Naraia Plus

Leaflet accompanying the packaging: information for the user

Naraya Plus, 0.02 mg + 3 mg, coated tablets

Ethinylestradiol + Drospirenone

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 symptoms of blood clots have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness 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 Plus and what is it used for

2. Important information before using Naraya Plus

When not to use Naraya Plus
Warnings and precautions
Blood clots
Naraya Plus and cancer
Mental disorders
Irregular bleeding
What to do if bleeding does not occur during the placebo period
Naraya Plus and other medicines
Naraya Plus with food and drink
Lab tests
Pregnancy
Breastfeeding
Driving and using machines
Naraya Plus contains lactose and sodium

3. How to use Naraya Plus

Preparing the blister pack
When to start the first pack
Taking more than the recommended dose of Naraya Plus
Missing a dose of Naraya Plus
What to do if vomiting or severe diarrhea occurs
Delaying menstruation: what to know
Changing the first day of menstruation: what to know
Stopping Naraya Plus

4. Possible side effects

5. How to store Naraya Plus

6. Contents of the pack and other information

1. What is Naraya Plus and what is it used for

• Naraya Plus is a contraceptive pill used to prevent pregnancy.
• Each of the 24 pink coated tablets contains a small amount of two different female hormones: drospirenone and ethinylestradiol.
• The 4 white tablets do not contain active substances and are referred to as placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills.

2. Important information before using Naraya Plus

General notes

Before starting to use Naraya Plus, 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 using Naraya Plus, your doctor will ask you some questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop using Naraya Plus or in which the effectiveness of Naraya Plus may be reduced.
In such situations, you should not have sexual intercourse or use additional, non-hormonal methods of contraception, such as a condom or other mechanical methods. You should also not use the calendar method or the temperature method during this time. These methods may be unreliable because Naraya Plus alters the monthly changes in body temperature and cervical mucus.

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

When not to use Naraya Plus:

You should not use Naraya Plus 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 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 disorder that affects blood clotting - 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 (see "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a disease that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• 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) a type of migraine called "migraine with aura";
• if you have (or have ever had) liver disease and liver function has not returned to normal;
• if your kidneys do not work properly (renal failure);
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;
• 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.

You should not use Naraya Plus if you have hepatitis C and are taking medicines that contain ombitasvir, paritaprevir, and ritonavir, and dasabuvir, or products that contain glecaprevir and pibrentasvir, or sofosbuvir, velpatasvir, and voxilaprevir (see "Naraya Plus and other medicines").

Additional information for special patient groups

Children and adolescents
Naraya Plus is not indicated for use in patients who have not yet had their first menstruation.
Older women
Naraya Plus is not intended for use after menopause.
Women with liver function disorders
You should not take Naraya Plus if you have liver disease. See also "When not to use Naraya Plus" and "Warnings and precautions".
Women with kidney function disorders
You should not take Naraya Plus if your kidneys do not work properly or if you have acute renal failure. See also "When not to use Naraya Plus" and "Warnings and precautions".

Warnings and precautions

When to contact a doctor?
You should contact a doctor immediately

• if you notice any of the symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or 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 you are using Naraya Plus or other oral contraceptives in any of the following situations, regular medical check-ups are necessary. If any of the following conditions occur or worsen while using Naraya Plus, you should also tell your doctor.

• if a close relative has had breast cancer;
• if you have liver or gallbladder disease;
• 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 (SLE - a disease that affects the natural defense system);
• if you have hemolytic uremic syndrome (HUS - a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have increased levels of fats in the blood (hypertriglyceridemia) or a family history of 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 are immediately after childbirth, you are at increased risk of blood clots. You should consult your doctor for information on how soon you can start taking Naraya Plus after childbirth;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Naraya Plus and other medicines");
• if you have a disease that first occurred during pregnancy or while using hormonal sex hormones (e.g. hearing loss, a blood disease called porphyria, a skin rash with blisters that occurs during pregnancy (pregnancy pemphigoid), a nervous system disease that causes sudden movements of the body (Sydenham's chorea));
• if you have or have ever had chloasma (skin discoloration, especially on the face and neck, called melasma). In this case, you should avoid directexposure 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 a doctor immediately. Estrogen-containing medications may cause or worsen symptoms of hereditary or acquired angioedema.

You should discuss this with your doctor before starting to use Naraya Plus.

Blood Clots

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

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

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It is essential to remember that the overall risk of having a harmful blood clot due to Naraya Plus is small.

HOW TO RECOGNIZE A BLOOD CLOT
You should contact a doctor immediately if you notice any of the following symptoms.

Blood Clots in Veins

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur. They are most likely to occur in the first year of using 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 veins highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not using combined hormonal contraceptives.
If you stop using Naraya Plus, 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 associated with Naraya Plus is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). 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 using Naraya Plus for a few weeks before surgery or immobilization. If you need to stop using Naraya Plus, you should ask your doctor when you can resume using it;
• with age (especially over 35 years of age);
• 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 you have any of these risk factors, even if you are unsure. Your doctor may decide to stop using Naraya Plus.
You should inform your doctor if any of the above conditions change while using Naraya Plus, e.g., if you start smoking, if someone in your close 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?

Similarly 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 a heart attack or stroke associated with Naraya Plus is very small, but it may increase:

• with age (over approximately 35 years of age);
• if you smoke.While using a hormonal contraceptive like Naraya Plus, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years of age, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years of age). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your close 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, arrhythmia called atrial fibrillation);
• 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 using Naraya Plus, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Naraya Plus and Cancer

Women using combined hormonal contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by these medicines. It is possible, for example, that more breast cancers are detected in women using combined hormonal contraceptives because they are examined by doctors more often. The frequency of breast cancer decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to regularly examine your breasts and contact your doctor if you feel any lumps.
Women using combined hormonal contraceptives have, in rare cases, been diagnosed with benign liver tumors, and in even rarer cases, malignant liver tumors.
You should contact your doctor if you experience severe abdominal pain.

Mental Disorders

Some women using hormonal contraceptives, including Naraya Plus, 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 using Naraya Plus, unexpected bleeding (outside of the placebo period) may occur. If bleeding occurs for longer than a few months or if it occurs after a few months, you should contact your doctor, who should determine the cause.

What to do if bleeding does not occur during the placebo period

If all the pink 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 bleedings do not occur, you may be pregnant. In this case, you should contact your doctor immediately. Before starting the next pack, you should rule out pregnancy.

Naraya Plus and Other Medicines

Always tell your doctor about all medicines or herbal products you are currently taking. You should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that you are using Naraya Plus. They may tell you whether you should use additional contraceptive methods (e.g., condoms) and for how long, and whether you should change the way you take other medicines.
Some medicines

• may affect the level of Naraya Plus in your blood
• may make it less effective in preventing pregnancy
• may cause unexpected bleeding. This includes
• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• 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),
• pulmonary hypertension (bosentan),
• herbal products containing St. John's Wort (Hypericum perforatum).

Naraya Plus may affect the actionof other medicines, such as:

• cyclosporine-containing medicines,
• the antiepileptic medicine 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).

You should not use Naraya Plus if you have hepatitis C and are taking medicines that contain ombitasvir, paritaprevir, and ritonavir, and dasabuvir, or products that contain glecaprevir and pibrentasvir, or sofosbuvir, velpatasvir, and voxilaprevir, as they may cause abnormal liver function test results (elevated liver enzymes).
Your doctor will prescribe a different type of contraception before you start taking these medicines.
You can start taking Naraya Plus again about 2 weeks after finishing the above treatment. See "When not to use Naraya Plus".
Before taking any medicine, you should consult your doctor or pharmacist.

Naraya Plus with Food and Drink

Naraya Plus can be taken with or without food, and if necessary, it can be washed down with a small amount of water.

Lab Tests

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

Pregnancy and Breastfeeding

Pregnancy

Pregnant women should not use Naraya Plus. If a woman becomes pregnant while using Naraya Plus, she should stop using it immediately and contact her doctor. If a woman plans to become pregnant, she can stop using Naraya Plus at any time (see also "Stopping Naraya Plus").
Before taking any medicine, you should consult your doctor or pharmacist.

Breastfeeding

Naraya Plus is not recommended during breastfeeding. If a woman wants to use contraceptives while breastfeeding, she should consult her doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and Using Machines

There is no information to suggest that using Naraya Plus affects the ability to drive or use machines.

Naraya Plus Contains Lactose 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 of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to Use Naraya Plus

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Each pack contains 24 pink tablets containing active substances and 4 white tablets that are placebos.
The two types of Naraya Plus tablets of different colors are arranged in order. One blister pack contains 28 tablets.
One Naraya Plus tablet should be taken every day, if necessary, with a small amount of water. The tablets can be taken with or without food, but they should be taken every day at about the same time.
Do not confuse the tablets:the pink tablets should be taken for the first 24 days, followed by the white tablets for the last 4 days. A new blister pack should be started immediately (24 pink, followed by 4 white tablets). There should be no gap between two blister packs.
Due to the differences in tablet composition, it is essential to start taking the tablets from the first tablet at the top left and then take the tablets every day in the direction of the arrows on the blister pack.

Preparing the Blister Pack

To help remember the day of tablet intake, each Naraya Plus blister pack comes with 7 self-adhesive strips with the days of the week printed on them. You should choose a strip that starts with the day of the week you want to start taking the tablets. For example, if you start taking the tablets on a Wednesday, you should use the strip that starts with "Wed".
The sticker should be stuck to the top of the blister pack where it says "Place the day-of-the-week sticker here". This way, the first day of the week you have chosen will be above the tablet marked with the number "1".
The arrows indicate the order in which the tablets should be taken.
During the 4 days of taking the white placebo tablets (placebo period), bleeding (so-called withdrawal bleeding) should occur. This bleeding usually starts on the 2nd or 3rd day after taking the last pink tablet containing the active substances of Naraya Plus. After taking the last white tablet, you should start a new blister pack, regardless of whether the bleeding has stopped or is still ongoing.
This means that you should start each new blister pack on the same day of the week, and the bleeding should occur on the same day every month.
If you take Naraya Plus as directed, you will also be protected against pregnancy during the 4 days of taking the placebo tablets.

When to Start the First Pack

• If you have not used any hormonal contraceptives in the previous monthYou can start taking Naraya Plus on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Naraya Plus on the first day of your period, you will be immediately protected against pregnancy. You can also start taking it from the 2nd to the 5th day of your cycle, but you will need to use additional contraceptive methods (e.g., a condom) for the first 7 days.
• 2. to 5. day of the cycle, but you should use additional contraceptive methods (e.g., a condom) for the first 7 days.
• Changing from a combined hormonal contraceptive or a vaginal ring or a transdermal patchIt is best to start taking Naraya Plus the next day after taking the last active tablet (the last tablet containing the active substance) of your previous contraceptive, but no later than the day after the usual break from taking the previous tablets (or after taking the last inactive tablet of the previous contraceptive). When changing from a transdermal patch or vaginal ring, you should follow your doctor's instructions.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)The change from progestogen-only pills can be made at any time (from an implant or intrauterine system on the day of its removal, from injections on the day of the planned next injection), but in all cases, it is recommended to use an additional contraceptive method (e.g., a condom) for the first 7 days of taking Naraya Plus.
• After a miscarriageYou should follow your doctor's instructions.
• After childbirthYou can start taking Naraya Plus between the 21st and 28th day after giving birth. If you start taking it later than 28 days after giving birth, you should use a mechanical method (e.g., a condom) for the first 7 days of taking Naraya Plus. If you have had sexual intercourse after giving birth, before starting to use Naraya Plus again, you should first make sure you are not pregnant or wait for your next menstrual period.
• If you are breastfeeding and want to start taking Naraya Plus again after childbirthSee "Breastfeeding".

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

Taking More Than the Recommended Dose of Naraya Plus

There are no reports of serious harmful effects from taking too many Naraya Plus tablets at once.
If a large number of tablets are taken at the same time, you may experience nausea, vomiting, or vaginal bleeding. This type of bleeding can occur even in girls who have not yet started their periods but have taken the medicine by mistake.
If you have taken too many Naraya Plus tablets or think a child has swallowed some, you should contact a doctor or pharmacist.

Missing a Dose of Naraya Plus

The last 4 tablets in the 4th rowof the blister pack are placebo tablets. If you forget to take one of them, the contraceptive effectiveness of Naraya Plus is maintained. You should discard the missed placebo tablet.
If you miss a pink tablet containing the active substance (tablets 1 to 24 on the blister pack), you should follow these instructions:

• If less than 24 hourshave passed since you missed the tablet, contraceptive protection is not reduced. You should take the tablet as soon as you remember and take the next tablets at the usual time.
• If more than 24 hourshave passed since you missed the tablet, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant. The risk of reduced contraceptive protection is highest if you miss a tablet at the beginning or end of the pack. Therefore, you should follow these rules (see also the diagram below):

Missed More Than One Tablet in the Blister Pack

You should contact your doctor.

Missed One Tablet in Days 1-7 (First Row)

You should take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. You should then take the next tablets at the usual time and use additional protection(e.g., a 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, you should contact your doctor.

Missed One Tablet in Days 8-14 (Second Row)

You should take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. You should then take the next tablets at the usual time. Contraceptive protection is not reduced, and there is no need to use additional protection.

Missed One Tablet in Days 15-24 (Third or Fourth Row)

There are two options to choose from:

• 1. Take the missed 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 placebo period, you should discard the placebo tablets and start a new blister pack immediately (the first day of intake will be different from before).

It is likely that withdrawal bleeding will occur at the end of the second pack - during the placebo period - but it may also occur as spotting or bleeding similar to a menstrual period during the second pack.

• 2. You can also stop taking the pink tablets containing the active substance and go directly to the 4 white placebo tablets (before starting the placebo period, you should note the day you missed the tablet). If

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Naraya Plus, a doctor should be consulted.
All women using combined hormonal contraceptives have an increased risk of developing 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, see section 2 "Important information before taking Naraya Plus".
The following side effects have been reported with the use of Naraya Plus:

• Common side effects(may affect 1 to 10 in every 100 people taking the medicine): mood swings, headaches,

nausea,
breast pain, menstrual disorders, such as irregular bleeding, absence of bleeding.

• Uncommon side effects(may affect 1 to 10 in every 1,000 people taking the medicine): depression, nervousness, drowsiness, dizziness of central origin, tingling sensation, migraine, varicose veins, high blood pressure, abdominal pain, vomiting, nausea, intestinal gas, gastritis, diarrhea, acne, itching, rash, painful conditions, e.g. back pain, limb pain, muscle cramps, fungal infection of the vagina, pelvic pain, breast enlargement, benign breast tumor, uterine and/or vaginal bleeding (which usually subsides during continued use of the medicine), discharge, hot flashes, vaginal inflammation, menstrual disorders, painful menstrual bleeding, scant menstrual bleeding, very heavy menstrual bleeding, vaginal dryness, abnormal Pap smear, decreased libido, lack of energy, increased sweating, fluid retention, weight gain.
• Rare side effects(may affect 1 to 10 in every 10,000 people taking the medicine): candidiasis (fungal infection), anemia, increased platelet count, allergic reaction, endocrine disorders, increased appetite, loss of appetite, significant increase in potassium levels in the blood, significant decrease in sodium levels in the blood, anorgasmia, insomnia, dizziness of labyrinthine origin, tremors, eye disorders, e.g. conjunctivitis, dry eyes, significant acceleration of heart rate, vein inflammation, nosebleeds, fainting, abdominal distension, gastrointestinal disorders, bloating, hiatal hernia, oral thrush, constipation, dry mouth, biliary colic or cholecystitis, cholecystitis, yellow-brown spots on the skin, rash, hair loss, skin inflammation resembling acne, dry skin, nodular skin inflammation, excessive hair growth, skin diseases, stretch marks on the skin, skin inflammation, skin sensitivity to light, skin nodules, difficult or painful intercourse, vulvovaginitis, post-coital bleeding, withdrawal bleeding, breast cyst, increased cell growth (hyperplasia) in the breast glands, malignant breast tumor, significant growth of the cervical mucosa, shrinkage or atrophy of the endometrium, ovarian cysts, uterine enlargement, general malaise, weight loss, harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis)
• in the lungs (e.g. pulmonary embolism)
• myocardial infarction
• stroke
• mini-stroke or transient stroke-like symptoms, known as transient ischemic attack
• blood clots in the liver, stomach, and intestines, kidneys, or eyes.

The likelihood of developing 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).
The following side effects have been observed, but their frequency cannot be determined from the available data: hypersensitivity, erythema multiforme (rash with redness or ulcers in a target shape).
A doctor should be consulted immediately if the patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria with difficulty breathing (see also "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Naraya Plus

The medicine should be stored out of sight and reach of children.
No special precautions for storage of the medicinal product are necessary.
This medicine should not be used after the expiry date which is stated on the outer packaging and blister after "EXP:". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be consulted on how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Naraya Plus contains

• The active substances of the medicine are ethinylestradiol and drospirenone. Each pink film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
• The white film-coated tablets do not contain active substances.
• The other ingredients are:
• Composition of the pink tablets containing active substances:
• Core: lactose monohydrate, maize starch, povidone K-30 (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate.
• Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• Composition of the white tablets not containing active substances:
• Core: anhydrous lactose, povidone K-30 (E1201), magnesium stearate.
• Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What Naraya Plus looks like and contents of the pack

• Each blister of Naraya Plus contains 24 pink film-coated tablets containing active substances in rows 1, 2, 3, and 4, and 4 white film-coated placebo tablets in row 4.
• Naraya Plus tablets, both pink and white, are film-coated; the core of the tablet is covered with a coating.
• Naraya Plus is available in packs containing 1, 3, 6, or 13 blisters, each containing 28 (24+4) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Exeltis Poland Sp. z o.o.
ul. 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:
Czech Republic:
Velmari
Poland:
Naraya Plus
Hungary
Velgyn 3 mg/0.02 mg, film-coated tablet
Date of last revision of the leaflet:21.11.2024