Novinette

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Novynette(Desorelle 20)
0.02 mg + 0.15 mg, film-coated tablets
Ethinylestradiol + Desogestrel
Novynette and Desorelle 20 are different trade names for the same medicine.

Important information about combined hormonal contraceptives:

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Novynette and what is it used for
• 2. Important information before using Novynette
• 3. How to use Novynette
• 4. Possible side effects
• 5. How to store Novynette
• 6. Contents of the packaging and other information

1. What is Novynette and what is it used for

Novynette is a combined oral contraceptive containing ethinylestradiol (estrogen) and desogestrel (progestogen) in low doses.
The mechanism of action of Novynette involves inhibiting ovulation and causing 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 it may be necessary to discontinue the medicine (see section 2). In such cases, it is recommended to either abstain from sexual intercourse or use other contraceptive methods, such as condoms or spermicides.

Remember that combined oral contraceptives, such as Novynette, do not

protect against sexually transmitted diseases (such as AIDS).Only the use of condoms has a protective effect.

2. Important information before using Novynette

General notes

Before starting to use Novynette, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Novynette should not be used to delay the start of bleeding.
In exceptional cases, when there is a need to delay the start of bleeding, you should consult a doctor.
Before starting to use Novynette, the doctor will ask the patient a few questions about her health and the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may perform some other tests.

When not to use Novynette

Novynette should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, she should inform her doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• If the patient is allergic to ethinylestradiol or desogestrel or any of the other ingredients of this medicine (listed in section 6); may cause itching, rash or swelling;
• If the patient currently has (or has ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• If the patient knows she has blood clotting disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If the patient needs to have surgery or will be immobilized for a long time (see section "Blood clots");
• If the patient has had a heart attack or stroke;
• If the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• If the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• If the patient has (or has had in the past) a type of migraine called "migraine with aura";
• If the patient has (or has had in the past) pancreatitis;
• If the patient has (or has had in the past) liver disease, and liver function has not returned to normal;
• If the patient has (or has had in the past) liver tumors;
• If the patient has (or has had in the past) or suspects breast or genital cancer;
• If the patient has unexplained vaginal bleeding;
• If the patient has an enlarged endometrium (abnormal growth of the uterine lining);
• If the patient is pregnant or may be pregnant.

Novynette should not be used in patients with hepatitis C and 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 to use Novynette, you should discuss it with your doctor or pharmacist.

When to contact a doctor?

A doctor should be contacted immediately

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

In order to get a description of the serious side effects listed, see "How to recognize blood clots".
In some cases, it is necessary to exercise particular caution when using Novynette or other combined hormonal contraceptives, and regular visits to the doctor may be necessary.

The doctor should be told if the patient has any of the following conditions.

If these symptoms appear or worsen during the use of Novynette, the doctor should also be told.

• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with breathing difficulties, a doctor should be contacted immediately. Estrogen-containing products may cause or worsen symptoms of hereditary and acquired angioedema.
• if the patient smokes;
• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has heart valve problems or heart rhythm disorders;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, she is at increased risk of blood clots. A doctor should be consulted for information on how soon Novynette can be started after childbirth;
• if the patient has varicose veins;
• if breast cancer has occurred or occurred in close family members;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression or mood changes;
• if the patient has epilepsy (see section "Novynette and other medicines");
• if the patient has a disease that first appeared during pregnancy or while using sex hormones [e.g., hearing loss, a blood disease called porphyria, herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a neurological disorder characterized by involuntary movements of the body)];
• if the patient has or has ever had chloasma (brown patches on the skin, especially on the face).

Blood Clots

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

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis"),
• in arteries (also known as "arterial thromboembolism" or "arterial thrombosis").

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

How to Recognize Blood Clots

A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering?

• 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 only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color of the leg, such as pallor, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should contact a doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Symptoms usually occur in one eye:

• sudden loss of vision or,
• painless vision disturbances, which may lead to Retinal vein thrombosis (blood clot in the eye)

vision loss.

• chest pain, discomfort, feeling of pressure, heaviness;
• feeling of squeezing or fullness in the chest,

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 thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins highest?

The risk of forming blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Novynette, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots in veins?

The risk of blood clots associated with Novynette is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to temporarily stop using Novynette for a few weeks before surgery or immobilization. If the patient needs to stop using Novynette, they should ask their doctor when they can resume using the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the use of Novynette.
If any of the above conditions change during the use of Novynette, e.g., the patient starts smoking, someone in their close family is diagnosed with thrombosis without a known cause, or the patient gains significant weight, the doctor should be informed.

Blood Clots in Arteries

What can happen if blood clots form in arteries?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with Novynette is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.When using a hormonal contraceptive like Novynette, it is recommended to quit smoking. If the patient is unable to quit 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 someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has been diagnosed with high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be further increased.
The doctor should be informed if any of the above conditions change during the use of Novynette, e.g., the patient starts smoking, someone in their close family is diagnosed with thrombosis without a known cause, or the patient gains significant weight.

Pill and Cancer

In women using the pill, breast cancer is diagnosed slightly more often than in women of the same age who do not use the pill. This small increase in the frequency of breast cancer diagnosis gradually disappears within 10 years after stopping the use of the pill. It is not known whether this difference is caused by the use of the pill. It may be related to the fact that women using the pill are more often examined by a doctor and breast cancer is diagnosed earlier in them.
In women using the pill, rare cases of benign liver tumors and even more rarely, malignant liver tumors have been reported. If the patient feels unusual, severe abdominal pain, they should contact a doctor.

Psychiatric Disorders

Some women using hormonal contraceptives, including Novynette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.

Irregular Bleeding

During the first few months of using Novynette, unexpected bleeding (bleeding outside of the withdrawal week) may occur. If such bleeding persists for longer than a few months or starts after a few months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the withdrawal week

If all the tablets were taken correctly, there was no vomiting, or severe diarrhea, and no other medicines were taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur for two consecutive times, it may indicate pregnancy. The patient should contact their doctor immediately. The next pack of Novynette should only be started when the patient is sure she is not pregnant.

Children and Adolescents

The safety and efficacy of using Novynette in adolescents under 18 years of age have not been established. There are no available data.

Novynette and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. They should also inform any other doctor or dentist who prescribes any other medicine (or pharmacist) about the use of Novynette. Doctors may say whether additional contraceptive methods should be used (e.g., condoms) and for how long.
Novynette should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (elevated liver enzyme activity).
Before starting to take these medicines, the doctor will prescribe a different type of contraception.
Novynette can be started again about 2 weeks after the end of the above-mentioned treatment. See section "When not to use Novynette".
Certain medicines may affect the blood levels of Novynette, leading to reducedcontraceptive effectivenessand 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 (so-called 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 blood vessels of the lungs (bosentan),
• herbal products containing St. John's Wort (Hypericum perforatum). If the patient wants to use herbal products containing St. John's Wort while using Novynette, they should consult their doctor first.

The following medicines may reduce the tolerance of Novynette:

• ketokonazole, 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 diseases and high blood pressure);
• etoricoxib (used to treat arthritis, osteoarthritis).

Novynette may affect the action of other medicines, such as:

• cyclosporin (a medicine used to prevent organ rejection after transplants),
• the antiepileptic medicine lamotrigine (may lead to an increased frequency of seizures),
• tizanidine (a medicine used to treat muscle spasticity),
• levothyroxine (a medicine used to treat hypothyroidism),
• theophylline (a medicine used to treat asthma).

Before using any medicine, the patient should consult their doctor or pharmacist.

Lab Tests

The patient should inform their doctor or laboratory staff about the use of oral contraceptives, as they may affect the results of some laboratory tests.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Novynette should not be used if the patient is pregnant. If the patient is pregnant or suspects they may be pregnant, they should stop using Novynette immediately and inform their doctor without delay.
The use of Novynette is not recommended during breastfeeding. If the patient is breastfeeding and wants to use oral contraceptives during this time, they should contact their doctor.

Driving and Using Machines

While using Novynette, the patient can drive vehicles and operate machinery.

Novynette Contains Lactose Monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Novynette.

3. How to Use Novynette

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Each pack of Novynette contains 1 blister pack of 21 film-coated tablets or 3 blister packs of 21 film-coated tablets. The special labeling of the blister packs with symbols of the days of the week helps control the regular use of oral contraceptives (translation of the day symbols on the packaging is at the end of the leaflet and on the sachet attached to the packaging).
Each tablet in the pack is marked with a symbol of the day of the week on which it should be taken. The patient should take 1 tablet daily for 21 consecutive days, following the direction of the arrow on the blister pack, until the pack is empty.
After taking all 21 tablets from the blister pack, there is a 7-day break in taking tablets. During the 2nd or 3rd day of the break, withdrawal bleeding should occur, similar to menstrual bleeding.
The patient should start taking tablets from the next pack on the 8th day (after the 7-day break), even if the bleeding has not stopped. With regular use of Novynette, the start of taking tablets from the next pack will always fall 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.
Taking tablets in the morning (first thing in the morning) or late in the evening (last thing before bedtime) can help with regular use.
Tablets should be swallowed whole, with water if necessary.

How to Start Using Novynette

In case the patient has not used hormonal contraceptives in the previous month
The patient should start taking tablets on the first day of their natural menstrual cycle (i.e., on the first day of menstruation). It is allowed to start taking tablets between the 2nd and 5th day, but during the first cycle, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet use.
Switching from another combined contraceptive (tablet, vaginal ring, transdermal patch)
The patient should start using Novynette the next day after taking the last active tablet of the previous oral contraceptive, or at the latest on the first day of the usual break in the use of the previous contraceptive. No additional contraceptive methods are required.
If the patient previously used a vaginal ring or transdermal patch, they should start taking Novynette on the day the ring or patch is removed, or at the latest on the day the next ring or patch would have been applied. No additional contraceptive methods are required.
Switching from progestogen-only contraceptives (minipill, injections, implants)
The patient can switch from a progestogen-only pill (from an implant on the day of its removal or from injections on the day the next injection is scheduled) to Novynette at any time, but in all cases, additional contraceptive methods should be used for the first 7 days of tablet use.
Use after miscarriage in the first trimester of pregnancy
The patient should start taking tablets immediately. No additional contraceptive methods are required.
Use after childbirth or miscarriage in the second trimester of pregnancy
For 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 miscarriage in the second trimester. If tablet use is started later, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet use. However, if the woman has already had sexual intercourse, she should make sure she is not pregnant before starting to use tablets or wait for her first menstrual period.

Overdose of Novynette

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

Missed Dose of Novynette

If a dose of Novynette is missed, the following rules should be followed.
If the tablet is delayed by less than 12 hours, the contraceptive protection is not reduced. The patient should take the missed tablet as soon as they remember and take the next tablets at the usual time.
If the tablet is delayed by more than 12 hours, the contraceptive protection may be reduced. The more missed tablets, the higher the risk of reduced contraceptive effectiveness. A higher risk of pregnancy exists if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the scheme).

More Than One Missed Tablet from the Pack

The patient should consult their doctor.
In the case of missed tablets, the patient should follow the two basic rules:

• 1. The break in continuous tablet use should never be longer than 7 days.
• 2. Continuous tablet use for 7 days is necessary for adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, in daily practice, the doctor may give the following advice:
Week 1
The patient should take the last missed tablet as soon as they remember, even if it means taking 2 tablets at the same time. Then, they should continue taking the tablets at the usual time of day. For the next 7 days, they should use additional mechanical contraceptive methods (e.g., condoms). If sexual intercourse occurred during the 7 days preceding the missed tablet, pregnancy should be considered. The more tablets missed and the closer they are to the break in tablet use, the higher the risk of pregnancy.
Week 2
The patient should take the last missed tablet as soon as they remember, even if it means taking 2 tablets at the same time. Then, they should continue taking the tablets at the usual time of day. If the tablets were taken correctly during the 7 days preceding the missed tablet, there is no need for additional contraceptive methods. However, if this was not the case or if the patient missed more than 1 tablet, additional contraceptive methods should be used for 7 days.
Week 3
The risk of reduced contraceptive protection is inevitable due to the approaching break in tablet use. However, this can be prevented by adjusting the tablet use. Therefore, there is no need for additional contraceptive methods if one of the two following alternative rules is followed, provided that all tablets were taken correctly during the 7 days preceding the missed tablet. If not, the patient should follow the first of the two alternative rules and use additional contraceptive methods for 7 days.

• 1. The patient should take the last missed tablet as soon as they remember, even if it means taking 2 tablets at the same time. Then, they should continue taking the tablets at the usual time of day. The next pack should be started immediately after finishing the current pack, without a break between packs. Withdrawal bleeding may not occur until the end of the next pack, but spotting or breakthrough bleeding may occur during tablet use.
• 2. The doctor may advise the patient to stop taking tablets from the current pack. In this case, the patient should have a break of up to 7 days, including the days they missed tablets, and then continue taking tablets from the next pack.

If the patient misses tablets and does not experience withdrawal bleeding during the first break in tablet use, they should consider the possibility of pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe and persistent ones, or changes in your health that you think are related to the use of Novynette, you should consult your doctor.
You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with difficulty breathing (see also the section "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should 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, diarrhea, rash, hives, breast enlargement.
Rare (may affect up to 1 in 1000 people):hypersensitivity, increased libido, eye irritation due to contact lenses, skin disorders (erythema nodosum, erythema multiforme), abnormal cervical smear, breast discharge, 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 stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

The likelihood of developing blood clots may be higher if you have any other risk factors (see section 2 for more information on risk factors and symptoms of blood clots).

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Novynette

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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.
Other ingredients are:
Tablet core: all-rac-α-tocopherol, 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 what the package contains

Pale yellow, round, biconvex tablets with engravings: "RG" on one side and "P9" on the other side.
A cardboard box contains 1 blister or 3 blisters of 21 coated tablets.
A cardboard sachet is attached to the package, in which the blister should be placed.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Belgian marketing authorization number, the country of export:BE339412

Parallel import authorization number: 112/24

Translation of the symbols of the days of the week 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

Date of leaflet approval: 14.03.2024

[Information about the trademark]