Naraia

Leaflet accompanying the packaging: information for the user

Naraya, 3 mg + 0.02 mg, coated tablets

Drospirenone + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots")

You should read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Naraya and what is it used for

2. Important information before taking Naraya

3. How to take Naraya

4. Possible side effects

5. How to store Naraya

6. Contents of the pack and other information

1. What is Naraya and what is it used for

Naraya is a contraceptive pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones: drospirenone
and ethinylestradiol.
Contraceptive pills that contain two hormones are called "combined" pills.

2. Important information before taking Naraya

1/19

General notes

Before starting to take Naraya, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start taking Naraya, your doctor will ask you a few questions about your health
and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on
the individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop taking Naraya or in which the effectiveness of Naraya may be reduced.
In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive products, such as condoms or other mechanical methods, during that time.
You should also not use the calendar method or the temperature method during that time. These methods may be unreliable because Naraya modifies the monthly changes in body temperature and cervical mucus.

Naraya, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

When not to take Naraya:

You should not take Naraya if you have any of the conditions listed below.
If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling;
• if you have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism) or other organs;
• if you know that you have a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Naraya for a few weeks before surgery or immobilization. If you need to stop taking Naraya, you should ask your doctor when you can start taking it again.
• if you have (or have ever had) a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinemia
• if you have (or have ever had) migraine (with so-called focal neurological symptoms);

2/19

• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) pancreatitis;
• if you have (or have had in the past) liver disease; and liver function has not yet returned to normal;
• if your kidneys do not work properly (renal failure);
• if you have (or have had in the past) a liver tumor
• if you have (or have had in the past) been diagnosed with or suspected to have breast cancer or genital cancer;
• if you have any unexplained vaginal bleeding; You should not take Naraya if you have liver disease and are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see section "Naraya and other medicines").

Additional information for special patient groups

Children and adolescents
Naraya is not indicated for use in patients who have not yet had their first menstrual period.

Warnings and precautions

When to exercise special caution when taking Naraya

When should you contact your doctor?
You should contact your doctor immediately

• if you notice any of the following symptoms that may indicate the formation of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

In order to describe the symptoms of these serious side effects, see "How to recognize blood clots".

You should tell your doctor if you have any of the following conditions.

If symptoms occur or worsen while taking Naraya, you should also tell your doctor. If you are taking Naraya or other oral contraceptives in any of the following situations, regular medical check-ups are necessary.
Before starting to take Naraya, you should discuss this with your doctor:

• if a close relative has (or has had) breast cancer
• if you have cancer
• if you have liver disease (such as bile duct obstruction, which can cause jaundice or itching) or gallstones (such as gallstones)
• if you have other kidney problems and are taking medicines that can increase potassium levels in your blood
• if you have diabetes
• if you have depression

3/19

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases)
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system)
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure)
• if you have a blood disease called sickle cell anemia (a hereditary disease of red blood cells)
• if you have been found to have high levels of fats in your blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots")
• if you have just given birth, you are at increased risk of blood clots. You should contact your doctor to find out how soon you can start taking Naraya after giving birth
• if you have superficial thrombophlebitis (blood clots in the veins under the skin)
• if you have varicose veins
• if you have epilepsy (see "Naraya and other medicines")
• if you have a disease that first occurred during pregnancy or during previous use of sex hormones (e.g. hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pregnancy pemphigoid), a neurological disease that causes uncontrolled body movements (Sydenham's chorea))
• if you have high blood pressure that is not well controlled by medicines
• if you have (or have had in the past) chloasma (skin discoloration, especially on the face and neck, also known as "pregnancy spots"). In this case, you should avoid direct exposure to sunlight and ultraviolet radiation
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and (or) throat, and (or) difficulty swallowing or hives with difficulty breathing, you should contact your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Naraya, is associated with an increased risk of blood clots, compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form

• in veins (also called "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also called "arterial thromboembolism" or "arterial thrombosis").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Naraya is small.

HOW TO RECOGNIZE BLOOD CLOTS
You should contact your doctor immediately if you notice any of the following symptoms.
4/19
Are you experiencing any of these symptoms?
What is the likely cause of your symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or discoloration. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, you should contact your doctor,
because some of these symptoms, such as coughing or shortness of breath, can be mistaken for milder conditions, such as a respiratory infection (e.g. a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, tightness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the upper body, radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack

Stroke

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding; 5/19

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not taking combined hormonal contraceptives.
If you stop taking Naraya, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
6/19
The overall risk of blood clots in the legs or lungs associated with Naraya is small.

• In a year, about 2 out of 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In a year, about 9-12 out of 10,000 women who take combined hormonal contraceptives containing drospirenone, such as Naraya, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Naraya is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m);
• if someone in your immediate family has had blood clots in their legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Naraya for a few weeks before surgery or immobilization. If you need to stop taking Naraya, you should ask your doctor when you can start taking it again.
• with age (especially over 35 years old);
• if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is important to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop you from taking Naraya.
You should inform your doctor if any of the above conditions change while you are taking Naraya, e.g. if someone in your immediate family is found to have a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similar to blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is important to note that the risk of heart attack or stroke associated with Naraya is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Naraya, it is recommended that you stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, irregular heartbeat called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while you are taking Naraya, e.g. if you start smoking, if someone in your immediate family is found to have a blood clot without a known cause, or if you gain weight significantly.

Naraya and cancer

Women taking combined hormonal contraceptives have a slightly higher risk of breast cancer than those not taking them, but it is not known if this is caused by the medicines. It is possible, for example, that more breast cancers are detected in women taking hormonal contraceptives because they are examined by a doctor more often. The frequency of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is important to regularly examine your breasts and contact your doctor if you find any lumps.
Women taking combined hormonal contraceptives have, in rare cases, been found to have benign liver tumors, and in even rarer cases, malignant liver tumors.
You should contact your doctor if you experience severe stomach pain or notice swelling of the stomach (which may be caused by liver enlargement), vomiting blood, or black tarry stools (which may be signs of stomach bleeding).
Psychiatric disorders:
8/19
Some women taking hormonal contraceptives, including Naraya, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Irregular bleeding

During the first few months of taking Naraya, unexpected bleeding (outside of the week without tablets) may occur. If bleeding occurs for longer than the first few months or if it occurs after several months, you should contact your doctor, who must determine the cause.

What to do if withdrawal bleeding does not occur during the tablet-free period

If all the tablets were taken correctly, there was no vomiting or severe diarrhea, and you did not take any other medicines, it is unlikely that you are pregnant.
If two consecutive withdrawals do not occur, you may be pregnant. In this case, you should contact your doctor immediately. Before starting the next pack of Naraya, you should rule out pregnancy.

Naraya and other medicines

You should always tell your doctor about all medicines or herbal products you are currently taking or have recently taken, as well as any medicines you plan to take. You should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Naraya. They may tell you if you should use additional contraceptive products (e.g. condoms) and for how long.
You should not take Naraya if you have liver disease and are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme ALT activity).
Before starting these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Naraya again after about 2 weeks after stopping the above-mentioned treatment. See section "When not to take Naraya".

• Certain medicines may make Naraya less effective in preventing pregnancy or may cause unexpected bleeding or spotting. These include medicines used to treat:
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate)
• tuberculosis (e.g. rifampicin)
• HIV or hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• arthritis, degenerative joint disease (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)
• herbal products containing St. John's wort ( Hypericum perforatum) 9/19

If you are taking any of the above medicines with Naraya, you should use additional contraceptive methods (e.g. condoms) during and for 28 days after stopping these medicines.
Naraya may affect the action of other medicines, such as:

• medicines containing cyclosporin
• antiepileptic medicines, lamotrigine (this may lead to an increased frequency of seizures)
• theophylline (used for breathing problems)
• tizanidine (used to treat muscle pain and (or) muscle spasms).

Your doctor may recommend monitoring your potassium levels if you have heart disease and are taking certain medicines (e.g. diuretics).

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking a contraceptive, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant should not take Naraya. If you become pregnant while taking Naraya, you should stop taking it immediately and contact your doctor.
If you plan to become pregnant, you can stop taking Naraya at any time (see also "Stopping Naraya").
Breastfeeding
Naraya should not be taken during breastfeeding. If you want to take a contraceptive during breastfeeding, you should consult your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There is no information to suggest that taking Naraya affects your ability to drive or use machines.

Naraya contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Naraya

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
10/19
You take one Naraya tablet every day, if necessary with a small amount of water. You can take the tablets with or without food, but you should take them at the same time every day.
One pack contains 21 tablets. The day of the week is printed next to each tablet. If, for example, you start taking the tablets on a Wednesday, you take the tablet with "WED" printed next to it. You take the tablets in the direction indicated by the arrows on the pack until you have taken all 21 tablets.
Then you do not take any tablets for 7 days. During this 7-day tablet-free period, you should have a withdrawal bleed. The bleed usually starts on the 2nd or 3rd day of the tablet-free period.
On the 8th day after taking the last Naraya tablet (i.e. after the 7-day tablet-free period), you start the next pack, even if the bleeding has not stopped. This means that you start the next pack on the same day of the week as you did previously, and the bleeding should occur on the same day every month.
If you take Naraya as directed, you will also be protected against pregnancy during the 7-day tablet-free period.

When can you start the first pack?

• If you are not taking any hormonal contraceptives in the previous monthYou can start taking Naraya on the first day of your period (i.e. the first day of menstruation). If you start taking Naraya on the first day of your period, you will be immediately protected against pregnancy. You can also start taking Naraya from the 2nd to the 5th day of your period, but you will need to use additional contraceptive methods (e.g. condoms) for the first 7 days.
• Changing from a combined hormonal contraceptive or a vaginal ring or a transdermal patchYou should start taking Naraya the next day after taking the last active tablet (i.e. the last tablet containing active substances) of your previous contraceptive, but no later than the day after the tablet-free period or the day you would have taken the next tablet (or the day you would have applied the next patch or ring).
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS))You can change from a progestogen-only pill at any time (from an implant or IUS on the day of its removal; from injections when the next injection would be due) but in all cases, you should use additional contraceptive methods (e.g. condoms) for the first 7 days of taking Naraya.
• After a miscarriageYou should follow your doctor's advice.
• After childbirth

11/19
You can start taking Naraya between the 21st and 28th day after giving birth. If you start taking Naraya later than 28 days after giving birth, you should use a so-called barrier method (e.g. condoms) for the first 7 days of taking Naraya.
If you have had sexual intercourse after giving birth before starting to take Naraya again, you should make sure you are not pregnant before starting Naraya or wait until your next menstrual period.

• If you are breastfeeding and want to start taking Naraya again after giving birthSee the section on "Breastfeeding".

If you are unsure when to start taking Naraya, you should consult your doctor.

What to do if you take more Naraya than you should

There are no reports of serious harmful effects from taking too many Naraya tablets at once. If you have taken too many tablets, you may feel sick or vomit. In young girls, vaginal bleeding may occur.
If you have taken too many Naraya tablets or think a child has taken some, you should contact your doctor or pharmacist.

What to do if you forget to take Naraya

• If it has been less than 12 hourssince you forgot to take a tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as you remember and take the next tablets at the usual time.
• If it has been more than 12 hourssince you forgot to take a tablet, your protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of pregnancy.

The risk of reduced protection against pregnancy is greatest if you forget a tablet at the beginning or end of the pack. Therefore, you should follow the rules below (see also the diagram below):

You have forgotten more than one tablet in the pack

You should contact your doctor.

You have forgotten one tablet in week 1.

You should take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. You should take the next tablets at the usual time and use additional protection(e.g. condoms) for the next 7 days. If you had sexual intercourse in the week before forgetting the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.

You have forgotten one tablet in week 2.

You should take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. You should take the next tablets at the usual time. Your protection against pregnancy has not been reduced and you do not need to use additional protection.

You have forgotten one tablet in week 3.

There are two options to choose from:
12/19

• 1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the next tablets at the usual time. Instead of the tablet-free period, start the next pack immediately.

It is likely that you will have a withdrawal bleed at the end of the second pack, but you may also experience spotting or bleeding during the second pack.

• 2. You can also stop taking the tablets from the current pack and start the 7-day tablet-free period immediately ( you should note the day you forgot to take the tablet). If you want to start the next pack on the day you usually start, the tablet-free period should be shorter than 7 days.

If you follow one of the above recommendations, your protection against pregnancy will be maintained.

• If you have forgotten any tablets from the current pack and do not have a withdrawal bleed during the tablet-free period, you may be pregnant. In this case, you should consult your doctor before starting the next pack.

13/19
The diagram shows how to proceed if you forget to take a tablet (tablets):

What to do if you vomit or have severe diarrhea

If vomiting or severe diarrhea occur within 3-4 hours of taking a tablet, there is a risk that the active substances in the tablet may not have been fully absorbed into your system, which may result in the need for additional protection (e.g. condoms) to prevent pregnancy. The situation is almost the same as if you had forgotten a tablet. After vomiting or diarrhea, you should take another tablet from a reserve pack as soon as possible. If possible, you should take the tablet within 12 hoursof the usual time of taking the tablet. If this is not possible, or if more than 12 hours have passed, you should follow the instructions described in the section "If you forget to take Naraya".
14/19

Delaying withdrawal bleeding: what you need to know

Although it is not recommended, you can delay withdrawal bleeding by starting the next pack of Naraya immediately, without taking the tablet-free period, until the pack is finished. During the second pack, you may experience spotting or bleeding.
Before deciding to delay withdrawal bleeding, you should consult your doctor.

Changing the first day of withdrawal bleeding: what you need to know

If you take the tablets as directed, withdrawal bleeding will start during the tablet-free period. If you need to change this day, you should shorten ( but never extend - 7 days is the maximum length of the tablet-free period!) the tablet-free period. For example, if the tablet-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), you should start the next pack 3 days earlier than usual. If you significantly shorten the tablet-free period (e.g. to 3 days or less), you may not have withdrawal bleeding during that time. You may, however, experience spotting or bleeding.
If you are unsure what to do, you should contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to the use of Naraya, you should consult your doctor.
In all women using combined hormonal contraceptive products, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptive products, you should refer to section 2 "Important information before taking Naraya".

In case of the following side effects, immediate medical attention is necessary. You should stop taking Naraya and immediately contact your doctor or go to the nearest hospital.

Uncommon side effects(may occur in up to 1 in 100 people):
15/19

• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat) and/or difficulty swallowing, or hives with accompanying breathing difficulties (angioedema)
• harmful blood clots in the lungs (e.g., pulmonary embolism)

Rare side effects(may occur in up to 1 in 1000 people):

• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) or heart attack or stroke or mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack or blood clots in the liver, stomach, and intestine, kidneys, or eye.

The likelihood of blood clots may be higher if you have any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Conditions that may appear or worsen during pregnancy or while taking the pill:

• systemic lupus erythematosus (SLE, a disease affecting the immune system)
• inflammation of the colon or other parts of the intestine (with symptoms such as bloody diarrhea, pain during bowel movements, abdominal pain) (Crohn's disease and ulcerative colitis)
• epilepsy
• uterine fibroids (a non-cancerous tumor that grows in the muscle tissue of the uterus)
• porphyria (a blood disorder)
• herpes gestationis (a blistering rash) during pregnancy
• Sydenham's chorea (a nerve disease characterized by sudden movements of the body)
• certain blood diseases that cause kidney damage (hemolytic-uremic syndrome with symptoms such as decreased urine output, blood in the urine, decreased red blood cell count, nausea, vomiting, disorientation, and diarrhea)
• jaundice caused by narrowing of the bile ducts (cholestatic jaundice)

Additionally, breast cancer (see section 2 "Naraya and tumors") and non-cancerous (benign) and cancerous (malignant) tumors of the liver (with symptoms such as abdominal swelling, weight loss, liver function disorders, which may be visible in blood tests) and chloasma (yellow-brown spots on the skin, especially the face, so-called "pregnancy spots"), which may be a permanent change, especially in women who had chloasma during pregnancy.

Other possible side effects

Common side effects(may occur in up to 1 in 10 people):

• mood swings
• headache
• abdominal pain
• acne
• breast tenderness, breast enlargement, painful or irregular periods
• weight gain.

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

• vaginal yeast infection

16/19

• herpes simplex
• allergic reactions (hypersensitivity)
• increased appetite
• depression, nervousness, sleep disorders, decreased interest in sex
• tingling and numbness, dizziness
• vision problems
• heart rhythm disorders or extremely rapid heart rate
• blood clots (thrombosis) in a blood vessel in the leg or lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
• hair loss (alopecia), rash, itching, hives, dry skin, seborrheic dermatitis
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast tumors (benign), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, very heavy menstruation, discharge, vaginal inflammation or infection, vaginal dryness, pelvic pain, abnormal Pap smear (Papanicolaou or Pap), decreased interest in sex
• fluid retention, lack of energy, increased thirst, increased sweating
• weight loss
• generalized pain.

Rare side effects(may occur in up to 1 in 1000 people):

• asthma
• hearing loss
• blockage of a blood vessel by a blood clot formed somewhere in the body
• erythema nodosum (characterized by painful red nodules on the skin)
• erythema multiforme (a rash with redness resembling targets or gunshot wounds).

You should immediately contact your doctor if you experience any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives with accompanying breathing difficulties (see also "Warnings and precautions").

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medication.

5. How to store Naraya

The medication should be stored out of sight and reach of children.
17/19
Store at a temperature below 30°C.
Do not use Naraya after the expiration date stated on the blister pack and carton, after the words "Expiration date:" or "EXP:". The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Naraya contains

• -The active substances of Naraya are ethinylestradiol 0.02 mg and drospirenone 3 mg.
• Other ingredients of Naraya are: Core of the tablet: lactose monohydrate, cornstarch, povidone K 30, croscarmellose sodium, polysorbate 80, magnesium stearate. Tablet coating: Opadry II 85F34610 Pink coating with the composition: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), brown iron oxide (E172).

What Naraya looks like and what the pack contains

Pink, round, film-coated tablets with a diameter of approximately 5.7 mm.
Naraya is available in packs containing 1, 2, and 3 blisters, each containing 21 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera.

• 24193 - Villaquilambre, León, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia
Jangee 0.02 mg/3 mg film-coated tablets
18/19
Lithuania
Etindros 0.02 mg/3 mg film-coated tablets
Latvia
Etindros 0.02 mg/3 mg coated tablets
Poland
Naraya
Slovakia
Lunytta
Hungary
Jangee 3 mg/0.02 mg film tablet
Date of last revision of the leaflet: 19.11.2024
19/19