НАОМИ 0.1 мг/0.02 мг Coated tablet

Содержание инструкции

1. NAOMI 0.1 mg/0.02 mg coated tablets
   1. What is NAOMI and what is it used for
2. NAOMI può essere ridotta.

NAOMI 0.1 mg/0.02 mg coated tablets

Levonorgestrel/Ethinylestradiol
Generic medicine

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

• If used correctly, this is one of the most reliable reversible methods of contraception.
• They may slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after an interruption of 4 or more weeks.
• Be careful and see a doctor if you think you have symptoms of a blood clot (see section 2 "blood clots").

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist Contents of this leaflet:
• 1. What NAOMI is and what it is used for
• 2. What you need to know before you take NAOMI
• 3. How to take NAOMI
• 4. Possible side effects
• 5. How to store NAOMI
• 6. Contents of the pack and other information

1. What is NAOMI and what is it used for

NAOMI is used:

• for pregnancy prevention(contraception).

Each tablet contains a small amount of two different female hormones, called levonorgestrel and
ethinylestradiol.
Contraceptive pills that contain two hormones are called “combined pills”

2What you need to know before you take NAOMI
General notes
Before starting to take NAOMI, read the information on blood clots in section 2. It is
particularly important that you read the symptoms of a blood clot - see section 2 “Blood clots”.
Before you start taking NAOMI, your doctor will ask you some questions about your medical history
and that of your close relatives. The doctor will also measure your blood pressure and, a
several situations are described in which it is necessary to stop using NAOMI or where the reliability of

NAOMI può essere ridotta.

In tali situazioni , non deve avere rapporti sessuali o deve usare altri metodi contraccettivi non ormonali,
come il profilattico. Non si affidi a metodi basati sul calendario o sulla temperatura. Questi metodi
possono essere inaffidabili perché NAOMI altera le variazioni mensili della temperatura corporea e del
muco cervicale
Come per tutte le “pillole” orali, NAOMI non protegge affatto dalle infezioni da HIV, chiamate anche
AIDS, o da altre malattie trasmesse sessualmente.

Non prenda NAOMI
Non usi NAOMI 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’operazioneo se starà in posizione sdraiata per un lungo periodo(vedere paragrafo “Coaguli di sangue”);
• se ha mai avuto un attacco di cuoreo 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 o ha avuto una malattia del fegatoe la funzionalità del fegato non ancora normale;
• se ha o ha avuto in p assato tumore al fegato,se ha o sospetta di avere tumore al seno o agli organigenitali;
• se presenta emorragiavaginale di originesconosciuta;
• in caso di assenza di mestruazionise la causa non è stata diagnosticata;
• se è allergicaall’etinilestradiolo, al levonorgestrel o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Non usi NAOMI se ha l’epatite C e sta prendendo medicinali contenenti ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir e sofosbuvir/velpatasvir/voxilaprevir (vedere anche il paragrafo “Altri medicinali e NAOMI”).

Informazioni aggiuntive per le popolazioni speciali

Uso nei bambini
NAOMI non è destinato all'uso nelle donne in cui il periodo fertile non è ancora iniziato.

Avvertenze e precauzioni
Informi il medico o il farmacista prima di prendere NAOMI.
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”.

Si rivolga al medico se una qualsiasi delle seguenti circostanze la riguardano
Se questa condizione compare o peggiora mentre sta prendendo NAOMI deve informare il medico.
Tali rischi potrebbero richiedere durante il trattamento un particolare monitoraggio, che il medico le
spiegherà in dettaglio:

• pressione sanguigna costantemente elevata;
• diabete(diabete mellito);
• itteroe/o pruritodovuto a stasi della bile;
• calcolibiliari;
• 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 insufficienza renale);
• 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 NAOMI;
• se ha un’infiammazione alle vene poste sotto la pelle(tromboflebite superficiale);
• se ha le vene varicose;
• ridotta formazione di pigmento nel sangue(porfiria);
• una particolare forma di ballo di San Vito(corea di Sydenham);
• eruzione cutaneadella vescicadurante la gravidanza ( herpes gestationis);
• una forma di perdita di udito(otosclerosi);
• umore depresso;
• se manifesta sintomi di un angioedema,come gonfiore del viso, della lingua e/o della faringe e/o difficoltà a deglutire o orticaria potenzialmente con difficoltà respiratorie contatti immediatamente un medico. I prodotti contenenti estrogeni possono causare o peggiorare i sintomi dell'angioedema ereditario e acquisito
• epilessia;
• formazioneattuale o precedente di nei pigmentati di colorebruno-giallastro(cloasma, detti anche macchie da gravidanza, prevalentemente al viso). In questo caso si consiglia di evitare l’esposizione alla luce solare o ai raggi ultravioletti;
• emicrania

COAGULI DI SANGUE
L’uso di un contraccettivo ormonale combinato come NAOMI 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 NAOMI è
basso.
COME RICONOSCERE UN COAGULO DI SANGUE
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.

COAGULI DI SANGUE IN UNA VENA
Cosa può accadere se si forma un coagulo di sangue in una vena?

• L’uso di contraccettivi ormonali combinati è stato correlato a un aumento del rischio di formazione di coaguli di sangue nelle vene (trombosi venosa). Questi effetti indesiderati, però, sono rari. Nella maggior parte dei casi essi si verificano nel primo anno di utilizzo di un contraccettivo ormonale combinato.
• Se un coagulo di sangue si forma in una vena della gamba o del piede, può causare una trombosi venosa profonda (TVP).
• Se un coagulo di sangue si sposta dalla gamba e si colloca nel polmone, può causare un’embolia polmonare.
• Molto raramente il coagulo può formarsi in un altro organo come l’occhio (trombosi della vena retinica).

Quando è più alto il rischio di sviluppare un coagulo di sangue in una vena?
Il rischio di sviluppare un coagulo di sangue in una vena è più alto durante il primo anno in cui si assume per
la prima volta un contraccettivo ormonale combinato. Il rischio può essere anche superiore se si ricomincia
ad assumere un contraccettivo ormonale combinato (lo stesso medicinale o un medicinale diverso) dopo una
pausa di 4 o più settimane.
Dopo il primo anno, il rischio si riduce ma è sempre leggermente superiore che se non si stesse utilizzando
un contraccettivo ormonale combinato.
Quando si interrompe l’assunzione di NAOMI, il rischio di sviluppare un coagulo di sangue torna ai livelli
normali entro alcune settimane.

Qual è il rischio di sviluppare un coagulo di sangue?
Il rischio dipende dal suo rischio naturale di TEV e dal tipo di contraccettivo ormonale combinato che sta
assumendo.
Il rischio globale di sviluppare un coagulo di sangue nella gamba o nel polmone (TVP o EP) con NAOMI è
basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono incinte, circa 2 svilupperanno un coagulo di sangue in un anno.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente levonorgestrel, come NAOMI, circa 5-7 svilupperanno un coagulo di sangue in un anno.
• Il rischio che si formi un coagulo di sangue dipende dalla sua anamnesi medica (vedere sotto “Fattori che aumentano il rischio di formazione di un coagulo di sangue”).

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

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in a leg, in the lung or in another 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 an operation or if you have to lie down for a long period due to an injury or illness or if you have a leg in plaster. It may be necessary to stop taking NAOMI a few weeks before the operation or during the time when you are less mobile. If you need to stop taking NAOMI ask your doctor when you can start taking it again;
• the increase in age (especially over 35 years);
• 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 more than 4 hours) can temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed.

It is important that you inform your doctor if any of these conditions apply to your case, even if you are not
sure. The doctor may decide to stop you from taking NAOMI.
If any of the above conditions change while you are using NAOMI, for example if a close relative
develops 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 a 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 NAOMI is very low
but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like NAOMI it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, 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 of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing
a blood clot may be even higher.
If any of the above conditions change while you are using NAOMI, for example if you start to
smoke, if a close relative develops thrombosis for no known reason or if you gain a lot of weight,
contact your doctor.

“The pill” and tumors
Breast cancer is diagnosed somewhat more frequently in women who take
“the pill” compared to those of the same age who do not practice birth control with “the pill”. After
stopping “the pill”, the statistics relating to breast cancer slowly realign and after
10 years there is no longer any verifiable difference between former “pill” users and other women.
Since breast cancer is relatively rare in women under 40 years of age, the number of new
cases of breast cancer in women who use or have used “the pill” is limited compared to the overall risk of breast cancer.
It is important that all women, especially those over 35 years of age, undergo regular breast
exams while taking NAOMI.
You should contact your doctor if you notice any lumps.
In rare cases, benign and, even more
rarely, malignant liver tumors have been diagnosed in “pill” users. In very few cases these tumors have caused internal bleeding
potentially fatal. If you develop sudden severe abdominal pain, consult your
doctor immediately.
In women taking “the pill” for long periods, the occurrence of
cervical cancer has been observed to some extent. However, there continues to be controversy over how
sexual behavior and other factors such as the human papillomavirus contribute to this outcome.

Psychiatric disorders
Some women using hormonal contraceptives including Naomi have reported depression or depressed mood.
Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, seek medical advice as soon as possible.

Reduced effectiveness
The contraceptive effect may be reduced due to forgetting one or more pills, vomiting, or
severe diarrheal bowel movements or the concomitant use of other drugs.

Irregular bleeding
All “pills” can cause irregular bleeding (spotting or breakthrough bleeding), in
particular in the first few months of use. In half of the users, spotting and breakthrough bleeding were observed during the first 6 cycles of intake. If this irregular bleeding continues to occur
after 3 months, consult your doctor.
In some users, no withdrawal bleeding may occur in the pill-free intervals. If you have
taken the tablets correctly, pregnancy is unlikely. However, if you have not taken the pill as
prescribed before the first missed withdrawal bleeding or if the withdrawal bleeding does not
occur a second time, you may be pregnant. Contact your doctor immediately.
Do not start the next blister until pregnancy has been ruled out.

If you are planning a pregnancy
During the use of “the pill”, the levels of folic acid in the blood may decrease; a possible deficiency of
folic acid can compromise the development of the brain and spinal cord (neural tube defects) of the
fetus. If you stop treatment with NAOMI because you are planning a pregnancy, eat
foods rich in folic acid (vegetables, fruits, whole grains) and take folic acid tablets before and after
conception. Consult your doctor or pharmacist for adequate preparation.

Other medicines and NAOMI
Tell your doctor or pharmacist if you are taking or have recently taken or may take other
medicines
Also tell your doctor or dentist who prescribes you other medicines (or the pharmacist) that you are taking
NAOMI. They can tell you if you need additional contraceptive measures (such as condoms) and, if so, for how long.
Some medicines can have an influence on the levels of NAOMI in the blood and can make it less
effective in preventing pregnancy or can cause unexpected bleeding. These include:
Medicines for the treatment of

• disorders of intestinal motility(such as metoclopramide);
• epilepsy, such as hydantoins (e.g. phenytoin), barbiturates, barbexaclone, primidone, carbamazepine, oxcarbazepine, topiramate and felbamate;
• tuberculosis (such as rifampicin, rifabutin)
• fungal infections (griseofulvin , azole antifungals such as itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, such as clarithromycin, erythromycin);
• some heart conditions, high blood pressure (calcium channel blockers such as verapamil, diltiazem);
• HIV and hepatitis C virus infections(called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nelfinavir, nevirapine, efavirenz);
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the pulmonary vessels (bosentan)
• medicines containing St. John's wort
• grapefruit juice

If you are being treated with one of the above drugs, during this period and for 28 days after, you should use additional non-hormonal contraceptive methods, such as a condom, in addition to
NAOMI.
If you need to take one of these drugs for long periods, consult your doctor. If necessary, in
these cases you should resort to another non-hormonal method of contraception.
If the use of a barrier method proves necessary for a period longer than that corresponding to
the current pack of “pills”, you should start the next pack of NAOMI immediately, without
respecting the 7-day pill-free interval.
NAOMI and other “pills” can also affect the metabolism of other drugs.
The effectiveness or tolerability of the following medicines may be compromised due to the use of
levonorgestrel/ethinylestradiol:

• cyclosporine, a medicine used to suppress the immune system;
• theophylline, a medicine used to treat asthma;
• tizanidine (used for muscle pain/muscle cramps)
• lamotrigine, a medicine for epilepsy;
• melatonin (used to treat insomnia)
• midazolam(used as a sedative)
• troleandomycin, a medicine for bacterial infections. The concomitant use of the pill and the antibiotic troleandomycin may increase the risk of biliary thrombosis.

In women with diabetes, the need for blood sugar-lowering agents (e.g. insulin) may be altered.
Do not use NAOMI if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir
because these medicines can cause an increase in liver test results (increased
liver enzyme ALT).
Your doctor will prescribe you another type of contraception before starting treatment with these medicines.
NAOMI can be resumed about 2 weeks after completion of this treatment. See the
section "Do not use NAOMI”.

Pregnancy and breastfeeding
Pregnancy
Do not use NAOMI if you are pregnant.
Pregnancy must be ruled out before starting treatment with NAOMI. If this occurs in
course of therapy with NAOMI, stop the medicinal product immediately and contact your
doctor.

Breastfeeding
Do not use NAOMI during breastfeeding, as the availability of milk may be reduced and the
its composition modified. Small amounts of the active ingredient and/or their degradation products
may also pass into breast milk.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
No precautions need to be taken.

NAOMI contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose or sucrose),
contact him before taking this medicine.

Laboratory tests
If you are going to have a blood test, tell your doctor that you are taking NAOMI: the use of “the pill” is in fact
able to influence the results of some laboratory tests.

3How to take NAOMI
Always take this medicine exactly as your doctor has told you. If you have doubts consult
your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the recommended dose is one tablet per day.
Always take the tablets at about the same time of day, if necessary with a glass of water.
Intake takes place in the direction of the arrow, respecting the day of the week, until all 21 tablets have been taken.
Afterwards, do not take tablets for 7 days. During this interval, bleeding should occur (from
withdrawal), usually on the second or third day after taking the last tablet.
On day 8, start taking the first tablet of the next blister, whether the bleeding has persisted or not.
The start of each new blister occurs on the same day of the week and the start of bleeding occurs
around the same day of the month.

Note: correct use ensures contraceptive control from the first day of intake

Start the first blister

No “pill” taken in the previous month
You start taking it on the first day of your cycle (the first day of your menstrual period). If you start taking
NAOMI between day 2 and day 5, you must adopt additional contraceptive measures during the first 7 days,
such as a condom. Always take the tablet from the position marked with the corresponding day
of the week.

Switching from another combined preparation (“pill”, vaginal ring or transdermal patch)
You can start NAOMI preferably the day after the last active tablet (the last
tablet containing the active ingredient) of the previous pill or the day after removing the
vaginal ring or transdermal patch, but no later than the day after the pill-free period of the
previous pill (or after the last non-active tablet of the previous pill) or after the break without
ring or patch.

Switching from a progestogen-only contraceptive (progestin-only pill, injection, implant or

progesterone-releasing intrauterine system (IUD))
You can switch from a progestin-only pill at any time (for the implant or IUD on the day of
removal, for the injectable on the day the next injection is due), but in any case use additional
protective measures (e.g., a condom) for the first 7 days of treatment.

After childbirth
Start taking NAOMI no earlier than 21-28 days after delivery. If you start treatment with NAOMI
after 28 days, you must use additional contraceptive measures during the first 7 days, such as a
condom. However, if you have already had sexual intercourse, you must rule out a possible
pregnancy before starting to use NAOMI or wait for the first menstrual period to occur. If you are
breastfeeding and wish to take NAOMI at the same time, consult your doctor.

After termination of pregnancy or spontaneous abortion
Ask your doctor for advice.
If you feel that the effects of NAOMI are too weak or too strong, consult your doctor
or pharmacist.

If you take more NAOMI than you should
There are no reports of serious harmful effects from taking too many NAOMI tablets.
The following symptoms may occur: nausea, vomiting (usually after 12-24 hours), which may perhaps
persist for several days, breast tenderness, drowsiness, abdominal pain, sleepiness/fatigue. In
women and young girls, vaginal bleeding may occur. Girls who have not yet had their first menstrual
period and have accidentally taken this medicine may also experience such bleeding. If you have taken
more than the prescribed amount, consult a doctor, who will take care of treating the symptoms.

If you forget to take NAOMI
Less than 12 hours have passed since the scheduled time
The contraceptive effect of NAOMI is still guaranteed. Take the forgotten tablet immediately. In
then follow the normal dosage schedule.

More than 12 hours have passed since the scheduled time
The contraceptive effect of NAOMI is no longer guaranteed. The risk of unwanted pregnancy is
particularly high if you have forgotten a tablet at the beginning or end of the blister. In this case,
proceed as described below.

More than 1 tabletfrom the current blister forgotten
Ask your doctor or pharmacist for advice.

Only 1 tablet forgotten in the first week
Take the forgotten tablet immediately, even if you have to take two at the same time, then
continue as usual. However, during the first 7 days, use additional
contraceptive measures, such as a condom. If you had sex in the week before forgetting, there is a
risk of pregnancy: in this case, immediately inform your doctor.

Only 1 tablet forgotten in the second week
Take the forgotten tablet immediately, even if you have to take two at the same time. If the tablets
have been taken correctly for the 7 days before, the contraceptive effect is guaranteed and no
further precautions are necessary. Otherwise, during the first 7 days, use additional
contraceptive measures, such as a condom.

Only 1 tablet forgotten in the third week
No further contraceptive measures are necessary, but only if you have taken the tablets correctly for the previous 7 daysand if one of the two possibilities described below occurs. Otherwise
you must follow the first of the two options and use additional contraceptive measures, such as a
condom, during the first 7 days.

• 1. Take the forgotten tablet immediately, even if this means taking two at the same time. Then continue as usual. Do not observe the pill-free interval and start taking the tablets from the next blister directly. You will probably not experience withdrawal bleeding, while spotting and breakthrough bleeding are possible during the intake of the tablets from the second blister.

OR

• 2. Immediately stop taking from the current blister and take nothing for a maximum of 7 days, including the day of forgetting. Then start a new blister as usual, even if this may reduce the pill-free interval.

If no bleeding occurs during the pill-free interval following the forgetting of NAOMI,
you may be pregnant. Before starting a new blister, consult your doctor.

In case of vomiting or severe diarrhea
If you vomit within 3-4 hours of taking a tablet or if you have severe diarrhea, there is a risk
that the active ingredients contained in the pill are not completely absorbed by the body. This
situation is similar to forgetting a tablet. After vomiting or diarrhea, take another tablet from a
reserve blister as soon as possible. If possible, take it within 12 hours of when you normally take
your pill. If this is not possible or if 12 hours have already passed, follow the advice given in the
“If you forget to take NAOMI” section.

If you want to delay your menstrual period
In this case, start a new blister immediately without observing the pill-free interval. You can
continue until you have finished all the tablets from the second blister, or stop earlier if
you want to have bleeding. Start taking the tablets from the next blister after the usual
7-day pill-free interval.

If you want to change the day of the week your menstrual period starts
In this case, shorten, but never prolong, the usual pill-free interval, as shown in the
following example: your cycle usually starts on Friday and you want it to start on Tuesday instead, i.e.
3 days earlier. In this case, start taking the tablets 3 days earlier than usual. If the pill-free
intervals are shorter than normal (3 days or less), withdrawal bleeding may not occur, even though
spotting and breakthrough bleeding may occur during the intake of the tablets from the new blister.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any side effect, especially if serious or persistent, or if you experience any
change in your health that you think may be due to NAOMI, tell your doctor.
A greater risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots
in the arteries (arterial thromboembolism (ATE)) is present in all women 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 taking NAOMI”.

Serious side effects – go to your doctor immediately
Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling
of the face, tongue and/or pharynx and/or difficulty swallowing or urticaria potentially with difficulty
breathing (see also section "Warnings and precautions").
Rare side effects(may affect up to 1 in 1000 people)

• Blood clots in a vein or in an artery for example: in a leg or foot (i.e. DVT) or in a lung (i.e. PE) or heart attack or stroke or mini-stroke or temporary stroke-like symptoms, known as transient ischemic attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye. The possibility of having a blood clot may be greater if you have one of the other conditions that increase the risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of blood clots).

Very rare side effects(may affect up to 1 in 10,000 people)

• painful swelling of the skin and mucous membranes (angioedema)
• very serious allergic reactions with respiratory and circulatory symptoms

Not known: the frequency cannot be established based on available data

• inflammation of the optic nerve that can lead to partial or total loss of vision
• worsening of varicose veins
• pancreatitis in case of concomitant severe disorders of fat metabolism
• gallbladder disorders including gallstones
• a form of hearing impairment (otosclerosis)
• worsening of depression.

For other serious side effects such as the formation of blood clots, increased blood pressure, liver tumors, breast cancer, chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), impaired formation of blood pigments (porphyria), immune system disease such as systemic lupus erythematosus (where the body attacks and destroys its own organs and tissues), herpes in late pregnancy, rapid involuntary movements or involuntary contractions (Syndeham's chorea), a form of kidney impairment (hemolytic uremic syndrome, a condition that occurs after E. coli-caused diarrhea) or jaundice and/or itching due to bile stasis see section 2.

Less serious side effects
Very common side effects(may affect more than 1 in 10): associated with taking
the pill are headache (including migraine), spotting and breakthrough bleeding.

Common side effects(may affect up to 1 in 10)

• vaginal inflammation including fungal inflammation (candidiasis)
• mood swings including depression
• nervousness
• drowsiness
• dizziness
• headache
• visual disturbances
• nausea
• abdominal pain
• acne
• breast pain
• breast tension
• menstrual pain
• change in menstrual flow
• increased vaginal secretions
• lack of menstrual bleeding
• weight gain

Uncommon side effects(may affect up to 1 in 100)

• change in appetite (increase or decrease)
• fluid retention
• decreased sexual drive
• migraine
• diarrhea
• vomiting
• abdominal cramps
• flatulence
• skin rash that may be itchy
• yellow-brown pigment spots on the face (chloasma), probably permanent
• increased body and facial hair
• hair loss
• skin rash
• urticaria
• breast enlargement
• changes in blood lipid levels

Rare side effects(may affect up to 1 in 1000)

• signs of hypersensitivity or allergic reactions
• increased glucose levels in the blood (glucose intolerance)
• increased sexual drive
• intolerance to contact lenses
• erythema nodosum
• redness of the skin with blisters and nodules (erythema multiforme)
• vaginal or breast discharge
• weight loss
• decrease in folic acid levels in the blood

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

5How to store NAOMI
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 outer packaging and on the blister
after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine in water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6Package contents and other information
The active substancesare levonorgestreland ethinylestradiol.
Each tablet contains:

• 0.1 mg (100 micrograms) of levonorgestrel
• 0.02 mg (20 micrograms) of ethinylestradiol

The excipients are:
lactose monohydrate, magnesium stearate, corn starch, povidone K25, talc, calcium carbonate, carnauba wax,
macrogol 6000, povidone K90, sucrose and talc

Description of the appearance of NAOMI and contents of the pack
The coated tablets are round, biconvex, and white in color.
The coated tablets are packaged in PVC/PVDC/Aluminum blisters and inserted into a
cardboard box. Each blister contains 21 coated tablets.
Pack sizes: 1 x 21, 3 x 21, 6 x 21, 13 x 21 and 50 x 21 coated tablets.
Not all pack sizes may be marketed

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Sandoz S.p.A, Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturers responsible for batch release:
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek S.A
Ul. Podlipie 16 C, 95 010 Strykow, Poland
with production site located in Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals d.d
Verovskova 57, 1526 Ljubljana, Slovenia
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
D-48159 Münster, Germany

This medicinal product has been authorised in the member states of the European Economic Area
under the following denominations:
Austria: Xyliette 0.1 mg/0.02 mg coated tablets
Belgium: Eleonor 20 0.1 mg/0.02 mg coated tablets
Germany: Illina 0.1 mg/0.02 mg coated tablets
France: LEELOO 0.1 mg/0.02 mg, coated tablet
Italy: NAOMI
Netherlands: Ethinylestradiol/levonorgestrel Sandoz 0.02/0.1 mg, coated tablets