Drosurelle

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

DROSURELLE 0.02 mg / 3 mg film-coated tablets

Ethinylestradiol/Drospirenone
Generic Medicine
Please read all of 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 adverse reaction, 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 blood clots forming in veins and arteries, especially 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 are experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

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

1. What DROSURELLE is and what it is used for
DROSURELLE 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 DROSURELLE

General notes
Before starting to use DROSURELLE, 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 DROSURELLE, 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 additional tests.
This patient information leaflet describes various situations in which you should stop taking
DROSURELLE or in which the reliability of DROSURELLE may be reduced. In these
situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive
precautions, such as using a condom or another barrier method. Do not use the rhythm method or
basal body temperature method. These methods may be unreliable because DROSURELLE alters
monthly variations in body temperature and cervical mucus.
Like other hormonal contraceptives, DROSURELLE does not protect against HIV infection
(AIDS) or other sexually transmitted infections.
Do not take DROSURELLE
Do not take DROSURELLE 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
birth control methods that might be more suitable for your situation.

• if you have (or have ever had) a blood clot in a blood vessel 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 about 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 could increase the risk of forming 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 hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”
• if you have (or have ever had) liver disease and your liver function is not yet normal
• if your kidneys do not work properly (renal failure)
• if you have (or have ever had) liver tumour
• if you have (or have ever had) or suspect you have breast or genital organ cancer
• if you have unexplained vaginal bleeding
• if you are allergic to ethinylestradiol or drospirenone or any of the excipients of this medicine (listed in section 6). This may include itching, rash or swelling.

Do not take DROSURELLE if you have hepatitis C and are taking medicinal products containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see section “Other medicines and
DROSURELLE”).
Warnings and precautions
When to be especially careful with DROSURELLE
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 clots”).

For a description of the symptoms of these serious side effects, see 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 occur or worsen while you are using DROSURELLE, inform your
doctor. In some situations, you need to be especially careful when using DROSURELLE or any
other combined oral contraceptive pill, and your doctor may need to examine you regularly.
Contact your doctor or pharmacist before taking DROSURELLE:

• if a close relative has or has ever had breast cancer
• if you have a tumour
• if you have 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 other kidney problems and are taking medicines that increase potassium levels in the blood
• if you have diabetes
• if you are depressed; Some women using hormonal contraceptives, including DROSURELLE, 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 about to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking DROSURELLE;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see “Other medicines and DROSURELLE”)
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements (Sydenham’s chorea))
• if during treatment you develop high blood pressure that is not controlled by medication
• if you have or have ever had chloasma (skin pigmentation changes, especially on the face or neck, also known as “melasma”). In this case, you should avoid direct sunlight and ultraviolet light during treatment with this medicine
• if you have hereditary angioedema, products containing oestrogens may cause or worsen symptoms. You should contact 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 DROSURELLE 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)
in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).
Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with
DROSURELLE 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 blood
clots forming 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 can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can 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 if you restart a combined hormonal
contraceptive (the same or a different medicine) 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 DROSURELLE, 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 natural risk of VTE (venous thromboembolism) 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 DROSURELLE is low.

• Among 10,000 women who do not use any 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 DROSURELLE, about 9–12 will develop a blood clot in one year.
• The likelihood of a blood clot forming 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 DROSURELLE is low, but certain conditions can increase it. 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 a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may 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 DROSURELLE several weeks before surgery or during periods of reduced mobility. If you need to stop taking DROSURELLE, 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 less than a few weeks ago. 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 clots, especially if you have any of the other risk factors listed. 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 have you stop taking DROSURELLE. If any of the above conditions change while you are using DROSURELLE—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 can cause 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 DROSURELLE is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as DROSURELLE, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, 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 DROSURELLE—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.

DROSURELLE and tumors
Breast cancer occurs slightly more frequently in women using combined oral contraceptives, 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 tumors gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you notice a lump.
In rare cases, benign liver tumors have been reported in users of oral contraceptives, 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 DROSURELLE, you may experience unexpected bleeding (bleeding outside the interval week). If such bleeding occurs for more than a few months or starts 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 vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected menstruation 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 DROSURELLE
Inform your doctor about any medicines or herbal products you are currently taking, have recently taken, or might take. Also inform any other doctor or dentist prescribing other medicines (or your pharmacist) that you are using DROSURELLE. They will advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.
Some medicines may affect blood levels of DROSURELLE and 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) or tuberculosis (e.g., rifampicin) or HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz) or fungal infections (griseofulvin, ketoconazole) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the pulmonary blood vessels (bosentan);
• the herbal remedy St. John’s wort (Hypericum perforatum).

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

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (thereby 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 need to monitor your blood potassium levels if you are taking certain medicines used to treat heart conditions, such as diuretics.
Do not take DROSURELLE 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/ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicinal products. DROSURELLE may be restarted approximately 2 weeks after completion of treatment with the aforementioned drugs. See the section “Do not take DROSURELLE”.

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 can affect the results of certain tests.

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

Breastfeeding
The use of DROSURELLE is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

DROSURELLE 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 DROSURELLE

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Take one DROSURELLE tablet 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 “interval” or “break week”), you should experience your menstrual period. This so-called “withdrawal bleeding” usually begins on the 2nd or 3rd day of the interval week.
On the 8th day after taking the last DROSURELLE tablet (i.e., after the 7-day interval), start a new pack, even if your menstrual bleeding has not finished. This means you will start each new pack on the same day of the week, and your period will occur on the same days each month.
If you use DROSURELLE in this way, you will be protected against pregnancy even during the 7 days when you are not taking tablets.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous month Start taking DROSURELLE on the first day of your usual menstrual cycle, i.e., the first day of your period. If you start taking DROSURELLE 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 You should preferably start taking DROSURELLE the day after the last active tablet (i.e., 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, you should preferably start taking DROSURELLE 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 a progestogen-only pill on any day (from an implant or IUD, switch on the day of removal; from an injectable product, switch at the time 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 DROSURELLE between day 21 and day 28 after childbirth. If you start after day 28, use a barrier contraceptive method (e.g., a condom) during the first seven days of taking DROSURELLE. If you have had sexual intercourse after childbirth but before starting DROSURELLE, ensure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking DROSURELLE 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 DROSURELLE than you should

No serious harmful effects have been reported with taking too many DROSURELLE 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 DROSURELLE tablets or if you find that a child has taken some, consult your doctor or pharmacist for advice.

If you forget to take DROSURELLE

• If less than 12 hours have passed since your usual time of taking the tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time.

• If more than 12 hours have passed since your usual time of taking the tablet, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of becoming pregnant. The risk of incomplete contraceptive protection is greater if you miss a tablet at the beginning or end of the pack. In this case, follow the instructions 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 contraceptive precautions (e.g., a condom) for the next 7 days. If you had sexual intercourse in 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. Contraceptive protection is not reduced, and no additional precautions are needed.

• 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 likely experience a withdrawal bleed at the end of the second pack, but you may have 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 the new pack on your usual starting day, make the tablet-free interval shorter than 7 days.

If you follow either of these two recommendations, contraceptive protection 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 have not been completely absorbed by your body. In this case, you may need to use additional contraceptive protection (e.g., a condom) to avoid pregnancy. This situation is similar to missing 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 tablet-taking time. 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 DROSURELLE”.

To delay menstruation: what you should know
Although not recommended, you may delay your period by starting a new pack of DROSURELLE immediately, without taking a 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 day of your period: what you should know
If you take the tablets as instructed, your periods will occur during the tablet-free interval week. If you wish to change the day, reduce 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 move 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 DROSURELLE
You may stop taking DROSURELLE 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 DROSURELLE and wait for a menstrual period before trying to conceive. This will help you calculate the expected date of delivery more easily.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 DROSURELLE, inform your doctor.
There is an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking DROSURELLE”.
If you experience any of the following side effects, you may need urgent medical attention. Stop taking DROSURELLE and contact a doctor or go immediately to the nearest hospital.
Uncommon (may affect up to 1 in 100 people):

• sudden swelling of the skin and/or mucous membranes (e.g. tongue and throat) and/or difficulty swallowing or hives associated with breathing difficulties (angioedema)
• dangerous blood clots in the lung (e.g. pulmonary embolism, PE)

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

• dangerous blood clots in a vein or an artery, for example:
• in a leg or foot (deep vein thrombosis, DVT)
• 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 immune 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 body movements)
• a blood clotting disorder causing kidney damage (haemolytic uraemic syndrome, with signs such as reduced urine output, blood in the urine, reduced red blood cells in the blood, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to blockage of the bile ducts (cholestatic jaundice).

In addition, breast cancer (see section 2 “DROSURELLE and tumours”), non-malignant (benign) and malignant liver tumours (with signs such as abdominal swelling, weight loss, abnormalities in liver function that may be detected by blood tests), and chloasma (patchy yellow skin pigmentation, particularly on the face, known as “melasma” or “pregnancy mask”), which may be permanent, especially in women who previously had chloasma during pregnancy, have also been observed.
Other possible side effects
Common (may affect up to 1 in 10 people):

• mood changes
• headache
• abdominal pain (stomach ache)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain

Uncommon (may affect up to 1 in 100 people):

• Candida (fungal infection)
• herpes simplex
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling sensation, dizziness
• vision problems
• irregular heartbeat or unusually high heart rate
• high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhoea, constipation
• hair loss (alopecia), eczema, itching, skin rashes, dry skin, oily skin (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lumps (benign), milk production without pregnancy (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, very heavy periods, vaginal discharge, vaginal infection or vaginal inflammation, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou test or Pap test), reduced sexual desire
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss
• generalized pain

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

• asthma
• hearing impairment
• erythema nodosum (characterized by painful reddish skin nodules)
• erythema multiforme (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 DROSURELLE

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

6. Package contents and other information

What DROSURELLE contains
The active substances are ethinylestradiol 0.02 mg and drospirenone 3 mg.
The excipients are:
Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone,
sodium croscarmellose, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350,
talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Description of the appearance of DROSURELLE and package contents
The tablets are pink, round, film-coated.
DROSURELLE 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 European Economic Area member states under the
following names:
Norway Naiwanel
Belgium Drospibel 0.02 mg / 3.0 mg film-coated tablet
Germany Sidretella 20 0.02 mg/3 mg Filmtabletten
France Drospibel 0.02 mg / 3.0 mg, comprimé pelliculé
Italy Drosurelle
Luxembourg Drospibel 0.02 mg / 3 mg