Novynette

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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 following an interval of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm them.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Novynette is and what it is used for
2. What you need to know 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 inhibition of ovulation and changes in the consistency of cervical mucus.
When used correctly, Novynette provides an effective and reversible method of 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, it is recommended either to abstain from sexual intercourse or to use other contraceptive methods (e.g. condoms or spermicides) to ensure effective contraception.
Remember that combined oral contraceptives such as Novynette do not protect against sexually transmitted infections (such as AIDS). Only the use of condoms provides protection.

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 cases, when there is a need to delay the start 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 situation, may carry out some other examinations.

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

• If you are allergic to ethinylestradiol, desogestrel, or any of the other ingredients of this medicine (listed in section 6); itching, rash or swelling may occur;
• If you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or 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 long time (see section "Blood clots");
• If you have had a heart attack or stroke;
• If you 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 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 ever had a type of migraine called "migraine with aura";
• If you currently have or have had pancreatitis;
• If you currently have or have had liver disease and liver function has not returned to normal;
• If you currently have or have had liver tumours;
• If you currently have, have had in the past, 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 use Novynette in patients with hepatitis C who are taking medicinal products containing ombitasvir, paritaprevir, or ritonavir and dasabuvir (see also section "Novynette and other medicines").

Warnings and precautions
Before starting to use Novynette, discuss this with your doctor or pharmacist.

When to contact your doctor?
You should contact your doctor immediately:

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

For a description of the symptoms of these serious adverse effects, see "How to recognize 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 any of the following conditions apply to you.
If any of these symptoms develop or worsen during treatment with Novynette, you should also inform your doctor.

• If you experience symptoms of hereditary or acquired angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, potentially with breathing difficulties, contact your doctor immediately. 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 heart rhythm disorders;
• If you have superficial thrombophlebitis (inflammation of the 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 defense system);
• If you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• If you have sickle cell anaemia (an inherited disorder of red blood cells);
• If you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have 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 long time (see section 2 "Blood clots");
• If you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after childbirth 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 appeared during pregnancy or previous use of sex hormones [e.g. hearing loss, a blood disorder called porphyria, pemphigoid gestationis (skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disorder with involuntary body movements)];
• If you currently 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 is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (referred to below 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.

Remember that the overall risk of harmful blood clots associated with using Novynette is low.

HOW TO RECOGNIZE BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis, especially if accompanied by:
• Pain or tenderness in the leg, which may occur only when standing or walking,
• Increased warmth in the affected leg,
• Change in skin colour of the leg, such as pallor, redness, or blueness.
• Sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• Sudden cough without an obvious cause, which may be associated with coughing up blood;
• Sharp chest pain, which may worsen with deep breathing;
• Severe dizziness or lightheadedness;
• Rapid or irregular heartbeat;
• Severe stomach pain.

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

Symptoms most commonly occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• Sudden loss of vision, or
• Painless visual disturbances, which may progress to vision loss.
• Chest pain, discomfort, pressure, heaviness; Myocardial infarction
• Feeling of tightness or fullness in the chest,

VENOUS BLOOD CLOTS
What can happen if blood clots form in a vein?

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

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is greatest during the first year of using 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 does the risk of venous blood clots depend on?
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 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's medical history (see "Factors that increase the risk of blood clots," below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Novynette is low; however, certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close 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 such a case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. Temporary discontinuation of Novynette may be necessary several weeks before surgery or during immobilization. If the patient must stop taking Novynette, she should consult her doctor about when she can resume taking the medicine;
• 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 listed above.
It is important to inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Novynette.
The patient should inform the doctor if any of the above conditions change during treatment with Novynette, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may 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 heart attack or stroke associated with the use of Novynette is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Novynette, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close 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, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia such 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.
The patient should inform the doctor if any of the above conditions change during treatment with Novynette, for example, if she starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if she 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 tumours have been reported, rarely, in women using oral contraceptives, and malignant liver tumours have been reported 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 low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her 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 of use, 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 diarrhoea, and no other medicines have been taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur twice in succession, pregnancy may be possible. 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
The patient should inform her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take. She should also inform any other doctor, dentist, or pharmacist prescribing another medicine that she is taking Novynette. The doctor may advise whether additional contraceptive methods (e.g., condoms) should be used, and if so, for how long.
Novynette should not be used in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (increased activity of liver enzymes ALT).
Before starting these medicines, the doctor will prescribe another type of contraception.
Novynette may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Novynette".
Some medicines may affect the blood concentration 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 infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz, nelfinavir),
• hepatitis C virus infection (boceprevir, telaprevir),
• fungal infections (griseofulvin),
• pulmonary hypertension (bosentan),
• herbal products containing St. John’s wort (Hypericum perforatum). If the patient wishes to use herbal products containing St. John’s wort while taking Novynette, she should first consult her doctor.

The following medicines may reduce tolerance to 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 (which 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
The patient should inform her doctor or laboratory staff that she is taking 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 is planning a pregnancy, she should consult her doctor or pharmacist before using this medicine.
Novynette must not be used during pregnancy. If the patient is pregnant or suspects pregnancy, she should stop taking Novynette immediately and inform her doctor without delay.
Novynette is not recommended during breastfeeding. If the patient is breastfeeding and wishes to use Novynette tablets during this time, she should consult her doctor.

Driving and using machines
The patient may drive and operate machinery while taking Novynette.

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

3. How to take Novynette

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, please consult your doctor or pharmacist.
Each pack of Novynette contains either 1 blister strip with 21 coated tablets or 3 blister strips with 21 coated tablets each. Special markings on the blister strips with the symbols of the days of the week help ensure regular use of the contraceptive tablets (the translation of the day-of-the-week symbols marked next to each tablet on the immediate packaging can be found at the end of this leaflet and on the sachet included in the package).
Each tablet in the pack is marked with the symbol of the day of the week on which it should be taken. You should take 1 tablet daily for 21 consecutive days, following the direction of the arrow on the blister strip, until the blister is completely empty.
After taking all 21 tablets from the blister, there follows a 7-day break during which no tablets are taken. Withdrawal bleeding, similar to menstruation, should occur on the 2nd or 3rd day of this break.
Tablet-taking from the next blister should begin on the 8th day (after the 7-day break), 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 each month.
Tablets should always be taken at the same time of day.
Taking the 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 use.
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-taking should begin on the first day of the woman’s natural menstrual cycle (i.e. the first day of menstruation). Starting between the 2nd and 5th day is also acceptable, but in this case, during the first cycle, additional mechanical contraceptive methods (e.g. condoms) should be used for the first 7 days of tablet-taking.

Switching from another combined hormonal contraceptive (pill, vaginal contraceptive system, transdermal patch)
The 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 after the usual break period of the previous contraceptive or after taking the last placebo tablet. Additional contraceptive methods are not required.
If the patient previously used a vaginal contraceptive system or a 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 have occurred. Additional contraceptive methods are not required.

Switching from progestogen-only contraceptives (mini-pills, injections, implants)
The woman may switch to Novynette on any day from a progestogen-only pill (from an implant on the day of removal, or from an injectable formulation on the day the next injection is due), but in all cases, additional contraceptive precautions must be used for the first 7 days of tablet-taking.

After first-trimester abortion
Tablet-taking should be started immediately. Additional contraceptive methods are not required.

After childbirth or second-trimester abortion
Women who are breastfeeding – 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-taking is started later, additional mechanical contraceptive methods (e.g. condoms) should be used for the first 7 days of tablet-taking. However, if the woman has already had sexual intercourse, she should either be confirmed not pregnant before starting tablets, or wait for the onset of the first menstruation.

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 in young girls may occur. If such symptoms occur, contact your doctor, who will provide appropriate treatment if necessary.

Missed dose of Novynette
If you miss a dose of Novynette, follow the instructions below.
If a tablet is taken less than 12 hours late, contraceptive protection is not reduced. The woman should take the missed tablet as soon as she remembers, and continue taking the following tablets at the usual time.
If a tablet is taken more than 12 hours late, contraceptive protection may be reduced. The more tablets missed, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the diagram).

More than one missed tablet in a pack
Consult your doctor.
If tablets have been missed, observe the following two basic rules:

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

Based on this, your doctor may give the following advice:
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. For the next 7 days, additional mechanical contraceptive methods (e.g. condoms) should be used. If sexual intercourse occurred in the 7 days before the missed tablet, consider the possibility of pregnancy. The greater the number of 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. 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 unavoidable 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 methods 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 methods 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. The next pack should be started immediately after 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-taking.
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-taking for up to 7 days, including the days when tablets were missed, and then continue with tablets from the next pack.

If the patient missed tablets and withdrawal bleeding does not occur during the first tablet-free interval, consider the possibility of pregnancy.

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 have been 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 (tablets) 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 the current one, without a break.
Tablet-taking can be continued until the second pack is finished. Breakthrough bleeding or spotting may occur during the second pack.
Regular Novynette use should resume after a 7-day break from tablet-taking.

To shift withdrawal bleeding to a different day of the week than usual, different from the day on which bleeding currently occurs, shorten (but never extend) the upcoming tablet-free interval by any number of days. For example, if bleeding currently starts on Friday, but 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 when delaying withdrawal bleeding).

Absence of withdrawal bleeding
If contraceptive tablets were taken correctly, without vomiting or severe diarrhoea, and no other medicines were taken concurrently, 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 this case, contact your doctor immediately. Contraceptive tablet use may be continued only after the doctor confirms that the patient is not pregnant.

Stopping Novynette
Novynette may be discontinued on any chosen day. If the reason for stopping the contraceptive tablets is planned pregnancy, another contraceptive method should be used until menstrual bleeding occurs. This will help the doctor determine the expected date of delivery.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Novynette, medical advice should be sought from a doctor.

Immediate medical attention must 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 breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (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 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 factors increasing the risk of blood clots and symptoms of their occurrence).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects 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.
Store below 30°C. Keep 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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
0.02 mg (20 micrograms) of ethinylestradiol and 0.15 mg (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, lactose monohydrate, 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.
The cardboard box contains 1 blister or 3 blisters of 21 coated tablets each.
A cardboard pouch is included with the package, in which the blister should be placed.
For more detailed information, please contact the responsible party or the 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Authorisation Number in Belgium, country of export: BE339412
Parallel Import Authorisation Number: 112/24

Translation of the weekday symbols 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