, approximately 5–7 will develop a blood clot over one year.

• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as DROSURE, approximately 9–12 will develop a blood clot over one year.
• Your risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with DROSURE is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking DROSURE several weeks before surgery or during periods of reduced mobility. If you need to stop taking DROSURE, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth within the last few weeks. The risk of developing a blood clot increases when you have multiple such conditions. Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have other listed risk factors. It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to discontinue your use of DROSURE. If any of the above conditions change while you are using DROSURE—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of DROSURE is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as DROSURE, it is advisable to stop smoking. If you cannot 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 relative has had a heart attack or stroke at a young age (under approximately 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 fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using DROSURE—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

DROSURE and tumors
Breast cancer occurs slightly more frequently in women using combined pills, but it is not known whether this is caused by the treatment. For example, more tumors may be detected in women taking combined pills because they are examined more frequently by their doctor. The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly check your breasts and contact your doctor if you notice a lump.
In rare cases, benign liver tumors have been reported in users of the pill, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusual severe abdominal pain, abdominal swelling (which may be due to liver enlargement), or gastrointestinal bleeding.

Intermenstrual bleeding
During the first few months of taking DROSURE, you may experience unexpected bleeding (bleeding outside the interval week). If such bleeding occurs for more than a few months or begins after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the interval week
If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected period does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and DROSURE
Inform your doctor about any medicines or herbal products you are currently using, have recently used, or might use. Also inform any other doctor or dentist prescribing other medicines (or the pharmacist) that you are using DROSURE. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long.
Some medicines can affect blood levels of DROSURE and may reduce its effectiveness 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 virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz)
  • fungal infections (griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• the herbal remedy St. John’s wort (Hypericum perforatum)

If you are taking any of the above medicines together with DROSURE, you must use additional contraceptive precautions (e.g., condoms) during treatment and for 28 days after stopping the treatment.
DROSURE may affect the action of other medicines, such as:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (possibly increasing the frequency of seizures)
• theophylline (used in the treatment of respiratory disorders)
• tizanidine (used to treat muscle pain and/or muscle cramps)

Your doctor may require monitoring of your blood potassium levels if you are taking certain medicines used to treat heart conditions, such as diuretics.
Do not take DROSURE if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in liver function laboratory test results (elevations in the liver enzyme GPT transaminase).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicinal products. DROSURE may be restarted approximately 2 weeks after completion of treatment with the mentioned drugs. See the section “Do not take DROSURE”.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, do not take DROSURE. If you become pregnant while taking DROSURE, stop immediately and contact your doctor. If you wish to become pregnant, you may stop taking DROSURE at any time (see also "If you wish to discontinue treatment with DROSURE").

Breastfeeding
The use of DROSURE is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Driving and use of machines
There is no information suggesting that the use of DROSURE affects the ability to drive or operate machinery.

DROSURE contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DROSURE

Take this medicine exactly as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet of DROSURE daily, with or without a small amount of water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
The pack contains 21 tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, take the tablet marked “WED” next to it. Follow the direction of the arrow on the pack until all 21 tablets have been taken.
Then do not take any tablets for 7 days. During these 7 tablet-free days (also called the "rest" or "interval" week), your menstrual period should begin. This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the interval week.
On the 8th day after the last DROSURE tablet (i.e., after the 7-day interval), you must start a new pack, even if your menstrual bleeding has not finished. This means you should start each new pack on the same day of the week, and your period should occur on the same days each month.
If you use DROSURE in this way, protection against pregnancy will remain effective during the 7 days when you do not take tablets.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous month Start taking DROSURE on the first day of your regular cycle (i.e., the first day of your menstrual period). If you start taking DROSURE on the first day of your period, protection against pregnancy is immediate. You may also start between the 2nd and 5th day of your cycle, but in this case you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive, vaginal ring, or combined contraceptive patch Start taking DROSURE preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, and at the latest the day after the tablet-free interval of your previous pill (or after the last inactive tablet of your previous pill). If you previously used a vaginal ring or a combined contraceptive patch, start taking DROSURE preferably on the day of removal, but no later than the day you would have applied the next ring or patch.

• Switching from a progestogen-only method (progestogen-only pill, injectable contraceptive, implant, or progestogen-releasing IUD) You may switch from the progestogen-only pill on any day (from an implant or IUD, switch on the day of removal; from an injectable product, switch on the day the next injection would have been due); however, in all these cases, use additional contraceptive precautions (e.g., a condom) for the first 7 days of tablet intake.

• After an abortion or termination of pregnancy Follow your doctor’s advice.

• After childbirth You may start taking DROSURE between the 21st and 28th day after delivery. If you start after the 28th day, use a barrier contraceptive method (e.g., a condom) during the first seven days of using DROSURE.
  If you have had sexual intercourse after childbirth but before starting (or restarting) DROSURE, make sure you are not pregnant, or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking DROSURE after childbirth Read the section “Breast-feeding”.
  Ask your doctor what to do if you are unsure about when to start.

If you take more DROSURE than you should
No serious harmful effects have been reported with taking too many DROSURE tablets.
If you take several tablets at once, you may experience signs of overdose such as nausea or vomiting. Young girls may experience vaginal bleeding.
If you have taken too many DROSURE tablets or if you find that a child has taken some, consult your doctor or pharmacist.

If you forget to take DROSURE

• If less than 12 hours have passed since your usual time of intake, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and then take the next tablets at your usual time.
• If more than 12 hours have passed since your usual time of intake, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

The risk of incomplete protection against pregnancy is greater if you miss a tablet at the beginning or end of the pack. Therefore, follow the rules below (see the diagram below):

• More than one tablet missed in a pack
  Consult your doctor.

• One tablet missed during the first week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions for the next 7 days, such as a condom. If you had sexual intercourse during the week before the missed tablet, contact your doctor, as you may be pregnant.

• One tablet missed during the second week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and no additional precautions are necessary.

• One tablet missed during the third week
  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 tablets at your usual time. Instead of starting the tablet-free interval, start the next pack immediately.
   You will most likely have your period at the end of the second pack, or you may experience light bleeding or spotting during the second pack.

2. You may also stop taking tablets and go directly into the 7-day tablet-free interval (including the days when you missed tablets; record the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, make the tablet-free interval shorter than 7 days.

If you follow either of these two recommendations, protection against pregnancy will not be reduced.

• If you have missed any tablets in a pack and do not have a withdrawal bleed during the first tablet-free interval, you may be pregnant. Consult your doctor before starting a new pack. The following diagram illustrates what to do if you forget to take one or more tablets:

What to do in case of vomiting or severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours after taking a tablet, there is a risk that the active ingredients of the tablet have not been completely absorbed by your body. In this case, use additional contraceptive protection (e.g., a condom) to prevent pregnancy. This situation is similar to forgetting to take a tablet. After vomiting or severe diarrhoea, take another tablet as soon as possible from a spare pack. If possible, take it within 12 hours of your usual time of taking the tablet. If this is not possible or if more than 12 hours have passed, follow the advice given in the section “If you forget to take DROSURE”.

To delay menstruation: what you should know
Although not recommended, you may delay your period by starting a new pack of DROSURE immediately, without taking the tablet-free interval, and completing that pack. You may experience light bleeding or spotting during the second pack. After finishing the second pack, wait the usual 7-day tablet-free interval, then start a new pack.
You must consult your doctor before deciding to delay your menstrual flow.

To change the first day of your period: what you should know
If you take the tablets as instructed, your periods will start during the tablet-free interval week. To change the day of your period, shorten the number of tablet-free days (but never extend it—7 days is the maximum!). For example, if your tablet-free interval usually starts on Friday and you wish to shift it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If you shorten the tablet-free interval significantly (e.g., to 3 days or fewer), you may not have a period during those days. You may experience light bleeding or spotting.
If you are unsure how to proceed, consult your doctor.

If you stop taking DROSURE
You may stop taking DROSURE at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of birth control.
If you wish to become pregnant, stop taking DROSURE and wait for a menstrual period before trying to conceive. This will help you estimate the expected date of delivery more easily.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to DROSURE, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you should know before taking DROSURE".
If you experience any of the following side effects, you may require urgent medical attention. Stop taking DROSURE immediately and contact a doctor or go immediately to the nearest hospital.
Rare side effects (may affect up to 1 in 1,000 users):

• hypersensitivity (with signs such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives associated with breathing difficulties)
• dangerous blood clots in a vein or an artery, for example:
• in a leg or foot (deep vein thrombosis, DVT)
• in a lung (pulmonary embolism, PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to stroke, 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 on conditions that increase the risk of blood clots and symptoms of a blood clot).
Conditions that may occur or worsen during pregnancy or with the use of the pill include the following:

• systemic lupus erythematosus (SLE, a disease affecting the body's natural defence system)
• inflammation of the colon or other parts of the intestine (with signs such as diarrhoea with blood, pain during bowel movements, abdominal pain) (Crohn’s disease and ulcerative colitis)
• epilepsy
• uterine fibroids (a non-malignant tumour developing in the muscular tissue of the uterus)
• a blood pigment disorder (porphyria)
• blistering skin rash during pregnancy (herpes gestationis)
• Sydenham's chorea (a nervous system disorder causing sudden, involuntary movements of the body)
• a blood clotting disorder causing kidney failure (haemolytic uraemic syndrome, with signs such as reduced urine output, blood in urine, reduced red blood cells, nausea, vomiting, confusion, and diarrhoea)
• yellowing of the skin or whites of the eyes due to blockage of bile ducts (cholestatic jaundice).

In addition, breast cancer (see section 2 "DROSURE and cancer"), malignant and non-malignant (benign) liver tumours (with signs such as abdominal swelling, weight loss, liver function abnormalities detectable through blood tests), and chloasma (patchy yellowish skin pigmentation, particularly on the face), which may be permanent, especially in women who previously had chloasma during pregnancy, have also been reported.
Other possible side effects
Common side effects (may affect up to 1 in 10 users):

• menstrual flow disorders, intermenstrual bleeding, breast pain
• headache, depressed mood
• migraine
• nausea
• thick, whitish vaginal discharge and vaginal yeast infection

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

• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• breast enlargement, increased or decreased sexual desire, vaginal infection
• fluid retention and weight gain or weight loss

Rare side effects (may affect 1–10 in 1,000 users):

• asthma
• breast milk secretion
• impaired hearing
• skin disorders such as nodular erythema (characterised by painful red skin nodules) or erythema multiforme (characterised by skin rash with redness or "target-like" blisters)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DROSURE

Keep this medicine out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and on the blister
after “Use by:” or “Exp.”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What DROSURE contains
The active substances are ethinylestradiol 0.03 mg and drospirenone 3 mg.
The excipients are:
Tablet core: monohydrate lactose, corn starch, pregelatinized starch (from corn), crospovidone, povidone, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
Description of the appearance of DROSURE and pack contents
Yellow, round, film-coated tablets.
DROSURE is available in packs containing 1, 2, 3, 6 and 13 blisters, each blister containing 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Effik Italia S.p.A.
Via dei Lavoratori 54,
20092 Cinisello Balsamo (MI)
Italy
Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Villaquilambre, León.
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Norway Ospen
Belgium Drospibel 0.03 mg / 0.03 mg film-coated tablet
Germany Yiznell 30 0.03 mg / 3 mg Filmtabletten
France Drospibel 0.03 mg / 3.0 mg, comprimé pelliculé
Italy Drosure
Luxembourg Drospibel 0.03 mg/3.0 mg