Novynette

Package leaflet: Information for the user

Novynette 150 microgram/20 microgram film-coated tablets

desogestrel, ethinylestradiol
Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you are experiencing symptoms of a blood clot (see section 2 "Blood clots").

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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, also known as "the pill". Novynette contains a low dose of two types of female hormones: a progestogen, desogestrel, and an oestrogen, ethinylestradiol.
These hormones help prevent pregnancy in the same way that natural hormones prevent further conception during pregnancy.
The combined oral contraceptive pill prevents pregnancy through a triple mechanism of action. The hormones it contains:

1. inhibit the monthly release of the egg (ovulation);
2. thicken cervical mucus, hindering sperm from reaching the egg;
3. alter the lining of the uterus, making implantation of a fertilised egg unlikely.

General information
When taken correctly, the pill is an effective and reversible method of contraception. However, in certain circumstances, its effectiveness may decrease or you may need to stop taking it (see below).
In such cases, abstain from sexual intercourse or use additional precautions (such as condoms or spermicides) during sexual intercourse to ensure effective contraception.
Please remember that combined oral contraceptive pills such as Novynette do not protect against sexually transmitted infections (such as AIDS); only condoms can help protect you from these diseases.

2. What you should know before taking Novynette

General information
Before starting to take Novynette, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot – see section 2 “Blood clots”.
Before you start taking Novynette, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional examinations.

DO NOT take Novynette
Do not take Novynette if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other methods of birth control that might be more suitable for your case.

• If you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs.
• If you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you are due to undergo surgery or will be confined to bed for a prolonged period (see section “Blood clots”).
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms).
• If you have any of the following conditions, which may increase the risk of developing clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia.

If you have (or have ever had) a type of migraine called “migraine with aura”.
If you have or have ever had liver disease and your liver function is not yet normal.
If you have or have ever had a liver tumour.
If you have or may have breast cancer or other types of cancer, for example, cancer of the ovaries, cervix, or uterus.
If you have unusual vaginal bleeding.
If you are pregnant or suspect you may be pregnant.
If you have had endometrial hyperplasia, a condition characterized by excessive growth of the uterine lining.
If you have or have ever had pancreatitis (inflammation of the pancreas).
If you are allergic to ethinylestradiol, desogestrel, or any of the other ingredients of this medicine (listed in section 6). This reaction may manifest as itching, rash, or swelling.
Do not take Novynette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Novynette”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Novynette.
If you suffer from any of these conditions/disorders, you may take Novynette only under strict medical supervision, as these disorders may worsen with the use of this oral contraceptive.

When should you contact a doctor?
Seek urgent medical advice
if you notice possible signs of a blood clot indicating that you may be suffering from a blood clot in the leg (such as deep vein thrombosis), in the lung (such as pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots (thrombosis)”).
For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you
If any of these conditions appear or worsen while you are taking 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 hives with potential breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (a hereditary red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be confined to bed for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Novynette;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have high blood pressure;
• if you have a heart valve disorder or certain heart rhythm disorders;
• if you suffer from migraine;
• if you have diabetes;
• if you have a hereditary hearing disorder called otosclerosis;
• if you suffer from depression or mood changes;
• if you have a movement disorder called Sydenham’s chorea;
• if you have certain liver and/or gallbladder disorders (jaundice, gallstones);
• if you have a hereditary condition called porphyria;
• if you have itching;
• if you have a skin rash called herpes gestationis;
• if you have dark patches on the face and body (chloasma), which may fade by avoiding sun exposure and not using sunbeds or sunlamps.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Novynette increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems. Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).
  Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects can be fatal.
  It is important to remember that the overall risk of a harmful blood clot associated with Novynette is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as paleness, redness, or bluish discolouration.

• Sudden and unexplained shortness of breath or rapid breathing

• Sudden cough without an obvious cause, possibly with coughing up blood

• Sharp chest pain that may worsen when breathing deeply

• Severe dizziness or lightheadedness

• Rapid or irregular heartbeat

• Severe stomach pain
  → Pulmonary embolism

Symptoms occurring more frequently in one eye: Retinal vein thrombosis

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and travels to the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than in women who are not using a combined hormonal contraceptive.
When you stop taking Novynette, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Novynette is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as Novynette, about 9–12 will develop a blood clot in one year.
• The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Novynette is low, but certain conditions can increase this risk. Your risk is higher:

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if a close relative developed a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Novynette several weeks before surgery or during periods of reduced mobility. If you need to stop taking Novynette, ask your doctor when you can restart it.
• as you get older (especially over 35 years of age);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting > 4 hours) may temporarily increase the risk of blood clots, especially if you have some of the other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Novynette.
If any of the above conditions change while you are using Novynette—for example, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Novynette is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Novynette, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
• if you are overweight;
• if you have high blood pressure;
• if a close relative had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Novynette—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

The pill and cancer
Every woman has a risk of developing breast cancer, regardless of whether she takes the pill. Breast cancer occurs slightly more frequently in women who use the pill compared to women of the same age who do not. When stopping oral contraceptive therapy, the risk decreases, and after 10 years from discontinuation, the risk of developing breast cancer is equivalent to that of women who have never used it. It is not certain that the pill increases the risk of developing breast cancer. It is likely that women who use oral contraceptives undergo more frequent medical check-ups, leading to earlier detection of cancer.

Malignant and benign liver tumors have been observed in women using oral contraceptives. Liver tumors can cause potentially fatal intra-abdominal bleeding (bleeding into the abdomen). If you experience persistent pain in the upper part of your abdomen, inform your doctor.

Some studies also report an increased risk of cervical cancer with long-term use of the pill. However, it is not certain that this increase is due to oral contraception, as it may depend on the effects of sexual behavior and other circumstances.

Psychiatric disorders
Some women using hormonal contraceptives, including Novynette, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, consult your doctor as soon as possible for further medical advice.

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

Other medicines and Novynette
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also inform any other doctor or dentist who prescribes you another medicine (or the pharmacist who dispenses it) that you are using Novynette. They can advise you whether additional contraceptive precautions (e.g., condoms) are needed, for how long they should be used, or whether you may need to adjust the dose of other medicines you are taking.

Do not take Novynette if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines can cause increases in liver function blood test results (elevated liver enzymes ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Novynette can be restarted approximately 2 weeks after completion of this treatment. See section "Do not take Novynette".

Some medicines can affect the levels of Novynette in the blood and may reduce its effectiveness in preventing pregnancy, or cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, efavirenz, nevirapine, nelfinavir);
• hepatitis C infections (boceprevir, telaprevir);
• other infections (griseofulvin);
• increased pressure in the blood vessels of the lungs (bosentan);
• the herbal remedy St. John's wort (Hypericum perforatum). If you wish to use herbal products containing St. John's wort while taking Novynette, you must first consult your doctor.

Interactions between Novynette and other medicines may also lead to an increase or marked occurrence of side effects. The following medicines may compromise the tolerability of Novynette:

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

Novynette may affect other concomitantly administered medicines, such as those containing the following active substances:

• ciclosporin (used to prevent tissue rejection after organ transplantation);
• lamotrigine (an anti-epileptic medicine; concomitant use with Novynette may lead to increased frequency of seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle spasm);
• levothyroxine (a medicine used to treat hormonal deficiency).

Ask your doctor or pharmacist for advice before taking any medicine.

Before blood tests
Inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may alter the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Novynette is not recommended during pregnancy. If you become pregnant or suspect you are pregnant, stop taking Novynette and contact your doctor immediately.
The use of Novynette is not recommended during breastfeeding. If you wish to take an oral contraceptive while breastfeeding, you should discuss this with your doctor first.

Driving and using machines
Novynette has no effect or negligible effects on the ability to drive vehicles or use machinery.

Novynette contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Novynette

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Each pack of Novynette contains either one blister of 21 coated tablets or three blisters of 21 coated
tablets. This packaging helps you remember to take the tablets.
The pack shows the days of the week on which the tablets should be taken. Following the direction of the arrow printed on the blister, take one tablet daily for 21 days until the blister is empty.
After that, do not take any tablets for 7 days. During this 7-day tablet-free interval, withdrawal bleeding, similar to menstruation (i.e., your monthly menstrual period), usually occurs on the 2nd or 3rd day.
Start the next blister on the 8th day (after the 7-day tablet-free interval), even if bleeding is still occurring. As long as you take Novynette correctly, you should always start the new blister on the same day of the week and have your menstrual period on the same day of the week.
It is advisable to take the tablet at the same time every day. It may be easier to take it in the evening before going to sleep or in the morning upon waking.
Swallow each tablet with water if necessary, without chewing.

Starting the first pack
If no hormonal contraceptive has been used during the previous menstruation
Take the first tablet on the first day of your cycle, i.e., the first day of menstrual bleeding. Take the tablet marked for that day of the week (for example, if your period starts on Tuesday, take the tablet marked Tuesday on the blister). Then continue in the order indicated by the arrows, taking one tablet daily until the blister is finished. If you start between the 2nd and 5th day of your cycle, you must use an additional contraceptive method, such as a condom, for the first 7 days of tablet intake, but only for the first pack. It is not necessary to use another type of contraception during the 7-day tablet-free interval, provided that all 21 tablets were taken correctly and the next pack is started at the correct time.

Switching to Novynette from another combined oral contraceptive
You may start taking Novynette the day after the last active tablet of your previous contraceptive. If the previous contraceptive pack contains inactive tablets, start Novynette the day after the last active tablet, but no later than the day after the tablet-free interval of the previous combined oral contraceptive (or the day after the last inactive tablet of the previous pack). If in doubt or for further clarification, consult your doctor or pharmacist.

Switching to Novynette from a progestogen-only pill (mini-pill)
You may stop taking the mini-pill at any time and start taking Novynette the next day at the same time. However, for the first 7 days of tablet intake, use an additional contraceptive method (such as a condom or spermicide) during sexual intercourse.

Switching to Novynette from an injectable or implant contraceptive
If you have used a progestogen injection or implant, you may start Novynette on the day the next injection would have been due or on the day the implant is removed. However, for the first 7 days of tablet intake, you must use an additional contraceptive method (such as a condom or spermicide) during sexual intercourse.

Starting after childbirth, miscarriage, or surgical abortion
The timing of starting the pill after childbirth, miscarriage, or surgical abortion should be determined by your doctor. You may start Novynette therapy immediately after a miscarriage or surgical abortion occurring in the first three months of pregnancy. In this case, no additional contraceptive method is required. If childbirth or abortion occurred in the second trimester of pregnancy, medical advice is required before starting the pill.

If you forget to take Novynette
If you forget to take a tablet, follow these instructions.

If the delay in taking a tablet is less than 12 hours
Contraceptive protection is not reduced. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time. This may mean taking two tablets in one day.

If the delay in taking a tablet is more than 12 hours
If the delay in taking a tablet exceeds 12 hours, contraceptive protection may be reduced and you should use additional contraceptive methods. The greater the number of missed tablets, the higher the risk of reduced contraceptive effectiveness.
If you forget to take more than one tablet, consult your doctor.

What to do if you forget a tablet in the first week
Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. In addition, use a barrier method (e.g., condom) for the next 7 days. If you had sexual intercourse during the previous week, consider the possibility of pregnancy. The greater the number of missed tablets and the closer they are to the tablet-free interval, the higher the risk of pregnancy.

What to do if you forget a tablet in the second week
Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. No additional contraceptive method is required, provided that all tablets were taken correctly in the 7 days before the first missed tablet. However, if this is not the case or if more than one tablet has been missed, additional precautions are recommended for 7 days.

What to do if you forget a tablet in the third week
Because the tablet-free interval is approaching, the risk of reduced contraceptive effectiveness is higher. However, by modifying the dosing schedule, you can still prevent a loss of contraceptive efficacy. By following one of the two options below, additional contraceptive methods are not required, provided that all tablets were taken correctly in the 7 days before the first missed tablet. If Novynette tablets were not taken correctly in the 7 days before the first missed tablet, follow the first of the two options and simultaneously use a barrier method (e.g., condom) for the next 7 days.

1. Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. Start the next pack immediately after taking the last tablet of the current pack, i.e., without observing a tablet-free interval between packs. In this case, withdrawal bleeding before the end of the second pack is unlikely, but spotting or breakthrough bleeding may occur during tablet intake.
2. You may also stop taking tablets from the current pack. In this case, observe a tablet-free interval lasting up to 7 days, including the days on which tablets were missed, then start a new pack. If you missed tablets and do not have withdrawal bleeding during the first regular tablet-free interval, consider the possibility of an existing pregnancy.

What to do in case of stomach upset
If you feel unwell or have diarrhoea within 3–4 hours after taking the tablet, the active ingredients may not have been completely absorbed. In this case, consider the recommendations above for missed tablets. In case of vomiting or diarrhoea, use additional contraceptive methods, such as condoms, during sexual intercourse occurring during the illness and for the 7 days following.

What to do if you wish to delay or shift your menstrual period
Consult your doctor if you wish to delay or shift your menstrual period.
If you wish to delay your menstrual period, continue with the next pack of Novynette immediately after taking the last tablet of the current pack, i.e., without observing a tablet-free interval. You may take any desired number of tablets from the new pack until the end of the new blister. During intake of the second pack, withdrawal bleeding or spotting may occur. Resume regular Novynette intake after the usual 7-day tablet-free interval.

If you wish to shift your menstrual period to another day of the week
If you take Novynette correctly, your menstrual period will always occur on the same day of the week. If you wish to shift your period to another day of the week instead of maintaining the current schedule, you may shorten (but never extend) the next tablet-free interval by the desired number of days. For example, if your period usually starts on Friday and you wish to shift it to Tuesday (three days earlier), you should start the next pack of Novynette three days earlier. The shorter the tablet-free interval, the greater the likelihood of no withdrawal bleeding and the possibility of breakthrough bleeding or spotting during the second pack.

If you experience bleeding between menstrual periods
During the first months of taking Novynette, a few women may experience light breakthrough bleeding or spotting. These episodes are usually normal and do not last longer than two days. Continue taking the pill regularly, and the problem should resolve after completing the first packs. If bleeding is recurrent, bothersome, or prolonged, consult your doctor.

Absence of menstruation
Correct intake of the pill, absence of stomach upset, and not taking other medicines ensure the reliability of the contraceptive method. Continue taking Novynette as usual. The absence of menstruation for two consecutive cycles may indicate pregnancy, so you should consult your doctor immediately. You may continue contraceptive therapy only after a pregnancy test and consultation with your doctor.

If you take more Novynette than you should
Overdose with Novynette does not cause serious harmful effects, but symptoms such as nausea, vomiting, or vaginal bleeding may occur. If these symptoms occur, consult your doctor for advice.

If you stop taking Novynette
You may stop Novynette treatment at any time. If you decide to stop Novynette to become pregnant, use another contraceptive method until you have a true menstrual period, so your doctor can calculate the expected date of delivery.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Novynette, inform your doctor.
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 with potential breathing difficulties (see also section “Warnings and precautions”).
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Novynette”.
Very common (may affect more than 1 in 10 people): irregular bleeding.
Common (may affect up to 1 in 10 people): depression, mood changes, nervousness, headache, dizziness, nausea, abdominal pain, acne, breast tenderness, breast pain, absence of menstruation, painful menstruation, premenstrual syndrome (physical and emotional problems before the start of menstruation), weight gain.
Uncommon (may affect up to 1 in 100 people): fluid retention, decreased sexual desire, migraine, hearing impairment (otosclerosis), high blood pressure, diarrhoea, vomiting, rash, urticaria, breast enlargement.
Rare (may affect up to 1 in 1,000 people): hypersensitivity, increased sexual desire, eye irritation due to contact lenses, skin disorders (erythema nodosum: a skin disease associated with joint pain, fever, hypersensitivity or infection, characterised by small, painful, pink to blue subcutaneous nodules on the shins that tend to recur; erythema multiforme: a skin disease characterised by raised solid spots on the skin or blister-like lesions containing fluid, along with redness or skin colour changes, often in concentric rings around the lesions), chloasma (skin pigmentation changes, so-called “pregnancy mask”), vaginal discharge, breast secretion and weight loss. Harmful blood clots in a vein or artery, for example:

• in a leg or foot (e.g. DVT)
• in a lung (e.g. PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help 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 use this medicine after the expiry date stated on the pack (Exp.). The expiry date refers to the last
day of that month.
Do not store above 30 °C. Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. 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 20 micrograms of
ethinylestradiol and 150 micrograms of desogestrel.
The other components are:
Tablet core: potato starch, stearic acid, alpha-tocopherol, lactose monohydrate, magnesium stearate, anhydrous colloidal silica, povidone K30, quinoline yellow E104.
Tablet coating: hypromellose, macrogol 6000, propylene glycol.

Description of the appearance of Novynette and package contents

Pale yellow, round, biconvex coated tablets, imprinted with “ ” (Grünenthal logo) on one side and “P9” on the other side.
Each pack contains 1 or 3 calendar blister packs, each with 21 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Igixon, 150 microgram/20 microgram film-coated tablets: Denmark
Novynette, 150 microgram/20 microgram film-coated tablets: Portugal and Italy
Bemasive, 150 µg/20 µg coated tablets: Spain