Naraya

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Naraya (Etindros), 3 mg + 0.02 mg, coated tablets
Drospirenone + Ethinylestradiol
Naraya and Etindros are different brand names of the same medicinal product.
Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read the entire leaflet before using this medicine, as it contains important information for you.

• Keep this leaflet, so you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Naraya is and what it is used for
2. What you need to know 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 Naraya is and what it is used for

Naraya is a contraceptive tablet used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones: drospirenone and ethinylestradiol.
Contraceptive tablets containing two hormones are known as "combined" oral contraceptives.

2. Important information before using Naraya

General notes
Before starting treatment with Naraya, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before you can start using Naraya, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out certain other tests.
This patient information 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 avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods.
During this time, you should not use the calendar method or the temperature method. These methods may be unreliable because Naraya modifies monthly changes in body temperature and cervical mucus.
Naraya, like other hormonal contraceptive products, does not protect against HIV (AIDS) or other sexually transmitted infections.

When not to use Naraya:
Do not use Naraya if you have any of the following conditions.
If you have any of the following conditions, inform your doctor. Your doctor will discuss with you which alternative contraceptive method may be more suitable.

• 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 currently have (or have ever had in the past) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you currently have (or have ever had in the past) a heart attack or stroke;
• if you currently suffer (or have suffered in the past) from angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you currently suffer from any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia
• if you currently have (or have ever had in the past) migraine with focal neurological symptoms;
• if you currently have (or have ever had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have ever had in the past) pancreatitis;
• if you currently have (or have ever had in the past) liver disease; and liver function has not yet returned to normal;
• if your kidneys are not functioning properly (kidney failure);
• if you currently have (or have ever had in the past) a liver tumour;
• if you currently have (or have ever had in the past) breast cancer or cancer of the genital organs, or if such cancer is suspected;
• if you have any unexplained vaginal bleeding;
• if you currently have (or have ever had) hepatitis C and are taking medications 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 exercise particular caution when using Naraya
When should you contact your doctor?
You should contact your doctor immediately:

• if you notice symptoms suggesting a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

You should inform your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Naraya, you should also inform your doctor. If you are taking Naraya or other oral contraceptives in any of the following situations, regular medical monitoring is necessary. Discuss this with your doctor before starting Naraya:

• if a close relative currently has or has ever had breast cancer;
• if you have cancer;
• if you have liver disease (e.g. biliary obstruction, which may cause jaundice or itching) or gallbladder disease (e.g. gallstones);
• if you have other kidney disorders and are taking medications 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 affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have a blood disorder called sickle cell anaemia (an inherited disorder of red blood cells);
• if you have elevated blood lipid levels (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Naraya;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Naraya and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash occurring during pregnancy (pemphigoid gestationis), a nervous system disorder causing uncontrolled body movements (Sydenham's chorea));
• if you develop high blood pressure while taking the medicine, which is not well controlled by antihypertensive drugs;
• if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as "melasma"). In such cases, avoid direct exposure to sunlight and ultraviolet radiation;
• if you have hereditary angioedema, products containing estrogens may cause or worsen angioedema symptoms. If angioedema symptoms occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with breathing difficulties, seek immediate medical attention.

BLOOD CLOTS
Using combined hormonal contraceptives such as Naraya is associated with an increased risk of blood clots compared to not using these products. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Naraya is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.

Do you experience any of these symptoms? What might be the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, e.g. pallor, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden cough without obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, contact your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as a respiratory tract infection (e.g. cold).
Symptoms most commonly affect one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or blurred vision

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (either the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Naraya, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Naraya is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Naraya, will develop blood clots.
• The risk of developing blood clots depends on the individual woman's medical history ("Factors increasing the risk of venous blood clots" and "Factors increasing the risk of arterial blood clots", below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Naraya is small, however,
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. below 50 years of age). In this case, the patient may have an inherited blood clotting disorder;
• if the patient needs to undergo surgery, if she is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Naraya for several weeks before surgery or immobilization. If the patient needs to stop taking Naraya, ask the doctor when it is safe to restart taking the medicine.
• with increasing age (especially above 35 years of age);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Naraya.
Inform the doctor if any of the above conditions change during treatment with Naraya, e.g. if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
Similar to venous blood clots, arterial blood clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Naraya is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Naraya, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (below 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of developing blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Naraya, e.g. if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Naraya and cancer
Breast cancer has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is caused by the use of these medicines. It is possible, for example, that more cancers are detected in women using hormonal contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to regularly examine your breasts and contact your doctor if you detect any lumps.

Benign liver tumours have been observed rarely, and malignant liver tumours very rarely, in women using combined hormonal contraceptives.
Contact your doctor if you experience severe abdominal pain or notice abdominal swelling (which may be due to liver enlargement), vomiting blood, blood in stool, or black tarry stools (which may be signs of gastrointestinal bleeding).

Psychiatric disorders
Some women using hormonal contraceptives, including Naraya, have reported depression or depressed mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Naraya, unexpected bleeding (outside the week without tablets) may occur. If bleeding continues beyond the first few months or occurs after several months of use, consult your doctor, who must determine the cause.

What to do if withdrawal bleeding does not occur during the tablet-free interval
If all tablets have been taken correctly, there have been no episodes of vomiting or severe diarrhoea, and the patient has not taken any other medicines, it is unlikely that she is pregnant.
If two consecutive withdrawal bleeds do not occur, the patient may be pregnant. In this case, contact a doctor immediately. Pregnancy must be ruled out before starting the next pack of tablets.

Naraya and other medicines
Always inform your doctor about all medicines or herbal products currently used, recently used, or planned to be used. Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Naraya. They may advise whether additional contraceptive methods (e.g. condoms) should be used, and for how long.

Do not use Naraya in patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir or dasabuvir, as this may cause abnormalities in liver function tests (increased liver enzyme AlAT activity).
The doctor will recommend using another method of contraception before starting these medicines.
Naraya may be restarted approximately 2 weeks after stopping these medicines.
See section "When not to use Naraya".

• Some medicines may reduce the effectiveness of Naraya 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole)
• joint inflammation, osteoarthritis (etoricoxib)
• pulmonary hypertension (bosentan)
• herbal products containing St John's wort (Hypericum perforatum)

If the patient is taking any of the above medicines together with Naraya, she should use additional contraceptive methods (e.g. condoms) during concomitant use and for 28 days after stopping the treatment.

Naraya may affect the action of other medicines, for example:

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

The doctor may recommend monitoring blood potassium levels if the patient is taking certain medicines for heart disease (e.g. diuretics).

Laboratory tests
If blood tests are required, inform the doctor or laboratory staff that you are taking a contraceptive, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Naraya must not be used during pregnancy. If the patient becomes pregnant while taking Naraya, she should stop taking the medicine immediately and contact her doctor. If the patient plans to become pregnant, she may stop taking Naraya at any time (see also "Discontinuing Naraya").

Breastfeeding
Naraya is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should consult her doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
There is no information indicating that Naraya affects the ability to drive or operate machinery.

Naraya contains monohydrate lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Naraya

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Take one Naraya tablet daily, swallowing it with a small amount of water if necessary. Tablets may
be taken with or without food, but should be taken every day at approximately the same time.
One blister contains 21 tablets. Each tablet is marked with the day of the week on which it should be
taken. For example, if treatment is started on Wednesday, take the tablet marked “Trečiadienis/Trešdiena”
(corresponding to Wednesday; see “Translation of the days of the week marked next to each tablet
on the immediate packaging” at the end of the leaflet).
Tablets should be taken in the order 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 (referred to as the weekly break),
a withdrawal bleed should occur. This bleeding, also known as “withdrawal bleeding,” usually begins
on the 2nd or 3rd day of the break.
On the 8th day after taking the last Naraya tablet (i.e., after the 7-day break), start a new blister pack,
even if bleeding has not finished. This means starting the new pack on the same day of the week,
so that bleeding occurs on approximately the same day each month.
If Naraya is taken as directed, protection against pregnancy continues during the 7-day tablet-free
interval.

When to start the first pack?

• If no hormonal contraceptives were used in the previous month
  Start taking Naraya on the first day of your cycle (i.e., the first day of menstruation). If you start Naraya
  on the first day of your period, you are protected from pregnancy immediately. You may also start
  between days 2 and 5 of your cycle, but in this case, an additional contraceptive method (e.g., condom)
  should be used for the first 7 days.

• Switching from a combined hormonal contraceptive or from a vaginal ring or transdermal patch
  Start Naraya the day after taking the last active tablet (i.e., the last tablet containing active ingredients)
  of the previous contraceptive, but no later than the day after the tablet-free interval of the previous
  contraceptive (or after the last inactive tablet). If switching from a vaginal ring or transdermal patch,
  start Naraya on the day of removal, but no later than the day the next application of the previous
  system would have been due.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen IUS)
  Switching from a progestogen-only pill can be done at any time (from an implant or intrauterine device
  on the day of removal; from injectable contraceptives on the day the next injection would have been due).
  However, in all cases, an additional contraceptive method (e.g., condom) should be used for the first 7 days
  of taking Naraya tablets.

• After miscarriage
  Follow your doctor’s advice.

• After childbirth
  Naraya may be started between 21 and 28 days after delivery. If treatment starts later than 28 days
  after childbirth, use a barrier method (e.g., condom) for the first 7 days of taking Naraya. If sexual
  intercourse has occurred after childbirth and before starting (or restarting) Naraya, the woman should
  first confirm she is not pregnant or wait until the next menstrual bleed.

• If breastfeeding and wishing to start (or restart) Naraya after childbirth
  See section: “Breastfeeding”.

If in doubt about when to start taking Naraya, consult your doctor.

Taking more Naraya than you should
There are no reports that taking too many Naraya tablets causes serious harmful effects.
If a large number of tablets are taken at once, nausea or vomiting may occur. In young girls, vaginal
bleeding may occur.
If you have taken too many Naraya tablets or if you suspect a child has swallowed some tablets,
contact your doctor or pharmacist immediately.

Missed dose of Naraya

• If less than 12 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and take the next tablets at the usual time.
• If more than 12 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the higher the risk of pregnancy.

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

• More than one tablet missed from the blister
  Contact your doctor.
• One tablet missed in Week 1
  Take the missed tablet as soon as you remember, even if this means taking two tablets at once. Take the remaining tablets at the usual time and use additional contraception (e.g., condom) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, contact your doctor.
• One tablet missed in Week 2
  Take the missed tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Protection against pregnancy is not reduced, and additional contraception is not needed.
• One tablet missed in Week 3
  You have two options:
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Instead of the tablet-free interval, immediately start the next blister pack. Bleeding will likely occur towards the end of the second pack, but spotting or breakthrough bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets from the current pack and immediately begin the 7-day tablet-free interval (note the day on which the dose was missed). If you wish to start the new pack on the day you usually start, the tablet-free interval should be shorter than 7 days.

If you follow either of these recommendations, protection against pregnancy will be maintained.

• If you have missed any tablet from the current blister and no bleeding occurs during the tablet-free interval, this may indicate that you are pregnant. In this case, consult your doctor before starting the next blister pack.

The diagram below shows what to do if you miss a tablet(s):
Missed more than
Seek advice from your doctor
1 tablet from 1 blister
Yes
Did sexual intercourse occur in the week
Week 1
preceding the missed tablet?
No

• Take the missed tablet
• Use a barrier method (condom) for the next 7 days and
• Finish the current blister pack Missed only one tablet (taken after
• Take the missed tablet more than 12 hours) Week 2.
• Finish the current blister
• Take the missed tablet and
• Finish the blister
• Instead of the weekly break, immediately start the next blister pack

Week 3 or

• Immediately stop taking tablets from the current blister
• Start the 7-day tablet-free interval (no longer than 7 days, including the day the tablet was missed)
• Then start the next blister pack

What to do if vomiting or severe diarrhoea occurs
If vomiting or severe diarrhoea occurs within 3–4 hours after taking a tablet, there is a risk that the active
substances in the tablet have not been completely absorbed, which may require the use of additional
contraception (e.g., condom) to prevent pregnancy. This situation is similar to missing a tablet. After
vomiting or diarrhoea, take another tablet from a spare blister as soon as possible. If possible, take the
tablet within 12 hours of your usual time. If this is not possible, or if more than 12 hours have passed,
follow the instructions under “Missed dose of Naraya”.

Delaying withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by immediately starting a new
Naraya blister pack without taking the tablet-free interval, continuing until the pack is finished. Spotting
or breakthrough bleeding may occur during the second pack. After the usual 7-day tablet-free interval,
start taking tablets from the next blister pack.
Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the day of withdrawal bleeding: what you should know
If you take the tablets as directed, bleeding will occur during the tablet-free week. If you wish to change
this day, shorten (but never extend – the maximum break is 7 days!) the tablet-free interval. For example,
if the tablet-free interval starts on Friday and you wish to change it to Tuesday (3 days earlier), start the
new blister 3 days earlier than usual. If you significantly shorten the tablet-free interval (e.g., to 3 days or
less), withdrawal bleeding may not occur during that time. However, light bleeding or spotting may occur.
If you are unsure what to do, consult your doctor.

Stopping Naraya treatment
You may stop taking Naraya at any time. If you do not wish to become pregnant, consult your doctor about
other effective contraceptive methods.
If you are planning a pregnancy, stop taking the tablets and wait until your next menstrual period before
trying to conceive. This will make it easier to calculate the expected delivery date.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Naraya, medical advice should be sought immediately.

In all women using combined hormonal contraceptives, there is an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Naraya".

If any of the following adverse reactions occur, immediate medical attention is required. Naraya must be discontinued immediately and the patient should contact a doctor or go to the nearest hospital without delay.

Uncommon adverse reactions (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 urticaria accompanied by breathing difficulties (angioedema)
• harmful blood clots in the lungs (e.g. pulmonary embolism)

Rare adverse reactions (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 transient ischaemic attack (TIA)
  • blood clots in the liver, stomach and intestine, kidneys, or eye.

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

Conditions that may appear or worsen during pregnancy or during previous use of contraceptive pills:

• systemic lupus erythematosus (SLE, an autoimmune disorder)
• ulcerative colitis or inflammation of other parts of the intestine (with symptoms such as bloody diarrhoea, pain during defecation, abdominal pain) (Crohn’s disease and ulcerative colitis)
• epilepsy
• uterine fibroids (benign tumour growing in the muscular tissue of the uterus)
• blood pigment disorder (porphyria)
• blistering rash during pregnancy (pemphigoid gestationis)
• Sydenham’s chorea (a neurological disorder characterised by sudden involuntary movements)
• certain blood disorders causing kidney damage (haemolytic uraemic syndrome with symptoms such as reduced urine output, blood in urine, reduced red blood cell count, nausea, vomiting, confusion, and diarrhoea)
• yellowing of the skin or whites of the eyes due to bile duct obstruction (cholestatic jaundice)

In addition, cases of breast cancer have been observed (see section 2 "Naraya and cancer"), as well as benign (non-cancerous) and malignant (cancerous) liver tumours (with symptoms such as abdominal swelling, weight loss, liver function abnormalities detectable in blood tests), and chloasma (yellowish-brown skin patches, especially on the face, also known as "pregnancy mask"), which may be permanent, particularly in women who previously experienced chloasma during pregnancy.

Other possible adverse reactions

Common adverse reactions (may occur in up to 1 in 10 people):

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

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• vaginal candidiasis (yeast infection)
• herpes simplex
• allergic reactions (hypersensitivity)
• increased appetite
• depression, nervousness, sleep disturbances, decreased libido
• tingling and numbness, dizziness
• visual disturbances
• heart rhythm disorders or abnormally rapid heartbeat
• blood clot (thrombosis) in a leg vessel or lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestinal mucosa, diarrhoea, constipation
• hair loss (alopecia), rash, itching, skin eruptions, dry skin, seborrhoeic dermatitis
• neck pain, limb pain, muscle cramps
• urinary bladder infection
• breast lumps (benign), milk secretion in non-pregnant women (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, very heavy periods, vaginal discharge, inflammation or infection of the vagina, vaginal dryness, pelvic pain, abnormal cervical smear (Papanicolaou or Pap test), decreased libido
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss
• generalized pain

Rare adverse reactions (may occur in up to 1 in 1000 people):

• asthma
• hearing impairment
• blockage of a blood vessel by a clot formed elsewhere in the body
• erythema nodosum (characterized by painful red nodules on the skin)
• erythema multiforme (rash with red, target-like lesions resembling bullseyes or sores)

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Naraya

Keep the medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Naraya contains

• The active substances are ethinylestradiol 0.02 mg and drospirenone 3 mg.
• The other components are:
  Tablet core: monohydrate lactose, gelatinized corn starch, povidone K 30, sodium croscarmellose, polysorbate 80, magnesium stearate.
  Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Naraya looks like and contents of the pack
Pink, round film-coated tablets with a diameter of approximately 5.7 mm.
Naraya is available in packaging containing 1, 2 or 3 blisters, each containing 21 tablets. A cardboard sleeve is included with the package, in which the blister should be placed.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Lithuania, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Lithuania, country of export: LT/1/10/1891/001
Parallel Import Authorisation Number: 339/21
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
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 δiσkio εττikαλνμμένo με λεττό νμένio
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 printed on each tablet in the immediate packaging:
Pirmadienis/Pirmdiena - Monday
Antradienis/Otrdiena - Tuesday
Trečiadienis/Trešdiena - Wednesday
Ketvirtadienis/Ceturtdiena - Thursday
Penktadienis/Piektdiena - Friday
Šeštadienis/Sestdiena - Saturday
Sekmadienis/Svētdiena - Sunday