Ethinylestradiol and drospirenone Doc Generici: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

ETHINYLESTRADIOL AND DROSPIRENONE DOC

0.02 mg/3 mg film-coated tablets
Generic Medicine
Please read all of this leaflet carefully before you start taking this medicine, as it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if
their symptoms seem identical to yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor, pharmacist, or nurse. See section 4.
Important information about combined oral contraceptives (COCs):
They are one of the most reliable reversible methods of contraception when used correctly.
They slightly increase the risk of developing blood clots in veins and arteries, 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 consult your doctor if you suspect symptoms of a blood clot (see section 2 “Blood clots”).
Contents of this leaflet:
1. What ETINYLESTRADIOL AND DROSPIRENONE DOC is and what it is used for
2. What you need to know before taking ETINYLESTRADIOL AND DROSPIRENONE DOC
3. How to take ETINYLESTRADIOL AND DROSPIRENONE DOC
4. Possible side effects
5. How to store ETINYLESTRADIOL AND DROSPIRENONE DOC
6. Contents of the pack and other information
1. What ETINYLESTRADIOL AND DROSPIRENONE DOC is and what it is used for
ETINYLESTRADIOL AND DROSPIRENONE DOC is a 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 DOC

General information
Before starting ETINILESTRADIOLO E DROSPIRENONE DOC, 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 DOC, your doctor will ask you 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 DOC or in which the effectiveness of ETINILESTRADIOLO E DROSPIRENONE DOC may be reduced. In these situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods. Do not use fertility awareness-based methods such as calendar tracking or temperature monitoring. These methods are not reliable because ETINILESTRADIOLO E DROSPIRENONE DOC alters the monthly changes in body temperature and cervical mucus.
ETINILESTRADIOLO E DROSPIRENONE DOC, like all hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted infections.
Do not take ETINILESTRADIOLO E DROSPIRENONE DOC:
Do not use ETINILESTRADIOLO E DROSPIRENONE DOC 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 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 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 ischaemic attack (TIA – temporary stroke-like symptoms);
if you have one of the following conditions, which may increase the risk of developing clots in the arteries:
severe diabetes with blood vessel damage
very high blood pressure
very high levels of fats (cholesterol or triglycerides) in the blood
a condition known as hyperhomocysteinaemia
if you have (or have ever had) a type of migraine called “migraine with aura”;
if you have (or have ever had) liver disease and your liver function is not yet normal
if your kidneys are not working properly (renal failure)
if you have (or have ever had) a liver tumour
if you have (or have ever had) or if it is suspected that you have a tumour 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 DOC if you have hepatitis C and are taking
medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section "Other
medicines and ETINILESTRADIOLO E DROSPIRENONE DOC).
Warnings and precautions
When to take ETINILESTRADIOLO E DROSPIRENONE DOC with caution
When should you contact a doctor?
Contact a doctor immediately

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

For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.
Inform your doctor if any of the following conditions apply to you
You should inform your doctor even if a condition appears or worsens during use of ETINILESTRADIOLO E DROSPIRENONE DOC.
In some situations, you must be particularly cautious when using ETINILESTRADIOLO E DROSPIRENONE DOC or any other combined pill, and your doctor may need to examine you regularly.
Contact your doctor or pharmacist before taking ETINILESTRADIOLO E DROSPIRENONE DOC:

if a close relative has or has had breast cancer
if you have a tumour
if you have liver disease (e.g. bile duct obstruction 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 have depression. Some women using hormonal contraceptives, including ETINILESTRADIOLO E DROSPIRENONE DOC, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor 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 ETINILESTRADIOLO E DROSPIRENONE DOC
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 ETINILESTRADIOLO E DROSPIRENONE DOC")
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 rashes 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 had or have chloasma (skin discoloration, especially on the face and neck, also known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light while taking this medicine.
if you have hereditary angioedema, products containing oestrogens may trigger 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 must see a doctor immediately.

Blood clots
Using a combined hormonal contraceptive such as ETINILESTRADIOLO E DROSPIRENONE DOC 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 can 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 DOC 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 one 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, which may only be felt when standing or walking - increased warmth in the affected leg - change in skin color of the leg, such as paleness, reddish or bluish discoloration	Deep vein thrombosis
sudden and unexplained shortness of breath or rapid breathing; - sudden cough without an obvious cause, possibly with blood; - sharp chest pain that may worsen upon deep breathing; - severe dizziness or lightheadedness; - rapid or irregular heartbeat; - severe stomach pain If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision or painless blurring of vision which may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, or heaviness - squeezing sensation or fullness in the chest, in one arm, or under the sternum; - feeling of fullness, indigestion, or suffocation; - discomfort in the upper body spreading to the back, jaw, throat,	Heart attack
arms and stomach; sweating, nausea, vomiting, or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat
sudden numbness or weakness of the face, one arm, or one leg, especially on one side of the body; - sudden confusion, difficulty speaking or understanding speech; - sudden difficulty seeing in one or both eyes; - sudden difficulty walking, dizziness, loss of balance or coordination; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; - severe abdominal pain (acute abdomen)	Blood clots blocking other blood vessels

Blood clots in a vein
What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, 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 first-time use of a combined hormonal contraceptive. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different drug) 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 ETINYLESTRADIOL AND DROSPIRENONE DOC, 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 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 ETINYLESTRADIOL AND DROSPIRENONE DOC 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 using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
Among 10,000 women using a combined hormonal contraceptive containing drospirenone, such as ETINYLESTRADIOL AND DROSPIRENONE DOC, 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”).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women out of 10,000
Women who use ETHINYLESTRADIOL AND DROSPIRENONE DOC	About 9-12 women out of 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with ETINILESTRADIOLO E DROSPIRENONE DOC is low, but certain conditions can increase it. Your risk is higher:

if you are significantly 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 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, illness, or if you have a leg in a cast. It may be necessary

to stop taking ETINILESTRADIOLO E DROSPIRENONE DOC
several weeks before surgery or during periods of reduced mobility. If you need to stop
taking ETINILESTRADIOLO E DROSPIRENONE DOC, ask your doctor when you can
resume taking it;

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 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 to have you stop taking ETINILESTRADIOLO E DROSPIRENONE DOC.
If any of the above conditions change while you are using ETINILESTRADIOLO E DROSPIRENONE DOC—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 DOC is very low but may increase:

with increasing age (over 35 years);
if you smoke. When using a combined hormonal contraceptive such as ETINILESTRADIOLO E DROSPIRENONE DOC, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
if you are overweight;
if you have high blood pressure;
if a close 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 ETINILESTRADIOLO E DROSPIRENONE DOC—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 DOC and cancer
A slightly increased frequency of breast cancer has been observed 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 visit their doctor more frequently. The occurrence of breast tumors 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 lump.
In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of oral contraceptives. Contact your doctor 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 DOC, you may experience unexpected bleeding (bleeding occurring outside the pill-free week). If such bleeding persists 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 during the pill-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, 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 blister pack if you are not certain you are not pregnant.

Other medicines and ETINILESTRADIOLO E DROSPIRENONE DOC
Always inform your doctor about any medicines or herbal products you are taking, have recently taken, or might take. Also inform any other doctor, dentist (or pharmacist) who prescribes a medicine that you are taking ETINILESTRADIOLO E DROSPIRENONE DOC. They will advise you whether you need to use additional contraceptive measures (for example, condoms) and, if so, for how long.
Some medicines can affect the blood levels of ETINILESTRADIOLO E DROSPIRENONE DOC and may reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding.
These include:

medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate) 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, efavirenz) or fungal infections (griseofulvin, ketoconazole) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the pulmonary 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 DOC, you must use additional contraceptive precautions (e.g., condoms) during treatment and for 28 days after stopping the treatment.
ETINILESTRADIOLO E DROSPIRENONE DOC may affect the action of other medicines, for example:

medicines containing cyclosporine
the antiepileptic lamotrigine (this may lead to an increase in seizure frequency)
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 conditions (e.g., diuretics).
Do not use ETINILESTRADIOLO E DROSPIRENONE DOC if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may lead to increased liver function test results (elevated ALT liver enzymes).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
ETINILESTRADIOLO E DROSPIRENONE DOC can be restarted approximately 2 weeks after completing this treatment. See section "Do not take ETINILESTRADIOLO E DROSPIRENONE DOC".

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 DOC if you are pregnant. If you become pregnant while taking ETINILESTRADIOLO E DROSPIRENONE DOC, stop immediately and inform your doctor. If you wish to become pregnant, you may stop taking ETINILESTRADIOLO E DROSPIRENONE DOC at any time (see also “If you want to stop taking ETINILESTRADIOLO E DROSPIRENONE DOC”).

Breastfeeding
The use of ETINILESTRADIOLO E DROSPIRENONE DOC is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.

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

ETINILESTRADIOLO E DROSPIRENONE DOC contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take ETINILESTRADIOLO E DROSPIRENONE DOC

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 DOC daily, if necessary with a small amount of water. You may take the tablet with or without food, but you must take it every day at approximately 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 known as the "tablet-free interval"), you should experience bleeding. This so-called "withdrawal bleeding" usually begins on the second or third day of the tablet-free interval.
On the eighth day after the last tablet of ETINILESTRADIOLO E DROSPIRENONE DOC (i.e., at the end of the 7-day tablet-free interval), start the next blister pack, regardless of whether bleeding has stopped or not. This means you should start each blister pack on the same day of the week, and withdrawal bleeding will occur on the same day each month.
If you use ETINILESTRADIOLO E DROSPIRENONE DOC in this way, contraceptive protection continues throughout the 7 days when you do not take tablets.

When to start the first blister pack?

If you have not used a hormonal contraceptive in the previous month Start taking ETINILESTRADIOLO E DROSPIRENONE DOC on the first day of your normal menstrual cycle (i.e., the first day of your period). If you start ETINILESTRADIOLO E DROSPIRENONE DOC on the first day of your cycle, you are immediately protected against pregnancy. You may also start between days 2 and 5 of your cycle, 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 device, or a patch Start ETINILESTRADIOLO E DROSPIRENONE DOC preferably on 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 of your previous pill). When switching from a combined vaginal device or a patch, start taking ETINILESTRADIOLO E DROSPIRENONE DOC preferably on the day of removal, or at the latest on the day you would have applied the next device or patch.
If switching from a progestogen-only method (progestin-only pill, injection, implant, or progesterone-releasing IUD)
You may switch at any time from a progestin-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 abortion or induced termination of pregnancy Follow your doctor's advice.
After childbirth You may start ETINILESTRADIOLO E DROSPIRENONE DOC between 21 and 28 days after delivery. If you start more than 28 days after delivery, use a so-called barrier contraceptive method (e.g., a condom) during the first 7 days of taking ETINILESTRADIOLO E DROSPIRENONE DOC. If you have had sexual intercourse after childbirth before starting ETINILESTRADIOLO E DROSPIRENONE DOC, ensure that you are not pregnant or wait for the next menstrual period.
If you are breastfeeding and wish to start (or restart) ETINILESTRADIOLO E DROSPIRENONE DOC after childbirth See the section "Breastfeeding".

Ask your doctor what to do if you are unsure about when to start.

If you take more ETINILESTRADIOLO E DROSPIRENONE DOC than you should
No serious adverse events have been reported following an overdose of ETINILESTRADIOLO E DROSPIRENONE DOC 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 DOC tablets or if a child has taken them, consult your doctor or pharmacist.

If you forget to take ETINILESTRADIOLO E DROSPIRENONE DOC

If you are less than 12 hours late in taking a 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 you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The greater the number of tablets you have missed, 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 the tablets at your usual time and use additional precautions for the next 7 days, for example, a condom. If you had sexual intercourse during the week before you missed the tablet, contact your doctor, as you may be pregnant.
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 the tablets at your usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions.
One tablet missed in Week 3

You have two options:

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 taking the 7-day tablet-free interval, start the next blister pack immediately. You will most likely experience bleeding at the end of the second blister pack, but you may also have light bleeding or bleeding similar to menstruation during the use of the second blister pack.
You may also stop taking tablets from the current blister pack and proceed directly to the 7-day tablet-free interval (including the days when you missed the tablet—mark the day you missed the tablet). If you wish to start a new blister pack on your usual starting day, reduce 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 outlines what to do if you forget to take one or more tablets:

Did you have sexual intercourse the week before forgetting?

No

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

Delaying menstruation: what you need to know
Although not recommended, you can delay your period by immediately starting a new pack of ETINILESTRADIOLO E DROSPIRENONE DOC without taking the usual pill-free interval, continuing directly with the next pack. You may experience light bleeding or bleeding similar to a period while taking the second pack. After finishing the second pack, take your usual 7-day pill-free interval, and then start the next pack.
You must consult your doctor before deciding to delay your menstrual period.

Changing the first day of menstruation: what you need to know
If you take the tablets as directed, your period will start during the pill-free week. If you wish to change this date, shorten the number of pill-free days (but never extend them – 7 days is the maximum!). For example, if your pill-free interval normally 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 pill-free interval considerably (for example, to 3 days or fewer), you may not have any bleeding during these days. You may subsequently experience light bleeding or bleeding similar to a period.
If you are unsure what to do, consult your doctor.

If you stop taking ETINILESTRADIOLO E DROSPIRENONE DOC
You may stop taking ETINILESTRADIOLO E DROSPIRENONE DOC at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods. If you wish to become pregnant, stop taking ETINILESTRADIOLO E DROSPIRENONE DOC 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 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 ETINILESTRADIOLO E DROSPIRENONE DOC, 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 DOC”.
If you experience any of the following side effects, you may need urgent medical attention. Stop taking ETINILESTRADIOLO E DROSPIRENONE DOC, contact your doctor immediately or go 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 or throat), and/or difficulty swallowing or rash with difficulty breathing (angioedema),
harmful blood clots in a lung (i.e. pulmonary embolism, PE)

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

harmful blood clots in a vein or artery, for example:
in a leg or foot (e.g. 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/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
Conditions that may occur or worsen during pregnancy or 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 signs 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)
Additionally observed were: breast cancer (see section 2 ‘ETINILESTRADIOLO E DROSPIRENONE DOC and cancer’), non-cancerous (benign) and cancerous (malignant) liver tumours (with signs such as abdominal swelling, weight loss, altered liver function detectable by blood tests), and chloasma (dark yellowish-brown patches on the skin, especially on the face, known as “pregnancy mask”), which may be permanent, particularly in women who previously developed chloasma during pregnancy.

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

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

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

Candida (fungal infection)
cold sores (herpes simplex)
allergic reactions
increased appetite
depression, nervousness, sleep disturbances
tingling sensations, dizziness
vision problems
irregular or abnormally rapid heartbeat
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, rashes, dry skin, disorders related to oily skin (seborrhoeic dermatitis)
neck pain, back pain, muscle cramps
bladder infection
breast lumps (benign), milk production outside pregnancy (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, very heavy periods, vaginal discharge, vaginal infections or inflammation, vaginal dryness, pelvic pain (lower abdominal pain), abnormal cervical smear (Pap test), decreased sexual desire
fluid retention, lack of energy, excessive thirst, increased sweating
weight loss
general pain.

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

asthma
hearing impairment
erythema nodosum (characterized by painful red skin nodules)
erythema multiforme (rash with red spots or target-shaped sores)

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 ETINILESTRADIOLO E DROSPIRENONE DOC

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ETINILESTRADIOLO E DROSPIRENONE DOC 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 hydrolysed 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 ETINILESTRADIOLO E DROSPIRENONE DOC and pack contents
The tablets are pink, round and film-coated.
ETINILESTRADIOLO E DROSPIRENONE DOC 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 European Economic Area countries under the
following names:
France: Drospirenone/Ethinylestradiol Mylan 3 mg/ 0.02 mg, comprimé pelliculé
Germany: Georgette-20 3 mg/0.02 mg Filmtabletten
Italy: ETINILESTRADIOLO E DROSPIRENONE DOC
Norway: Iren
Netherlands: Vallclara
United Kingdom: Vallclara