ESTINETTE 0.075 MG/0.020 MG Coated tablet

Содержание инструкции

1. Estinette 75 micrograms/20 micrograms coated tablets
   1. WHAT ESTINETTE IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING ESTINETTE
   3. HOW TO TAKE ESTINETTE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE EXTINETTE
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Estinette 75 micrograms/20 micrograms coated tablets

gestodene/ethinylestradiol

Equivalent Medicinal Product
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 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”)

Read this leaflet carefully before taking this medicine as 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 pass it on to others, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ESTINETTE IS AND WHAT IT IS USED FOR

Estinette is a combined oral contraceptive pill and belongs to a group of
medicines often called The Pill. Estinette contains two types of hormones: an estrogen,
ethinylestradiol, and a progestin, gestodene. These hormones prevent the ovaries from
producing an egg each month (ovulation). Furthermore, they thicken the fluid (mucus) in the
cervix (cervical opening), making it more difficult for sperm to contact the eggs. Finally,
they alter the lining of the uterus to make it more difficult for a fertilized egg to
implant.
Medical research and extensive experience demonstrate that, when taken correctly, The Pill is
an effective and reversible method of contraception.
It should be remembered that combined oral contraceptive pills like Estinette do not protect against
sexually transmitted diseases (such as AIDS); only a condom can help protect you from these diseases.

YOU AND THE PILL
How your body prepares for pregnancy(the menstrual cycle).
Usually you can become pregnant (i.e. conceive) from when you start having
menstruations (this normally happens during adolescence), until you no longer have
menstruations (i.e. when you enter menopause). Each menstrual cycle lasts approximately 28
days, and approximately halfway through this cycle one of the ovaries produces an egg, which
passes into one of the two Fallopian tubes. This process is called ovulation.
The egg descends inside the tube towards the uterus. When you have sexual intercourse, millions of sperm are released from
your partner's penis. From the vagina, these sperm
pass through the uterus into the Fallopian tubes, and if one of the tubes contains an egg and
a sperm reaches it, you may become pregnant. This process is called
‘conception’.
Once fertilized, the egg implants in the lining of the uterus and within nine months
grows into a baby. Because eggs can live for up to two
days, while sperm survive for up to five days, you can become pregnant
having intercourse up to five days before ovulation, and for some time
after ovulation. If the egg is not fertilized by a sperm, at the
end of the menstrual cycle the body eliminates it together with the lining of the uterus, with
‘menstruation’.

How do natural hormones work?
Your menstrual cycle is controlled by two sex hormones produced by the ovaries: estrogen and
progesterone (a progestin). Estrogen levels rise in the first half of the menstrual cycle and cause the uterus to produce a thick lining, ready to receive
the egg if conception occurs. Progesterone acts later during the menstrual cycle and changes the lining of the uterus to prepare it for pregnancy.
If you do not become pregnant, you will produce less of these hormones and the lining of the uterus will
break down. As mentioned earlier, the lining of the uterus is eliminated from the body
with menstruation. If, however, you were to become pregnant, the ovaries and the placenta (which keeps the
fetus connected to the uterus and nourishes it) continue to produce progesterone and estrogen to
prevent the ovaries from secreting other eggs. In other words, while you are pregnant you will not be able to
ovulate or have menstruation.

How does the pill work?
Combined contraceptive pills, like Estinette, contain hormones similar to those
produced by your body (estrogen and progestin). These hormones help you not to
become pregnant, just as your natural hormones prevent you from conceiving
when you are already pregnant.
The combined contraceptive pill protects you from possible
pregnancy in three ways.

• 1. There will be no egg available for sperm to fertilize.
• 2. The fluid inside the cervix thickens, making it more difficult for sperm to penetrate.
• 3. The lining of the uterus does not thicken enough to allow the egg to grow.

2. WHAT YOU NEED TO KNOW BEFORE USING ESTINETTE

General Notes
Before starting to use Estinette, read the information on blood clots
(thrombosis) in section 2.
It is particularly important that you read the symptoms of a blood clot (see section
2 “Blood clots”).

Do not use Estinette
Do not use Estinette 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 if you will be bedridden for a long 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 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 (or have ever had) a type of migraine called “migraine with aura”;
• if you have any 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) inflammation of the pancreas (pancreatitis) associated with high levels of lipids in the blood;
• if you have (or have ever had) liver disease and liver function tests are not

yet back to normal;

• if you have or have ever had a liver tumor;
• if you have (or have ever had) a tumor sensitive to sex hormones (e.g. breast cancer or cancer of the reproductive organs);
• if you have unusual vaginal bleeding;
• if you are allergic to gestodene or ethinylestradiol or any of the other ingredients of this medicine (listed in section 6);

Do not use Estinette if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see also the section “Other medicines and
Estinette”).
If you suffer from any of these conditions while taking Estinette, stop taking the pills and
contact your doctor immediately. In the meantime, use another method of contraception,
such as a condom or diaphragm plus spermicide.

Warnings and precautions
Talk to your doctor or pharmacist before taking Estinette
When should you see a doctor?
Seek urgent medical attention

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

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

Regular checks
Before starting to take Estinette, your doctor will ask you about your medical history,
asking you some questions about you and other members of your family. In addition, the doctor
will measure your blood pressure and rule out that you are pregnant. The doctor may also
examine you. When you started taking Estinette, you should see your doctor again
for regular check-ups, which will take place when you visit the doctor to request other
packs of pills.

Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using Estinette, tell your
doctor.
The doctor may ask you to stop using Estinette and advise you on another method
of contraception.

• if you have high levels of fats in your 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 have systemic lupus erythematosus (SLE, a disease that affects the natural defenses of the body);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you are going to have surgery or if you will be bedridden for a long period (see section 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Estinette;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.

If you suffer from:
high blood pressure (hypertension);
yellowing of the skin (jaundice);
itching all over the body;
gallstones;
an inherited disease called porphyria;
a movement disorder called Sydenham's chorea;
the skin rash called herpes gestationis;
the hereditary form of hearing loss called otosclerosis;
liver dysfunction;
diabetes;
depression or mood changes;
dark spots on the face and body (chloasma), which can be alleviated by not
exposing yourself to the sun and not using sunbeds or sunlamps

BLOOD CLOTS
The use of a combined hormonal contraceptive like Estinette causes an increased 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 the veins (a condition called “venous thrombosis”, "venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, these effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
Estinette is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been linked to 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
in which you start taking 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 Estinette, 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 Estinette is low.

• In 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. In 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or noregestimate, about 5-7 will develop a blood clot in a year.
• In 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Estinette, 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 forming a blood clot”).

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

• if you are severely overweight (body mass index or BMI greater than 30 kg/m );
• if a close relative of yours has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you will be bedridden for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking Estinette a few weeks before surgery or during the time you are less mobile. If you need to stop taking Estinette, 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 (duration >4 hours) may 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. The doctor may decide to stop you from taking Estinette. If any of the above conditions change while you are using Estinette, for example if a close relative develops thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

If you suffer from:
high blood pressure (hypertension);
yellowing of the skin (jaundice);
itching all over the body;
gallstones;
an inherited disease called porphyria;
a movement disorder called Sydenham's chorea;
the skin rash called herpes gestationis;
the hereditary form of hearing loss called otosclerosis;
liver dysfunction;
diabetes;
depression or mood changes;
dark spots on the face and body (chloasma), which can be alleviated by not
exposing yourself to the sun and not using sunbeds or sunlamps

BLOOD CLOTS
The use of a combined hormonal contraceptive like Estinette causes an increased 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 the veins (a condition called “venous thrombosis”, "venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, these effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
Estinette is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been linked to 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
in which you start taking 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 Estinette, 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 Estinette is low.

• In 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. In 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or noregestimate, about 5-7 will develop a blood clot in a year.
• In 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Estinette, 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 forming a blood clot”).

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

• if you are severely overweight (body mass index or BMI greater than 30 kg/m );
• if a close relative of yours has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you will be bedridden for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking Estinette a few weeks before surgery or during the time you are less mobile. If you need to stop taking Estinette, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have just 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) may 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. The doctor may decide to stop you from taking Estinette. If any of the above conditions change while you are using Estinette, for example if a close relative develops thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

If you suffer from:
high blood pressure (hypertension);
yellowing of the skin (jaundice);
itching all over the body;
gallstones;
an inherited disease called porphyria;
a movement disorder called Sydenham's chorea;
the skin rash called herpes gestationis;
the hereditary form of hearing loss called otosclerosis;
liver dysfunction;
diabetes;
depression or mood changes;
dark spots on the face and body (chloasma), which can be alleviated by not
exposing yourself to the sun and not using sunbeds or sunlamps

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
Estinette is very low but can increase:

• with increasing age (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like Estinette, it is advisable to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraception;
• 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 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 Estinette, for
example if you start smoking, if a close relative develops thrombosis for no known reason
or if you gain a lot of weight, contact your doctor.

The pill and cancer
Some studies have found a possible increased risk of cervical cancer with long-term use of
the pill. This increased risk may not be due to
the pill, but rather to the effects of sexual behavior and other circumstances. The
most important risk factor for cervical cancer is infection with the human papillomavirus (HPV).
All women are at risk of breast cancer, even if they do not take the pill. This
cancer rarely affects women under 40 years of age, and has been found to a slightly greater extent in women who take the pill compared to their peers who
do not use the pill. If you stop taking the pill, this risk is reduced, and after 10 years
after stopping the pill, the incidence of breast cancer is the same among women who
took the pill and those who never took it. Because breast cancer is rare
in women under 40 years of age, the increase in the number of diagnosed cases of
breast cancer in women who take the pill and have taken it in the past is low compared to
the risk of developing breast cancer over a lifetime.
In rare cases, the use of the pill has led to liver diseases, such as jaundice and benign
liver tumors. In very rare cases, the pill has been associated with some forms of malignant liver tumors (cancer) in women who use it for a long time. Liver tumors can
cause internal bleeding (bleeding in the abdomen) that can be life-threatening. If you
experience pain in the upper abdomen that does not improve quickly, tell your
doctor. Also see a doctor if you notice yellowing of the skin (jaundice).

Psychiatric disorders
Some women who use hormonal contraceptives including Estinette have reported
depression or depressed mood. Depression can be severe and sometimes can lead to
suicidal thoughts. If you experience changes in mood and depressive symptoms, see your
doctor as soon as possible for further medical advice.

Migraine/headache
Immediately inform your doctor if your migraine worsens or is recurrent, persistent, or
a severe headache develops (see also section 2 “Blood clots”).

Immune system disorder
Estinette may induce or worsen the symptoms of angioedema (sudden swelling of the face,
tongue and trachea that can cause difficulty breathing and swallowing). The risk is
higher if you or your close relatives have had problems with angioedema.

Other medicines and Estinette
Tell your doctor or pharmacist if you are taking or have recently taken or may
take any other medicines.
Also tell your doctor or dentist, who prescribes other medicines, that you are taking
Estinette. They can tell you if you need to use additional contraceptive precautions
(for example condoms) and if so, for how long, or if you need to change the use of
other medicines.
Do not use Estinette if you have hepatitis C and are taking medicines containing ombitasvir/
paritaprevir/ritonavir and dasabuvir, as this may cause an increase in laboratory test results
relating to liver function (increased ALT).
Your doctor will prescribe you another type of contraception before starting
treatment with these medicines.
Estinette can be restarted approximately 2 weeks after completion of treatment
with these medicines. See section “Do not use Estinette”.
Some medicines can affect the plasma levels of Estinette and may render
Estinette less effective in preventing pregnancy, or may cause
unexpected bleeding. These include medicines used for the treatment of:

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g. rifampicin);
• HIV and hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin);
• medicines used for the treatment of pulmonary arterial hypertension (bosentan);
• arthritis, osteoarthritis (etoricoxib) The herbal remedy St John's Wort. If you wish to use herbal products containing St John's Wort while already using Estinette, consult your doctor first.

Estinette can affect the effectiveness of other medicines, e.g.:

• cyclosporine (a medicine used for the treatment of rejection suppression following transplantation);
• theophylline (a medicine for the treatment of asthma);
• lamotrigine (medicines for the treatment of epilepsy - this may lead to an increase in the frequency of seizures);
• tizanidine (a medicine used for the treatment of pain and/or muscle cramps);

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

Before undergoing any laboratory tests
Inform your doctor or laboratory personnel that you are taking an oral contraceptive,
because oral contraceptives can affect the results of some tests.

Estinette with food and drink
Taking food and drink has no influence on the contraceptive effect of
the pill.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.

Pregnancy
If you suspect you are pregnant, stop taking Estinette and see your doctor immediately.
Until you speak to your doctor, use a different method of contraception,
such as a condom or diaphragm plus a spermicide. Ask your doctor or
pharmacist for advice before taking any medicine.

Breastfeeding
Ask your doctor or pharmacist for advice before taking Estinette.
Do not take Estinette
while breastfeeding your baby.

Driving and using machines
The effects of Estinette on the ability to drive vehicles or operate machinery have not
been studied.

Estinette contains lactose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

3. HOW TO TAKE ESTINETTE

Take this medicine always exactly as your doctor has told you. If you have
any doubts, ask your doctor.
This pack is designed to help you remember to take the pills.

How to start the first pack
Take the first pill on the first day of your period. This is the first day of your
menstruation, that is, when bleeding starts.
If you start the pill between the 2nd and 5th day of your cycle, also use another
contraceptive method, such as a condom, for the first 7 days of using the pill. However, this
only applies to the first pack.
You can take the pill at any time, but it is easier to take it at about the same time
each day. It may be easier to take it before bedtime, or when you wake up in the
morning. Take one pill every day, following the order indicated on the pack, until you
finish the entire pack of 21 pills.
After taking all 21 pills, stop for seven days. You will probably have bleeding during some of
these seven days.
You do not need to use other contraceptive methods during the 7 days you do not take the pill,
as long as the 21 pills have been taken correctly and you start the next pack without
delays.

Switching to the next pack
After seven days without taking any pills, start the next pack. Do this
even if the bleeding has not yet stopped. You should always start a new
pack on the same day of the week.

How to switch to Estinette from another combined hormonal contraceptive
Start taking Estinette the day after the end of the pill-free period of your previous
contraceptive (or after the last inactive pill of your previous contraceptive)

How to switch to Estinette from a progestin-only product (pills containing only

progestin, injection, implant)
You can switch from a progestin-only pill at any time, but you must
use additional protection (for example, a condom) for the first 7
days.
If you have had an injection, an implant, or an intrauterine device inserted, you can start taking Estinette on the day scheduled for your next injection, or on the day your implant or intrauterine system is removed, but in all these cases you must use additional contraceptive measures (for example, a condom) for the first
7 days.

How to start after childbirth, or after a spontaneous or surgical abortion
After childbirth or after a surgical or spontaneous abortion, your doctor will advise
on the suitability of using the pill.
You can start taking Estinette immediately after a spontaneous or surgical abortion that
occurs in the first trimester of pregnancy. In this case, you do not need to take further
contraceptive measures.
In the case of childbirth or abortion in the second trimester of pregnancy, Estinette can be started
21-28 days later. While breastfeeding, it is not advisable to take a combined pill,
as it may reduce milk production. Use a different contraceptive method (such as a
condom) for the first 7 days you take the pill. If you have had unprotected sex, do not start taking Estinette until the start of your menstrual cycle, or until pregnancy can be ruled out. If you have any doubts about using Estinette after childbirth or
after an abortion, consult your doctor or pharmacist.

If you take more Estinette than you should
If you take more Estinette than you should, it is unlikely to harm you, however
you may feel nauseous, vomit or have vaginal bleeding. If you experience
any of these symptoms, talk to your doctor, who may advise you whether anything needs to
be done.

If you forget to take Estinette
If you forget to take a pill, follow these instructions.
If you forgot to take the pill at the usual time and less than 12
hourshave passed, take it as soon as you remember. Then continue taking the pills
at the usual time.
If you forgot to take the pill at the usual time and more than 12
hourshave passed, or if you forgot to take more than one pill, the
contraceptive protection may be reduced. Take the forgotten pill as soon as you
remember, even if this means taking two pills in one day. Then continue to
take the pills at the usual time. In addition, a non-hormonal contraceptive method should be used for the next 7 days (e.g. condoms or a cervical cap with spermicide).
If you take the last pill from the blister during this 7-day period, you must
start taking pills from a new blister as soon as the current pack is
finished; no interval should be left between blisters. You are unlikely to
have a withdrawal bleed during the second pack, but you may experience spotting or
breakthrough bleeding. If you do not have a withdrawal bleed after the second pack, talk to your
doctor. The possibility of pregnancy must be ruled out before taking Estinette again.

If you stop taking Estinette
If you stop taking Estinette, you may become pregnant. Discuss other
contraceptive methods with your doctor to avoid pregnancy.

What to do if you vomit or have diarrhea
If you vomit or have diarrhea within 3-4 hours of taking the pill, the active ingredients
it contains may not be fully absorbed by the body. In this case, follow the advice given above regarding forgotten pills. In case of vomiting or
diarrhea, use additional contraceptive precautions, such as a condom, for all intercourse while you have an upset stomach, and for the next seven days.

What to do if you want to delay or move your period
If you want to delay or move your menstrual cycle, contact your doctor for advice.

If you want to delay your period
Continue with the next pack of Estinette after taking the last pill
in the current pack, without any breaks. You can take the desired number of
pills from the next pack, until the end of the second blister. When using the
second pack, you may notice spotting or some blood loss. At the end of the
usual 7-day non-pill-free interval, you start taking Estinette as usual.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think
may be due to Estinette, inform your doctor.
A greater 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
various risks associated with taking combined hormonal contraceptives, see paragraph
2 “What you need to know before using Estinette”.
The following side effects are related to the use of Estinette.
Side effects very common(may affect more than 1 in 10 people):
headache, irregular bleeding and spotting, between periods.
Side effects common(may affect up to 1 in 10 people):
vaginitis, fungal infections of the vagina, mood changes including depression and
nervousness, dizziness, nausea, upper abdominal pain, acne, painful menstruation,
change in vaginal secretion, absence of menstruation, weight gain, breast tension,
breast pain, breast secretion.
Side effects uncommon(may affect up to 1 in 100 people):
migraine, fluid retention, changes in appetite (increased or decreased), increased
blood pressure, vomiting, diarrhea, skin rashes, urticaria, chloasma (brownish-yellow patches on the skin), excessive hair growth, hair loss, changes
in serum lipid levels including hypertriglyceridemia, change in sexual interest
(reduced libido).
Side effects rare(may affect up to 1 in 1,000 people):
anaphylactic reactions (reactions, with very rare cases of urticaria, swelling of the face and
tongue, severe circulatory and respiratory disorders), glucose intolerance, jaundice, eye irritation
during the use of contact lenses, ear and labyrinth disorders, various
skin diseases (such as erythema multiforme, characterized by skin rashes, also target-like, and sores), erythema nodosum, (characterized by reddish and
painful skin nodules, reduction in blood folate levels, other diseases of the gastrointestinal tract,
change in sexual interest (increased libido).
Dangerous blood clots in the veins or arteries, for example:

• in a leg or foot (e.g. DVT)
• in a lung (e.g. PE)
• heart attack,
• stroke,
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eyes. The likelihood of having a blood clot may be higher if you have any other condition that increases the risk of blood clots (see paragraph 2 for more information on conditions that increase the risk of blood clots and the associated symptoms of blood clots.

Side effects very rare(may affect up to 1 in 10,000 people):
benign or malignant liver tumors, worsening of varicose veins, exacerbation of
systemic lupus erythematosus – SLE (a disorder in which blood clots cause
renal failure), exacerbation of porphyria, exacerbation of chorea (pathology
characterized by involuntary movements), optic nerve inflammation, clots in the blood
vessels of the eyes, weight loss, pancreatitis (inflammation of the pancreas), inflammatory bowel diseases (Crohn's disease, ulcerative colitis), gallbladder disorders, gallstones, a blood condition called hemolytic uremic syndrome HUS (a disorder in
which blood clots cause renal failure).

Not known( frequency cannot be estimated based on available data):
liver damage (such as hepatitis, abnormal liver function).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE EXTINETTE

Keep this medicine out of the sight and reach of children.
Store at a temperature below 25° C.
Store in the original package in order to protect from light and humidity
Do not use this medicine after the expiry date which is reported on the package after
the abbreviation Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Estinette contains
The active ingredients are: 75 micrograms of gestodene and 20 micrograms of ethinylestradiol in
each coated tablet.
The excipients are:
Tablet: Calcium edetate sodium, Magnesium stearate, Colloidal anhydrous silica, Povidone K-30,
Corn starch, Lactose monohydrate
Coating: Quinoline Yellow (E104), Povidone K-90, Titanium dioxide (E171), Macrogol
6000, Talc, Calcium carbonate (E170), Sucrose

Description of the appearance of Estinette and contents of the pack
Light yellow, round, biconvex, sugar-coated tablets, without
embossing.
Packaging:
Blisters: PVC/PVDC/aluminium.
Blisters: PVC/PVDC/aluminium in PETP/aluminium/PE bag.
Pack sizes: 1 x 21 tablets; 3 x 21 tablets; 6 x 21 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
Budapest
1103
Hungary

Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
Budapest
1103
Hungary