Naraya plus

Package leaflet: Information for the user

Naraya Plus, 0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Important information about 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 a doctor if you suspect symptoms of blood clot formation (see section 2, "Blood clots").

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

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

Contents of the leaflet
1. What Naraya Plus is and what it is used for
2. Important information before taking Naraya Plus
When not to use Naraya Plus
Warnings and precautions
Blood clots
Naraya Plus and cancer
Psychiatric disorders
Intermenstrual bleeding
What to do if no bleeding occurs during the placebo tablet period
Naraya Plus and other medicines
Naraya Plus with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and operating machinery
Naraya Plus contains lactose and sodium

3. How to take Naraya Plus

Blister preparation
When to start the first pack
Taking more Naraya Plus than you should
If you forget to take Naraya Plus
If you vomit or have severe diarrhoea
Delayed menstrual bleeding: what you should know
Changing the first day of your period: what you should know
Stopping Naraya Plus
4. Possible side effects
5. How to store Naraya Plus
6. Contents of the pack and other information
1. What Naraya Plus is and what it is used for

• Naraya Plus is a combined oral 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 any active substances and are referred to as placebo tablets.
• Contraceptive pills containing two hormones are known as "combined" pills.

2. Important information before using Naraya Plus

General notes
Before starting to take Naraya Plus, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2, "Blood clots").
Before you can start taking Naraya Plus, 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 case, may carry out additional tests.
This patient information leaflet describes several situations in which you should stop taking Naraya Plus or in which the effectiveness of Naraya Plus 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 Plus alters the monthly changes in body temperature and cervical mucus.
Naraya Plus, like other hormonal contraceptive products, does not protect against HIV (AIDS) or other sexually transmitted infections.

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

• 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 blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have ever had a heart attack or stroke;
• if you currently have (or have had in the past) 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 have (or have had in the past) any of the following conditions that may increase the risk of arterial blood clots:
  o severe diabetes with blood vessel damage,
  o very high blood pressure,
  o very high levels of fats in the blood (cholesterol or triglycerides),
  o a condition called hyperhomocysteinemia;
• 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) liver disease and liver function has not returned to normal;
• if your kidneys are not functioning properly (kidney failure);
• if you currently have (or have ever had in the past) 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 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.

Do not use Naraya Plus if you have hepatitis C and are taking medicinal products containing ombitasvir with paritaprevir and ritonavir and dasabuvir, or products containing glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section "Naraya Plus and other medicines").

Additional information for special patient groups
Children and adolescents
Naraya Plus is not indicated for use in girls who have not yet had their first menstrual period.

Women of advanced age
Naraya Plus is not intended for use after menopause.

Women with impaired liver function
Do not take Naraya Plus if you have liver disease. See also section "When not to use Naraya Plus" and "Warnings and precautions".

Women with impaired kidney function
Do not take Naraya Plus if your kidneys are not working properly or if you have acute kidney failure. See also section "When not to use Naraya Plus" and "Warnings and precautions".

Warnings and precautions
When should you contact your doctor?
You should contact your doctor immediately:

• if you notice possible symptoms of blood clots, which may indicate 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 you are taking Naraya Plus or other oral contraceptive products and have any of the conditions listed below, regular medical monitoring is necessary. If any of the following conditions develop or worsen during treatment with Naraya Plus, you should also inform your doctor.

• if a close relative has or has ever 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 affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (HUS—a blood clotting disorder causing kidney failure);
• if you have a blood disorder called sickle cell anaemia (a hereditary disorder of red blood cells);
• if you have high blood fat levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to determine how soon after delivery you can start taking Naraya Plus;
• 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 condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, pregnancy-related skin rash with blistering (herpes gestationis), a nervous system disorder causing sudden body movements (Sydenham's chorea));
• if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as melasma). In such cases, you should avoid direct exposure to sunlight and ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives with breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Discuss these conditions with your doctor before starting Naraya Plus.

BLOOD CLOTS
Using 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 may block a blood vessel and cause serious complications.
Blood clots may occur:

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

Recovery from 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 associated with the use of Naraya Plus is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

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 blood clots in veins (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 highest?
The risk of developing blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of four 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 Plus, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
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 Plus is low.

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

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

• if the patient is very overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient 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, the patient may have an inherited clotting disorder;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Naraya Plus several weeks before surgery or immobilization. If the patient must stop taking Naraya Plus, ask the doctor when it is safe to resume;
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the past 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, especially if the patient has another risk factor present.
It is important to inform the doctor if any of these factors apply to the patient, even if uncertain. The doctor may decide to discontinue Naraya Plus.
Inform the doctor if any of the above conditions change during treatment with Naraya Plus, for example, if a close family member develops thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial 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 Plus is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Naraya Plus, smoking should be avoided. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially 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 are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Naraya Plus, for example, if the patient starts smoking, a close family member develops thrombosis without a known cause, or if the patient gains significant weight.

Naraya Plus 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 combined 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 the breasts and contact a doctor if any lumps are detected.
Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been observed in women using combined hormonal contraceptives. Contact the treating doctor if the patient experiences severe abdominal pain.

Psychiatric 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 or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of using Naraya Plus, unexpected bleeding (outside the placebo tablet period) may occur. If bleeding persists for longer than a few months or occurs after several months of use, consult a doctor to determine the cause.

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

Naraya Plus and other medicines
Always inform the doctor about all medicines or herbal preparations currently being taken. Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that Naraya Plus is being used. They may advise whether additional contraceptive methods (e.g., condoms) should be used, for how long, and whether the use of other medicines needs to be adjusted.

Some medicines:

• may affect the blood concentration of Naraya Plus;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding. These include medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g., rifampicin);
• HIV or hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• pulmonary hypertension (bosentan);
• herbal products containing St John’s wort (Hypericum perforatum).

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

• medicines containing cyclosporine;
• the antiepileptic drug 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).

Do not use Naraya Plus if the patient has hepatitis C and is taking medicines containing ombitasvir with paritaprevir and ritonavir, and dasabuvir, or products containing glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased activity of liver enzymes AlAT).
Before starting these medicines, the doctor will prescribe a different type of contraception.
Naraya Plus may be restarted approximately 2 weeks after stopping the above-mentioned treatment. See section “When not to use Naraya Plus”.
Before taking any medicine, consult a doctor or pharmacist.

Naraya Plus with food and drink
Naraya Plus may be taken with or without food. If necessary, it can be taken with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that hormonal contraceptives are being used, as oral contraceptives may affect the results of certain tests.

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

Before taking any medicine, consult a doctor or pharmacist.

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

Before taking any medicine, consult a doctor or pharmacist.

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

Naraya Plus contains 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 of sodium (23 mg) per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Naraya Plus

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Each pack contains 24 pink tablets containing active substances and 4 white placebo tablets.
The two types of Naraya Plus tablets of different colours are arranged in a specific order. One blister contains
28 tablets.
One tablet of Naraya Plus should be taken every day, if necessary with a small amount of water. Tablets may be taken with or without food, but they should be taken every day at approximately the same time.
Do not confuse the tablets: take the pink tablets for the first 24 days, followed by the white
tablets for the last 4 days. A new blister should be started immediately (24 pink, then 4 white
tablets). Therefore, do not take a break between two blisters.
Due to differences in tablet composition, it is essential to start from the first tablet at the top left corner, and then take the tablets each day in the direction indicated by the arrows on the blister.
Preparing the blister
To help remember which day of the week to take the tablet, each Naraya Plus blister is supplied with 7 self-adhesive strips printed with the days of the week. Choose the strip starting with the day on which you begin taking the tablets. For example, if you start taking tablets on Wednesday, use the strip beginning with "Wed".
Stick the label in the upper part of the blister, in the area marked "Place the day-of-the-week label here". In this way, the first selected day of the week will be above the tablet marked "1".
This ensures that each tablet is marked with the corresponding day of the week, allowing you to check whether the correct tablet has been taken each day. Arrows indicate the order of tablet intake.
During the 4 days of taking white placebo tablets (the placebo period), withdrawal 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, start the next blister immediately, regardless of whether bleeding has stopped or is still ongoing.
This means that each subsequent blister should be started on the same day of the week, and bleeding should occur on the same day each month.
If Naraya Plus is taken according to instructions, protection against pregnancy is maintained during the 4 days of taking placebo tablets.
When to start the first pack?

• If no hormonal contraceptives have been used in the previous month Naraya Plus may be started on the first day of the cycle (i.e. on the first day of menstruation). If the patient starts taking Naraya Plus on the first day of menstruation, immediate protection against pregnancy is ensured. It is also possible to start taking the medicine from day 2 to
  day 5 of the cycle, but in this case, additional contraceptive methods (e.g. condoms) should be used for the first 7 days.
• Switching from a combined hormonal contraceptive product or delivery system vaginal ring) or transdermal system (patch) It is best to start taking Naraya Plus the next day after taking the last active tablet (last tablet containing active substances) of the previously used medicine, but no later than the day after the break from the previous tablets (or after taking the last inactive tablet of the previous medicine). When switching from a vaginal contraceptive system (ring) or transdermal system (patch), follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only tablet, injection, implant or intrauterine system (IUS) releasing progestogen) Switching from progestogen-only tablets can occur at any time (from an implant or intrauterine device on the day of removal, from an injectable form on the day of the next scheduled injection), but in all cases, it is recommended to use an additional contraceptive method (e.g. condom) for the first 7 days of taking tablets.
• After miscarriage Follow your doctor's advice.
• After childbirth Naraya Plus may be started between day 21 and day 28 after delivery. If tablet intake begins later than day 28 after childbirth, a mechanical method (e.g. condom) should be used for the first 7 days of taking Naraya Plus. If sexual intercourse has occurred after childbirth, before restarting Naraya Plus, the patient should first confirm she is not pregnant or wait until the next menstrual bleeding occurs.
• If the patient is breastfeeding and wishes to start (or restart) taking Naraya Plus after childbirth See section "Breastfeeding".

If in doubt about when to start taking the medicine, consult your doctor.
Taking more Naraya Plus than recommended
There are no reports that taking too many Naraya Plus tablets causes serious harmful effects.
If a large number of tablets are taken at once, nausea, vomiting or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken this medicine.
If the patient has taken too many Naraya Plus tablets or realizes that a child has swallowed several tablets, contact a doctor or pharmacist.
Missed dose of Naraya Plus
The last 4 tablets in the 4th row of the blister are placebo tablets. If one of these is missed,
the contraceptive effectiveness of Naraya Plus remains unchanged. The missed placebo tablet should be discarded.
If a missed pink tablet containing active substances (tablets 1 to 24 on the blister) occurs, follow these instructions:

• If less than 24 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.
• If more than 24 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 incomplete protection is greatest if a pink tablet at the beginning or end of the pack is missed. Therefore, follow the rules below (see also the diagram below):
• More than one tablet missed in the blister Contact your doctor.
• One tablet missed on days 1 to 7 (first row) Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the following tablets at the usual time and use additional protection (e.g. condom) for the next 7 days. If the patient 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 on days 8 to 14 (second row) Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the following tablets at the usual time. Protection against pregnancy is not reduced and there is no need for additional protection.
• One tablet missed on days 15 to 24 (third or fourth row) Two options are available:
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the following tablets at the usual time. Instead of taking the white placebo tablets, discard them and immediately start the next blister (the starting day will be different than before).

Most likely, withdrawal bleeding will occur at the end of the second blister –
during the intake of placebo tablets – but spotting or menstrual-like bleeding may also occur during the intake of tablets from the second blister.

2. Alternatively, stop taking the active pink tablets and go directly to the 4 white placebo tablets (before starting the placebo tablets, note the day on which the dose was missed). If
   the patient wishes to start the new blister on the day she usually starts taking tablets, the placebo period can be shortened to less than 4 days.
   If either of these recommendations is followed, protection against pregnancy will be maintained.

• If any tablet from the current blister was missed and no bleeding occurred during the first placebo period, this may indicate that the patient is pregnant. In this case, contact your doctor before starting the next blister.

What to do if vomiting or severe diarrhoea occurs
If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a pink tablet containing active substances, there is a risk that the active substances in the tablet have not been fully absorbed. This situation is almost the same as missing a tablet. After vomiting or diarrhoea, take another pink tablet from a spare blister as soon as possible. If possible, take the tablet within 24 hours of the usual time of tablet intake. If this is not possible, or if more than 24 hours have passed, follow the advice described in the section "Missed dose of Naraya Plus".
Delayed menstrual bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by skipping the white placebo tablets in the 4th row and starting a new blister of Naraya Plus, continuing until it is finished. During intake of tablets from the second blister, spotting or menstrual-like bleeding may occur. Complete the second pack by taking the 4 white placebo tablets in the 4th row of the second pack. Then start taking tablets from the next blister.
Before deciding to delay bleeding, consult your doctor.
Changing the first day of menstruation: what you should know
If the patient takes the tablets as directed, bleeding will start during the placebo tablet period. If it is necessary to change this day, shorten (but never lengthen – 4 days is the maximum!) the placebo tablet period. For example, if the placebo period starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. In this case, bleeding may not occur. Spotting or menstrual-like bleeding may then occur.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping treatment with Naraya Plus
Naraya Plus may be discontinued at any time. If pregnancy is not desired, consult your doctor about other effective contraceptive methods. If the patient plans to become pregnant, stop taking Naraya Plus and wait until the next menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your
doctor, pharmacist or nurse.

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 user considers related to the use of Naraya Plus, medical advice should be sought from a doctor.

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 using Naraya Plus".

Listed below are adverse reactions associated with the use of Naraya Plus:

• Common adverse reactions (may occur in 1 to 10 out of every 100 users):

  • mood swings,
  • headache,
  • nausea,
  • breast tenderness,
  • menstrual disorders such as irregular bleeding, absence of bleeding.

• Uncommon adverse reactions (may occur in 1 to 10 out of every 1,000 users):

  • depression, nervousness, drowsiness,
  • central dizziness, paraesthesia (tingling sensation),
  • migraine, varicose veins, high blood pressure,
  • abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhoea,
  • acne, pruritus (itching), rash,
  • pain-related symptoms, e.g. back pain, limb pain, muscle cramps,
  • fungal vaginal infection, pelvic pain, breast enlargement, benign breast tumour, uterine and (or) vaginal bleeding (which usually resolves during continued use of the medicine), hot flushes, vaginal dryness, abnormal cervical smear, decreased interest in sex,
  • fatigue, increased sweating, fluid retention,
  • weight gain.

• Rare adverse reactions (may occur in 1 to 10 out of every 10,000 users):

  • candidiasis (fungal infection),
  • anaemia, increased platelet count,
  • allergic reaction,
  • endocrine disorders (hormonal disturbances),
  • increased appetite, loss of appetite, marked increase in blood potassium levels, marked decrease in blood sodium levels,
  • anorgasmia, insomnia,
  • labyrinthine dizziness, tremor,
  • eye disorders, e.g. blepharitis, dry eyes,
  • marked tachycardia (rapid heartbeat),
  • phlebitis, epistaxis (nosebleed), syncope (fainting),
  • increased abdominal girth, intestinal disorders, bloating, gastric hernia, fungal infection of the mouth, constipation, dry mouth,
  • biliary or gallbladder pain, cholecystitis (inflammation of the gallbladder),
  • yellowish-brown skin patches, skin eruption, hair loss, acneiform dermatitis, dry skin, nodular dermatitis, hirsutism (excessive hair growth), skin diseases, striae (stretch marks), dermatitis, photosensitivity (skin sensitivity to light), skin nodules,
  • dyspareunia (painful intercourse), vulvovaginitis, post-coital bleeding, withdrawal bleeding, breast cyst, glandular cell hyperplasia in the breast, malignant breast tumour, marked endocervical hyperplasia, endometrial atrophy or stenosis, ovarian cysts, uterine hyperplasia,
  • general malaise,
  • weight loss,
  • harmful blood clots in veins or arteries, for example:
    • in the leg or foot (e.g. deep vein thrombosis)
    • in the lungs (e.g. pulmonary embolism)
    • myocardial infarction (heart attack)
    • stroke
    • transient ischaemic attack (mini-stroke or temporary stroke-like symptoms)
    • blood clots in the liver, stomach and intestine, kidneys or eye.

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

The following adverse reactions have been observed, but their frequency cannot be determined from available data: hypersensitivity, erythema multiforme (a rash with red or ulcerated lesions in a target-like shape).

Immediate medical attention should be sought if any symptoms of angioedema occur, such as swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria (hives) accompanied by breathing difficulties (see also section "Warnings and precautions").

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. 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.
Adverse reactions can also be reported to the marketing authorization holder.

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

5. How to store Naraya Plus

Keep this medicine out of sight and reach of children.
No special precautions for storage of the medicinal product.
Do not use this medicine after the expiry date stated on the outer packaging and blister after: "EXP:". 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Naraya Plus contains

• The active substances in this medicine are: ethinylestradiol and drospirenone. Each pink coated tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone.
• The white coated tablets do not contain any active substances.
• Other components are:
• Composition of the pink tablets containing active substances:
• Tablet core: monohydrate lactose, pregelatinized corn starch, povidone K-30 (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate.
• Tablet 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:
• Tablet core: anhydrous lactose, povidone K-30 (E1201), magnesium stearate.
• Tablet 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 coated active tablets in rows 1, 2, 3 and 4, and 4 white coated placebo tablets in row 4.
• Naraya Plus tablets, both pink and white, are film-coated tablets; the tablet core 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 Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
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 authorised 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, filmtabletta