EGOGYN 0.150 MG/0.030 MG Coated tablet

Содержание инструкции

1. Egogyn 0.150 mg + 0.030 mg coated tablets
   1. Che cos’è Egogyn e a cosa serve
   2. Cosa deve sapere prima di prendere Egogyn
   3. How to take Egogyn
   4. Possible side effects
   5. How to store Egogyn
   6. Contents of the pack and other information

Egogyn 0.150 mg + 0.030 mg coated tablets

levonorgestrel + ethinylestradiol

Read this leaflet carefully before you start using 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, even if they have the same symptoms, 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.

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 blood clots forming in the 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 “Blood clots”).

Contents of this leaflet:

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

1. Che cos’è Egogyn e a cosa serve

• Egogyn è un contraccettivo ormonale combinato (COC) utilizzato per prevenire una gravidanza.
• Ogni compressa contiene una piccola quantità di due ormoni femminili differenti, levonorgestrel e etinilestradiolo (categoria farmacoterapeutica dei progestinici ed estrogeni).
• Le pillole contraccettive che contengono due ormoni sono chiamate “pillole combinate”.

2. Cosa deve sapere prima di prendere Egogyn

Note generali
Prima di iniziare a prendere Egogyn deve leggere le informazioni sui coaguli di sangue al paragrafo “Coaguli
di sangue”. È particolarmente importante che legga i sintomi di un coagulo di sangue (vedere paragrafo
“Coaguli di sangue”).
Prima di iniziare o ricominciare ad assumere Egogyn si consiglia di effettuare un’accurata visita medica e
deve essere esclusa una gravidanza. Inoltre è consigliabile effettuare periodiche visite di controllo, almeno
una volta l'anno, durante l'impiego del medicinale. La frequenza e il tipo di visita, saranno stabilite dal
medico e rivolte in particolare al controllo della pressione del sangue, ad un esame del seno, dell'addome e
ginecologico generale compreso un Pap-test e relative analisi del sangue.

Come tutte le pillole contraccettive, Egogynnon protegge nei confronti dell’infezione da HIV (AIDS) o
di qualunque altra malattia a trasmissione sessuale.

Egogyn è prescritto per un utilizzo personale e non deve essere a disposizione di più persone
contemporaneamente.

Non usi Egogyn

• se è allergica al levonorgestrel, all’etinilestradiolo o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6); Non usi Egogyn se presenta una delle condizioni elencate sotto. Se presenta una qualsiasi delle condizioni elencate sotto, si rivolga al medico. Il medico discuterà con lei degli altri metodi di controllo delle nascite che potrebbero essere più adatti al suo caso.
• se ha (o ha mai avuto) un coagulo di sangue in un vaso della gamba (trombosi venosa profonda, TVP), del polmone (embolia polmonare, EP) o di altri organi;
• se sa di avere un disturbo che colpisce la coagulazione del sangue, come carenza di proteina C, carenza di proteina S, carenza di antitrombina-III, fattore V di Leiden o anticorpi antifosfolipidi;
• se deve sottoporsi a un’operazione o se starà in posizione sdraiata per un lungo periodo (vedere paragrafo “Coaguli di sangue”);
• se ha mai avuto un attacco di cuore o un ictus;
• se ha (o ha mai avuto) un’angina pectoris (una condizione che causa un forte dolore al torace e che può rappresentare un primo segno di attacco di cuore) o un attacco ischemico transitorio (TIA - sintomi di ictus temporaneo);
• se ha una delle seguenti malattie, che potrebbe aumentare il rischio che si formino coaguli di sangue nelle arterie: o diabete grave con lesione dei vasi del sangue, o pressione del sangue molto alta, o livello molto alto di grassi (colesterolo o trigliceridi) nel sangue, o una malattia nota come iperomocisteinemia (elevata quantità di omocisteina nel sangue);
• se ha (o ha mai avuto) un tipo di emicrania chiamata “emicrania con aura”;
• se ha malattie degli occhi di origine vascolare;
• se ha o ha avuto in passato ittero (ingiallimento della pelle) o una grave malattia del fegato; in questo caso non usi Egogyn fino a quando i valori della funzionalità del fegato non sono tornati alla norma;
• se ha o ha avuto in passato tumore al seno o agli organi genitali;
• se ha o ha avuto in passato tumore al fegato benigno o maligno;
• se presenta emorragia vaginale di origine sconosciuta;
• se è o sospetta di essere in gravidanza;
• in associazione con Ritonavir (medicinale antivirale).

Se una qualunque di queste condizioni compare per la prima volta durante l’uso del medicinale, sospenda
immediatamente l’assunzione e consulti il medico. Nel frattempo usi metodi contraccettivi non ormonali.
Vedere anche “Note generali”.
Non usi Egogyn se ha l’epatite C e se sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir
e dasabuvir (vedere anche il paragrafo “Altri medicinali e Egogyn”).

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Egogyn.

Quando fare particolarmente attenzione con Egogyn
Quando deve rivolgersi a un medico?
Si rivolga urgentemente a un medico

• se osserva segni possibili di un coagulo di sangue che possono indicare che soffre di un coagulo di sangue nella gamba (trombosi venosa profonda), di un coagulo di sangue nel polmone (embolia polmonare), di un attacco di cuore o di un ictus (vedere il paragrafo seguente "Coagulo sanguigno (trombosi)"). Per una descrizione dei sintomi di questi gravi effetti indesiderati vada al paragrafo “Come riconoscere un coagulo di sangue”.

del medicinale o nelle quali può verificarsi una riduzione dell’efficacia del medicinale stesso. In tali
situazioni non deve avere rapporti sessuali o deve adottare precauzioni contraccettive aggiuntive non
ormonali quali l’uso del profilattico o di altro metodo di barriera. Non usi i metodi del ritmo e della
temperatura basale, che possono risultare inaffidabili, poiché la pillola altera le normali variazioni della
temperatura e del muco cervicale che si verificano durante il ciclo mestruale.
In presenza di una qualunque delle condizioni sottoelencate, l’uso della pillola di tipo combinato può
richiedere una stretta sorveglianza da parte del medico. Avverta il medico dell’eventuale presenza di una
qualunque delle condizioni sotto indicate prima di iniziare ad usare Egogyn. Il medico potrebbe consigliarle
un metodo di contraccezione diverso (non ormonale).

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
Se questa condizione compare o peggiora mentre sta prendendo Egogyn deve informare il medico.
fumo;
diabete;
sovrappeso;
aumento della pressione del sangue (ipertensione);
vizi valvolari cardiaci o alcuni disturbi del ritmo cardiaco;
flebite superficiale (infiammazione venosa delle vene);
vene varicose;
storia di trombosi, attacco di cuore o ictus (anche in familiari prossimi);
emicrania (mal di testa unilaterale);
depressione;
epilessia (vedere “Altri medicinali e Egogyn”);
storia di livelli elevati di colesterolo e trigliceridi (grassi) nel sangue (anche in familiari prossimi);
noduli al seno;
storia familiare di tumore al seno;
malattie del fegato o della colecisti;
porfiria (anomalia metabolica del sangue);
se soffre o ha sofferto di cloasma (macchie sulla pelle di colore giallo- bruno, in particolare sul viso). In
tal caso, eviti l’esposizione prolungata al sole o ai raggi ultravioletti;
se ha sofferto di herpes gestationis (malattia autoimmune della pelle che coinvolge le donne durante
gravidanza o nell’immediato periodo dopo il parto);
alcune condizioni patologiche caratterizzate da resistenza alla proteina C attivata, iperomocisteinemia,
deficit di antitrombina III, deficit di proteina C, deficit di proteina S, anticorpi antifosfolipidici (anticorpi
anticardiolipina, lupus anticoagulante), che predispongono all'insorgenza di trombosi venosa o arteriosa;
corea di Sydenham (disturbo del sistema nervoso centrale);
perdita dell'udito da otosclerosi;
se è affetta da angioedema ereditario, i medicinali contenenti estrogeni possono indurre o aggravare i
sintomi dell’angioedema. Se nota i sintomi dell’angioedema come gonfiore del viso, lingua e/o faringe
e/o difficoltà a deglutire o orticaria con difficoltà di respirazione, avvisi immediatamente il suo medico.
se ha la malattia di Crohn o la colite ulcerosa (malattia intestinale infiammatoria cronica);
se ha il lupus eritematoso sistemico (LES, una malattia che colpisce il sistema di difese naturali);
se ha la sindrome emolitica uremica (SEU, un disturbo della coagulazione del sangue che causa alterata
funzionalità dei reni);
se ha l’anemia falciforme (una malattia ereditaria dei globuli rossi);
se ha livelli elevati di grassi nel sangue (ipertrigliceridemia) o una storia familiare positiva per tale
condizione. L’ipertrigliceridemia è stata associata a un maggior rischio di sviluppare pancreatiti
(infiammazioni del pancreas);
se deve sottoporsi a un’operazione o se starà in posizione sdraiata per un lungo periodo (vedere
paragrafo “Coaguli di sangue”);

se ha appena partorito, il suo rischio di sviluppare coaguli di sangue è maggiore. Chieda al medico
quanto tempo dopo il parto può iniziare a prendere Egogyn;
se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
se ha le vene varicose.
In caso di prima comparsa, recidiva o peggioramento di una qualunque delle suddette condizioni durante
l’uso della pillola, consulti il medico.
Non assuma preparazioni a base di iperico ( Hypericum perforatum) in contemporanea con medicinali
contenenti contraccettivi orali, digossina, teofillina, carbamazepina, fenobarbital, fenitoina a causa del
rischio di un decremento dei livelli nel sangue e di diminuzione dell'efficacia terapeutica di contraccettivi
orali, digossina, teofillina, carbamazepina, fenobarbital, fenitoina (vedi ”Altri medicinali e Egogyn”).

Disturbi psichiatrici
Alcune donne che usano contraccettivi ormonali tra cui Egogyn hanno segnalato depressione o umore
depresso. La depressione può essere grave e a volte può portare a pensieri suicidari. Se si verificano
cambiamenti d’umore e sintomi depressivi, si rivolga al più presto al medico per ricevere ulteriori consigli
medici.

COAGULI DI SANGUE
L’uso di un contraccettivo ormonale combinato come Egogyn causa un aumento del rischio di sviluppare un
coagulo di sangue rispetto al non utilizzo. In rari casi un coagulo di sangue può bloccare i vasi del sangue e
causare problemi gravi.
I coaguli di sangue possono svilupparsi

• nelle vene (condizione chiamata “trombosi venosa”, "tromboembolia venosa” o TEV)
• nelle arterie (condizione chiamata “trombosi arteriosa”, “tromboembolia arteriosa” o TEA). La guarigione dai coaguli di sangue non è sempre completa. Raramente, si possono verificare effetti gravi di lunga durata o, molto raramente, tali effetti possono essere fatali.

È importante ricordare che il rischio globale di un coagulo di sangue dannoso associato a Egogyn è
basso.
COME RICONOSCERE UN COAGULO DI SANGUE
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.
Presenta uno di questi segni? Di cosa soffre probabilmente?
Gonfiore a una gamba o lungo una vena della gamba o del
piede, specialmente se accompagnato da:

• dolore o sensibilità alla gamba che può essere avvertito solo in piedi o camminando;
• maggiore sensazione di calore nella gamba colpita;
• variazione del colore della pelle della gamba, come pallore, colorazione rossastra o bluastra. Trombosi venosa profonda
• mancanza di respiro o respirazione accelerata improvvisa e inspiegabile;
• tosse improvvisa senza una causa evidente, con possibile emissione di sangue; Embolia polmonare

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 clot formation in the veins (venous thrombosis). However, these undesirable effects are rare. In most cases, they occur in the first year of use of 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 of 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 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 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 Egogyn 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, norethisterone or norgestimate like Egogyn, about 5-7 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 a blood clot forming”).

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 some conditions increase it. Your risk is higher:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative 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 have to lie down 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 Egogyn a few weeks before surgery or during the time you are less mobile. If you need to stop taking Egogyn, 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 of these conditions.
Air travel (lasting more than 4 hours) can 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. Your doctor may decide to stop you from taking Egogyn.
If any of the conditions above change while you are using Egogyn, for example if a close relative develops a thrombosis for no known reason or if you gain a lot of 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 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 Egogyn is very low, but it can increase:

• as you get older (over 35 years of age);
• if you smoke. When using a combined hormonal contraceptive like Egogyn, it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years of age, your doctor may advise you to use 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 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 conditions above change while you are using Egogyn, for example if you start smoking, if a close relative develops a thrombosis for no known reason, or if you gain a lot of weight, contact your doctor.

Tumors
Diagnoses of breast cancer are slightly more frequent in women who use the pill compared to those of the same age who do not use it. The slight increase in the number of breast cancer diagnoses gradually disappears within 10 years of stopping treatment. It is not known whether the difference is due to the pill.
This increase may be due to earlier diagnosis, as women are visited more frequently, the biological effect of the pill, or both factors. Breast cancer diagnosed in women who take the pill tends to be clinically less advanced than that diagnosed in women who do not use it.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. Such tumors can cause internal bleeding. Consult your doctor immediately if you experience severe abdominal pain.

Cervical cancer has been reported to be more frequent in women who use the pill for a long time. This may not be due to the pill, but to sexual behavior and other factors occasionally involved in the genesis of tumors in general.

Periodic checks
While using the pill, your doctor will ask you to attend periodic check-up visits, generally every year.

Consult your doctor as soon as possible:
if you notice any change in your state of health, particularly with regard to “Precautions”. Do not forget references to close relatives);
if you feel a lump in your breast;
if you have to use other medicines (see also “Other medicines and Egogyn”);
if you are immobilized or have to undergo surgery (consult your doctor at least four weeks before);
if you have heavy and unusual vaginal bleeding;
if you forgot to take the tablets in the first week of use and had sex in the seven days before the missed dose;
if you do not have a period for two consecutive cycles or if you suspect you are pregnant, do not start a new pack without your doctor's permission.
Stop taking the tablets and consult your doctor immediately if you notice possible signs of thrombosis:
cough that starts suddenly;
severe chest pain that may radiate to the left arm;
sudden shortness of breath;
unusual, severe, prolonged headache or migraine;
partial or total loss of vision or double vision;
slurred speech or inability to speak;
sudden changes in hearing, smell, and taste;
dizziness or fainting;
weakness or numbness of any part of the body;
severe abdominal pain;
severe pain or swelling in a leg.
The situations and symptoms above are illustrated and explained in more detail in other sections of

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 impaired liver function
Do not take Egogyn if you suffer from liver disease. See “Do not use Egogyn” and “Warnings and precautions”.

Patients with impaired kidney function
Egogyn has not been specifically studied in patients with reduced kidney function.

Other medicines and Egogyn
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can prevent the pill from working effectively. 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 some heart conditions and high blood pressure),
• etoricoxib (used in the treatment of arthritis, osteoarthritis).

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

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

St. John's Wort preparations should not be taken concurrently with oral contraceptives, as this may lead to a loss of contraceptive efficacy. Unwanted pregnancies and resumption of the menstrual cycle have been reported. This is due to the induction of enzymes responsible for drug metabolism by St. John's Wort preparations. The induction effect can persist for at least 2 weeks after stopping treatment with St. John's Wort products (see “Egogyn with food and drinks”).
Troleandomycin (a macrolide antibiotic) may increase the risk of intrahepatic cholestasis (inability of bile to flow from the liver to the duodenum) when administered concurrently with combined oral contraceptives.
Always inform your doctor who prescribes the pill about the medicines you are already taking, and also inform all other doctors or dentists who prescribe you other medicines that you are using Egogyn, so that they can establish whether and for how long you need to use additional contraceptive methods.
The use of the pill can affect the results of some blood tests, but these changes are generally within the normal range. Therefore, it is appropriate to inform the doctor who requested the tests that you are taking the pill.

Egogyn with food and drinks
Do not take Egogyn with grapefruit juice.
During the use of oral contraceptives, do not take St. John's Wort preparations. Concurrent intake may lead to a loss of contraceptive efficacy (see “Other medicines and Egogyn”).

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

Do not use Egogyn if you are pregnant or suspect you may be pregnant.
If you become pregnant during the use of Egogyn, stop using 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 have effects on the baby.

Driving and operating machinery
Egogyn does not alter or alters negligibly the ability to drive vehicles 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 always exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
The pack of Egogyn contains 21 tablets, all marked with the day of the week on which
each one must be taken. Take the tablet at approximately the same time each day, if necessary with a
little water. Follow the direction of the arrows until all 21 tablets have been taken. Do not take pills
for the 7 days following, during which menstruation (withdrawal bleeding) should occur, which
usually starts 2-3 days after taking the last Egogyn tablet. Start the new pack
on the eighth day, even if menstruation has not yet started. By doing so you will start the new
pack always on the same day of the week and the withdrawal bleeding will occur approximately
always on the same days of the week, each month.
Combined oral contraceptives, when taken correctly, have a failure rate of
1% per year. The failure rate increases when pills are forgotten or not taken correctly.

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

Switching from another combined pill, vaginal ring, or patch
You can start taking Egogyn the day after the last pill of your previous contraceptive (i.e. without
observing any interval). If the pack of your previous contraceptive also contains inactive pills,
you can take Egogyn the day after the last activepill (if in doubt, ask your
doctor). You can also start later, but not later than the day after the pill-free interval (or the
day after the last inactive pill) of your previous contraceptive. If you have used a
vaginal ring or a patch, you should start using Egogyn preferably on the day the last ring or patch of a cycle is removed, or at the latest, when the next
application should be made.

Switching from a progestin-only pill (mini-pill)
You can stop taking the mini-pill at any time and start taking Egogyn the next day, at the
same time. However, for the first seven days of taking the tablets, use an additional contraceptive
method (barrier method) when you have sexual intercourse.

Switching from an injectable contraceptive, implant, or progestin-releasing intrauterine system (IUS)

Start using Egogyn on the day you are due to have your next injection or the day the implant is removed
However, for the first seven days of taking the tablets, use an additional contraceptive
method (barrier method) when you have sexual intercourse.

After childbirth
The start of taking the pill after childbirth must be decided by your doctor. He/she will decide whether
to start treatment between the 21st and 28th day, or later. In the latter case, it is advisable to
use an additional barrier method for the first 7 days of taking the tablets. However, if
you have had sexual intercourse in the meantime, exclude pregnancy before actually starting to take the pill
or wait for your first menstruation.
If you are breastfeeding and want to take Egogyn, talk to your doctor first (see “Pregnancy and
breastfeeding”).

After a spontaneous or induced abortion
Follow your doctor's instructions.

If you take more Egogyn than you should
There are no reports of serious adverse effects in case of taking more tablets
at the same time. In such a case, you may experience nausea, vomiting and vaginal bleeding.
Even girls who have not yet had their period, but who have accidentally taken this
medicine may experience bleeding.
If you accidentally ingest/take an excessive dose of Egogyn, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Egogyn
If less than 12 hourshave passed since the usual time of taking, the reliability of the pill is
preserved. Take the forgotten tablet as soon as you remember and continue as usual.
If more than 12 hourshave passed since the usual time of taking, the reliability of the pill
may be reduced. The more tablets you forget to take consecutively,
the greater the risk that the contraceptive effect is reduced. The risk of pregnancy is
particularly high if you forget pills at the beginning and end of the pack. Follow
the instructions below (see also the diagram below).

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

One tablet forgotten during the first week
Take the 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 method) for the next 7 days.
If you had sexual intercourse in the week before the forgotten pill, it is possible
that you may be pregnant. Inform your doctor immediately.

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

One tablet forgotten during the third week
You can choose one of the following alternatives, without the need for additional contraceptive
precautions.

• 1. Take the forgotten tablet as soon as you remember (even if this means taking two tablets simultaneously) and continue as usual. Start the new pack as soon as you have finished the current one, withoutan interval between the two packs. You may experience breakthrough bleeding or spotting until the end of the second pack, but you may also experience intermenstrual bleeding (spotting) during the days of taking. or
• 2. Stop taking the tablets from the pack in use, observe an interval of 7 days or less ( including the day the pill was forgotten) and continue with a

new pack. If you choose this alternative, you can start the new pack on the
same day of the week as you usually start. If you make the break between cycles too short (e.g. 3 days or
less), you may not have a menstruation during that interval. In this case you may
have breakthrough bleeding or spotting during the next cycle of treatment.

Ask your doctor for advice before deciding to delay your period.
Changing the day your period starts: what you need to know
If you take the tablets according to the instructions, your periods will start approximately on the
same day of the week. If you need to change that day, you can shorten ( never lengthen) the normal
break between two consecutive packs. For example, if your periods usually start on
Friday and you want them to start on Tuesday (3 days earlier), you will need to start the next pack
3 days earlier. If you make the break between cycles too short (e.g. 3 days or
less), you may not have a menstruation during that interval. In this case you may
have breakthrough bleeding or spotting during the next cycle of treatment.

Consult your doctor if you have doubts about how to proceed.
In case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods in the first few months of taking them. Usually, irregular bleeding disappears once
the body gets used to the pill (usually after about 3 cycles of taking).

Consult your doctor if this bleeding persists, becomes heavy or recurs at
intervals.
If your period does not occur
If all the tablets have been taken correctly, you have not vomited and have not taken
other medicines, it is very unlikely that you are pregnant. Continue using the
medicine as usual.
If your period does not occur for two consecutive times, it is possible that you are
pregnant.

Consult your doctor immediately.Do not start the new pack until your doctor has
ruled out pregnancy.

If you stop taking Egogyn
You can stop taking Egogyn at any time. If you do not want to become pregnant, consult your doctor
about other methods of contraception.
If you want to stop taking Egogyn because you want to become pregnant, talk to your doctor. In this case it is in
generally advisable to wait until your periods return to be regular, before
trying to conceive.
If you have any questions about using this medicine, ask 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 Egogyn, inform your doctor.

A higher 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 different risks associated with taking
combined hormonal contraceptives, see ”Warnings and precautions” .

Serious side effects
Serious side effects associated with the use of the pill, and related symptoms, are described in the paragraph
“When to be particularly careful with Egogyn”, “Blood clots” and “Tumors”. For more
information read these paragraphs and immediately consult your doctor.
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 swings,
• breast tenderness,
• breast pain. Uncommon(may affect up to 1 in 100 people)
• vomiting,
• diarrhea,
• 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 discharge,
• vaginal discharge,
• skin diseases (erythema nodosum, erythema multiforme),
• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), or in the lung (PE), or heart attack, or stroke, or mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility of developing a blood clot may be higher if you have any other
condition that increases this risk (see paragraph “Warnings and precautions” for more
information on conditions that increase the risk of blood clots and the symptoms of a blood
clot).

Other side effects:

• oligomenorrhea (increase in the time interval between one menstruation and the next),

• amenorrhea (absence of menstruation),
• breakthrough bleeding.

In women with hereditary angioedema (rare inherited disease characterized by the appearance of swelling
[edema] of the skin, mucous membranes and internal organs) exogenous estrogens (hormone replacement therapy)
may induce or worsen the symptoms of angioedema.

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
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Egogyn

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging (blister, carton) after
“EXP.” The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
Do not use the medicine if you notice a change in colour or crumbling of the tablet, or in the presence of
any other visible sign of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Egogyn contains

• The active ingredients are levonorgestrel and ethinylestradiol. Each coated tablet contains 0.150 mg of levonorgestrel and 0.030 mg of ethinylestradiol.
• The other ingredients are: lactose monohydrate, corn starch, povidone 25, talc, magnesium stearate, sucrose, povidone 90, macrogol 6.000, calcium carbonate, glycerol 85%, titanium dioxide, yellow iron oxide (E172), ethylene glycol monostearate (wax E).

Description of the appearance of Egogyn and contents of the pack
Coated tablets for oral use.
The product is packaged in a calendar blister containing 21 coated tablets.

Marketing Authorisation Holder
Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen (Germany)

Manufacturer
Bayer AG, Muellerstrasse, 178, 13353 Berlin (Germany)