Novynette

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Novynette (Desorelle 20)
0.02 mg + 0.15 mg, coated tablets
Ethinylestradiolum + Desogestrelum
Novynette and Desorelle 20 are different brand names of the same medicine.
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 the medication following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

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

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm other people.
• 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 Novynette is and what it is used for
2. Important information before taking Novynette
3. How to take Novynette
4. Possible side effects
5. How to store Novynette
6. Contents of the pack and other information

1. What Novynette is and what it is used for

Novynette is a combined oral contraceptive containing ethinylestradiol
(an estrogen) and desogestrel (a progestogen) in low doses. The mechanism of action of Novynette involves suppression of ovulation and changes in the consistency of cervical mucus.
When used correctly, Novynette provides effective and reversible contraception.
However, in certain situations, its contraceptive effectiveness may be reduced or discontinuation of the medicine may be necessary (see section 2). In such cases, either sexual intercourse should be avoided or alternative contraceptive methods such as condoms or spermicides should be used to ensure effective contraception.
Please remember that combined oral contraceptives such as Novynette do not protect against
sexually transmitted infections (such as AIDS). Only the use of condoms provides protective effect.

2. Important information before using Novynette

General notes
Before starting to take Novynette, you should read the information about blood clots (thrombosis) in section 2. It is especially important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Novynette must not be used to delay the onset of bleeding.
In exceptional circumstances, when there is a need to delay the start date of bleeding, you should consult your doctor.
Before starting Novynette, 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.

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

• If you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients of this medicine (listed in section 6); symptoms may include itching, rash or swelling;
• If you currently have (or have ever had) a blood clot in the blood vessels of your legs (deep vein thrombosis), in your 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 have had a heart attack or stroke;
• If you have (or have previously had) 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 have 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 previously had) a type of migraine called "migraine with aura";
• If you currently have or have previously had pancreatitis;
• If you currently have or have previously had liver disease, and liver function has not returned to normal;
• If you currently have or have previously had liver tumours;
• If you currently have, have previously had, or are suspected of having breast or genital organ cancers;
• If you have vaginal bleeding of unknown cause;
• If you have an enlarged endometrium (abnormal growth of the uterine lining);
• If you are or may be pregnant.

Do not take Novynette in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Novynette and other medicines").

Warnings and precautions
Before starting Novynette, discuss this with your doctor or pharmacist.
When should you contact your doctor?
Seek immediate medical advice if:

• You notice possible symptoms of a blood clot, 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 development of blood clots".
In certain cases, special caution is required when using Novynette or other combined hormonal contraceptives, and regular visits to your doctor may be necessary.

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Novynette, inform your doctor.

• If you experience symptoms of angioedema (such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, potentially with breathing difficulties), seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• If you smoke;
• If you are obese;
• If you have high blood pressure;
• If you have heart valve disorders or cardiac arrhythmias;
• If you have superficial thrombophlebitis (inflammation of veins under the skin);
• 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 hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• If you have sickle cell anemia (an inherited disorder of red blood cells);
• If you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia 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 at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Novynette;
• If you have varicose veins;
• If breast cancer is currently present or has occurred in close family members;
• If you have liver or gallbladder disease;
• If you have diabetes;
• If you have depression or mood changes;
• If you have epilepsy (see section "Novynette and other medicines");
• If you have a condition that first occurred during pregnancy or previous use of sex hormones [e.g. hearing loss, porphyria (a blood disorder), herpes gestationis (skin rash with blisters during pregnancy), Sydenham’s chorea (a nervous system disorder causing involuntary movements)];
• If you have or have ever had chloasma (brownish pigmentation patches, so-called "pregnancy mask", especially on the face). In such cases, avoid direct exposure to sunlight or ultraviolet radiation.

BLOOD CLOTS
Using combined hormonal contraceptives such as Novynette increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious health problems.
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").
  Full recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots caused by using Novynette is low.

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

Do you have any of these symptoms?
Likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  Deep vein thrombosis

• 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. paleness, redness, or blueness.

• Sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• Sudden cough without obvious cause, possibly accompanied by coughing up blood;

• Sudden sharp chest pain, which may worsen on deep breathing;

• Severe dizziness or vertigo;

• Rapid or irregular heartbeat;

• Severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

Symptoms most commonly occur in one eye:
Retinal vein thrombosis

• Sudden loss of vision, or
• Painless visual disturbances, which may progress to vision loss (blood clot in the eye).

VENOUS BLOOD CLOTS
What can happen if blood clots form in the veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). 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 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 venous blood clots 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 (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 Novynette, the risk of 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 venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs while using Novynette is low.

• In the course of 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 the course of 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 the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing desogestrel, such as Novynette, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (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 Novynette is small, however,
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. Temporary discontinuation of Novynette a few weeks before surgery or during immobilization may be necessary. If the patient needs to stop taking Novynette, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially above 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of venous 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 listed risk factor.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Novynette.
Inform the doctor if any of the above conditions change during treatment with Novynette,
for example, 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 arteries?
Similar to venous blood clots, arterial clots can lead to serious
consequences, such as myocardial infarction (heart attack) or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of myocardial infarction or stroke associated with the use of Novynette is very low, but may increase:

• with age (above approximately 35 years);
• if the patient smokes cigarettes. While using a hormonal contraceptive such as Novynette, it is recommended to stop smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient has overweight;
• if the patient has high blood pressure;
• if a close relative has had myocardial infarction or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of myocardial infarction or stroke;
• if the patient or a close relative 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 arterial blood clots may be further increased.

Inform the doctor if any of the above conditions change during treatment with Novynette, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

The pill and cancer
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. This small increase in breast cancer incidence gradually disappears within 10 years after stopping oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. It may be related to the fact that women using oral contraceptives undergo more frequent medical examinations, leading to earlier detection of breast cancer.
Benign liver tumors have been reported, rarely, in women using oral contraceptives, and malignant liver tumors even more rarely. If the patient experiences an unusual, severe abdominal pain, she should contact her doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Novynette, 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 the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Novynette, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the pill-free week
If all tablets have been taken correctly, without vomiting or severe diarrhea, and no other medications have been taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur for two consecutive cycles, this may indicate pregnancy. The patient should contact her doctor immediately. The next pack of tablets should only be started once pregnancy has been ruled out.

Children and adolescents
The safety and efficacy of Novynette in adolescents under 18 years of age has not been established. No data are available.

Novynette and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Also inform any other doctor or dentist (or pharmacist) who prescribes another medicine about the use of Novynette. The doctor may advise whether additional contraceptive methods (e.g., condoms) should be used, and if so, for how long.
Do not use Novynette in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir,
glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these drugs may cause abnormal liver function test results (increased activity of liver enzymes AlAT). Before starting these medications, the doctor will prescribe another type of contraception. Novynette may be restarted approximately 2 weeks after completing the above-mentioned treatment. See section "When not to use Novynette".
Some medicines may affect the blood levels of Novynette, leading to reduced contraceptive effectiveness and unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (e.g., phenytoin, phenobarbital, primidone, carbamazepine, felbamate, oxcarbazepine, topiramate),
• tuberculosis (e.g., rifampicin, rifabutin),
• HIV infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz, nelfinavir),
• hepatitis C virus infections (boceprevir, telaprevir),
• fungal infections (griseofulvin),
• high blood pressure in the pulmonary blood vessels (bosentan),
• herbal products containing St. John's wort (Hypericum perforatum). If the patient wishes to use herbal products containing St. John's wort during treatment with Novynette, she should first consult her doctor.

The following medicines may reduce the tolerance of Novynette:

• ketoconazole, itraconazole, fluconazole (used to treat fungal infections);
• macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections);
• calcium channel blockers such as diltiazem (used to treat certain heart conditions and high blood pressure);
• etoricoxib (used to treat arthritis and osteoarthritis).

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

• cyclosporine (a medicine used to prevent organ transplant rejection),
• the antiepileptic drug lamotrigine (this may lead to increased seizure frequency),
• tizanidine (a medicine used to treat muscle spasticity),
• levothyroxine (a medicine used to treat hormone deficiency),
• theophylline (a medicine used to treat asthma).

Before taking any medicine, consult a doctor or pharmacist.

Laboratory tests
Inform the doctor or laboratory staff about the use of oral contraceptives,
as oral contraceptives may affect the results of certain laboratory tests.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Do not use Novynette if the patient is pregnant. If the patient is pregnant or suspects pregnancy, she should immediately stop taking Novynette and inform her doctor without delay.
Novynette is not recommended during breastfeeding. If the patient is breastfeeding and wishes to use Novynette during this period, she should contact her doctor.

Driving and operating machinery
It is safe to drive and operate machinery while taking Novynette.

Novynette contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Novynette

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Each pack of Novynette contains either 1 blister strip of 21 coated tablets or 3 blister strips of 21 coated tablets. The special marking of blisters with symbols of the days of the week facilitates control over regular intake of contraceptive tablets.

Each tablet in the pack is marked with the symbol of the day of the week on which it should be taken. One tablet should be taken daily for 21 consecutive days, following the direction of the arrow on the blister, until the blister is completely empty.

After taking all 21 tablets from the blister, a 7-day break without tablets follows. Withdrawal bleeding, resembling menstrual bleeding, should occur on the 2nd or 3rd day of this break.

Tablet intake from the next blister should begin on the 8th day (after the 7-day tablet-free interval), even if bleeding has not yet stopped. When Novynette is taken regularly, starting a new pack will always occur on the same day of the week, and bleeding will occur on the same day of the month.

Tablets should always be taken at the same time of day.

Taking tablets in the morning (as the first activity of the day) or late in the evening (as the last activity before going to sleep) may help ensure regular intake.

Tablets should be swallowed whole, with water if necessary.

How to start taking Novynette

If no hormonal contraceptives have been used in the previous month

Tablet intake should begin on the first day of the woman's natural menstrual cycle (i.e., the first day of menstruation). It is acceptable to start between the 2nd and 5th day of the cycle, but in this case, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet intake during the first cycle.

Switching from another combined hormonal contraceptive (pill, vaginal ring, transdermal patch)

A woman should start taking Novynette the day after taking the last active tablet of the previous oral contraceptive, or at the latest on the first day of the usual tablet-free interval of the previous contraceptive or the day after taking the last placebo tablet. Additional contraceptive methods are not required.

If the patient previously used a vaginal ring or transdermal patch, she should start taking Novynette on the day of removal of the system, or at the latest on the day the next application would normally occur. Additional contraceptive methods are not required.

Switching from progestogen-only contraceptives (mini-pills, injections, implants)

A woman may switch at any time from a progestogen-only pill (from an implant on the day of removal, or from an injectable form on the day the next injection is due) to Novynette, but in all cases additional barrier methods must be used for the first 7 days of tablet intake.

After first-trimester abortion

Tablet intake should be started immediately. Additional contraceptive methods are not necessary.

After childbirth or second-trimester abortion

Breastfeeding women – see section: "Pregnancy and breastfeeding".

The doctor will advise the patient to start taking tablets between the 21st and 28th day after childbirth or second-trimester abortion. If tablet intake is started later, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet intake. However, if sexual intercourse has already occurred, pregnancy should be ruled out before starting tablets, or the patient should wait for the first menstrual period.

Taking more Novynette than prescribed

If an overdose of Novynette occurs, there is no risk of serious health problems, although nausea, vomiting, or slight vaginal bleeding may occur in young girls. If such symptoms occur, contact a doctor, who will provide appropriate treatment if necessary.

Missed dose of Novynette

If a dose of Novynette is missed, follow the instructions below.

If tablet intake is delayed by less than 12 hours, contraceptive protection is not reduced. The missed tablet should be taken as soon as remembered, and subsequent tablets should be taken at the usual time.

If tablet intake is delayed by more than 12 hours, contraceptive protection may be reduced. The more tablets missed, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is higher if tablets are missed at the beginning or end of the cycle. Please review the information below (see also the diagram).

More than one missed tablet in a pack

Consult your doctor.

In case of missed tablets, two basic principles should be observed:

1. The break in continuous tablet intake should never exceed 7 days.
2. Continuous tablet intake for 7 days is necessary to adequately suppress the hypothalamic-pituitary-ovarian axis.

Based on this, in daily practice, the following advice may be given by a doctor:

Week 1

The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then she should continue taking tablets at the usual time of day. For the next 7 days, additional mechanical contraceptive methods (e.g., condoms) should be used. If sexual intercourse occurred within the 7 days before the missed tablet, the possibility of pregnancy should be considered. The more tablets missed and the closer to the tablet-free interval, the higher the risk of pregnancy.

Week 2

The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then she should continue taking tablets at the usual time of day. If tablets were taken correctly for the 7 days preceding the missed tablet, no additional contraceptive method is needed. However, if this was not the case, or if more than one tablet was missed, an additional contraceptive method should be used for 7 days.

Week 3

The risk of reduced contraceptive protection is inevitable due to the approaching tablet-free interval. However, this can be prevented by adjusting the way tablets are taken.

Thus, additional contraceptive methods are not necessary if one of the two alternative procedures below is followed, provided that all tablets were taken correctly during the 7 days preceding the missed tablet. Otherwise, follow the first of the two alternative procedures and use an additional contraceptive method for the next 7 days.

1. The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then she should continue taking tablets at the usual time of day. The next pack should be started immediately after taking the last tablet of the current pack, i.e., without a break between packs. Withdrawal bleeding will probably not occur until the end of the next pack, but breakthrough bleeding or spotting may occur during tablet intake.
2. The doctor may advise the patient to stop taking tablets from the current pack. In this case, the patient should take a break from tablet intake for up to 7 days, including the days when tablets were missed, and then continue with tablets from the next pack.

If a patient missed tablets and no withdrawal bleeding occurred during the first tablet-free interval, pregnancy should be considered.

Use of Novynette in case of vomiting or severe diarrhoea

If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a tablet, the tablet may not be fully absorbed. In this case, follow the instructions for missed tablets described above. If the patient does not wish to change her usual tablet-taking routine, she should take an additional tablet(s) from another pack.

How to delay withdrawal bleeding

If Novynette is taken correctly, withdrawal bleeding will always occur on the same day of the month.

To delay withdrawal bleeding, continue taking Novynette from the next blister immediately after finishing one blister, without a break.

Tablet intake may continue until the second pack is finished. Breakthrough bleeding or spotting may occur during intake of the second pack.

Regular intake of Novynette should resume after a 7-day tablet-free interval.

To shift withdrawal bleeding to a different day of the week than usual, different from the current bleeding day, shorten (but never extend) the upcoming tablet-free interval by any number of days. For example, if bleeding currently starts on Friday and Tuesday (3 days earlier) is preferred, start the next pack 3 days earlier. The shorter the tablet-free interval, the higher the risk that withdrawal bleeding will not occur and that breakthrough bleeding or spotting will occur during the next pack (similar to delaying withdrawal bleeding).

Absence of withdrawal bleeding

If contraceptive tablets were taken correctly, with no vomiting or severe diarrhoea and no concomitant use of other medicines, the likelihood of pregnancy is very low. Continue taking tablets as usual.

If withdrawal bleeding does not occur in two consecutive cycles, pregnancy is possible. In such a case, contact a doctor immediately. Contraceptive tablet use may continue only after pregnancy has been ruled out, as advised by a doctor.

Discontinuing Novynette

Novynette may be discontinued at any time. If discontinuation is due to planned pregnancy, another contraceptive method should be used until menstrual bleeding occurs. This will help the doctor determine the expected date of delivery.

For any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe or persistent ones, or any changes in health status that the patient considers related to the use of Novynette, a doctor should be consulted.
Immediate medical advice should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially accompanied by difficulty breathing (see also section "Warnings and precautions").

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

Common (may affect up to 1 in 10 people): depression, mood changes, headache, nausea, abdominal pain, breast pain, breast tenderness, weight gain.

Uncommon (may affect up to 1 in 100 people): fluid retention, decreased libido, migraine, vomiting, diarrhoea, rash, urticaria, breast enlargement.

Rare (may affect up to 1 in 1000 people): hypersensitivity, increased libido, eye irritation due to contact lenses, skin disorders (nodular erythema, erythema multiforme), abnormal cervical discharge, galactorrhoea, 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),
• heart attack,
• stroke,
• mini-stroke or transient ischaemic attack (TIA),
• blood clots in the liver, stomach and/or intestines, kidneys or eye.

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

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 also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 Novynette

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should 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 Novynette contains
The active substances are ethinylestradiol and desogestrel. One coated tablet contains 20
micrograms of ethinylestradiol and 150 micrograms of desogestrel.
The other ingredients are:
Tablet core: all-rac-α-tocoferol, magnesium stearate, colloidal anhydrous silica, stearic acid,
povidone K 30, potato starch, monohydrate lactose, quinoline yellow (E 104).
Coating: propylene glycol, macrogol 6000, hypromellose.
What Novynette looks like and contents of the pack
Pale yellow, round, biconvex tablets, with engraved markings: “RG” on one side and “P9” on the other side.
The carton box contains 1 blister or 3 blisters of 21 coated tablets each.
A cardboard pouch is included in the package, in which the blister should be placed.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
Manufacturer:
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Belgium, country of export: BE339412
Parallel import authorisation number: 85/25
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Lu/Mo/ma – Monday
Ma/Di/di – Tuesday
Me/Mi/woe – Wednesday
Je/Do/don – Thursday
Ve/Fr/vrij – Friday
Sa/zat – Saturday
Di/So/zon – Sunday