Naraia

Leaflet accompanying the packaging: user information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Naraya (Etindros), 3 mg + 0.02 mg, film-coated tablets

Drospirenone + Ethinylestradiol
Naraya and Etindros are different trade names for the same drug.

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.
• In case of 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 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 packaging and other information

1. What is Naraya and what is it used for

Naraya is a contraceptive pill used to prevent pregnancy.
Each pill 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

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 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 following conditions.
If you have any of the following conditions, 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 you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, 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 sign 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);
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have ever had) 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 insufficiency);
• if you have (or have ever had) liver cancer
• if you currently (or have ever had) breast cancer or genital cancer;
• if you have any unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir (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 be particularly careful 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 a blood clot, such as a clot in the leg (deep vein thrombosis), a clot in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots").

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

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

If symptoms appear 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 ever had) breast cancer
• if you have cancer
• if you have liver disease (such as bile duct obstruction, which can cause jaundice or itching) or gallbladder disease (such as gallstones)
• if you have other kidney problems and are taking medicines that increase potassium levels in the blood
• if you have diabetes
• if you have depression
• 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 a family history of high levels of fats in the blood (hypertriglyceridemia) or have high levels of fats in the blood. 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 are immediately postpartum, you are at increased risk of blood clots. You should consult your doctor about how soon you can start taking Naraya after delivery
• 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 appeared during pregnancy or during previous use of sex hormones (such as hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pemphigoid gestationis), a nervous system 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 ever had) 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 have hereditary angioedema, estrogen-containing products may cause or worsen the symptoms of angioedema. If symptoms of angioedema occur, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, you should seek medical attention immediately.

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 occur

• in veins (also known as "venous thromboembolism")
• in arteries (also known as "arterial thromboembolism").

Not everyone who has a blood clot will recover fully. 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 A BLOOD CLOT
You should contact your doctor immediately if you notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
these symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, 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 the color of the leg skin, such as pallor, redness, or cyanosis.
• 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 abdominal pain.

If the patient is unsure, they should contact their doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Symptoms usually occur in one eye:

• sudden loss of vision or retinal vein thrombosis (blood clot in the eye)

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms 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 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 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 factors increase the risk of blood clots in veins?

The risk of blood clots in veins 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 the 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 recently given birth.

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 essential 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 taking Naraya, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

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

Factors that increase the risk of blood clots in arteries

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

• with age (over approximately 35 years old);
• if you smoke.While taking a hormonal contraceptive like Naraya, you are advised 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 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 someone in your immediate family has 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);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Naraya, e.g., if you start smoking, if someone in your immediate family is diagnosed with 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, but it is not known if this is caused by taking these medicines. It is possible that more breast cancers are detected in women taking hormonal contraceptives because they are examined by a doctor more often.
The risk of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is essential to regularly check your breasts and consult 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 consult your doctor if you experience severe abdominal pain or notice swelling of the abdomen (which may be caused by liver enlargement), vomiting blood, or black tarry stools (which may be signs of stomach bleeding).

Psychological disorders:

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 consult 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 pills) may occur. If bleeding occurs for longer than the first few months or if it occurs after several months, you should consult your doctor, who must determine the cause.

What to do if withdrawal bleeding does not occur during the pill-free interval

If all the pills have been taken correctly, there has been no vomiting or severe diarrhea, and you have not taken 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 need to use additional contraceptive methods (e.g., condoms) and for how long.
Some 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 infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g., griseofulvin, ketoconazole)
• arthritis or degenerative joint disease (etoricoxib)
• high blood pressure in the blood vessels of the lungs (bosentan)
• herbal products containing St. John's Wort (Hypericum perforatum)

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 the medicine.
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).

Laboratory 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 consult your doctor.
If you plan to become pregnant, you can stop taking Naraya at any time (see also "Stopping Naraya").
Breastfeeding
Naraya is not recommended during breastfeeding. If you want to take a contraceptive while breastfeeding, you should consult your doctor.
If you are pregnant, 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 monohydrate and sodium.

If you have been diagnosed with 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.
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 blister 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 should take the tablet with "Wednesday" printed next to it (see "Translation of the days of the week on the packaging" at the end of the leaflet).
Take the tablets in the direction indicated by the arrows on the blister pack until all 21 tablets have been taken.
Then do not take any tablets for 7 days. During this 7-day break (also called a pill-free interval), you should have a withdrawal bleed. The bleed usually starts on the 2nd or 3rd day of the pill-free interval.
On the 8th day after taking the last Naraya tablet (i.e., after the 7-day break), you should start the next blister pack, even if you are still bleeding. This means you will start the next blister pack on the same day of the week as you did previously, and you should have your withdrawal bleed on the same day every month.
If you take Naraya as directed, you will also be protected from pregnancy during the 7-day pill-free interval.

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 bleeding). If you start taking Naraya on the first day of your period, you will be immediately protected from pregnancy. You can also start taking Naraya from day 2 to 5 of your period, but you will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a vaginal ring or transdermal patchYou should start taking Naraya the next day after taking the last active tablet (i.e., the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the pill-free interval (or the day you would have taken the next tablet). When switching from a vaginal ring or transdermal patch, you should start taking Naraya on the day you remove the ring or patch, or on the day you would have applied a new ring or patch.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system (IUS))You can switch 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 childbirthYou can start taking Naraya between 21 and 28 days after giving birth. If you start taking Naraya more than 28 days after childbirth, you should use a barrier method (e.g., condoms) for the first 7 days of taking Naraya. If you have had sex after giving birth before starting Naraya again, you should make sure you are not pregnant before starting Naraya or wait for your next period.
• If you are breastfeeding and want to start taking Naraya again after childbirthSee section "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 take 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 if you discover that a child has taken some, you should consult your doctor or pharmacist.

What to do if you forget to take Naraya

• If it has been less than 12 hourssince you missed a tablet, your protection from 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 missed a tablet, your protection from pregnancy may be reduced. The more tablets you have missed, the higher the risk of pregnancy.

The risk of reduced protection is highest if you miss a tablet at the beginning or end of the pack. Therefore, you should follow the instructions below (see also the diagram below):

• You have missed more than one tablet in this packYou should consult your doctor.
• You have missed one tablet in week 1.You should take the missed tablet as soon as you remember and take the next tablets at the usual time, even if this means taking two tablets in one day. You should also use additional contraceptive methods (e.g., condoms) for the next 7 days. If you have had sex in the week before missing the tablet, there is a risk of pregnancy. In this case, you should consult your doctor.
• You have missed one tablet in week 2.You should take the missed tablet as soon as you remember and take the next tablets at the usual time, even if this means taking two tablets in one day. Your protection from pregnancy is not reduced, and you do not need to use additional contraceptive methods.
• You have missed one tablet in week 3.There are two options to choose from:
• 1. Take the missed tablet as soon as you remember and take the next tablets at the usual time, even if this means taking two tablets in one day. Instead of the pill-free interval, start the next pack immediately. You will probably have a withdrawal bleed at the end of the second pack, but you may have spotting or bleeding during the second pack.
• 2. You can also stop taking the tablets in the current pack and start the 7-day pill-free interval immediately ( make a note of the day you missed the tablet). If you want to start the next pack on the day you usually start, your pill-free interval may be shorter than 7 days.

If you follow one of these options, your protection from pregnancy will be maintained.

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

The diagram shows what to do if you miss a tablet (tablets):
Missed more
than 1 tablet
from 1 pack
Yes
Did you have sex in the week before missing the tablet?
In week 1.
No

• Take the missed tablet
• Use a barrier method (e.g., condoms) for the next 7 days and
• Finish the rest of the pack Missed only 1 tablet (taken after 12 hours)
• Take the missed tablet
• Finish the rest of the pack In week 2.
• Take the missed tablet and
• Finish the pack In week 3.

or

• Stop taking the tablets in the current pack
• Start the 7-day pill-free interval immediately
• Start the next pack after the pill-free interval

What to do if you vomit or have severe diarrhea

If you vomit or have severe diarrhea within 3-4 hours of taking a tablet, there is a risk that the active ingredients in the tablet may not have been fully absorbed into your body, which may lead to a need for additional contraceptive methods (e.g., condoms) to prevent pregnancy. The situation is almost the same as if you had missed a tablet. After vomiting or diarrhea, you should take another tablet from a spare pack as soon as possible. If possible, you should take the tablet within 12 hoursof the usual time you take your tablet. If more than 12 hours have passed, you should follow the instructions in the section "If you forget to take Naraya".

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by starting the next pack of Naraya immediately after finishing the previous pack, without taking the 7-day pill-free interval, until the pack is finished. During the second pack, you may experience spotting or bleeding. After the usual 7-day pill-free interval, you should starttaking the tablets from the next pack.
Before deciding to delay your period, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Naraya, they should consult their doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before taking Naraya".

In case of the following side effects, immediate medical attention is necessary. The patient should discontinue taking Naraya and immediately contact their doctor or go to the nearest hospital.

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

• 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)
• heart attack
• stroke
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack
• blood clots in the liver, stomach, and intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Diseases that may occur or worsen during pregnancy or previous tablet use:

• systemic lupus erythematosus (SLE, a disease affecting the immune system)
• inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis, with symptoms such as bloody diarrhea, pain during bowel movements, abdominal pain)
• 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 urine, decreased red blood cell count, nausea, vomiting, disorientation, and diarrhea)
• jaundice due to bile duct obstruction (cholestatic jaundice)

Additionally, breast cancer (see section 2 "Naraya and tumors") and non-cancerous (benign) and cancerous (malignant) liver tumors (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 on the face, so-called "pregnancy spots") have been observed, which may be a permanent change, especially in women who previously 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
• 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 rhythm
• 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, gastritis, 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, amenorrhea, heavy menstrual bleeding, discharge, vaginal inflammation or infection, vaginal dryness, pelvic pain (in the lower abdomen), 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 that has 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).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Naraya

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Do not use Naraya after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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.
• The other ingredients of Naraya are: Tablet core: lactose monohydrate, corn starch, povidone K 30, croscarmellose sodium, polysorbate 80, magnesium stearate. Tablet coating: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).

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. A cardboard wallet is included with the packaging, in which the blister should be placed.
For more detailed information, please contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

UAB "Exeltis Baltics"
Islandijos pl. 209A
Kaunas, LT-49163
Lithuania

Manufacturer:

Laboratorios León Farma, S.A.
C/La Vallina s/n, Pol. Ind. Navatejera
24008 Villaquilambre – Leon
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, the country of export:LT/1/10/1891/001
Parallel import authorization number:339/21

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

Other information:

Austria
Jangee 0.02 mg/3 mg Filmtabletten
Bulgaria
Jangee 0.02 mg/3 mg филмирани таблетки
Denmark
Movinella filmovertrukne tablet
Estonia
Jangee 0.02 mg/3 mg ohukese polümeerikilega kaetud tablett
Greece
Estrofix 0.02 mg/3 mg δισκίο επικαλυμμένο με λεπτό υμένιο
Spain
Drosurelle 0,02 mg/3 mg comprimidos recubiertos con película EFG
Ireland
Ethinylestradiol/Drospirenone Leon Farma 0.02 mg/3 mg film coated tablets
Lithuania
Etindros 0.02 mg/3 mg plėvele dengtos tabletės
Latvia
Etindros 0.02 mg/3 mg apvalkotās tabletes
Poland
Naraya
Portugal
Drospirenona + Etinilestradiol Generis 3 mg + 0.02 mg Comprimidos revestidos por película
Romania
Taisa 0.02 mg/3 mg comprimate filmate
Slovenia
Etindros 0.02 mg/3 mg filmsko obložene tablete
Slovakia
Lunytta
Hungary
Jangee /3 mg/0.02 mg filmtabletta

Translation of the days of the week on the packaging:

Pirmadienis/Pirmdiena - Monday
Antradienis/Otrdiena

• Tuesday Trečiadienis/Trešdiena - Wednesday Ketvirtadienis/Ceturtdiena - Thursday Penktadienis/Piektdiena - Friday Šeštadienis/Sestdiena - Saturday Sekmadienis/Svētdiena - Sunday.

Date of approval of the leaflet: 15.03.2022
[Information about the trademark]