ETINILESTRADIOLO 0.03 mg/3 mg Film-coated tablets

Зміст інструкції

1. ETHINYLESTRADIOL AND DROSPIRENONE DOCgen
   1. Cosa deve sapere prima di prendere ETINILESTRADIOLO E DROSPIRENONE DOCgen
   2. How to take ETINILESTRADIOL AND DROSPIRENONE DOCgen
   3. Possible side effects
   4. How to store ETINILESTRADIOLO E DROSPIRENONE DOCgen
   5. Package contents and other information

ETHINYLESTRADIOL AND DROSPIRENONE DOCgen

0.03 mg/3 mg film-coated tablets
Equivalent Medicinal Product

Read this leaflet carefully before taking this medicinebecause 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 only for you. Do not give it to other people, even if
their symptoms are the same as yours, because it could be dangerous.
If any undesirable effects occur, including those not listed in this
leaflet, tell your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly
• They slightly increase the risk of blood clots forming in the 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
• Pay attention and see a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of this leaflet:

1. What ETINILESTRADIOL AND DROSPIRENONE DOCgen is and what it is used for

2. What you need to know before you take ETINILESTRADIOL AND DROSPIRENONE DOCgen

3. How to take ETINILESTRADIOL AND DROSPIRENONE DOCgen

4. Possible side effects

5. How to store ETINILESTRADIOL AND DROSPIRENONE DOCgen

6. Contents of the pack and other information

1. What ETINILESTRADIOL AND DROSPIRENONE DOCgen is and what it is used for

ETINILESTRADIOL AND DROSPIRENONE DOCgen is a contraceptive pill and is used to prevent
pregnancy.
Each of the 21 tablets contains small amounts of two different female hormones, more precisely
drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are called “combined” pills.

2. Cosa deve sapere prima di prendere ETINILESTRADIOLO E DROSPIRENONE DOCgen

Note generali
Before starting to use ETINILESTRADIOLO E DROSPIRENONE DOCgen, read the
information about blood clots in paragraph 2. It is particularly important that you read the
symptoms of a blood clot (see paragraph 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.
The doctor will also measure your blood pressure and, depending on your personal situation,
may perform some additional tests.
This leaflet describes various situations in which you should stop using
ETINILESTRADIOLO E DROSPIRENONE DOCgen or in which the reliability of ETINILESTRADIOLO E
DROSPIRENONE DOCgen may be reduced. In these situations, you should avoid having
sexual intercourse or take other non-hormonal contraceptive measures, such as using a
condom or another barrier method. Do not use methods based on calculating days or
body temperature. 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 disease.
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. The doctor will discuss with you other
methods of birth control that may be more suitable for your case.

• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden, or antiphospholipid antibodies;
• if you are going to have surgery or will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have had) a liver disease and your liver function is not yet normal
• if your kidneys are not working properly (renal insufficiency)
• if you have (or have had) a liver tumor
• if you have (or have had) or suspect you have a breast or genital tumor
• if you have unexplained vaginal bleeding
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in paragraph 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 paragraph "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 your doctor urgently

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

For a description of the symptoms of these serious side effects, see the paragraph “How to recognize a
blood clot”.

Tell your doctor if any of the following conditions apply to you
If this condition appears or worsens while you are using ETINILESTRADIOLO E DROSPIRENONE DOCgen
you should tell your doctor.
In some situations, you need to be particularly careful when using ETINILESTRADIOLO E DROSPIRENONE
DOCgen or any other combined pill, and your doctor may need to visit you regularly.

Talk to your doctor or pharmacist before taking ETINILESTRADIOLO E DROSPIRENONE DOCgen:

• if a close relative of yours has or has had breast cancer
• if you have cancer
• if you have a liver disease (e.g., obstruction of the bile duct that can 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 can lead to suicidal thoughts. If you experience mood changes and 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 that affects the body's defense system)
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure)
• if you have sickle cell anemia (an inherited red blood cell disease)
• 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 going to have surgery or will be bedridden for a long 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 delivery you can start taking ETINILESTRADIOLO E DROSPIRENONE DOCgen
• 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 ETINILESTRADIOLO E DROSPIRENONE DOCgen")
• if you have a disease that occurred during a pregnancy or during a previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering rashes during pregnancy (herpes gestationalis), a nerve disease that causes sudden movements of the body (Sydenham's chorea))
• if you suffer from high blood pressure that is not controlled by treatment with medicines
• if you have or have had chloasma (a discoloration of the skin, especially on the face and neck, known as “pregnancy spots”). If so, avoid direct sunlight or ultraviolet light while taking this medicine.
• if you have hereditary angioedema, products containing estrogens may cause or worsen symptoms. If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or rash and difficulty breathing, you should see a doctor immediately.

BLOOD CLOTS
The use of a combined hormonal contraceptive like ETINILESTRADIOLO E DROSPIRENONE DOCgen causes a
increased risk of developing a blood clot compared to not using it. In rare cases, a blood
clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term effects can occur, or, 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 your doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or sensitivity in the leg that can only be felt when standing or walking
• increased feeling of warmth in the affected leg
• change in skin color of the leg, such as paleness, redness, or bluish discoloration
• sudden shortness of breath or rapid breathing;
• sudden cough without a clear cause, with possible blood production;
• sharp chest pain that may increase with deep breathing;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain (acute abdomen) Deep vein thrombosis

Pulmonary embolism

• sudden loss of vision or
• painless blurred vision that Retinal vein thrombosis (blood clot in the eye) can progress to vision loss
• pain, discomfort, pressure, or heaviness in the chest
• feeling of squeezing or fullness in the chest, to an arm or under the sternum;
• feeling of fullness, indigestion, or choking;
• discomfort in the upper body, Heart attack

that radiates 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 blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 you take a combined hormonal
contraceptive for the first time. The risk may also be higher if you restart a combined hormonal
contraceptive (the same medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 TEV 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
ETHINYLESTRADIOL AND DROSPIRENONE DOCgen is low.

• Out of 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year. Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as ETHINYLESTRADIOL AND DROSPIRENONE DOCgen, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of a blood clot forming”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with ETHINYLESTRADIOL AND DROSPIRENONE DOCgen is low but
some conditions increase it. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m2);
• if a close relative of yours has had a blood clot in the leg, lung or another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you have to undergo surgery or if you have to stay in bed for a long period due to an injury or illness or if you have a leg in plaster. It may be necessary to stop taking ETHINYLESTRADIOL AND DROSPIRENONE DOCgen a few weeks before surgery or during the period when you are less mobile. If you need to stop taking ETHINYLESTRADIOL AND DROSPIRENONE DOCgen, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given 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 (duration >4 hours) can temporarily increase the risk of a blood clot
forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you are not
sure. Your doctor may decide to stop you from taking ETHINYLESTRADIOL AND DROSPIRENONE
DOCgen.
If any of the above conditions change while you are using ETHINYLESTRADIOL AND DROSPIRENONE
DOCgen, for example if a close relative develops a thrombosis for no known reason or if you significantly
gain 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 ETHINYLESTRADIOL AND
DROSPIRENONE DOCgen is very low but can increase:

• as you get older (over 35 years);
• if you smoke. When you use a combined hormonal contraceptive like ETHINYLESTRADIOL AND DROSPIRENONE DOCgen it is advisable that you quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high 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 (valve 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 ETHINYLESTRADIOL AND DROSPIRENONE
DOCgen, for example if you start smoking, if a close relative develops a thrombosis for no known reason
or if you significantly gain weight, contact your doctor.

ETHINYLESTRADIOL AND DROSPIRENONE DOCgen and cancer
Breast cancer has been observed slightly more frequently in women who use combined pills
but it is not known whether this is caused by the treatment. For example, it is possible that more tumors are
detected in women who take combined pills because they visit the doctor more frequently. The
occurrence of breast tumors gradually decreases after discontinuation of the combined hormonal
contraceptive. It is important that you regularly check your breasts and see a doctor if you feel any
lump.
In pill users, benign liver tumors have been reported in rare cases and, in even rarer cases,
malignant liver tumors. Contact your doctor if you experience unusual and severe abdominal pain,
abdominal swelling (which may be due to liver enlargement) or bleeding from the stomach.

Breakthrough bleeding
During the first few months of treatment with ETHINYLESTRADIOL AND DROSPIRENONE DOCgen you may have
unexpected bleeding (bleeding outside the pill-free week). If this bleeding persists beyond the first few months or if it
occurs after a few months of therapy, your doctor will need to find out the reasons.

What to do if you do not have bleeding during the pill-free week
If you have taken all the pills correctly, you have not vomited or had severe diarrhea and you have not taken any other
medicines, it is unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive times, it is possible that you are pregnant. Contact
your doctor immediately. Do not start the next blister until you are sure you are not pregnant.

Other medicines and ETHINYLESTRADIOL AND DROSPIRENONE DOCgen
Always tell your doctor what medicines or herbal products you are taking, have recently
taken or may take. Also tell any other doctor or dentist (or pharmacist) prescribing another medicine that you are taking ETHINYLESTRADIOL AND DROSPIRENONE DOCgen.
They can tell you if you need to take additional contraceptive measures (for example a
condom) and, if so, for how long.
Some medicines can affect the levels of ETHINYLESTRADIOL AND DROSPIRENONE DOCgen in the blood and
can make it less effective in preventing pregnancy or can cause unexpected bleeding. These include:

• medicines used for the treatment of 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, for example ritonavir, nevirapine and efavirenz) or fungal infections (griseofulvin or ketoconazole) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the pulmonary arteries (bosentan)
• the herbal medicine St John's wort (hypericum).

If you are taking one of the medicines listed above together with ETHINYLESTRADIOL AND DROSPIRENONE DOCgen
you must use additional contraceptive precautions (e.g. condoms) during and for 28 days
after therapy.
ETHINYLESTRADIOL AND DROSPIRENONE DOCgen can affect the effect of other medicines, for example:

• medicines containing cyclosporine
• the anti-epileptic lamotrigine (this can cause an increase in the frequency of seizures)
• theophylline (used for the treatment of breathing problems)
• tizanidine (used for the treatment of muscle pain and/or muscle cramps).

Your doctor will check your potassium levels in the blood if you are taking some medicines for the treatment of
heart problems (e.g. diuretics).
Do not use ETHINYLESTRADIOL AND DROSPIRENONE DOCgen if you have hepatitis C and are taking medicines
containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may determine an increase
in the results of blood tests on liver function (increased liver enzymes ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
ETHINYLESTRADIOL AND DROSPIRENONE DOCgen can be resumed about 2 weeks after completion of
this treatment. See section “Do not take ETHINYLESTRADIOL AND DROSPIRENONE DOCgen”.

Laboratory tests
If you are going to have a blood test, tell your doctor or laboratory staff that you are taking the pill,
because hormonal contraceptives can alter the results of some tests.

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

Breastfeeding
The use of ETHINYLESTRADIOL AND DROSPIRENONE DOCgen is not generally recommended during
breastfeeding. If you want to take the pill while breastfeeding, contact your doctor.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
There is no information to suggest that the use of ETHINYLESTRADIOL AND DROSPIRENONE DOCgen affects
the ability to use machines.

ETHINYLESTRADIOL AND DROSPIRENONE DOCgen contains lactose.
If your doctor has told you that you are intolerant to some sugars, ask your doctor before taking
this medicine.

3. How to take ETINILESTRADIOL AND DROSPIRENONE DOCgen

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
Take one tablet of ETINILESTRADIOL AND DROSPIRENONE DOCgen daily, if necessary with a
small amount of water. You can take the tablet with or without food, but you must always take it every day
around the same time.
The blister contains 21 tablets. Next to each tablet is printed the day of the week on which you must
take it. If, for example, you start on Wednesday, take a tablet that has the word “WED” next to it. Follow
the direction of the arrow on the blister until you have taken all 21 tablets.
Then do not take tablets for 7 days. During these 7 days without tablets (also called the break week)
you should experience bleeding. This so-called “withdrawal bleeding” usually starts on the
second or third day of the break week.
On the eighth day after the last tablet of ETINILESTRADIOL AND DROSPIRENONE DOCgen (i.e. at the end of the 7
days of the break week), you must start the next blister, whether the bleeding has finished or
not. This means that you must start each blister on the same day of the weekand that the withdrawal
bleeding will occur on the same day each month.
If you use ETINILESTRADIOL AND DROSPIRENONE DOCgen in this way, protection against pregnancy
includes the 7 days during which you do not take the tablet.

When to start the first blister?

• If you have not used a hormonal contraceptive in the previous monthStart with ETINILESTRADIOL AND DROSPIRENONE DOCgen on the first day of your normal cycle (i.e. the first day of your period). If you start ETINILESTRADIOL AND DROSPIRENONE DOCgen on the first day of your cycle, you are immediately protected against pregnancy. You can also start on days 2 to 5, but in this case you should use extra protective measures (for example, a condom) for the first 7 days.
• If you are switching from a combined hormonal contraceptive, a combined vaginal device, or a patchyou should start taking ETINILESTRADIOL AND DROSPIRENONE DOCgen preferably the day after the last active tablet (the last tablet containing active ingredients) of the previous pill, but no later than the day after the pill-free period of the previous pill (or after the last non-active tablet of the previous pill). When switching from a combined vaginal device or patch, you should start taking ETINILESTRADIOL AND DROSPIRENONE DOCgen preferably on the day of removal, or no later than when you would have applied the next one.
• If you are switching from a progestogen-only method (progestogen-only pill, injection, implant or IUD releasingprogestogen)You can switch at any time from a progestogen-only pill (you must replace implants and IUDs on the day of removal, for the injectable when the next injection is due) but in any case use extra protective measures (for example, a condom) for the first 7 days of treatment.
• After a spontaneous abortion or after a termination of pregnancyFollow your doctor's instructions.
• After childbirthYou can start ETINILESTRADIOL AND DROSPIRENONE DOCgen between 21 and 28 days after childbirth. If you start after 28 days, use a so-called barrier contraceptive method (for example, a condom) for the first seven days of using ETINILESTRADIOL AND DROSPIRENONE DOCgen. If, after childbirth, you have had sexual intercourse before starting to take ETINILESTRADIOL AND DROSPIRENONE DOCgen, make sure you are not pregnant or wait for your next period.
• If you are breastfeeding and want to start (resume) ETINILESTRADIOL AND DROSPIRENONE DOCgen after childbirthRead the paragraph “Breast-feeding”.

Ask your doctor what to do if you are not sure when to start.

If you take more ETINILESTRADIOL AND DROSPIRENONE DOCgen than you should
No serious adverse events have been reported following the intake of an excessive number of ETINILESTRADIOL AND DROSPIRENONE DOCgen tablets.
If you take several tablets at once, you may experience nausea or vomiting or vaginal bleeding. Even
young girls, who have not yet started their menstrual cycle and who have accidentally taken this
medicine, may experience vaginal bleeding.
If you have taken too many ETINILESTRADIOL AND DROSPIRENONE DOCgen tablets or if a
child has taken them, ask your doctor or pharmacist for advice.

If you forget to take ETINILESTRADIOL AND DROSPIRENONE DOCgen

• If you are less than 12 hourslate in taking the tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember and then continue taking the tablets at the usual time.
• If you are more than 12 hourslate in taking the tablet, protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of becoming pregnant.

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

• More than one tablet forgotten in this blisterAsk your doctor.
• One tablet forgotten in week 1Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the same time and use extraprecautionsfor the next 7 days, for example, a condom. If you had sexual intercourse in the week before forgetting the pill, you should contact your doctor because there is a possibility that you are pregnant.
• One tablet forgotten in week 2Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the same time. Protection against pregnancy is not reduced and you do not need to take additional precautions.
• One tablet forgotten in week 3

You can choose between two options:

• 1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the same time. Instead of having the pill-free period, start the next blister. You will most likely have bleeding at the end of the second blister but may also have some spotting or bleeding similar to your period during the use of the second blister.
• 2. You can also stop using that blister and go straight to the 7-day pill-free period (including the days in which you forgot the pill, mark the day on which you forgot thetablet). If you want to start a new blister on the day you usually do, reduce the pill-free period to less than 7 days.

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

• If you forgot a tablet from the blister and do not have bleeding during the first pill-free period, you may be pregnant. Ask your doctor before starting the next blister.

The following diagram describes how to proceed if you forget to take one or more tablets:
More than one
tablet
forgotten in a

blister

• Take the forgotten tablet
• Use a barrier method (condom) for the next 7 days
• Finish the blister Only one tablet forgotten (taken More than 12 hours late) Finish the blister

• Take the forgotten tablet
• Finish the blister
• Instead of the pill-free period start a new blister In the third Or week
• Stop using that blister immediately
• Start the 7-day pill-free period (including the day of the forgotten tablet)
• Start the next blister

What to do in case of severe vomiting or diarrhea
If you vomit within 3-4 hours of taking a tablet or if you have severe diarrhea, there is a risk that the
active ingredients contained in the pill are not fully absorbed by the body, in which case you may
need to use additional protection (for example, a condom) to avoid pregnancy. The situation is similar to that when a pill is forgotten. After vomiting or diarrhea,
take another tablet from a reserve blister as soon as possible. If possible, take it within 12 hoursof
when you normally take your pill. If this is not possible or if more than 12 hours have passed, follow the
advice given under “If you forget to take ETINILESTRADIOL AND DROSPIRENONE DOCgen”.

Delaying your period: what you need to know
Although it is not recommended, you can delay your period by starting a new blister of
ETINILESTRADIOL AND DROSPIRENONE DOCgen immediately instead of having the pill-free period, finishing it. You may have some spotting or even bleeding similar to your period when using the second blister. After finishing
the second blister, have your usual 7-day pill-free period, and then startthe next blister.

You must ask your doctor for advice before deciding to delay your period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, your period will start during the break week. If you want to change this date, reduce the number of days of the break ( but never increase them

• 7 is the maximum!). For example, if your break week normally starts on Friday and you want to move it to Tuesday (3 days earlier) start the new blister 3 days earlier. If you shorten the break week very much (for example, 3 days or less) you may not have any bleeding on those days. Afterwards you may have some spotting or bleeding similar to your period.

If you are not sure what to do, consult your doctor.
If you stop taking ETINILESTRADIOL AND DROSPIRENONE DOCgen
You can stop taking ETINILESTRADIOL AND DROSPIRENONE DOCgen at any time. If you do not want
to become pregnant, ask your doctor for advice on other reliable methods of contraception. If you want to become pregnant, stop taking ETINILESTRADIOL AND DROSPIRENONE DOCgen and wait for one cycle before trying to become
pregnant. It will be easier to calculate the due date.

If you have any other 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 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 ETINILESTRADIOLO E
DROSPIRENONE DOCgen, inform your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots
in the arteries (arterial thromboembolism (ATE)) is present in all women who take
combined hormonal contraceptives. For more detailed information on the different risks associated with taking
combined hormonal contraceptives, see paragraph 2 “What you need to know before taking
ETINILESTRADIOLO E DROSPIRENONE DOCgen”.

If you experience any of the following side effects, you may need 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 1000 people):

• hypersensitivity (with signs 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 an artery, for example:
• in a leg or foot (e.g. deep vein thrombosis DVT)
• in the lung (PE)
• heart attack
• stroke
• mini-stroke or transient symptoms similar to those of a stroke, known as a transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility of developing a blood clot may be higher if you have any other
condition that increases this risk (see paragraph 2 for more information on conditions that
increase the risk of blood clots and the symptoms of a blood clot).

Conditions that may occur or worsen during pregnancy or previous use of the
pill are:

• systemic lupus erythematosus (SLE, a disease that affects the immune system)
• inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain during defecation, abdominal pain) (Crohn's disease and ulcerative colitis)
• epilepsy
• uterine fibroids (non-cancerous tumour that grows inside the muscle tissue of the uterus)
• a disorder of blood pigment (porphyria)
• blistering and blistering rash (herpes gestationis) during pregnancy
• Sydenham's chorea (a disease of the nerves in which sudden movements of the body occur)
• a certain blood disorder that causes kidney damage (haemolytic-uraemic syndrome, with signs such as decreased urine output, blood in the urine, low red blood cell count, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to blockage of the bile duct (cholestatic jaundice) Breast cancer has also been observed (see paragraph 2 ‘ETINILESTRADIOLO E DROSPIRENONE DOCgen and cancer’), non-cancerous (benign) and cancerous (malignant) liver tumours (with signs such as abdominal swelling, weight loss, altered liver function that can be detected by blood tests) and chloasma (yellowish-brown spots on the skin and especially on the face, the so-called "mask of pregnancy"), which may be permanent, especially in women who have already 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, white vaginal discharge, vaginal fungal infections.

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

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

Rare(may affect up to 1 in 1000 people):

• asthma
• impaired hearing
• erythema nodosum (characterized by painful, red skin nodules) or erythema multiforme (rash with redness or target-shaped sores)
• breast secretion

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 ETINILESTRADIOLO E 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 which is stated on the blister and the package after "Do not use
after:" or "EXP:". The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

How ETINILESTRADIOLO E DROSPIRENONE DOCgen looks and package contents
The tablets are yellow, round and film-coated.
ETINILESTRADIOLO E DROSPIRENONE DOCgen is available in packs of 1, 2, 3, 6 and 13 blisters, each containing
21 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Community with the following names:
France: Drospirenone/Ethinylestradiol Mylan 3 mg/0.03 coated tablet
Germany: Georgette-30 3 mg/0.03 mg film-coated tablets
Italy: ETINILESTRADIOLO E DROSPIRENONE DOCgen
Norway: Rosal
Sweden: Rosal
Netherlands: Rosal 0.03mg/3mg film-coated tablets