Ethinylestradiol and drospirenone Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

ETHINYLESTRADIOL AND DROSPIRENONE DOCgen

0.03 mg/3 mg film-coated tablets
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 other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any adverse reactions, 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 contraceptive methods when used correctly.
• They slightly increase the risk of developing blood clots 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 vigilant 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 ETINYLESTRADIOL AND DROSPIRENONE DOCgen is and what it is used for
2. What you need to know before taking ETINYLESTRADIOL AND DROSPIRENONE DOCgen
3. How to take ETINYLESTRADIOL AND DROSPIRENONE DOCgen
4. Possible side effects
5. How to store ETINYLESTRADIOL AND DROSPIRENONE DOCgen
6. Contents of the pack and other information

1. What ETINYLESTRADIOL AND DROSPIRENONE DOCgen is and what it is used for
ETINYLESTRADIOL AND DROSPIRENONE DOCgen is an oral contraceptive pill used to prevent pregnancy.
Each of the 21 tablets contains small amounts of two different female hormones, specifically drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are known as “combined” pills.

2. What you should know before taking ETINILESTRADIOLO E DROSPIRENONE DOCgen

General information
Before starting to use ETINILESTRADIOLO E DROSPIRENONE DOCgen, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before you can start taking ETINILESTRADIOLO E DROSPIRENONE DOCgen, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes various situations in which you must stop using ETINILESTRADIOLO E DROSPIRENONE DOCgen or in which the effectiveness of ETINILESTRADIOLO E DROSPIRENONE DOCgen may be reduced. In these situations, you should avoid sexual intercourse or use other non-hormonal contraceptive measures, such as using a condom or another barrier method. Do not use fertility awareness-based methods or temperature-based methods. These methods are not reliable because ETINILESTRADIOLO E DROSPIRENONE DOCgen alters the monthly changes in body temperature and cervical mucus.
ETINILESTRADIOLO E DROSPIRENONE DOCgen, like all hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted infections.
Do not take ETINILESTRADIOLO E DROSPIRENONE DOCgen:
Do not use ETINILESTRADIOLO E DROSPIRENONE DOCgen 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 case.

• if you have (or have ever had) a blood clot in a vein of your 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 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 that may be an early sign of heart attack) or transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could 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 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) a liver tumor
• if you have (or have ever had) or if it is suspected that you have a tumor of the breast or genital organs
• if you have unexplained vaginal bleeding
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may manifest as itching, rash, or swelling.

Do not use ETINILESTRADIOLO E DROSPIRENONE DOCgen if you have hepatitis C and are taking medicines
containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section "Other medicines and
ETINILESTRADIOLO E DROSPIRENONE DOCgen").
Warnings and precautions
When to be particularly careful with ETINILESTRADIOLO E DROSPIRENONE DOCgen
When should you contact a doctor?
Contact a doctor urgently

• if you notice signs suggestive of a blood clot that may indicate 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 (thrombosis)").

For a description of the symptoms of these serious adverse 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 occur or worsen while you are using ETINILESTRADIOLO E DROSPIRENONE DOCgen, inform your doctor.
In certain situations, you must be particularly cautious when using ETINILESTRADIOLO E DROSPIRENONE DOCgen or any other combined oral contraceptive, and your doctor may need to examine you regularly.
Consult your doctor or pharmacist before taking ETINILESTRADIOLO E DROSPIRENONE DOCgen:

• if a close relative has or has had breast cancer
• if you have a tumor
• if you have liver disease (e.g., bile duct obstruction that 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 have depression. Some women using hormonal contraceptives, including ETINILESTRADIOLO E DROSPIRENONE DOCgen, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If mood changes or depressive symptoms occur, 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 defense system)
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anemia (an inherited red blood cell disorder)
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia 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 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins
• if you have epilepsy (see "Other medicines and ETINILESTRADIOLO E DROSPIRENONE DOCgen")
• if you have a condition that occurred during pregnancy or during 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 uncontrolled high blood pressure despite medication
• if you have or have had chloasma (skin discoloration, especially on the face and neck, known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light while taking this medicine.
• if you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. If symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or rash and difficulty breathing, you must see a doctor immediately.

BLOOD CLOTS
Using a combined hormonal contraceptive such as ETINILESTRADIOLO E DROSPIRENONE DOCgen 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, long-term serious effects may occur, and very rarely, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with ETINILESTRADIOLO E DROSPIRENONE DOCgen is low.
How to recognize a blood clot
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg that may only be felt when standing or walking – Deep vein thrombosis
• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness; – Pulmonary embolism
• rapid or irregular heartbeat;
• severe stomach pain

If you are unsure, inform your doctor as
some of these symptoms, such as cough or
shortness of breath, may be mistaken for a
milder condition such as a respiratory
infection (e.g., a “common cold”).
Symptoms occurring more frequently in one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or bleeding in the eye
• painless blurring of vision that may progress to loss of vision
• chest pain, discomfort, pressure, or heaviness
• squeezing or fullness sensation in the chest, in one arm, or under the sternum;
• feeling of fullness, indigestion, or choking; – Heart attack
• discomfort in the upper body spreading to the back, jaw, throat, arms, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;

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 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, a 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 taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen, 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 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen 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 a 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 a year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as ETINILESTRADIOLO E DROSPIRENONE DOCgen, about 9–12 will develop a blood clot in a year.
• The likelihood 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen 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 due to undergo 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen several weeks before surgery or during periods of reduced mobility. If you need to stop taking ETINILESTRADIOLO E DROSPIRENONE DOCgen, ask your doctor when you can start again;
• as you get older (especially over 35 years of age);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
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 that you should stop taking ETINILESTRADIOLO E DROSPIRENONE DOCgen.
If any of the above conditions change while you are using ETINILESTRADIOLO E DROSPIRENONE DOCgen, 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 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen is very low, but it may increase:

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

ETINILESTRADIOLO E DROSPIRENONE DOCgen and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it is possible that more tumours are detected in women taking combined pills because they are examined by a doctor more frequently. The occurrence of breast tumours gradually decreases after stopping the combined hormonal contraceptive. It is important that you regularly check your breasts and consult your doctor if you feel any lumps.
In users of the pill, benign liver tumours have been reported rarely, and malignant liver tumours even more rarely. Contact your doctor immediately if you experience unusual and severe abdominal pain, abdominal swelling (which may be due to liver enlargement), or gastrointestinal bleeding.

Intermenstrual bleeding
During the first months of treatment with ETINILESTRADIOLO E DROSPIRENONE DOCgen, you may experience unexpected bleeding (bleeding outside the pill-free week). If such bleeding recurs beyond the first few months or occurs after several months of treatment, your doctor will need to investigate the cause.

What to do if withdrawal bleeding does not occur
If you have taken all tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack if you are not sure you are not pregnant.

Other medicines and ETINILESTRADIOLO E DROSPIRENONE DOCgen
Always inform your doctor about any medicines or herbal products you are currently taking, have recently taken, or might take. Also tell any other doctor or dentist (or pharmacist) who prescribes you another medicine that you are taking ETINILESTRADIOLO E DROSPIRENONE DOCgen.
They may advise you whether you need to use additional contraceptive measures (for example, condoms), and if so, for how long.

Some medicines can affect the levels of ETINILESTRADIOLO E DROSPIRENONE DOCgen in the blood 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) or tuberculosis (e.g. rifampicin) or HIV and hepatitis C virus infections (medicines known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine and efavirenz) or fungal infections (griseofulvin or ketoconazole) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the lung arteries (bosentan);
• the herbal medicine St John’s wort (Hypericum perforatum).

If you are taking any of the above medicines together with ETINILESTRADIOLO E DROSPIRENONE DOCgen, you must use additional contraceptive precautions (e.g. condoms) during treatment and for 28 days after stopping it.

ETINILESTRADIOLO E DROSPIRENONE DOCgen may affect the action of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).

Your doctor will monitor your blood potassium levels if you are taking certain medicines for heart problems (e.g. diuretics).

Do not use ETINILESTRADIOLO E DROSPIRENONE DOCgen if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this could lead to increased liver function test results (elevated liver enzymes ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
ETINILESTRADIOLO E DROSPIRENONE DOCgen can be restarted approximately 2 weeks after completing this treatment. See section "Do not take ETINILESTRADIOLO E DROSPIRENONE DOCgen".

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 alter the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Do not take ETINILESTRADIOLO E DROSPIRENONE DOCgen if you are pregnant. If you become pregnant while taking ETINILESTRADIOLO E DROSPIRENONE DOCgen, stop immediately and inform your doctor. If you wish to become pregnant, you can stop taking ETINILESTRADIOLO E DROSPIRENONE DOCgen at any time (see also “If you want to stop taking ETINILESTRADIOLO E DROSPIRENONE DOCgen”).

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

Driving and use of machines
There are no data suggesting that ETINILESTRADIOLO E DROSPIRENONE DOCgen affects the ability to drive or operate machinery.

ETINILESTRADIOLO E DROSPIRENONE DOCgen contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take ETINILESTRADIOLO E DROSPIRENONE DOCgen

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure,
consult your doctor or pharmacist.

Take one tablet of ETINILESTRADIOLO E DROSPIRENONE DOCgen daily, with or without a
small amount of water. You may take the tablet with or without food, but you must take it every day
around the same time.

The blister 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 a tablet marked “MER”. Follow the
direction of the arrow on the blister pack until you have taken all 21 tablets.

Then, do not take any tablets for 7 days. During these 7 tablet-free days (also called the “tablet-free week”), you should experience bleeding. This so-called “withdrawal bleeding” usually starts on the second or third day of the tablet-free week.

On the eighth day after the last tablet of ETINILESTRADIOLO E DROSPIRENONE DOCgen (i.e., at the end of the 7-day tablet-free week), start the next blister pack, regardless of whether bleeding has stopped or not. This means you should start each new blister pack on the same day of the week, and withdrawal bleeding will occur on the same days each month.

If you use ETINILESTRADIOLO E DROSPIRENONE DOCgen in this way, contraceptive protection continues throughout the 7 tablet-free days.

When to start the first blister pack?

• If you have not used a hormonal contraceptive in the previous month: Start taking ETINILESTRADIOLO E DROSPIRENONE DOCgen on the first day of your normal menstrual cycle (i.e., the first day of menstrual bleeding). If you start ETINILESTRADIOLO E DROSPIRENONE DOCgen on the first day of your cycle, you are immediately protected against pregnancy. You may also start between days 2 and 5, but in this case, you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.
• If switching from a combined hormonal contraceptive, a combined vaginal ring, or a contraceptive patch: You should preferably start taking ETINILESTRADIOLO E DROSPIRENONE DOCgen the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the tablet-free interval of your previous pill (or after the last inactive tablet). When switching from a combined vaginal ring or a contraceptive patch, start taking ETINILESTRADIOLO E DROSPIRENONE DOCgen preferably on the day of removal, or at the latest on the day you would have applied the next device.
• If switching from a progestogen-only method (progestogen-only pill, injection, implant, or progesterone-releasing IUD): You may switch on any day from a progestogen-only pill (replace implants and IUDs on the day of removal; for injectables, switch when the next injection would have been due), but in any case, use additional contraceptive precautions (e.g., a condom) for the first 7 days of treatment.
• After a spontaneous or induced abortion: Follow your doctor’s advice.
• After childbirth: You may start ETINILESTRADIOLO E DROSPIRENONE DOCgen between 21 and 28 days after delivery. If you start after 28 days, use a so-called barrier contraceptive method (e.g., a condom) during the first 7 days of taking ETINILESTRADIOLO E DROSPIRENONE DOCgen. If you have had sexual intercourse after childbirth before starting ETINILESTRADIOLO E DROSPIRENONE DOCgen, ensure you are not pregnant or wait for the next menstrual period.
• If you are breastfeeding and wish to start (or restart) ETINILESTRADIOLO E DROSPIRENONE DOCgen 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen than you should

No serious adverse events have been reported following overdose of ETINILESTRADIOLO E DROSPIRENONE DOCgen tablets.

If you take several tablets at once, you may experience nausea, vomiting, or vaginal bleeding. Young girls who have not yet started menstruating and who have accidentally taken this medicine may also experience vaginal bleeding.

If you have taken too many ETINILESTRADIOLO E DROSPIRENONE DOCgen tablets or if a child has taken them, consult your doctor or pharmacist.

If you forget to take ETINILESTRADIOLO E DROSPIRENONE DOCgen

• If you are less than 12 hours late in taking the tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
• If you are more than 12 hours late, 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 a blister pack. Therefore, follow the rules below (see the chart below):

• More than one tablet missed in this blister pack: Consult your doctor.
• One tablet missed in week 1: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking tablets at your usual time and use additional precautions for the next 7 days, e.g., a condom. If you had sexual intercourse in the week before missing the tablet, contact your doctor, as there may be a risk of pregnancy.
• One tablet missed in week 2: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking tablets at your usual time. Contraceptive protection is not reduced, and no additional precautions are needed.
• One tablet missed in week 3:

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking tablets at your usual time. Instead of having a tablet-free interval, immediately start the next blister pack. You will most likely experience bleeding at the end of the second blister pack, but you may also have light or menstrual-like bleeding during use of the second blister pack.
2. Alternatively, you may stop taking tablets from the current blister pack and go directly to the 7-day tablet-free interval (including the days when you missed the tablet; mark the day on which you missed the tablet). If you wish to start a new blister pack on your usual starting day, shorten the tablet-free interval to less than 7 days.

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

• If you missed a tablet in the blister pack and do not have bleeding during the first tablet-free interval, you may be pregnant. Consult your doctor before starting the next blister pack.

The following chart describes what to do if you forget to take one or more tablets:

[Chart not included in translation]

More than one
tablet
forgotten in a
blister pack

• Take the missed tablet
• Use a barrier method (condom) for the next 7 days
• Finish the blister

In the second week – Missed tablet (more than 12 hours late)

• Take the missed tablet
• Finish the blister

In the third week

• Stop using that blister immediately
• Begin the hormone-free interval (no longer than 7 days, including the day of the missed tablet)
• Start the next blister

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or if you have severe diarrhoea, there is a risk that the
active substances in the tablet may not be completely absorbed by the body. In this case, you may need to
use additional contraceptive protection (e.g. a condom) to prevent pregnancy. The situation is similar to
forgetting a pill. After vomiting or diarrhoea, take another tablet as soon as possible from a spare blister.
If possible, take it within 12 hours of your usual pill-taking time. If this is not possible or if more than 12
hours have passed, follow the advice given under “If you forget to take ETINYLESTRADIOL AND DROSPIRENONE DOCgen”.

Delaying menstruation: what you need to know
Although not recommended, you can delay your period by immediately starting a new blister of
ETINYLESTRADIOL AND DROSPIRENONE DOCgen instead of taking the pill-free interval, finishing it. You may
experience light bleeding or bleeding similar to menstruation while using the second blister. After finishing
the second blister, take the usual 7-day pill-free interval, and then start the next blister.
You must consult your doctor before deciding to delay your menstrual period.

Changing the day your period starts: what you need to know
If you take the tablets as directed, your period will begin during the hormone-free interval. If you wish to
change this date, shorten the number of hormone-free days (but never extend them – 7 is the maximum!).
For example, if your hormone-free interval normally starts on Friday and you want to move it to Tuesday (3
days earlier), start the new blister 3 days earlier than usual. If you shorten the hormone-free interval
considerably (e.g. 3 days or fewer), you may not have any bleeding during these days. You may then have
light bleeding or bleeding similar in amount to a normal period later on.

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

If you stop taking ETINYLESTRADIOL AND DROSPIRENONE DOCgen
You may stop taking ETINYLESTRADIOL AND DROSPIRENONE DOCgen at any time. If you do not want a
pregnancy, ask your doctor about other reliable contraceptive methods. If you want to become pregnant,
stop taking ETINYLESTRADIOL AND DROSPIRENONE DOCgen and wait for one menstrual cycle before trying to
conceive. This will make it easier to calculate the due date.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to ETINILESTRADIOLO E DROSPIRENONE DOCgen, inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen”.
If you experience any of the following side effects, you may require urgent medical attention.
Stop taking ETINILESTRADIOLO E DROSPIRENONE DOCgen, contact your doctor immediately or go to the nearest hospital.
Rare (may affect up to 1 in 1,000 people):

• hypersensitivity (with symptoms such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with difficulty breathing)
• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (e.g. deep vein thrombosis DVT)
  • in a lung (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 previous use of the pill include:

• systemic lupus erythematosus (SLE, a disease affecting the immune system)
• inflammation of the colon or other parts of the intestine (with symptoms such as bloody diarrhoea, pain during defecation, abdominal pain) (Crohn’s disease and ulcerative colitis)
• epilepsy
• uterine fibroids (non-cancerous tumours growing within the muscular tissue of the uterus)
• a blood pigment disorder (porphyria)
• blistering and vesicular skin rash (herpes gestationis) during pregnancy
• Sydenham's chorea (a nerve disorder causing sudden, involuntary movements of the body)
• a specific blood disorder causing kidney damage (haemolytic-uraemic syndrome, with signs such as reduced urine output, blood in urine, low red blood cell count, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to bile duct obstruction (cholestatic jaundice)

In addition, the following have been observed: breast cancer (see section 2 ‘ETINILESTRADIOLO E DROSPIRENONE DOCgen and cancer’), non-cancerous (benign) and cancerous (malignant) liver tumours (with signs such as abdominal swelling, weight loss, changes in liver function detectable through blood tests), and chloasma (dark yellowish-brown patches on the skin, especially on the face, also known as "melasma" or "pregnancy mask"), which may be permanent, particularly in women who have previously experienced chloasma during pregnancy.

Other possible side effects
Common (may affect up to 1 in 10 people):

• depressed mood
• headache
• migraine
• nausea
• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• thick, whitish vaginal discharge, vaginal fungal infections.

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

• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• breast enlargement, changes in libido (increased or decreased), vaginal infection
• fluid retention, changes in body weight (increase or decrease).

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

• asthma
• hearing impairment
• erythema nodosum (characterised by painful red skin nodules) or erythema multiforme (rash with red patches or target-shaped sores)
• galactorrhea (milk-like discharge from the breasts)

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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ETINILESTRADIOL AND DROSPIRENONE DOCgen

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

6. Package contents and other information

What ETINILESTRADIOLO E DROSPIRENONE DOCgen contains
The active substances are ethinylestradiol 0.03 mg and drospirenone 3 mg.
The other components are:
Tablet core: lactose monohydrate, maize starch, pregelatinized starch (maize), crospovidone, povidone, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

What ETINILESTRADIOLO E DROSPIRENONE DOCgen looks like and contents of the pack
The tablets are yellow, round and film-coated.
ETINILESTRADIOLO E DROSPIRENONE DOCgen is available in packs containing 1, 2, 3, 6 and 13 blisters, each containing 21 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturer responsible for batch release:
Laboratorios León Farma S.A. - Pol. Ind. Navatejera - C/ La Vallina s/n - 24008 - Villaquilambre, León – Spain.

This medicinal product is authorized in the Member States of the European Community under the following names:
France: Drospirenone/Ethinylestradiol Mylan 3 mg/0.03 mg film-coated tablet
Germany: Georgette-30 3 mg/0.03 mg Filmtabletten
Italy: ETINILESTRADIOLO E DROSPIRENONE DOCgen
Norway: Rosal
Sweden: Rosal
Netherlands: Rosal 0.03 mg/3 mg film-coated tablets