Egogyn

Patient Information Leaflet: Information for the User

Egogyn 0.150 mg + 0.030 mg coated tablets

levonorgestrel + ethinylestradiol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others; it could be harmful to them.
• If you experience any adverse effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are among the most reliable reversible contraceptive methods when 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;
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section “Blood clots”).

Contents of this leaflet:

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

1. What Egogyn is and what it is used for

• Egogyn is a combined hormonal contraceptive (CHC) used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, levonorgestrel and ethinylestradiol (pharmacotherapeutic category: progestogens and estrogens).
• Contraceptive pills containing two hormones are known as "combined pills".

2. What you should know before taking Egogyn

General information
Before starting to take Egogyn, you must read the information about blood clots in the section “Blood clots”. It is particularly important that you read about the symptoms of a blood clot (see section “Blood clots”).
Before starting or restarting Egogyn, a thorough medical examination is recommended, and pregnancy must be ruled out. Furthermore, periodic check-ups—at least once a year—are advisable during treatment with this medicine. The frequency and type of examination will be determined by your doctor and should include monitoring of blood pressure, breast examination, abdominal and general gynaecological examination including a Pap test, and relevant blood tests.
Like all contraceptive pills, Egogyn does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Egogyn is prescribed for personal use only and should not be shared among multiple individuals simultaneously.
Do not use Egogyn

• if you are allergic to levonorgestrel, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6); Do not use Egogyn 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 methods of birth control that may be more suitable for your case.
• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE), or in another organ;
• 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 immobile 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 a heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have one of the following conditions, which could increase the risk of developing blood clots in the arteries: o severe diabetes with blood vessel damage, o very high blood pressure, o very high levels of fats (cholesterol or triglycerides) in the blood, or a condition known as hyperhomocysteinaemia (high levels of homocysteine in the blood);
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have eye diseases of vascular origin;
• if you currently have or have previously had jaundice (yellowing of the skin) or a serious liver disease; in this case, do not use Egogyn until liver function values have returned to normal;
• if you currently have or have previously had breast or genital organ cancer;
• if you currently have or have previously had benign or malignant liver tumours;
• if you have vaginal bleeding of unknown origin;
• if you are or suspect you may be pregnant;
• in combination with Ritonavir (an antiviral medicine).

If any of these conditions occurs for the first time while you are taking the medicine, stop taking it immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods.
See also “General information”.
Do not use Egogyn 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 Egogyn”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Egogyn.
When to be especially careful with Egogyn
When should you contact a doctor?
Contact a doctor urgently

• if you notice any possible signs 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 (thrombosis)”). For a description of the symptoms of these serious side effects, go to the section “How to

recognize a blood clot”.
This patient leaflet describes certain situations in which you must stop taking the medicine or in which the effectiveness of the medicine may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions such as condoms or other barrier methods. Do not use rhythm or basal body temperature methods, which may be unreliable, as the pill alters the normal variations in body temperature and cervical mucus that occur during the menstrual cycle.
If you have any of the following conditions, the use of a combined oral contraceptive may require close monitoring by your doctor. Inform your doctor if you have any of the conditions listed below before starting Egogyn. Your doctor may recommend a different (non-hormonal) method of contraception.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are taking Egogyn, inform your doctor.
smoking;
diabetes;
overweight;
high blood pressure (hypertension);
heart valve disorders or certain heart rhythm disorders;
superficial phlebitis (vein inflammation);
varicose veins;
history of thrombosis, heart attack, or stroke (even in close family members);
migraine (one-sided headache);
depression;
epilepsy (see “Other medicines and Egogyn”);
history of high cholesterol and triglyceride (fats) levels in the blood (even in close family members);
breast lumps;
family history of breast cancer;
liver or gallbladder diseases;
porphyria (a metabolic blood disorder);
if you suffer or have suffered from chloasma (yellow-brown skin patches, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
if you have had gestational pemphigoid (an autoimmune skin disease affecting women during pregnancy or immediately after childbirth);
certain medical conditions characterised by resistance to activated protein C, hyperhomocysteinaemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant), which predispose to venous or arterial thrombosis;
Sydenham's chorea (a central nervous system disorder);
hearing loss due to otosclerosis;
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. Medicines containing oestrogens may induce or worsen symptoms of hereditary or acquired angioedema;
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 impaired kidney function);
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 immobile for a prolonged period (see section “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 Egogyn;
if you have inflammation of veins under the skin (superficial thrombophlebitis);
if you have varicose veins.
If any of the above conditions appears for the first time, recurs, or worsens during use of the pill, consult your doctor.
Do not take St. John’s wort (Hypericum perforatum) preparations concurrently with medicines containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, or phenytoin due to the risk of decreased blood levels and reduced therapeutic effectiveness of oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, and phenytoin (see “Other medicines and Egogyn”).
Psychiatric disorders
Some women using hormonal contraceptives, including Egogyn, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Egogyn 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, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Egogyn is low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely suffering from?
Deep vein thrombosis
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, redness, or bluish discolouration.

Pulmonary embolism

• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up blood;
• sharp chest pain that may worsen when breathing

severe dizziness or fainting; • severe dizziness or lightheadedness; • rapid or irregular heartbeat; • severe stomach pain. If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a "common cold").
Symptoms occurring more frequently in one eye: • sudden loss of vision or • painless blurring of vision which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, or heaviness; • squeezing sensation or fullness in the chest, one arm, or under the breastbone; • feeling of fullness, indigestion, or choking; • discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach; • sweating, nausea, vomiting, or dizziness; • extreme weakness, anxiety, or shortness of breath; • rapid or irregular heartbeat.	Heart attack
sudden numbness or weakness of the face, arm, or leg, especially on one side of the body; • sudden confusion, difficulty speaking or understanding speech; • sudden trouble seeing with one or both eyes; • sudden difficulty walking, dizziness, loss of balance or coordination; • sudden severe or prolonged headache with no known cause; • loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; • severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels

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

• The use of combined hormonal contraceptives has been associated with an increased risk of 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, 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 of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medicine or a different one) 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 Egogyn, 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 on 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 Egogyn 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 within one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, such as Egogyn, about 5–7 will develop a blood clot within one year.
• The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of blood clot formation”).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill, patch or vaginal ring and who are not pregnant	About 2 women in 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women in 10,000
Women who use Egogyn	About 5-7 women in 10,000

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

• if you are very overweight (body mass index or BMI over 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 due to undergo surgery or need to remain lying down for a prolonged period due to injury or illness, or if you have a leg in a cast. It may be necessary to stop

taking Egogyn several weeks before surgery or during periods of reduced mobility. If you need to stop taking Egogyn, ask your doctor when you can start 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 over 4 hours) may temporarily increase the risk of blood clot formation, particularly if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Egogyn.
If any of the above conditions change while you are using Egogyn—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, such as 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 Egogyn is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Egogyn, 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 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 (valve defects, 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 Egogyn—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.
Tumours
Breast cancer diagnoses are slightly more frequent in women using the pill compared to women of the same age who do not use it. This slight increase in breast cancer diagnoses gradually disappears within 10 years after stopping treatment. It is not known whether this difference is due to the pill.
This increase could be due to earlier diagnosis, as women are examined more frequently, to the biological effect of the pill, or to a combination of both factors. Breast cancer diagnosed in women taking the pill tends to be less clinically advanced than in women who do not use it.

Benign liver tumours have been rarely reported in women taking the pill, and malignant liver tumours even more rarely. Such tumours may cause internal bleeding. Contact your doctor immediately if you experience severe abdominal pain.
It has been reported that cervical cancer (cervix) is more frequent in women who use the pill for a long time. This may not be due to the pill, but rather to sexual behaviour and other factors occasionally implicated in the development of tumours in general.
Regular check-ups
While using the pill, your doctor will ask you to attend regular check-ups, usually once a year.
Contact your doctor as soon as possible:

• if you notice any change in your health status, particularly related to what is described in this patient information leaflet (see also “Do not use Egogyn” and “Warnings and precautions”. Do not forget references to close family members);
• if you detect a lump in your breast;
• if you need to take other medicines (see also “Other medicines and Egogyn”);
• if you are immobilized or need to undergo surgery (consult your doctor at least four weeks in advance);
• if you have unusually heavy or unusual vaginal bleeding;
• if you missed taking tablets during the first week of use and had sexual intercourse in the seven days before the missed tablets;
• if you miss two consecutive periods or suspect pregnancy, do not start a new pack without your doctor’s approval.

Stop taking the tablets and contact your doctor immediately if you notice possible signs of thrombosis:

• sudden onset of cough;
• severe chest pain that may radiate to the left arm;
• sudden shortness of breath;
• unusual, severe, or prolonged headache or migraine attack;
• partial or complete loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell, or taste;
• dizziness or fainting;
• sudden weakness or numbness in any part of the body;
• severe abdominal pain;
• severe pain or swelling in one leg.

The above situations and symptoms are described and explained in greater detail in other sections of this patient information leaflet.
Children and adolescents
The safety and efficacy of Egogyn in children and adolescents under 18 years of age have not been established. No data are available.
Patients with hepatic impairment (liver)
Do not take Egogyn if you have liver disease. See “Do not use Egogyn” and “Warnings and precautions”.
Patients with renal impairment (kidneys)
Egogyn has not been specifically studied in patients with reduced kidney function.
Other medicines and Egogyn
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may reduce the effectiveness of the pill. These include:

• primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate (used to treat epilepsy),
• rifampicin and rifabutin (used to treat tuberculosis),
• ritonavir, nevirapine (used to treat HIV and hepatitis C infections),
• modafinil (used to treat excessive sleepiness associated with narcolepsy) and flunarizine,
• griseofulvin, and azole antifungals such as itraconazole, voriconazole, fluconazole (used to treat fungal infections),
• macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections),
• calcium channel blockers such as verapamil and diltiazem (used to treat certain heart conditions and high blood pressure),
• etoricoxib (used to treat arthritis and osteoarthritis).

Egogyn may interfere with the action of other medicines, such as:

• medicines containing cyclosporine (used to prevent transplant rejection),
• lamotrigine (used to treat epilepsy),
• melatonin (a hormone),
• midazolam (a sedative),
• theophylline (used to dilate the airways),
• tizanidine (used to relax muscles).

Preparations containing Hypericum perforatum should not be taken concurrently with oral contraceptives, as contraceptive effectiveness may be lost. Unintended pregnancies and resumption of menstruation have been reported. This is due to the induction of enzymes responsible for drug metabolism by Hypericum perforatum preparations. The inducing effect may persist for at least 2 weeks after stopping treatment with Hypericum perforatum-containing products (see “Egogyn with food and drink”).
Troleandomycin (a macrolide antibiotic) may increase the risk of intrahepatic cholestasis (impaired bile flow from the liver to the duodenum) when taken concomitantly with combined oral contraceptives.
Always inform the doctor prescribing the pill about any other medicines you are taking, and also inform any other doctors or dentists prescribing other medicines that you are using Egogyn, so they can determine whether and for how long additional contraceptive methods are needed.
Using the pill may affect the results of certain blood tests, but these changes are generally within the normal range. Therefore, it is advisable to inform the doctor requesting the tests that you are taking the pill.
Do not use Egogyn if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Egogyn may be resumed approximately 2 weeks after completing this treatment. See section “Do not use Egogyn”.
Egogyn with food and drink
Do not take Egogyn with grapefruit juice.
While taking oral contraceptives, do not take preparations containing Hypericum perforatum.
Concurrent use may lead to loss of contraceptive effectiveness (see “Other medicines and Egogyn”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Egogyn if you are pregnant or suspect pregnancy.
If you become pregnant while using Egogyn, stop taking the medicine immediately.
Egogyn is not recommended during breastfeeding.
Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk. These amounts may affect the infant.
Driving and using machines
Egogyn does not affect or affects negligibly the ability to drive or operate machinery.
Egogyn contains lactose and sucrose
This medicine contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Egogyn

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The Egogyn pack contains 21 tablets, each marked with the day of the week on which it should be taken. Take the tablet at approximately the same time every day, with a little water if necessary. Follow the direction of the arrows until all 21 tablets are used. Do not take any tablets for the next 7 days, during which menstruation (withdrawal bleeding) should occur, usually starting 2–3 days after the last Egogyn tablet. Start the new pack on the eighth day, even if menstruation has not yet finished. By doing so, you will always start the new pack on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
Combined oral contraceptives, when taken correctly, have a failure rate of 1% per year. The failure rate increases if tablets are missed or not taken correctly.

Starting the first pack
No previous hormonal contraception in the preceding month
Begin taking Egogyn on the first day of your cycle, i.e., the first day of menstruation, taking the tablet marked with that day of the week. For example, if menstruation starts on Friday, take the tablet marked Friday. Then continue in the order indicated by the arrows. You may also start between the second and fifth day of the cycle, but in this case, use an additional contraceptive method (barrier method) for the first seven days of tablet intake during the first cycle.

Switching from another combined oral contraceptive, vaginal ring, or contraceptive patch
You may start taking Egogyn the day after the last active tablet of the previous contraceptive (i.e., without any tablet-free interval). If the previous pack contains inactive tablets, take Egogyn the day after the last active tablet (in case of doubt, consult your doctor). You may start later, but never later than the day after the tablet-free interval (or the day after the last inactive tablet) of the previous contraceptive. If you have used a vaginal ring or patch, you should preferably start Egogyn on the day of removal of the last ring or patch of a cycle, or at the latest, when the next application would have been due.

Switching from a progestogen-only pill (mini-pill)

You may stop the mini-pill on any day and start taking Egogyn the following day at the same time. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.

Switching from a contraceptive injection, implant, or intrauterine system releasing progestogen (IUS)
Start using Egogyn on the day when the next injection is due or on the day the implant is removed. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.

After childbirth
The timing of starting the pill after childbirth should be determined by your doctor. Your doctor will decide whether to start treatment between day 21 and day 28, or later. In the latter case, an additional barrier method should be used during the first 7 days of tablet intake. However, if you have had sexual intercourse in the meantime, exclude pregnancy before starting the pill or wait for the onset of the first menstruation.
If you are breastfeeding and wish to take Egogyn, speak to your doctor first (see “Pregnancy and breastfeeding”).

After spontaneous or induced abortion
Follow your doctor’s instructions.

If you take more Egogyn than you should
No serious adverse effects have been reported following the accidental intake of multiple tablets at once. In such cases, nausea, vomiting, and vaginal bleeding may occur. Even girls who have not yet had their first menstruation may experience bleeding after accidental intake of this medicine.
In case of accidental ingestion/overdose of Egogyn, contact your doctor immediately or go to the nearest hospital.

If you forget to take Egogyn
If less than 12 hours have passed since your usual intake time, the reliability of the contraceptive remains unchanged. Take the missed tablet as soon as you remember and continue as usual.
If more than 12 hours have passed since your usual intake time, the contraceptive reliability may be reduced. The greater the number of consecutive missed tablets, the higher the risk that contraceptive protection is reduced. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. Follow the instructions below (see also the flowchart that follows).

More than one tablet missed in a pack
Consult your doctor.

One tablet missed during the first week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Use additional contraceptive methods (barrier methods) for the next 7 days.
If you had sexual intercourse during the week before the missed tablet, pregnancy may have occurred. Inform your doctor immediately.

One tablet missed during the second week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. The contraceptive reliability is maintained. No additional contraceptive precautions are necessary.

One tablet missed during the third week
You may choose one of the following alternatives, without needing additional contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Start the new pack immediately after finishing the current one, without any tablet-free interval. Withdrawal bleeding may not occur until the end of the second pack, but breakthrough bleeding (spotting) may occur during tablet intake.

or

2. Stop taking tablets from the current pack, observe a tablet-free interval of 7 days or less ( including the day the tablet was missed ), and then start a new pack. If you choose this option, you can start the new pack on the same day of the week as usual. If you miss one or more tablets and do not have withdrawal bleeding during the first tablet-free interval, pregnancy may have occurred. Consult your doctor before starting the new pack.

more than one consult your doctor
tablet
missed in a
cycle

yes

had sexual intercourse in the week
first week before the missed tablet?

no


• take the missed tablet
• use additional contraceptive precautions for 7 days
• finish the pack

only one
tablet
missed (more than second ▪ take the missed tablet
hours passed) week ▪ finish the pack

• take the missed tablet third ▪ finish the pack week ▪ do not observe a tablet-free interval
• continue with the new pack

or

• stop the current pack
• observe a tablet-free interval (no more than 7 days, including the day the tablet was missed)
• continue with a new pack

In case of gastrointestinal disturbances (e.g., vomiting and/or diarrhoea)
If you experience vomiting or severe diarrhoea within 3–4 hours after taking Egogyn, the active ingredient may not have been completely absorbed. This is similar to having missed a tablet. Therefore, follow the instructions for missed tablets.

Delaying menstruation: what you should know
Although not recommended, it is possible to delay menstruation by starting a new pack of Egogyn without observing the 7-day tablet-free interval. Breakthrough bleeding or spotting may occur during the second pack. Continue with the next pack after the usual 7-day interval.
Consult your doctor before deciding to delay menstruation.

Changing the day menstruation starts: what you should know
If you take the tablets as instructed, menstruation will start approximately on the same day of the week. If you wish to change this day, you may shorten ( never lengthen ) the usual 7-day break between two consecutive packs. For example, if menstruation usually starts on Friday and you wish it to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier. If the break between two cycles is made too short (e.g., 3 days or less), menstruation may not occur during that interval. In such cases, breakthrough bleeding or spotting may occur during the next treatment cycle.
Consult your doctor if you have any doubts about how to proceed.

In case of unexpected bleeding
With all oral contraceptives, vaginal bleeding between periods may occur during the first few months of use. Irregular bleeding usually resolves once the body has adjusted to the pill (typically after about 3 cycles).
Consult your doctor if such bleeding persists, becomes heavy, or recurs regularly.

If menstruation does not occur
If all tablets have been taken correctly, there has been no vomiting, and no other medicines have been taken, it is very unlikely that pregnancy has occurred. Continue taking the medicine as usual.
If menstruation does not occur for two consecutive cycles, pregnancy may have occurred.
Consult your doctor immediately. Do not start a new pack until your doctor has ruled out pregnancy.

If you stop taking Egogyn
You may stop taking Egogyn at any time. If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you wish to stop taking Egogyn because you want to become pregnant, speak to your doctor. In this case, it is generally advisable to wait until menstruation returns to a regular pattern before attempting conception.

If you have any doubts about how to use 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 it is severe or persistent, or if you notice any change in your health that you think could be due to Egogyn, inform your doctor.

Serious side effects
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 "Warnings and precautions".
Serious side effects associated with the use of the pill and their related symptoms are described in the section "When to take special care with Egogyn", "Blood clots" and "Tumours". For further information, please read these sections and contact your doctor immediately.
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 possible difficulty breathing (see also the section "Warnings and precautions").
The following side effects have been associated with the use of Egogyn:
Common (may affect up to 1 in 10 people)

• nausea,
• abdominal pain,
• weight gain,
• headache,
• depressed mood,
• mood changes,
• breast tenderness,
• breast pain.

Uncommon (may affect up to 1 in 100 people)

• vomiting,
• diarrhoea,
• fluid retention,
• migraine (unilateral headache),
• decreased libido,
• breast enlargement,
• skin reactions (rash, urticaria).

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

• intolerance to contact lenses,
• hypersensitivity reactions (allergy),
• weight loss,
• increased libido,
• breast secretion,
• vaginal discharge,
• skin disorders (erythema nodosum, erythema multiforme),
• 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), or 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 "Warnings and precautions" for further

information on conditions that increase the risk of blood clots and symptoms of a blood clot).
Frequency not known (frequency cannot be estimated from the available data)

• exacerbation of symptoms of hereditary and acquired angioedema

Other side effects:

• oligomenorrhoea (increased interval between menstrual periods),
• amenorrhoea (absence of menstruation),
• intermenstrual bleeding.

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the 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 Egogyn

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister, box) following "EXP." The expiry date refers to the last day of that month. The expiry date refers to the product in its original, undamaged packaging, properly stored.
Do not use the medicine if you notice any change in colour or crumbling of the tablet, or in the presence of any other visible signs of deterioration.
Do not dispose of any medicine 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 Egogyn contains

• The active substances are levonorgestrel and ethinylestradiol. Each coated tablet contains 0.150 mg of levonorgestrel and 0.030 mg of ethinylestradiol.
• The other components are: lactose monohydrate, maize starch, povidone 25, talc, magnesium stearate, sucrose, povidone 90, macrogol 6000, calcium carbonate, 85% glycerol, titanium dioxide, yellow iron oxide (E172), ethylene glycol ester of montanic acid (E wax).

Description of the appearance of Egogyn and pack contents
Coated tablets for oral use.
The product is packaged in calendar blisters containing 21 coated tablets.
Marketing Authorization Holder
Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen (Germany)
Manufacturer
Bayer AG, Muellerstrasse, 178, 13353 Berlin (Germany)
Bayer Weimar GmbH und Co. KG, Doebereinerstrasse 20, 99427 Weimar (Germany)