Estinette

PACKAGE LEAFLET: INFORMATION FOR THE USER

Estinette 75 micrograms/20 micrograms film-coated tablets

gestodene/ethinylestradiol
Generic Medicine

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

• 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 alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

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, 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 taking 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 commonly known as "the Pill". Estinette contains two types of hormones: an oestrogen, ethinylestradiol, and a progestogen, gestodene. These hormones prevent the ovaries from releasing an egg each month (ovulation). In addition, they thicken the fluid (mucus) in the neck of the womb (cervix), making it more difficult for sperm to meet the egg. Finally, they alter the lining of the womb to make it harder for a fertilised egg to implant.

Medical research and extensive experience show that, when taken correctly, the Pill is an effective and reversible method of contraception.

Please remember that combined oral contraceptive pills such as 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).

Normally, you can become pregnant (i.e. conceive) from when you start having periods (which usually occurs during adolescence) until you stop having periods (i.e. when you reach menopause). Each menstrual cycle lasts about 28 days. Approximately halfway through this cycle, one of the ovaries releases an egg, which moves into one of the two Fallopian tubes. This process is called ovulation.

The egg travels down the Fallopian tube towards the womb. When you have sexual intercourse, millions of sperm are released from your partner’s penis. From the vagina, these sperm pass through the womb into the Fallopian tubes, and if one of the tubes contains an egg and a sperm reaches it, you can become pregnant. This process is called 'conception'.

Once fertilised, the egg implants into the lining of the womb and over the course of nine months grows into a baby. Since eggs can survive for up to two days, while sperm can survive for up to five days, you can become pregnant from sexual intercourse up to five days before ovulation and for a short time afterwards. If the egg is not fertilised by a sperm, at the end of the menstrual cycle your body sheds it along with the lining of the womb, in what is known as 'menstruation'.

How do natural hormones work?

Your menstrual cycle is controlled by two sex hormones produced by the ovaries: oestrogen and progesterone (a progestogen). Oestrogen levels rise during the first half of the menstrual cycle and cause the womb to develop a thick lining, ready to receive the egg in case of conception. Progesterone acts later in the menstrual cycle and changes the lining of the womb to prepare it for pregnancy.

If you do not become pregnant, your body produces lower levels of these hormones and the lining of the womb breaks down. As mentioned earlier, the lining of the womb is expelled from the body during menstruation. However, if you do become pregnant, the ovaries and the placenta (which connects and nourishes the foetus to the womb) continue to produce progesterone and oestrogen to prevent the ovaries from releasing further eggs. In other words, while you are pregnant, you will not ovulate or have periods.

How does the Pill work?

Combined oral contraceptive pills such as Estinette contain hormones similar to those naturally produced by your body (oestrogen and progestogen). These hormones prevent you from becoming pregnant in the same way that your natural hormones prevent you from conceiving again while you are already pregnant.

The combined oral contraceptive pill protects you from possible pregnancy in three ways:

1. There will be no egg available for fertilisation by sperm.
2. The fluid in the neck of the womb thickens, making it harder for sperm to penetrate.
3. The lining of the womb does not thicken enough to allow the fertilised egg to grow.

2. WHAT YOU SHOULD KNOW BEFORE USING ESTINETTE

General Notes
Before starting to use Estinette, you must read the information about blood clots (thrombosis) in section 2. It is particularly important that you read about 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 these conditions, consult your doctor. Your doctor will discuss with you other methods of birth control that may be more suitable for your situation.

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in 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 and which may be an early sign of heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) any of the following conditions, which may increase the risk of clots forming in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinemia;
• if you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high lipid levels in the blood;
• if you have (or have ever had) liver disease and liver function tests have not yet returned to normal;
• if you have or have ever had a liver tumour;
• if you have (or have ever had) a hormone-sensitive tumour (e.g. breast cancer or reproductive organ cancers);
• if you have unusual vaginal bleeding;
• if you are allergic to gestodene or ethinylestradiol or to 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, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Estinette”).
If you develop any of these conditions while taking Estinette, stop taking the tablets immediately and contact your doctor. In the meantime, use another method of contraception, such as a condom or diaphragm with spermicide.

Warnings and Precautions
Talk to your doctor or pharmacist before taking Estinette.

When should you contact a doctor?
Seek urgent medical advice

• if you notice signs suggestive of a 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 Clots”).

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

Regular Check-ups
Before you start taking Estinette, your doctor should take a full medical history, asking you questions about yourself and other members of your family. In addition, your doctor will measure your blood pressure and rule out pregnancy. Your doctor may also perform a physical examination. Once you have started taking Estinette, you should return to your doctor for regular check-ups, which will occur when you visit for further supplies of tablets.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Estinette, inform your doctor.
Your doctor may advise you to stop using Estinette and recommend an alternative method of contraception.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• 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 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 Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• If you have sickle cell anaemia (an inherited red blood cell disorder);
• If you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood Clots”);
• If you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Estinette;
• If you have inflammation of veins near the skin surface (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 disorder called porphyria;
a movement disorder called Sydenham’s chorea;
a skin rash called herpes gestationis;
hereditary hearing loss called otosclerosis;
liver function disorders;
diabetes;
depression or mood changes;
dark patches on the face and body (chloasma), which may be reduced by avoiding sun exposure and not using sunbeds or sunlamps.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Estinette increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

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

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

It is important to remember that the overall risk of a harmful blood clot associated with Estinette is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice 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 associated with an increased risk of blood
clots forming 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 product) 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 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 venous thromboembolism (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 Estinette 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 one 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 one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Estinette, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Estinette is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in 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 Estinette several weeks before surgery or during periods of reduced mobility. 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 if you have several of these conditions. Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have 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 stop your use of Estinette.

If any of the above conditions change while you are using Estinette—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 Estinette is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Estinette, 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 Estinette—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.

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 itself, but rather to the effects of sexual behavior and other circumstances. The most important risk factor for cervical cancer is infection with 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 observed slightly more frequently in women taking the pill compared to women of the same age who do not use the pill. If you stop taking the pill, this risk decreases, and after 10 years from stopping the pill, the incidence of breast cancer is the same among women who took the pill and those who never used it. Since 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 or have taken the pill is low compared to the lifetime risk of developing breast cancer.

In rare cases, use of the pill has been associated with liver diseases such as jaundice and benign liver tumors. In very rare cases, the pill has been linked to certain forms of malignant liver tumors (cancer) in women who have used it for a long time. Liver tumors can cause intra-abdominal hemorrhage (bleeding in the abdomen), which may be life-threatening. If you experience upper abdominal pain that does not improve quickly, inform your doctor. Also consult your doctor if you notice yellowing of the skin (jaundice).

Psychiatric disorders
Some women using hormonal contraceptives, including Estinette, 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, consult your doctor as soon as possible for further medical advice.

Migraine/headache
Inform your doctor immediately if your migraine worsens or becomes recurrent or persistent, or if you develop a severe headache (see also section 2 “Blood clots”).

Children and adolescents
Estinette is not indicated before menarche (the first menstrual bleeding).

Other medicines and Estinette
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Also inform any doctor or dentist prescribing other medicines that you are taking Estinette. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of other medicines.

Do not use Estinette if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in blood test results related to liver function (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Estinette can be restarted approximately 2 weeks after completing treatment with these medicines. See section “Do not use Estinette”.

Some medicines can affect the plasma levels of Estinette and may make Estinette less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin);
• 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 using Estinette, consult your doctor first.

Estinette may affect the effectiveness of other medicines, for example:

• cyclosporine (a medicine used to prevent tissue rejection after organ transplantation);
• theophylline (a medicine used to treat asthma);
• lamotrigine (medicines used to treat epilepsy—which may lead to an increase in the frequency of epileptic seizures);
• tizanidine (a medicine used to treat pain and/or muscle spasms).

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

Before undergoing any laboratory tests
Inform your doctor or laboratory staff that you are taking an oral contraceptive, as oral contraceptives may affect the results of certain tests.

Estinette with food and drink
Taking food and drinks does not affect the contraceptive effect of the pill.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you suspect you are pregnant, stop taking Estinette and contact your doctor immediately. Until you speak with your doctor, use a different contraceptive method such as condoms or a diaphragm with spermicide. Consult your doctor or pharmacist before taking any medicine.

Breastfeeding
Consult your doctor or pharmacist before taking Estinette. Do not take Estinette while breastfeeding your baby.

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

Estinette contains lactose, sucrose, and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Estinette

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
This pack is designed to help you remember to take your pills.

Starting the first pack
Take the first pill on the first day of your menstrual period. This is the first day of bleeding.

If you start taking the pill between the 2nd and 5th day of your cycle, use a second contraceptive method (such as a condom) during the first 7 days of pill use. However, this applies only to the first pack.

You may take the pill at any time of day, but it should be taken at approximately the same time each day. It might be easier to take it before going to bed or when you wake up in the morning.

Take one pill every day, following the order indicated on the pack, until you have taken all 21 pills.

After taking all 21 pills, stop for seven days. During some of these seven days, you will likely experience bleeding.

You do not need to use additional contraceptive methods during the 7 pill-free days, provided all 21 pills have been taken correctly and you start the next pack without delay.

Starting the next pack
After the seven-day break without taking any pills, start the next pack. Begin the new pack even if bleeding has not yet stopped. You should always start a new pack on the same day of the week.

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

Switching to Estinette from a progestogen-only product (progestogen-only pills, injection, implant)
You may switch to Estinette on any day from a progestogen-only pill, but you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of taking Estinette.

If you have received an injection, implant, or intrauterine device (IUD), you may start taking Estinette on the day when the next injection would have been due, or on the day your implant or IUD is removed. However, in all these cases, you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of taking Estinette.

Starting after childbirth, miscarriage, or abortion
After childbirth or after a surgical or spontaneous abortion, your doctor will advise you on whether it is suitable to use the pill.

You may start taking Estinette immediately after a spontaneous or surgical abortion occurring in the first trimester of pregnancy. In this case, no additional contraceptive measures are needed.

After childbirth or an abortion in the second trimester of pregnancy, you may start taking Estinette 21–28 days later. Combined oral contraceptives are not recommended during breastfeeding, as they may reduce milk production. Use a different contraceptive method (such as a condom) during the first 7 days of taking the pill. If you have had unprotected intercourse, do not start taking Estinette until the beginning of your next menstrual cycle, or until pregnancy has been 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
Taking more Estinette than prescribed is unlikely to harm you, but you may experience nausea, vomiting, or vaginal bleeding. If you experience any of these symptoms, speak to your doctor, who may advise you on any necessary actions.

If you forget to take Estinette
If you forget to take a pill, follow the instructions below.

If you have forgotten to take your pill at the usual time and less than 12 hours have passed, take it as soon as you remember. Then continue taking your pills at the usual time.

If you have forgotten to take your pill at the usual time and more than 12 hours have passed, or if you have forgotten more than one pill, contraceptive protection may be reduced.

Take the most recently missed pill as soon as you remember, even if this means taking two pills in one day. Then continue taking your pills at your usual time. In addition, use a non-hormonal contraceptive method for the next 7 days (e.g., condoms or a cervical cap with spermicide).

If you take the last pill from the blister pack during this 7-day period, start taking pills from a new pack immediately after finishing the current one—do not leave any gap between packs. It is unlikely that you will 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, speak to your doctor. Pregnancy must be ruled out before restarting Estinette.

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 in case of vomiting or diarrhoea?
If you vomit or have diarrhoea within 3–4 hours of taking the pill, the active ingredients may not be fully absorbed by your body. In this case, follow the advice given for missed pills. If you experience vomiting or diarrhoea, use additional contraceptive precautions (e.g., a condom) for all sexual intercourse during the illness and for 7 days afterwards.

What to do if you wish to delay or shift your period
If you wish to delay or shift your menstrual period, contact your doctor for advice.

To delay your period, continue with the next pack of Estinette immediately after taking the last pill of the current pack, without a break. You may take as many pills as desired from the next pack, up to the end of the second blister. While taking the second pack, you may notice breakthrough bleeding or spotting. After completing the usual 7-day tablet-free interval, resume taking Estinette in the normal way.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Estinette, inform your doctor.
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with potential breathing difficulties (see also section “Warnings and precautions”).
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 using Estinette”.
The following side effects are associated with the use of Estinette.
Very common side effects (may affect more than 1 in 10 people):
Headache, irregular bleeding and spotting between periods.
Common side effects (may affect up to 1 in 10 people):
Vaginitis, fungal vaginal infections, mood changes (including depression and nervousness), dizziness, nausea, upper abdominal pain, acne, painful menstruation, changes in vaginal discharge, absence of menstruation, weight gain, breast tenderness, breast pain, breast discharge.
Uncommon side effects (may affect up to 1 in 100 people):
Migraine, fluid retention, changes in appetite (increased or decreased), increased blood pressure, vomiting, diarrhoea, skin rashes, urticaria, chloasma (brownish-yellow patches on the skin), excessive hair growth, hair loss, changes in serum lipid levels including hypertriglyceridaemia, change in sexual interest (reduced libido).
Rare side effects (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 disturbances), glucose intolerance, jaundice, eye irritation during contact lens use, general ear and labyrinth disorders, various skin diseases (such as erythema multiforme, characterised by skin rashes, including target-like lesions, and sores), nodular erythema, characterised by reddish and painful skin nodules, reduction in blood folate levels, other gastrointestinal tract disorders, change in sexual interest (increased libido).
Dangerous blood clots in 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 temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eyes. The likelihood of developing a blood clot may be higher if you have any other condition that increases the risk of blood clots (see section 2 for more information on conditions that increase the risk of blood clots and associated symptoms).

Very rare side effects (may affect up to 1 in 10,000 people):
Benign or malignant liver tumours, worsening of varicose veins, exacerbation of systemic lupus erythematosus – SLE (a disorder in which blood clots cause kidney failure), exacerbation of porphyria, exacerbation of chorea (a condition characterised by involuntary movements), optic nerve inflammation, blood clots in ocular blood vessels, weight loss, pancreatitis (inflammation of the pancreas), intestinal inflammatory diseases (Crohn’s disease, ulcerative colitis), gallbladder disorders, gallstones, a blood disorder called haemolytic uraemic syndrome (HUS) (a disorder in which blood clots cause kidney failure).
Not known ( frequency cannot be estimated from the available data ):
Liver damage (such as hepatitis, abnormal liver function).
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 the following website: 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 Estinette

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging in order to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton after the abbreviation
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 Estinette contains
The active substances are: 75 micrograms of gestodene and 20 micrograms of ethinylestradiol in each
coated tablet.
The excipients are:
Tablet: Calcium sodium edetate, magnesium stearate, anhydrous colloidal silica, povidone K-30, maize starch, lactose monohydrate
Coating: Quinoline yellow (E 104), povidone K-90, titanium dioxide (E 171), macrogol 6000, talc, calcium carbonate (E 170), sucrose
Description of the appearance of Estinette and contents of the pack
Light yellow, round, biconvex sugar-coated tablets without imprint.
Pack:
Blister: PVC/PVDC/aluminium.
Blister: PVC/PVDC/aluminium in PETP/aluminium/polyethylene 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 and Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Selling Agent:
Exeltis Italia s.r.l.
Via Lombardia 2/a
20068 Peschiera Borromeo (MI)
Italy