Ethinylestradiol and drospirenone Doc Generici

Package leaflet: Information for the user

ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici

0.02 mg/3 mg film-coated tablets
Generic Medicine
Please read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may be harmful to them.
• If you experience any side effect, 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 alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:
1. What ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici is and what it is used for
2. What you need to know before using ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici
When not to use ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici.
Warnings and precautions.
Blood clots.
ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici and cancer.
Intermenstrual bleeding.
What to do if menstruation does not occur during the placebo days.
Other medicines and ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici.
ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici with food and drink.
Laboratory tests.
Pregnancy.
Breast-feeding.
Driving and using machines.
ETINILESTRADIOLOLO E DROSPIRENONE DOC Generici contains lactose.

3. How to take ETINILESTRADIOLO E DROSPIRENONE DOC Generici

Blister preparation.
When can you start the first blister pack?
If you take more ETINILESTRADIOLO E DROSPIRENONE DOC Generici than you should.
If you forget to take ETINILESTRADIOLO E DROSPIRENONE DOC Generici.
What to do in case of vomiting or severe diarrhoea.
Delayed menstruation: what you should know.
Changing the day of onset of menstruation: what you should know.
If you stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici.
4. Possible side effects
5. How to store ETINILESTRADIOLO E DROSPIRENONE DOC Generici
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6. Contents of the pack and other information
1. What ETINILESTRADIOLO E DROSPIRENONE DOC Generici is and what it is used for

• ETINILESTRADIOLO E DROSPIRENONE DOC Generici is a contraceptive pill and is used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
• The 4 white tablets do not contain active substances and are also called placebo tablets.
• Contraceptive pills containing two hormones are known as combined pills.

2. What you should know before using ETINILESTRADIOLO E DROSPIRENONE DOC Generici

General information
Before starting to use ETINILESTRADIOLO E DROSPIRENONE DOC Generici, 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 taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici, your doctor will ask you several questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may perform additional tests.
This leaflet describes various situations in which you should stop using ETINILESTRADIOLO E DROSPIRENONE DOC Generici or in which the effectiveness of ETINILESTRADIOLO E DROSPIRENONE DOC Generici may be reduced. In such cases, you must avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as a condom or another barrier method.
Do not use the rhythm method or basal body temperature method. These methods may be unreliable because ETINILESTRADIOLO E DROSPIRENONE DOC Generici alters the monthly variations in body temperature and cervical mucus.
ETINILESTRADIOLO E DROSPIRENONE DOC Generici, like all hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.
When not to use ETINILESTRADIOLO E DROSPIRENONE DOC Generici
Do not use ETINILESTRADIOLO E DROSPIRENONE DOC Generici 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 may be more suitable for your case.
Do not take ETINILESTRADIOLO E DROSPIRENONE DOC Generici:

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are 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 ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of forming clots in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) a liver disease and liver function is still abnormal;
• if your kidneys do not work properly (renal failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or are suspected of having breast or genital organ cancer;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or to any of the excipients of this medicine (listed in section 6). This condition may manifest as itching, skin rash, or swelling.

Do not use ETINILESTRADIOLO E DROSPIRENONE DOC Generici 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 Generici").
Warnings and precautions
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs 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 clots"). 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.
In some situations, you must be particularly careful when using ETINILESTRADIOLO E
DROSPIRENONE DOC Generici or any other combined pill, and your doctor may need to examine you regularly. If any of these conditions appear or worsen while you are using ETINILESTRADIOLO E DROSPIRENONE DOC Generici, you must inform your doctor.

• if a close relative has or has ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you suffer from epilepsy (see "Other medicines and ETINILESTRADIOLO E DROSPIRENONE DOC Generici");
• if you have a disease that first appeared during pregnancy or during previous use of sex steroids (e.g. hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nerve disease causing sudden body movements (Sydenham's chorea));
• if you have or have ever had brownish patches of pigmentation (chloasma), known as “pregnancy mask”, especially on the face. In this case, avoid direct exposure to sunlight or ultraviolet rays;
• if you have hereditary angioedema, medicines containing oestrogens may trigger or worsen angioedema symptoms. If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with breathing difficulties, contact a doctor immediately. Contact your doctor before taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici

Blood clots
Using a combined hormonal contraceptive such as ETINILESTRADIOLO E DROSPIRENONE
DOC Generici 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 or, very rarely, these effects may be fatal.
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It is important to remember that the overall risk of a harmful blood clot associated with
ETINILESTRADIOLO E DROSPIRENONE DOC Generici is low.
How to recognize a blood clot
Contact a doctor immediately if you notice any of the following signs or symptoms.
What are you suffering from?
Do you have any of these signs?
Likely?

• 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 colour of the leg, such as paleness, reddish or bluish discoloration
• unexplained shortness of breath or sudden 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 vertigo
• rapid or irregular heartbeat
• severe stomach pain
  Pulmonary embolism

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 tract infection (e.g. a “common cold”).
Symptoms more frequently occurring in an eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision

• painless blurring of vision that may progress to loss of vision

• chest pain, discomfort, feeling of pressure or heaviness

• sensation of tightness or fullness in the chest, arm, or under the sternum

• feeling of fullness, indigestion, or suffocation

• discomfort in the upper body, radiating to the back, jaw, throat, arms, and stomach

• sweating, nausea, vomiting, or dizziness

• extreme weakness, anxiety, or shortness of breath

• rapid or irregular heartbeat
  Heart attack

What are you suffering from?
Do you have any of these signs?
Likely?

• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body
• sudden confusion, difficulty speaking or understanding
• sudden difficulty seeing with one or both eyes
• sudden difficulty walking, dizziness, loss of balance or coordination
• sudden severe or prolonged headache without known cause
• loss of consciousness or fainting with or without seizures
  Stroke

Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still contact a doctor urgently as you may be at risk of another stroke.
Blood clots blocking other blood vessels

• swelling and pale blue colouration of a limb
• severe stomach (abdominal) pain

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 clot formation in veins (venous thrombosis). These side effects, however, 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 moves from the leg and lodges in the lung, it may cause a pulmonary embolism.

• Very rarely, the clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year when first starting a combined hormonal contraceptive. The risk may also be higher if you restart taking 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 ETINILESTRADIOLO E DROSPIRENONE DOC Generici, the risk of developing a blood clot returns to normal levels within a few weeks.
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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 using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with ETINILESTRADIOLO E DROSPIRENONE DOC Generici 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 DOC Generici, about 9-12 will develop a blood clot in a year.
• The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

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

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici several weeks before surgery or during periods of reduced mobility. If you need to stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, especially if you have other listed risk factors.
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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 Generici.
If any of the above conditions change while you are using ETINILESTRADIOLO E DROSPIRENONE DOC Generici—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

Blood clots in an artery
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of ETINILESTRADIOLO E DROSPIRENONE DOC Generici 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 DOC Generici, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat 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 Generici—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 Generici and cancer
Breast cancer is observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, women using the pill may be diagnosed with more tumors simply because they undergo more frequent medical check-ups.
The occurrence of breast cancer gradually decreases after stopping combined hormonal contraception. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
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Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been observed in women using the pill. Contact your doctor if you experience unusual and severe abdominal pain.

Intermenstrual bleeding
During the first few months of taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici, unexpected bleeding (bleeding outside the placebo days) may occur. If this bleeding continues for more than a few months or starts after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the placebo days
If you have taken all the active pink tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are certain you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including ETINILESTRADIOLO E DROSPIRENONE DOC Generici, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.

Other medicines and ETINILESTRADIOLO E DROSPIRENONE DOC Generici
Always inform your doctor if you are taking any medicines or herbal products. Inform any other doctor or dentist (or pharmacist) who prescribes you another medicine that you are taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici. They will advise whether you need to use additional contraceptive measures (e.g., condoms), and if so, for how long, or whether the use of another medicine you may need should be adjusted.
Some medicines:

• affect the levels of ETINILESTRADIOLO E DROSPIRENONE DOC Generici in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include:

• medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
  • tuberculosis (e.g., rifampicin);
  • HIV infection and Hepatitis C virus (ritonavir, nevirapine, efavirenz, known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
  • fungal infections (griseofulvin, ketoconazole);
  • arthritis, osteoarthritis (etoricoxib);
  • high blood pressure in the pulmonary arteries (bosentan);

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• St. John’s wort (Hypericum perforatum), a herbal remedy.

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

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

Do not use ETINILESTRADIOLO E DROSPIRENONE DOC Generici 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 DOC Generici may be restarted approximately 2 weeks after completing this treatment. See section "Do not take ETINILESTRADIOLO E DROSPIRENONE DOC Generici".

Ask your doctor or pharmacist for advice before taking any medicine.

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

Pregnancy and breastfeeding
Pregnancy
You must not use ETINILESTRADIOLO E DROSPIRENONE DOC Generici if you are pregnant. If you become pregnant while taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici, stop taking the pill immediately and contact your doctor. If you wish to become pregnant, you may stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici at any time (see also “If you stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici”).

Breastfeeding
The use of ETINILESTRADIOLO E DROSPIRENONE DOC Generici is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
There is no evidence to suggest that ETINILESTRADIOLO E DROSPIRENONE DOC Generici affects the ability to drive vehicles or operate machinery.

ETINILESTRADIOLO E DROSPIRENONE DOC Generici contains lactose.
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If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici.

3. How to take ETINILESTRADIOLO E DROSPIRENONE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The two differently coloured tablets of ETINILESTRADIOLO E DROSPIRENONE DOC Generici are arranged in sequence. One blister contains 28 tablets.
Take one tablet of ETINILESTRADIOLO E DROSPIRENONE DOC Generici every day, with a little water if necessary. You may take the tablets with or without food, but you must take them at approximately the same time each day.
Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. Then immediately start a new blister (24 pink tablets and 4 white tablets). Therefore, there is no break between blisters.
Since the composition of the tablets differs, you must start with the first tablet in the top left corner and take the tablets daily in the order indicated. To ensure correct sequence, follow the direction of the arrows on the blister pack.

Blister preparation
To help you keep track of your daily pill intake, each blister of ETINILESTRADIOLO E DROSPIRENONE DOC Generici includes 7 adhesive labels with the 7 days of the week. Choose the label starting with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the adhesive label beginning with “WED”.
Apply the weekly adhesive label along the top edge of the blister pack where it says “Place label here”, so that the first day appears above the tablet marked with the number “1”. Now each tablet has a day marked above it, allowing you to visually check whether you have taken a particular tablet. The numbers indicate the order in which the tablets should be taken.

During the 4 days when you take the white placebo tablets (placebo days), you should experience menstruation (so-called “withdrawal bleeding”). This usually starts on the 2nd or 3rd day after the last active pink tablet of ETINILESTRADIOLO E DROSPIRENONE DOC Generici.
After taking the last white tablet, you must immediately start the next blister, even if menstruation is still ongoing. This means you will start each blister on the same day of the week, and your periods will occur on the same days every month.
When taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici as described above, you are protected against pregnancy even during the 4 days when you take the placebo tablet.

When can you start the first blister?

• If you have not used a hormonal contraceptive in the previous month
  Start taking ETINILESTRADIOLO and DROSPIRENONE DOC Generici on the first day of your cycle (i.e. the first day of menstruation). If you start ETINILESTRADIOLO and DROSPIRENONE DOC Generici on the first day of menstruation, contraceptive protection is immediate. You may also start between day 2 and day 5 of the cycle, but in this case you must use additional contraceptive measures (e.g. a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive, a combined vaginal ring, or a contraceptive patch
  Start taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the pill-free interval (or after the last inactive tablet of your previous pill). When switching from a combined vaginal ring or contraceptive patch, follow your doctor’s advice.

• Switching from a progestin-only method (progestin-only pill, injection, implant, or progestin-releasing intrauterine system (IUS))
  You may switch on any day from the progestin-only pill (from an implant or IUS on the day of removal, from an injectable when the next injection is due), but in all these cases you must use additional contraceptive measures (e.g. a condom) for the first 7 days of tablet intake.

• After an abortion
  Follow your doctor’s advice.

• After childbirth
  You may start taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici between day 21 and day 28 after delivery. If you start later than day 28, you must use a barrier method (e.g. a condom) during the first 7 days of taking ETINILESTRADIOLO and DROSPIRENONE DOC Generici. If, after childbirth, you have had sexual intercourse before starting (or restarting) ETINILESTRADIOLO E DROSPIRENONE DOC Generici, you must first ensure you are not pregnant or wait for menstruation.

• If you are breastfeeding and wish to start (or restart) taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici after childbirth
  Read the section “Breastfeeding”.

Ask your doctor for advice if you are unsure about when to start.

If you take more ETINILESTRADIOLO E DROSPIRENONE DOC Generici than you should
There are no reports of serious harmful effects following overdose with ETINILESTRADIOLO E DROSPIRENONE DOC Generici.
If you take several tablets at once, you may experience nausea or vomiting. Young girls may have vaginal bleeding.
If you have taken too many tablets of ETINILESTRADIOLO E DROSPIRENONE DOC Generici or if you find that a child has taken any tablets, contact your doctor or pharmacist.

If you forget to take ETINILESTRADIOLO E DROSPIRENONE DOC Generici
The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget one of these tablets, this does not affect the reliability of ETINILESTRADIOLO E DROSPIRENONE DOC Generici. Discard the forgotten placebo tablet.
If you forget an active pink tablet (tablets 1 to 24 in your blister), follow the instructions below:

• If the delay in taking a tablet is less than 24 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, then continue taking the tablets as scheduled.
• If the delay in taking a tablet is more than 24 hours, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy. This risk is greatest if you miss a pink tablet at the beginning or end of the blister. Therefore, follow the instructions below (see also the diagram below):
  • More than one tablet missed in this blister
    Contact your doctor.
  • One tablet missed during days 1–7 (first row)
    Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking tablets at your usual time and use additional contraceptive measures (e.g. a condom) for the next 7 days. If you had sexual intercourse in the week before the missed tablet, pregnancy may have occurred. In this case, contact your doctor.
  • One tablet missed during days 8–14 (second row)
    Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking tablets as scheduled. Contraceptive protection remains effective, and no additional precautions are needed.
  • One tablet missed during days 15–24 (third or fourth row)
    You have two options:
    1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets as scheduled. Instead of taking the placebo tablets in the current blister, discard them and immediately start the new blister (your starting day will change). Withdrawal bleeding will most likely occur at the end of the second blister, during the intake of the white placebo tablets, but spotting or breakthrough bleeding may occur during the second blister.
    2. Alternatively, you may stop taking the active pink tablets and switch directly to the 4 white placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start the next blister on your usual day, take fewer than 4 placebo tablets.

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

• If you have missed any tablet in the blister and do not have a withdrawal bleed during the placebo days, you may be pregnant. Contact your doctor before starting a new blister.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking an active pink tablet or have severe diarrhoea, the active ingredients may not be completely absorbed by your body. This situation is similar to forgetting a tablet. After vomiting or severe diarrhoea, take a new pink tablet from a spare blister as soon as possible. If possible, take it within 24 hours of your usual tablet-taking time. If this is not possible, or if more than 24 hours have passed, follow the instructions in the section “If you forget to take ETINILESTRADIOLO E DROSPIRENONE DOC Generici”.

Delayed menstruation: what you should know
Although not recommended, it is possible to delay menstruation by not taking the white placebo tablets from the 4th row and continuing directly with a new blister of ETINILESTRADIOLO E DROSPIRENONE DOC Generici. During use of this second blister, you may experience light bleeding or spotting. Complete this second blister, including the 4 white tablets from the 4th row. Then start the next blister.
You may consult your doctor before deciding to delay your period.

Changing the day your menstruation starts: what you should know
If you take the tablets as directed, your periods will start during the placebo days. If you wish to change the starting day, you may shorten (but never extend—4 days is the maximum!) the placebo period while taking the white placebo tablets. For example, if your placebo period starts on Friday and you wish to shift it to Tuesday (3 days earlier), you should start the next blister 3 days earlier. You may not have a period during this time. You may subsequently experience light bleeding or spotting.
Ask your doctor for advice if you are unsure what to do.

If you stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici
You may stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking ETINILESTRADIOLO E DROSPIRENONE DOC Generici and wait for menstruation before trying to conceive. This will allow you to calculate the expected date of delivery more accurately.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to ETINILESTRADIOLO E DROSPIRENONE DOC Generici, 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 various risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before using ETINILESTRADIOLO E DROSPIRENONE DOC Generici”.

The following side effects have been associated with the use of ethinylestradiol 0.02 mg / drospirenone 3 mg:

Common side effects (may affect between 1 and 10 out of 100 women):

• mood swings
• headache
• nausea
• breast tenderness, menstrual problems such as irregular periods, absence of periods.

Uncommon side effects (may affect between 1 and 10 out of 1,000 women):

• depression, nervousness, drowsiness
• dizziness, tingling
• migraine, varicose veins, increased blood pressure
• stomach ache, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea
• acne, itching, skin rashes
• pains such as back pain, limb pain, muscle cramps
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually decreases with continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual problems, painful periods, scanty periods, very heavy periods, vaginal dryness, abnormal Pap test, decreased interest in sex
• lack of energy, increased sweating, fluid retention
• weight gain.

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Rare side effects (may affect between 1 and 10 out of 10,000 women):

• candidiasis (fungal infection)
• anaemia, increased number of platelets in the blood
• allergic reaction
• hormonal disorders (endocrine)
• increased appetite, loss of appetite, excessively high potassium levels in the blood, excessively low sodium levels in the blood
• inability to achieve orgasm, insomnia
• vertigo, tremor
• eye disorders, such as eyelid inflammation, dry eyes
• abnormally rapid heartbeat
• vein inflammation, nosebleeds, fainting
• abdominal swelling, intestinal disorders, bloating sensation, hiatal hernia, fungal infection of the mouth, constipation, dry mouth
• pain in the bile ducts or gallbladder, gallbladder inflammation
• yellowish-brown skin spots, eczema, hair loss, acne-like skin inflammation, dry skin, granulomatous skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, skin inflammation due to light sensitivity, skin nodules
• painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast nodules, abnormal growth of the cervical mucosa, reduction or narrowing of the uterine lining, ovarian cysts, uterine enlargement
• general feeling of malaise
• weight loss
• harmful blood clots in a vein or an artery, for example:
• in a leg or foot (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).

The following side effects have also been reported, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (skin rash with red and inflamed target-shaped lesions).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
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avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ETINILESTRADIOL AND DROSPIRENONE DOC Generici

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 carton and blister pack after "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 Generici contains
The active substances are ethinylestradiol and drospirenone.
Each active pink film-coated tablet contains 0.02 milligrams of ethinylestradiol and
3 milligrams of drospirenone.
The white film-coated tablets do not contain any active substances.
The other components are:
Active pink film-coated tablet:
Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone (E1201),
sodium croscarmellose, polysorbate 80, magnesium stearate (E572).
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Inactive white film-coated tablet:
Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of ETINILESTRADIOLO E DROSPIRENONE DOC Generici and
pack contents
Each blister of ETINILESTRADIOLO E DROSPIRENONE DOC Generici contains 24 pink active
film-coated tablets in rows 1, 2, 3 and 4 of the blister, and 4 white placebo film-coated tablets in row 4.
ETINILESTRADIOLO E DROSPIRENONE DOC Generici, both pink and white tablets, are film-coated; the tablet core is coated.
ETINILESTRADIOLO E DROSPIRENONE DOC Generici is available in packs containing 1, 3, 6 and 13 blisters, each blister containing 28 (24 + 4) tablets.
It is possible that not all pack sizes are marketed.

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

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: ETINILESTRADIOLO E DROSPIRENONE DOC Generici
Netherlands: Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 DOC Generici, filmomhulde tabletten
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