Naomi

PACKAGE LEAFLET: INFORMATION FOR THE USER

NAOMI 0.1 mg/0.02 mg film-coated tablets

Levonorgestrel/Ethinylestradiol
Equivalent medicine

Important information about combined hormonal contraceptives (CHCs):

• When used correctly, this is one of the most reliable reversible methods of contraception.
• May slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 "blood clots").

Read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 NAOMI is and what it is used for

NAOMI is used:

• for prevention of pregnancy (contraception).

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

2. What you should know before taking NAOMI
General information
Before starting NAOMI, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot – see section 2 “Blood clots”.
Before you start taking NAOMI, your doctor will ask you questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your condition, may prescribe additional tests. This patient leaflet describes various situations in which you must stop using NAOMI or when its effectiveness may be reduced.
In such situations, you must not have sexual intercourse or you must use other non-hormonal contraceptive methods, such as the condom. Do not rely on calendar-based or temperature-based methods. These methods may be unreliable because NAOMI alters the monthly fluctuations in body temperature and cervical mucus.
Like all oral contraceptive pills, NAOMI does not protect against HIV infections (also known as AIDS) or other sexually transmitted infections.

Do not take NAOMI
Do not use NAOMI 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 birth control methods that may be more suitable for your case.

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will remain bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have one of the following conditions, which may 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 hyperhomocysteinemia (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 or have had liver disease and liver function is not yet normal;
• if you have or have had liver tumours, or if you have or suspect you have breast or genital organ cancer;
• if you have vaginal bleeding of unknown origin;
• if you have absent menstruation and the cause has not been diagnosed;
• if you are allergic to ethinylestradiol, levonorgestrel, or any of the other ingredients of this medicine (listed in section 6). Do not use NAOMI 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 NAOMI”).

Additional information for special populations
Use in children
NAOMI is not intended for use in women in whom the fertile period has not yet begun.

Warnings and precautions
Inform your doctor or pharmacist before taking NAOMI.
When should you contact a doctor?
Contact a doctor urgently:

• if you notice signs of a possible blood clot, which may indicate you have a blood clot in your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”).
  For a description of the symptoms of these serious side effects, see section “How to recognize a blood clot”.

Contact your doctor if any of the following conditions apply to you
If any of these conditions develop or worsen while you are taking NAOMI, inform your doctor.
These risks may require special monitoring during treatment, which your doctor will explain in detail:

• persistently high blood pressure;
• diabetes (diabetes mellitus);
• jaundice and/or itching due to bile stasis;
• gallstones;
• 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 defense system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• 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 scheduled for surgery or will remain bedridden 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 NAOMI;
• if you have inflammation of the veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• reduced pigment formation in the blood (porphyria);
• a particular form of Sydenham’s chorea (St. Vitus’ dance);
• blistering skin rash during pregnancy (herpes gestationis);
• a form of hearing loss (otosclerosis);
• depression;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, possibly with breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• epilepsy;
• current or previous development of brownish-yellow pigmented spots (chloasma, also known as pregnancy mask, mainly on the face). In this case, avoid exposure to sunlight or ultraviolet radiation;
• migraine

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

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with NAOMI is low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

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

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots 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 higher?
The risk of developing a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be increased 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 NAOMI, 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 individual baseline risk of venous thromboembolism (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 NAOMI is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as NAOMI, about 5–7 will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

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

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are 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. You may need to stop taking NAOMI several weeks before surgery or during periods of reduced mobility. If you need to stop taking NAOMI, ask your doctor when you can start taking it again;
• with increasing 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 multiple such conditions. Air travel (lasting more than 4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other listed risk factors.

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 NAOMI.
If any of the above conditions change while you are using NAOMI, for example, if a close relative develops thrombosis without a known cause or if you gain significant weight, contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems, for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of NAOMI is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as NAOMI, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defects, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if any 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 smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight, contact your doctor.

The "pill" and cancer
Breast cancer is diagnosed somewhat more frequently in women taking the "pill" compared to women of the same age who do not use the "pill" for contraception. After stopping the "pill," breast cancer statistics gradually return to normal, and after 10 years, there is no longer any measurable 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 examinations while taking NAOMI.
You should contact your doctor if you notice any lumps.
In rare cases, benign liver tumours have been diagnosed in users of the "pill," and even more rarely, malignant liver tumours. In very rare cases, these tumours have caused potentially fatal internal bleeding. If you suddenly develop severe abdominal pain, consult your doctor immediately.
A slightly increased incidence of cervical cancer has been observed in women who take the "pill" for long periods. However, there is ongoing debate about how sexual behaviour and other factors such as 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 lead to suicidal thoughts. If you experience mood changes or depressive symptoms, seek medical advice from your doctor as soon as possible.

Reduced effectiveness
The contraceptive effect may be reduced due to missing one or more pills, vomiting, intestinal diseases with severe diarrhoea, or concomitant use of other medications.

Irregular bleeding
All "pills" can cause irregular bleeding (spotting or breakthrough bleeding), especially during the first months of use. During the first 6 cycles of use, spotting and breakthrough bleeding have been observed in half of users. If this irregular bleeding continues beyond 3 months, consult your doctor.
In some users, withdrawal bleeding may not occur during the pill-free interval. If you have taken all tablets correctly, pregnancy is unlikely. However, if you did not take the pill as prescribed before the first missed withdrawal bleed, or if the withdrawal bleed does not occur a second time, you may be pregnant. Contact your doctor immediately. Do not start the next pack until pregnancy has been ruled out.

If you are planning a pregnancy
While using the "pill," blood levels of folic acid may decrease; a potential folic acid deficiency can impair the development of the brain and spinal cord (neural tube defects) of the unborn child. If you stop treatment with NAOMI because you are planning a pregnancy, consume foods rich in folic acid (vegetables, fruit, whole grains) and take folic acid tablets before and after conception. Consult your doctor or pharmacist for appropriate preparation.

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

• intestinal motility disorders (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);
• certain heart conditions, high blood pressure (calcium channel blockers such as verapamil, diltiazem);
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nelfinavir, nevirapine, efavirenz);
• arthritis, osteoarthritis (etoricoxib);
• high blood pressure in the lung vessels (bosentan);
• medicines containing St. John's wort;
• grapefruit juice.

If you are being treated with any of the above medicines, you must use non-hormonal contraceptive methods in addition to NAOMI during this period and for 28 days after, such as condoms.
If you need to take one of these medicines long-term, consult your doctor. If necessary, in such cases you should use another non-hormonal contraceptive method.
If the use of a barrier method is required for longer than the duration of the current "pill" pack, you should start the next pack of NAOMI immediately, without observing the 7-day pill-free interval.

NAOMI and other "pills" can also affect the metabolism of other medicines.
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. Concomitant use of the "pill" and the antibiotic troleandomycin may increase the risk of biliary thrombosis.

Take note of the information provided in the package leaflet of all other prescribed medicines.
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, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause an increase in liver blood test results (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
NAOMI can be resumed approximately 2 weeks after completing this treatment. See section "Do not use NAOMI".

Pregnancy and breastfeeding
Pregnancy
Do not use NAOMI if you are pregnant.
Before starting treatment with NAOMI, pregnancy must be excluded. If pregnancy occurs during treatment with NAOMI, stop the medicine immediately and contact your doctor.

Breastfeeding
Do not use NAOMI during breastfeeding, as milk supply may be reduced and its composition altered. Small amounts of the active substance and/or its breakdown products may also pass into breast milk.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
No special precautions are required.

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

Laboratory tests
If you need a blood test, inform your doctor that you are taking NAOMI: the use of the "pill" can influence the results of certain laboratory tests.

3 How to take NAOMI
Always take this medicine exactly as your doctor has instructed. If you have any 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 approximately the same time each day, with a glass of water if needed.
Take the tablets in the direction of the arrow, following the day of the week, until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During this interval, withdrawal bleeding should occur, usually on the second or third day after taking the last tablet.
On day 8, start taking the first tablet of the next pack, whether or not bleeding has occurred.
Each new pack should start on the same day of the week, and withdrawal bleeding should occur approximately on the same day of the month.

Note: Correct use ensures contraceptive protection from the first day of intake.

Starting the first pack
No previous "pill" use in the previous month
Start on the first day of your cycle (the first day of your menstrual period). If you start NAOMI between day 2 and day 5, you must use additional contraceptive measures (such as condoms) for the first 7 days. 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 may 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 removal of the vaginal ring or transdermal patch, but no later than the day after the pill-free interval of the previous pill (or after the last inactive tablet of the previous pill) or after the ring- or patch-free interval.

Switching from a progestogen-only contraceptive (progestin-only pill, injection, implant, or progestin-releasing intrauterine device (IUD))
You may switch on any day from a progestin-only pill (for implant or IUD, on the day of removal; for injectable, on the day the next injection would be due), but in any case, use additional protective measures (e.g., condoms) for the first 7 days of treatment.

After childbirth
Start taking NAOMI no earlier than 21–28 days after childbirth. If you start treatment with NAOMI after 28 days, you must use additional contraceptive measures (such as condoms) for the first 7 days. However, if you have already had sexual intercourse, a possible pregnancy must be excluded before starting NAOMI, or you must wait for the onset of your first menstrual cycle. If you are breastfeeding and wish to take NAOMI at the same time, consult your doctor.

After termination of pregnancy or miscarriage
Consult your doctor.

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 persist for several days, breast tenderness, drowsiness, abdominal pain, sleepiness/fatigue. In women and young girls, vaginal bleeding may occur. Even girls who have not yet had their first menstrual period and have accidentally taken this medicine may experience such bleeding. If you have taken more than prescribed, consult a doctor, who will treat the symptoms.

If you forget to take NAOMI
Less than 12 hours late
The contraceptive effect of NAOMI is still guaranteed. Take the missed tablet immediately. Then continue as usual.

More than 12 hours late
The contraceptive effect of NAOMI is no longer guaranteed. The risk of unintended pregnancy is particularly high if a tablet was missed at the beginning or end of the pack. In this case, follow the instructions below.

More than 1 tablet missed in the current pack
Consult your doctor or pharmacist.

Only 1 tablet missed in the first week
Take the missed tablet immediately, even if this means taking two tablets at the same time, then continue as usual. However, for the first 7 days, you must use additional contraceptive measures, such as condoms. If you had intercourse in the week before the missed tablet, there is a risk of pregnancy: in this case, inform your doctor immediately.

Only 1 tablet missed in the second week
Take the missed tablet immediately, even if this means taking two tablets at the same time. If you took all tablets correctly in the previous 7 days, contraceptive protection is maintained and no additional precautions are needed. Otherwise, use additional contraceptive measures (such as condoms) for the first 7 days.

Only 1 tablet missed in the third week
No additional contraceptive measures are needed, but only if you took all tablets correctly in the previous 7 days and one of the two following options is followed. Otherwise, follow the first of the two options and use additional contraceptive measures (such as condoms) for the first 7 days.

1. Take the missed tablet immediately, even if this means taking two tablets at the same time. Then continue as usual. Do not observe the pill-free interval and start taking tablets from the next pack immediately. Withdrawal bleeding may not occur, but spotting and breakthrough bleeding may occur during the second pack.

OR

2. Immediately stop taking tablets from the current pack and take no tablets for up to 7 days, including the day of the missed tablet. Then start a new pack as usual, although this may shorten the pill-free interval.

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

In case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active ingredients in the tablet may not be fully absorbed by your body. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual pill-taking time. If this is not possible or if more than 12 hours have passed, follow the advice in the section "If you forget to take NAOMI".

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

If you wish to change the day of the week on which your menstrual period starts
In this case, shorten—but never extend—the usual pill-free interval, as shown in the following example: your period usually starts on Friday, and you wish it to start 3 days earlier, i.e., on Tuesday. In this case, start taking tablets 3 days earlier than usual. With shorter-than-normal pill-free intervals (3 days or less), withdrawal bleeding may not occur, although spotting and breakthrough bleeding may occur during the new pack.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to NAOMI, inform your doctor.
An increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you should know before taking NAOMI".

Serious side effects – seek medical help immediately
Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties (see also section "Warnings and precautions").

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

• Blood clots in a vein or artery, for example: in a leg or foot (i.e., DVT), in a lung (i.e., 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/intestine, kidneys, or eye. The likelihood of a blood clot may be higher if you have any 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 severe allergic reactions with respiratory and circulatory symptoms

Not known: frequency cannot be determined from available data

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

For other serious side effects such as blood clot formation, increased blood pressure, liver tumours, breast cancer, chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), impaired blood pigment formation (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 (Sydenham's chorea), a form of kidney impairment (haemolytic uraemic syndrome, a condition occurring after E. coli-induced diarrhoea), or jaundice and/or itching due to biliary stasis, see section 2.

Less serious side effects
Very common side effects (may affect more than 1 in 10 people): associated with taking the pill are headache (including migraine), spots, and intermenstrual bleeding.
Common side effects (may affect up to 1 in 10 people)

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

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

• change in appetite (increase or decrease)
• fluid retention
• decreased sexual interest
• migraine
• diarrhoea
• vomiting
• abdominal cramps
• flatulence
• skin rash that may itch
• yellow-brown pigmentation spots on the face (chloasma), possibly permanent
• increased body and facial hair
• hair loss
• skin rash
• urticaria
• breast swelling
• changes in blood lipid levels

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

• signs of hypersensitivity or allergic reactions
• increased blood glucose levels (glucose intolerance)
• increased sexual interest
• intolerance to contact lenses
• erythema nodosum
• skin redness with blister and nodule formation (erythema multiforme)
• vaginal or breast discharge
• weight loss
• decreased blood levels of folic acid

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5 How 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6 Contents of the pack and other information
The active substances are levonorgestrel and ethinylestradiol.
Each tablet contains:

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

The excipients are:
monohydrate lactose, magnesium stearate, maize 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, white in colour.
The coated tablets are packed in PVC/PVDC/Aluminium blisters and placed in 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)
Responsible manufacturers 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 manufacturing site at 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 European Economic Area member states under the following names:
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 tablet