Package leaflet: Information for the user

NOVADIEN

2 mg/0.03 mg film-coated tablets
dienogest/ethinylestradiol
Equivalent medicine
Please read all of this leaflet carefully before you start 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, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

What Novadien is and what it is used for
What you need to know before taking Novadien
How to take Novadien
Possible side effects
How to store Novadien
Contents of the pack and other information

1. What Novadien is and what it is used for

Novadien is: either a contraceptive pill used to prevent pregnancy; or used for the treatment of moderate acne in women who agree to use a contraceptive pill after failure of appropriate topical or oral antibiotic treatments. Each tablet contains small amounts of the female hormones ethinylestradiol and dienogest.
Contraceptive pills containing two hormones are called "combined pills" or combined hormonal contraceptives.

2. What you need to know before taking Novadien

General information
Before starting to use Novadien, you must read the information about blood clots in section

It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before taking Novadien, 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 further examinations.
This patient information leaflet describes various situations in which you should stop using Novadien or in which the effectiveness of Novadien may be reduced. In such cases, you must abstain from sexual intercourse or use additional non-hormonal contraceptive measures (such as condoms or other barrier methods). Do not use the rhythm method or the basal body temperature method. These methods may be unreliable because Novadien alters the monthly changes in body temperature and cervical mucus.
Novadien, like all hormonal contraceptives, provides no protection against HIV (AIDS) or other sexually transmitted infections.
Acne usually improves after three to six months and may continue to improve beyond six months of treatment. Discuss with your doctor the need to continue treatment three to six months after starting therapy and periodically thereafter.

When not to use Novadien
Do not use Novadien if you have any of the conditions listed below. If any of the following conditions apply to you, consult your doctor. Your doctor will discuss with you other birth control methods that may be more suitable for your individual case.

Do not use Novadien

if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
if you know you have a blood clotting disorder, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
if you are about to undergo surgery or will be bedridden 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 a transient ischaemic attack (TIA – temporary stroke-like symptoms);
if you have any of the following conditions, which may increase the risk of arterial blood clots:
- 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) inflammation of the pancreas ( pancreatitis ) associated with very high levels of fats (lipids) in the blood (hypertriglyceridaemia);
if you currently have or have previously had a severe liver disease and liver function has not yet returned to normal;
if you have (or have ever had) a benign or malignant liver tumour;
if you have (or have ever had) or if there is suspicion that you may have a hormone-dependent malignancy of the genital organs or breast (e.g., breast cancer or cancer of the uterine lining);
if you experience unexplained vaginal bleeding;
if you are allergic to dienogest or ethinylestradiol or to any of the other ingredients of Novadien (listed in section 6);

Do not use Novadien if you have hepatitis C and are taking medicinal products containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir (also see section “Other medicines and Novadien”).
If any of these conditions develop while you are taking Novadien, stop taking the medicine immediately and contact your doctor. In the meantime, use another non-hormonal method of contraception.
For further information, see section “Warnings and precautions”.

Warnings and precautions
When to be especially careful with Novadien
When should you contact a doctor?
Contact a doctor urgently

if you notice signs suggestive of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”). 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.
In certain situations, you must be especially careful when using Novadien or any other combined oral contraceptive, and your doctor may need to examine you regularly.
If any of these conditions develop or worsen while you are using Novadien, inform your doctor:

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 defence system);
if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
if you have sickle cell anaemia (an inherited 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 about to undergo surgery or will be bedridden 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 Novadien;
if you have inflammation of the veins under the skin (superficial thrombophlebitis);
if you have varicose veins;
if you have heart valve defects or heart rhythm disorders;
if a close relative has or has had breast cancer;
if you have liver or gallbladder disease, or gallstones;
if you have jaundice or itching due to bile congestion; if you have patchy yellow-brown skin discoloration, especially on the face (chloasma), or
if you experienced it during a previous pregnancy; In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
if you have certain disorders affecting haemoglobin formation (porphyria);
if you suffer from depression;
if you suffer from epilepsy (see “Other medicines and Novadien”);
if you have a nervous system disorder causing sudden involuntary movements (Sydenham’s chorea);
if you had a skin rash with blisters during pregnancy (herpes gestationis);
if you have experienced hearing loss in the inner ear (hearing loss associated with otosclerosis);
if you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties, contact a doctor immediately. Medicinal products containing oestrogens can cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Novadien 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, serious long-term effects may occur, and very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
Novadien is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately 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
  → Deep vein thrombosis
sudden 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

If you are unsure, inform your doctor, as some of these
symptoms, such as cough or shortness of breath, may be mistaken
for a milder condition such as a respiratory tract infection (e.g., a “common cold”).

Symptoms occurring more frequently in one eye: •sudden loss of vision or •painless blurring of vision which may progress to loss of vision	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure or heaviness; •crushing sensation or fullness in the chest, one arm, or under the breastbone; •feeling of fullness, indigestion, or choking; •discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach; •sweating, nausea, vomiting, or dizziness; •extreme weakness, anxiety, or shortness of breath; •rapid or irregular heartbeat.	Heart attack
sudden numbness or weakness of the face, arm, or leg, especially on one side of the body; •sudden confusion, difficulty speaking or understanding speech; •sudden trouble seeing in one or both eyes; •sudden difficulty walking, dizziness, loss of balance or coordination; •sudden, severe or prolonged headache with no known cause; •loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; •severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels

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 developing blood clots 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 can cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it can 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 first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Novadien, 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 venous thromboembolism (VTE) 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 Novadien 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 dienogest and ethinylestradiol, such as Novadien, about 8–11 women will develop a blood clot in one year.
The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of blood clot formation”).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women out of 10,000
Women who use Novadien	About 8-11 women out of 10,000

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

if you are very overweight (body mass index or BMI over 30 kg/m²);
if a close relative has had 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 scheduled for surgery or need to remain bedridden for a prolonged period due to injury, illness, or if you have a plaster cast on your leg. You may need to stop taking Novadien several weeks before surgery or during periods of reduced mobility. If you need to stop taking Novadien, ask your doctor when you can start taking it again;
as you get older (especially over 35 years of age);
if you have given birth less than a few weeks ago.

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 clot formation, especially if you have 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 Novadien.
If any of the above conditions change while you are using Novadien—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, such as 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 Novadien is very low but may increase:

as you get older (over 35 years);
if you smoke. When using a combined hormonal contraceptive like Novadien, it is advisable to stop smoking. If you cannot 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 fat in the blood (cholesterol or triglycerides);
if you suffer from migraine, especially migraine with aura;
if you have heart problems (valvular defects, a heart rhythm disorder called atrial fibrillation);
if you have diabetes.
If you have more than one of these conditions, or if one 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 Novadien—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.

Novadien and cancer
Breast cancer has been detected slightly more frequently in women using combined oral contraceptives, but it has not been established whether this is due to the treatment. For example, more tumors may be diagnosed in women taking combined pills because they undergo medical examinations more frequently. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.
Rarely, benign liver tumors have been reported in women taking the pill, and even more rarely malignant liver tumors. In isolated cases, these tumors have caused life-threatening internal bleeding. Contact your doctor if you experience unusual, severe abdominal pain.
Some epidemiological studies have reported an increased risk of cervical cancer in women who have used combined oral contraceptives long-term. However, it is unclear how much sexual behavior (e.g., frequent partner changes) and other factors, such as human papillomavirus, contribute to this risk.

When should you consult a doctor?
Regular check-ups
If you take the pill, your doctor will recommend regular check-ups. Normally, you should consult your doctor at least once a year.
Additionally, consult your doctor immediately if:

you notice any change in your health, particularly those mentioned in the section "Do not use Novadien". Do not forget family medical history;
you feel a lump in your breast;
you are taking other medicines (see also section "Other medicines and Novadien");
you are confined to bed for a prolonged period or are about to undergo surgery (consult your doctor at least four weeks in advance);
you experience unusual and severe vaginal bleeding between menstrual periods;
you missed taking tablets during the first week of the contraceptive cycle and had sexual intercourse in the previous 7 days;
you have not had your period for two consecutive cycles despite regular tablet intake and suspect you may be pregnant.

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

If you have unexpected bleeding between periods:
During the first few months of using Novadien, you may experience unexpected spotting or bleeding. Irregular vaginal bleeding usually stops once your body adjusts to taking the pill (usually after about three regular cycles). If you experience heavier vaginal bleeding similar to a normal menstrual period, or light bleeding lasting several days, consult your doctor.

If your menstrual cycle is irregular:
If you have taken all tablets correctly, without vomiting, severe diarrhea, or taking other medicines, it is unlikely that you are pregnant. Continue taking Novadien as usual.
If you miss your period for two consecutive cycles, or if you did not take Novadien as directed before the missed period, you may be pregnant. Contact your doctor immediately. Do not take Novadien until your doctor has ruled out pregnancy.

Children and adolescents
Novadien is not indicated before the first menstrual period (menarche).

Other medicines and Novadien
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Some medicines may cause intermenstrual bleeding and/or reduce the contraceptive effectiveness of Novadien.

Effects of other medicines on Novadien

Always inform your doctor about any medicines or herbal products you are already taking.
Also inform any other doctor or dentist who prescribes you medicines (or the pharmacist dispensing the medicine) that you are taking Novadien. They can advise whether you need to use additional contraceptive measures (e.g., condoms) and, if so, for how long, or whether the use of another medicine should be adjusted.
Some medicines:

may affect Novadien levels in the blood;
may make it less effective in preventing pregnancy;
may cause unexpected bleeding.

These include:

medicines for the treatment of:
- epilepsy (primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (e.g., rifampicin);
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
- joint diseases: arthritis, osteoarthritis (etoricoxib);
- fungal infections (e.g., griseofulvin, ketoconazole);
the herbal remedy commonly known as St. John’s wort (Hypericum perforatum).

If you are taking any of the medicines listed above, you must temporarily use a barrier method (e.g., condom) or choose another contraceptive method.
You will need to use an additional contraceptive method (e.g., condom) while taking the other medicine and for 28 days after stopping it.
If the concomitant medicine treatment extends beyond the end of the Novadien blister pack, the next Novadien pack should be started immediately without observing the usual tablet-free interval.
If long-term treatment with any of the medicines listed above is required, it is advisable to choose another reliable, non-hormonal contraceptive method.

Effects of Novadien on other medicines

Novadien may affect the effectiveness of other medicines, for example:

the antiepileptic lamotrigine (this may cause an increase in seizure frequency);
cyclosporine (a medicine for immune system suppression);
theophylline (a medicine for treating asthma);
tizanidine (used to treat muscle pain or muscle cramps).

Please also read the package leaflets of other prescribed products. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

Do not use Novadien if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause an increase in blood markers related to liver function (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicinal products.
Novadien may be restarted approximately 2 weeks after completing this treatment. See section "Do not use Novadien".

Interactions with laboratory tests
The use of Novadien may affect the results of certain laboratory tests, including liver, adrenal, kidney, and thyroid function values, as well as the levels of certain proteins in the blood, such as proteins involved in fat digestion, carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes generally remain within normal limits.
Inform your doctor or laboratory staff that you are taking the pill.

Novadien with food and drinks
Novadien may be taken with or without food, if necessary with a small amount of water.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must not take Novadien if you are pregnant. If you become pregnant while using Novadien, stop taking it immediately and contact your doctor. If you are planning a pregnancy, you may stop taking Novadien at any time (see also "If you stop treatment with Novadien").

Breastfeeding
Generally, you should not take Novadien while breastfeeding, as milk production may decrease and small amounts of the active ingredient may pass into breast milk.
Consult your doctor or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
Novadien has no effect on the ability to drive vehicles or operate machinery.

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

3. How to take Novadien

Take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Take one Novadien tablet every day, with a little water if needed, swallowing it whole.
You may take the tablets with or without food, but you should try to take them at approximately the same time each day.
Each blister pack contains 21 film-coated tablets. Each tablet is marked with the day of the week on which it should be taken. Take one tablet daily.
Take the tablet marked with the day of the week on which you start treatment. For example, if you start on Friday, take the tablet marked “Fri” (Friday).
Take one tablet daily, following the order shown on the blister pack.
The time of day does not matter, but you should stick to the chosen time once established. Follow the direction of the arrows on the blister pack until all 21 tablets have been taken. Then do not take any tablets for 7 days. During these 7 tablet-free days, you should experience bleeding (the so-called withdrawal bleed). This usually starts 2–3 days after taking the last tablet.
Start the next blister pack on the eighth day after the last Novadien tablet (i.e., after the seventh day of the break), regardless of whether the bleeding has stopped or not. This means you will always start each new pack on the same day of the week and will have your monthly period at the same time each month.
If you use Novadien in this way, you will be protected against pregnancy even during the 7 days when you do not take a tablet.

When to start the first pack

If you have not used any hormonal contraception in the previous month: Start taking Novadien on the first day of your cycle (i.e., the first day of menstruation). Take the tablet marked with that day of the week.
Switching from a combined hormonal contraceptive: Start taking Novadien preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the tablet-free interval of your previous pill ends (or after the last inactive tablet of your previous pill).
Switching from a vaginal ring or transdermal patch: Start taking Novadien on the same day you remove the last ring or last patch of the pack, but no later than the day the next application would have been due.
Switching from a progestogen-only contraceptive method (minipill, injection, implant) or from an intrauterine system releasing progestogen (IUS): You may switch at any time from the progestogen-only pill (from an implant or IUS on the same day of removal, from an injectable contraceptive on the day the next injection would have been due), but in all these cases you must use additional protective measures (e.g., condom) for the first 7 days of tablet intake.
After a spontaneous abortion or first-trimester abortion: You should consult your doctor. In principle, you may start taking Novadien immediately.
After a second-trimester spontaneous abortion or childbirth: If you have recently given birth or had a second-trimester spontaneous abortion, your doctor will advise you to start taking Novadien between 21 and 28 days after the event. If you start later, you must use an additional barrier method (e.g., condom) during the first 7 days of using Novadien. However, if you have had sexual intercourse before starting (or restarting) Novadien, you must first ensure you are not pregnant or wait for the next menstrual period.
If you wish to breastfeed after childbirth and start taking Novadien: Read the section "Breast-feeding".

If you take more Novadien than you should
There are no reports of serious harmful effects if more Novadien tablets are taken.
If several tablets are taken at once, you may experience nausea, vomiting, and vaginal bleeding.
Vaginal bleeding may also occur in girls before menarche if they accidentally take the medicine.
If children have taken Novadien, a doctor should be consulted.
If you have taken too many Novadien tablets or discover that a child has taken any tablets, seek advice from your doctor or pharmacist.

If you forget to take Novadien

If the delay is less than 12 hours, take the missed tablet as soon as you remember. You are still protected against pregnancy. Continue taking the following tablets at your usual time.
If the delay is more than 12 hours, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of becoming pregnant.

The risk of pregnancy is higher if you forget to take the tablet at the beginning or near the end of a pack. In this case, follow the rules below:
If you have missed more than one tablet
Seek advice from your doctor.

What to do if you miss a tablet in Week 1
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. You must also use a barrier method, such as a condom, for the next 7 days. If you have had sexual intercourse during the previous 7 days, consider the possibility of pregnancy. In this case, seek advice from your doctor as soon as possible.

What to do if you miss a tablet in Week 2
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Protection against pregnancy is not reduced, provided you took the tablets correctly in the 7 days before the missed tablet. However, if you missed more than one tablet, you must use additional contraceptive measures for the next 7 days.

What to do if you miss a tablet in Week 3
Additional contraceptive measures are not necessary, provided you took the tablets correctly in the 7 days before the first missed tablet and you follow one of the two options below:

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 tablets at your usual time. Immediately start the next pack, skipping the tablet-free interval between the two packs. Withdrawal bleeding is unlikely until the end of the second pack, but you may experience spotting or breakthrough bleeding during the days you take tablets from the second pack.

You may also stop taking tablets from the current pack. In this case, proceed directly to the 7-day tablet-free interval ( Note the day you missed the tablet ); then continue with the next pack. If you wish to start a new pack on your usual day of the week, you may choose a tablet-free interval shorter than 7 days.

If you missed tablets and do not have withdrawal bleeding during the normal tablet-free interval, consider the possibility of pregnancy. In this case, speak with your doctor before starting the next pack.

What to do if you vomit or have severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours of taking a tablet, the active ingredients may not be fully absorbed by your body. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the instructions in the section “If you forget to take Novadien”.

What to do if you wish to delay your period
Although not recommended, you may delay your monthly period by starting the next Novadien blister pack immediately after taking the last tablet of the current pack, skipping the tablet-free interval. From this second pack, take all tablets until you wish your period to start. However, stop taking tablets no later than the end of this second pack. During use of the second pack, you may experience intermenstrual bleeding or spotting. Start the next pack after the usual 7-day tablet-free interval.
Consult your doctor before deciding to delay your menstrual period

What to do if you wish to change the day of the week on which your period starts
If you take Novadien correctly, your period will occur every 4 weeks on the same day of the week. If you wish to shift your period to another day of the week, you may shorten (but not extend) the next tablet-free interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday (i.e., three days earlier), take the first tablet of the next Novadien pack three days earlier than usual. If the tablet-free interval is greatly shortened (e.g., 3 days or less), you may not experience any bleeding during these days. You may then experience light bleeding.
If you are unsure what to do, consult your doctor.

If you wish to stop taking Novadien
You may stop taking Novadien at any time. If you do not wish to become pregnant, ask your doctor to recommend other reliable contraceptive methods.
If you wish to become pregnant, stop taking Novadien and wait for your period before trying to conceive. This will make it easier to calculate the expected date of delivery.
After stopping, it may take some time for your cycle to return to normal.

Additional information for special patient groups
Use in children and adolescents
Novadien may only be used after the first menstrual period (menarche).
Elderly patients
Novadien may only be used in women before menopause.
Patients with impaired liver function
Novadien must not be used in women with severe liver disease (see section 2 "Do not use Novadien").
Patients with impaired kidney function
The use of Novadien in women with impaired kidney function has not been studied. Available data do not suggest any change in treatment for this patient group.
If you have further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Novadien can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Novadien, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Novadien”.

Serious side effects
Serious reactions associated with the use of the pill, as well as related symptoms, are described in the following sections: "Blood clots" and "Novadien and cancer". Please read these sections carefully and consult your doctor immediately if necessary.
Contact a 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").

Other side effects
The following side effects have been observed in clinical studies with medicinal products containing 2 mg dienogest and 0.03 mg ethinylestradiol.

Common side effects (may affect up to 1 in 10 people):

Headache
Chest pain, including breast discomfort and tenderness

Uncommon side effects (may affect up to 1 in 100 people):

Inflammation of the vagina and/or external genitalia (vaginitis/vulvovaginitis), fungal infections of the vagina (candidiasis, vulvovaginal infections)
Increased appetite
Depressed mood
Migraine, dizziness (vertigo)
Low or high blood pressure
Abdominal pain (including bloating), nausea, vomiting or diarrhoea
Acne, hair loss (alopecia), skin rash, itching
Irregular bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), infrequent bleeding (oligomenorrhoea), and absence of bleeding (amenorrhoea)
Bleeding between periods, consisting of vaginal haemorrhage and irregular bleeding between menstrual cycles (metrorrhagia), menstrual pain (dysmenorrhoea)
Genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in internal genital organs, breast enlargement, breast oedema
Weakness, fatigue, and feeling unwell
Weight gain

Rare side effects (may affect up to 1 in 1,000 people):

Inflammation of the ovaries and fallopian tubes, urinary tract infections, bladder inflammation (cystitis), breast gland inflammation (mastitis), cervical inflammation (cervicitis), fungal infections (e.g. candida), viral infections (e.g. herpes labialis), fever (influenza), bronchitis, sinus infection (sinusitis), upper respiratory tract infections
Benign tumours in the uterus (fibroids), benign tumours in the breast fatty tissue (breast lipoma)
Decrease in the number of red blood cells (anaemia)
Allergic reactions
Masculinization (virilism)
Loss of appetite (anorexia)
Depression, psychiatric disorders, insomnia, sleep disorders, aggression
Circulatory disorders of the brain or heart, muscle disorders causing, for example, abnormal posture (dystonia)
Dry or irritated eyes, visual disturbances, blurred vision
Sudden hearing loss, ringing or other noises in the ears (tinnitus), dizziness, impaired hearing
Rapid heartbeat
Vein inflammation, increased diastolic blood pressure, dizziness or fainting when standing up from a sitting or lying position (orthostatic dysregulation), hot flushes, varicose veins (varices), vein disorders or pain
Harmful blood clots in a vein or artery, for example:
- in a leg or foot (deep vein thrombosis, DVT)
- in a lung (pulmonary embolism, PE)
- heart attack
- stroke
- mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
- blood clots in the liver, stomach/intestine, 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).
Asthma, increased breathing rate (hyperventilation)
Inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis), stomach discomfort (dyspepsia)
Allergic skin inflammations (dermatitis), skin rash (e.g. neurodermatitis), skin disease with thickened red patches (psoriasis), excessive sweating (hyperhidrosis), changes or disorders in skin pigmentation (e.g. chloasma), overproduction of oil by sebaceous glands (seborrhoea), dandruff, skin lesions, orange-peel skin (cellulite), a central red spot with radiating red extensions resembling a spider’s web (spider angioma)
Back pain, bone, joint and muscle pain (e.g. myalgia), arm and leg pain
Abnormal cell growth on the surface of the cervix (cervical dysplasia)
Pain or fluid-filled structures in the fallopian tubes and ovaries, fluid-filled structures in the breasts, pain/spasms during sexual intercourse (dyspareunia), milk-like secretion from the mammary glands (galactorrhoea), menstrual disorders
Chest pain, swelling of hands, ankles or feet (peripheral oedema), flu-like symptoms, inflammation, fever, irritability
Elevated levels of fats in the blood (increased triglyceride or cholesterol levels), weight loss, weight fluctuations
Congenital extra-mammary breast gland swelling (accessory breast tissue)

Other side effects observed in users of the pill, but whose exact frequency is unknown:
Mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, hives; skin and/or mucous membrane reactions with rash, nodules, blisters or tissue necrosis (erythema nodosum or multiforme); breast secretion, fluid accumulation in the body (oedema).

Tumours

The frequency of breast cancer diagnosis is slightly increased among users of combined oral contraceptives. Since breast cancer is rare in women under 40 years of age, the excess number is small in relation to the overall risk of breast cancer. For further information, see section "Novadien and cancer"
Liver tumours (benign and malignant)
Cervical cancer

Other conditions

Women with hypertriglyceridaemia (increased fat levels in the blood may increase the risk of pancreatitis during use of combined oral contraceptives)
Increased blood pressure
Onset or worsening of conditions whose association with combined oral hormonal contraceptives is not clear: jaundice and/or itching associated with cholestasis (impaired bile excretion), gallstone disease, a metabolic condition called porphyria, systemic lupus erythematosus (chronic autoimmune disease), haemolytic-uraemic syndrome (a disease caused by blood clot formation), a neurological condition called Sydenham's chorea, herpes gestationis (a type of skin disorder occurring during pregnancy), hearing loss due to otosclerosis
Liver dysfunction
Changes in glucose tolerance or peripheral insulin resistance
Crohn’s disease, ulcerative colitis
Chloasma

Interactions
Unexpected bleeding and/or contraceptive failure may result from interactions between other medicines and oral contraceptives (e.g. St. John’s wort, medicines for epilepsy, tuberculosis, HIV infection, and other infections). See also “Other medicines and Novadien”.
Other serious side effects as well as related symptoms are described in the section “Warnings and precautions”.

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 Novadien

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the outer box after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect from light. Store at a temperature below 30°C.
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. Contents of the pack and other information

What Novadien contains

The active substances are dienogest and ethinylestradiol. Each tablet contains: 2 mg of dienogest and 0.03 mg of ethinylestradiol.
The other components are:

Tablet core:
Monohydrate lactose
Maize starch
Povidone 30 K
Sodium glycolate starch
Magnesium stearate
Purified water
Coating:
Hypromellose
Hydroxypropylcellulose
Talc
Hydrogenated cottonseed oil
Titanium dioxide (E171)
Description of the appearance of Novadien and contents of the pack
White, round, biconvex, film-coated tablets.
Novadien 2 mg/0.03 mg film-coated tablets are packed in PVC/PVDC/Aluminium blisters containing 21 tablets. Presentations containing one or three blisters of 21 tablets are available on the market.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy
Manufacturer responsible for batch release
Helm Pharmaceuticals GmbH
Nordkanalstrasse 28,
20097 Hamburg (Germany)

Package leaflet: Information for the user

NOVADIEN

2 mg/0.03 mg film-coated tablets
dienogest/ethinylestradiol
Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (COCs):

They are one of the most reliable reversible methods of contraception when 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 vigilant and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

What Novadien is and what it is used for
What you need to know before taking Novadien
How to take Novadien
Possible side effects
How to store Novadien
Contents of the pack and other information

1. What Novadien is and what it is used for

Novadien is a contraceptive pill used to prevent pregnancy; or used for the treatment of moderate acne in women who agree to take a contraceptive pill after failure of appropriate topical or oral antibiotic treatments. Each of the 21 white tablets contains small amounts of the female hormones ethinylestradiol and dienogest and are also called active tablets. The 7 green tablets do not contain active substances and are also called placebo tablets.
Contraceptive pills containing two hormones are called "combined pills" or combined hormonal contraceptives.

2. What you should know before taking Novadien

General information
Before starting to use Novadien, you must read the information about blood clots in section

It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before taking Novadien, 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 further examinations.
This patient leaflet describes various situations in which Novadien should be discontinued or in which the effectiveness of Novadien may be reduced. In such cases, you should abstain from sexual intercourse or use additional non-hormonal contraceptive measures (such as condoms or other barrier methods). Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Novadien alters the monthly variations in body temperature and cervical mucus.
Novadien, like all hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.
Acne usually improves after three to six months and may continue to improve even after six months of treatment. Discuss with your doctor the need to continue treatment three to six months after starting therapy and periodically thereafter.

When you must not use Novadien
Do not use Novadien 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 birth control methods that may be more suitable for your case.
Do not use Novadien

if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
if you know you have a blood clotting disorder, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
if you are about to undergo surgery or will be bedridden 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 a heart attack) or a 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) inflammation of the pancreas ( pancreatitis ) associated with very high levels of fats (lipids) in the blood (hypertriglyceridaemia);
if you currently suffer or have previously suffered from severe liver disease and liver function has not yet returned to normal;
if you have (or have ever had) a benign or malignant liver tumour;
if you have (or have ever had), or if there is suspicion that you may have a hormone-dependent malignant disease of the genital organs or breast (e.g. breast cancer or cancer of the lining of the uterus);
if you experience unexplained vaginal bleeding;
if you are allergic to dienogest or ethinylestradiol or to any of the other ingredients of Novadien (listed in section 6);

Do not use Novadien if you have hepatitis C and are taking medicinal products containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Novadien”).
If any of these conditions occur while you are taking Novadien, stop taking the medicine immediately and contact your doctor. In the meantime, use another non-hormonal contraceptive method.
For further information, see section “Warnings and precautions”.

Warnings and precautions
When to be particularly careful with Novadien
When should you contact a doctor?
Contact a doctor urgently

if you notice signs suggestive of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”). 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.
You need to be particularly careful when using Novadien or any other combined oral contraceptive, and your doctor may need to examine you regularly.
If any of these conditions appear or worsen while you are using Novadien, inform your doctor:

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 defence system);
if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
if you have sickle cell anaemia (an inherited 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 about to undergo surgery or will be bedridden 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 Novadien;
if you have inflammation of the veins near the skin surface (superficial thrombophlebitis);
if you have varicose veins;
if you have heart valve defects or heart rhythm disorders;
if a close relative has or has had breast cancer;
if you have liver or gallbladder disease, or gallstones;
if you have jaundice or itching due to bile congestion; if you have patchy yellow-brown skin discoloration, especially on the face (chloasma), or
if you experienced this during a previous pregnancy; in such cases, avoid direct exposure to sunlight or ultraviolet radiation;
if you have certain disorders affecting haemoglobin production (porphyria);
if you suffer from depression;
if you suffer from epilepsy (see “Other medicines and Novadien”);
if you have a nervous system disorder causing sudden involuntary movements (Sydenham’s chorea);
if you had a skin rash with blisters during pregnancy (herpes gestationis);
if you have experienced hearing loss in the inner ear (hearing loss associated with otosclerosis);
if you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

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, serious long-term effects may occur, and very rarely, these effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with
Novadien is low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have one 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 unexplained shortness of breath or rapid breathing
Pulmonary embolism
sudden cough without an obvious cause, possibly with coughing up of blood
sharp chest pain that may worsen when breathing deeply
severe dizziness or vertigo
rapid or irregular heartbeat
severe stomach pain

Symptoms occurring more frequently in one eye: •sudden loss of vision or •painless blurring of vision which may progress to loss of vision	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure or heaviness; •squeezing sensation or fullness in the chest, one arm or under the breastbone; •feeling of fullness, indigestion or suffocation; •discomfort in the upper body spreading to the back, jaw, throat, arms or stomach; •sweating, nausea, vomiting or dizziness; •extreme weakness, anxiety or shortness of breath; •rapid or irregular heartbeat.	Heart attack
sudden numbness or weakness of the face, one arm or one leg, especially on one side of the body; •sudden confusion, difficulty speaking or understanding speech; •sudden difficulty seeing with one or both eyes; •sudden difficulty walking, dizziness, loss of balance or coordination; •sudden severe or prolonged headache with no known cause; •loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration of a limb; •severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels

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 developing blood clots 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 travels from the leg and lodges in 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 that you start taking a combined hormonal contraceptive. The risk may also be higher if you restart taking a combined hormonal contraceptive (either the same medicine or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Novadien, 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 Novadien 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 dienogest and ethinylestradiol such as Novadien, about 8–11 women will develop a blood clot in one year.
The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill and are not pregnant	About 2 women in 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women in 10,000
Women who use Novadien	About 8-11 women in 10,000

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

if you are very overweight (body mass index or BMI above 30 kg/m²);
if a close relative has had a blood clot in a 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 immobile for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Novadien several weeks before surgery or during periods of reduced mobility. If you need to stop taking Novadien, ask your doctor when you can start taking it again;
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 if you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have any 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 stop your use of Novadien.
If any of the above conditions change while you are using Novadien—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?
As with blood clots in a vein, clots in an artery can cause serious problems, for example, they may cause a heart attack or stroke.

with increasing age (over 35 years);
if you smoke. When using a combined hormonal contraceptive such as Novadien, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may recommend using a different type of contraceptive;
if you are overweight;
if you have high blood pressure;
if a close relative has 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 fat in the blood (cholesterol or triglycerides);
if you suffer from migraine, especially migraine with aura;
if you have heart problems (valvular defects, 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 Novadien—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.

Novadien and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it has not been established whether this is due to the treatment. For example, a higher number of tumours may be detected in women taking combined pills because they undergo medical examinations more frequently. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.
Rarely, benign liver tumours have been reported in women taking the pill, and even more rarely, malignant liver tumours.
In isolated cases, these tumours have caused life-threatening internal bleeding. Contact your doctor if you experience unusual and severe abdominal pain.
Some epidemiological studies have reported an increased risk of cervical cancer in women who use the pill long-term. However, it is unclear to what extent sexual behaviour (e.g., frequent partner changes) and other factors, such as human papillomavirus, contribute to this risk.

When should you consult a doctor?
Regular check-ups
If you take the pill, your doctor will recommend regular check-ups. Normally, you should consult your doctor at least once a year.

Additionally, consult your doctor immediately if:

you notice any change in your health, particularly those mentioned in the section "Do not use Novadien". Do not forget about conditions affecting your family;
you detect a lump in your breast;
you are taking other medicines (see also the section "Other medicines and Novadien");
you are confined to bed for a prolonged period or are about to undergo surgery (consult your doctor at least four weeks beforehand);
you experience unusual and severe vaginal bleeding between menstrual periods;
you forgot to take active tablets during the first week of taking the contraceptive pill and had sexual intercourse in the previous 7 days;
you have not had your periods twice in a row despite taking active tablets regularly and suspect you may be pregnant.

If you have had unexpected bleeding between periods:
During the first few months of using Novadien, you may experience unexpected spotting. Irregular vaginal bleeding usually stops once your body has adjusted to taking the pill (usually after about 3 cycles of regular tablet intake). If you experience vaginal bleeding that is heavier, similar to a normal menstrual period, or light bleeding lasting several days, consult your doctor.

If your menstrual cycle is irregular
If you have taken all tablets correctly, without vomiting, severe diarrhoea, or taking other medicines, it is unlikely that you are pregnant. Continue taking Novadien as usual.
If your periods do not occur for two consecutive cycles, or if you have not taken Novadien as prescribed before the missed period, you may be pregnant. Contact your doctor immediately. Do not take Novadien until your doctor has ruled out pregnancy.

Children and adolescents
Novadien is not indicated before the first menstrual period (menarche).

Other medicines and Novadien
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Some medicines may cause intermenstrual bleeding and/or reduce the contraceptive effectiveness of Novadien.

Effects of other medicines on Novadien

Always inform your doctor about any medicines or herbal products you are already taking. Also inform any other doctor or dentist who prescribes you medicines (or the pharmacist supplying the medicine) that you are taking Novadien. They can advise you whether you need to use additional contraceptive measures (e.g., condoms), and if so, for how long, or whether the use of another medicine should be adjusted.
Some medicines:

may affect Novadien levels in the blood;
may make it less effective in preventing pregnancy;
may cause unexpected bleeding.

These include:

medicines for the treatment of:
- epilepsy (primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (e.g., rifampicin);
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
- joint diseases: arthritis, osteoarthritis (etoricoxib);
- fungal infections (e.g., griseofulvin, ketoconazole);
the herbal remedy commonly known as St. John’s wort (Hypericum perforatum).

If you are taking any of the medicines listed above, you must temporarily use a barrier method (e.g., condom) or choose another contraceptive method.
You will need to use an additional contraceptive method (e.g., condom) while taking the other medicine and for 28 days after stopping it.
If the concomitant medicine is taken beyond the end of the active white tablet section of Novadien, the next blister pack should be started without taking the green placebo tablets.
If long-term treatment with any of the medicines listed above is required, it is advisable to choose another reliable, non-hormonal contraceptive method.

Effects of Novadien on other medicines

Novadien may affect the effectiveness of other medicines, for example:

the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures);
cyclosporine (a medicine used to suppress the immune system);
theophylline (a medicine used to treat asthma);
tizanidine (used to treat muscle pain or muscle cramps).

Do not use Novadien if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause an increase in blood values related to liver function (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicinal products.
Novadien may be taken again approximately 2 weeks after completion of this treatment. See section "Do not use Novadien".

Interactions with laboratory tests
The use of Novadien may affect the results of certain laboratory tests, including liver, adrenal, kidney, and thyroid function values, as well as levels of certain proteins in the blood, such as proteins affecting fat digestion, carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes generally remain within normal limits.
Inform your doctor or laboratory staff that you are taking the pill.

Novadien with food and drinks
Novadien can be taken with or without food, and if necessary, with a small amount of water.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you are pregnant, you must not take Novadien. If you become pregnant while using Novadien, stop taking it immediately and contact your doctor. If you are planning a pregnancy, you may stop taking Novadien at any time (see also "If you stop taking Novadien").

Breastfeeding
In general, you should not take Novadien while breastfeeding, as milk production may decrease and small amounts of the active ingredient may pass into breast milk.

Consult your doctor or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
Novadien has no effect on the ability to drive or use machinery.

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

3. How to take Novadien

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take one Novadien tablet every day, if necessary with a little water, and swallow it whole.
You may take the tablets with or without food, but you should try to take them at approximately the same time each day.
Each Novadien blister pack contains 28 film-coated tablets.
Take the tablets in the order shown on the blister pack. Do not confuse the tablets: take one white tablet once daily for the first 21 days, followed by one green tablet daily for the last 7 days. You must start a new blister pack (21 white tablets and 7 green tablets) the day after taking the last green placebo tablet of the previous pack. Therefore, there are no tablet-free days between packs.

During the 7 days when you take the green placebo tablets (the placebo days), you should experience bleeding (the so-called withdrawal bleeding). This usually starts 2–3 days after taking the last active white tablet. After taking the last green tablet, you must start a new pack, whether or not the bleeding has stopped. This means you should start each new pack on the same day of the week, and the withdrawal bleeding should occur on the same day each month.

If you use Novadien in this way, you will be protected against pregnancy even during the 7 days when you take the placebo tablets.

Blister pack preparation
The Novadien blister pack contains 28 tablets: 21 active white tablets (marked with numbers 1–21 in black) and 7 green placebo tablets (marked with numbers 22–28 in red).
Each time you start a new Novadien blister pack, begin with the active white tablet marked number 1 (see “Start”) and continue following the arrows. Follow the directions of the black arrows on the blister pack until you have taken all 21 white tablets. Then follow the red arrows and take one green tablet daily for 7 days.

Additionally, the days of the week are indicated on the blister pack so you can mark the day corresponding to when you start taking Novadien.

When to start the first pack

If you have not used any hormonal contraception in the previous month: Start taking Novadien on the first day of your cycle (i.e., the first day of menstruation). Take the tablet marked with “Start”.
Switching from a combined hormonal contraceptive:
Start taking Novadien preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the tablet-free interval of your previous pill ends (or after the last inactive tablet of your previous pill).
Switching from a vaginal ring or transdermal patch: Start taking Novadien on the same day you remove the last ring or patch of the pack, but no later than the day the next application would have been due.
Switching from a progestogen-only contraceptive method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): You may switch at any time from the progestogen-only pill (from an implant or IUS on the same day of removal, from an injectable contraceptive on the day the next injection would have been due), but in all these cases you must use additional protective measures (e.g., a condom) for the first 7 days of tablet intake.
After a spontaneous or induced abortion in the first trimester of pregnancy: Consult your doctor. In principle, it is possible to start taking Novadien immediately.
After a spontaneous abortion in the second trimester of pregnancy or after childbirth: If you have recently given birth or had a spontaneous abortion in the second trimester, your doctor will advise you to start taking Novadien between 21 and 28 days after the event. If you start taking the tablet later than this, you must use an additional barrier method (e.g., a condom) during the first 7 days of using Novadien. However, if you have had sexual intercourse before starting (or restarting) Novadien, you must first ensure that you are not pregnant or wait for your next menstrual period.
If you wish to breastfeed after childbirth and start taking Novadien: Read the section "Breast-feeding".

If you take more Novadien than you should
There are no reports of serious harmful effects from taking too many Novadien tablets.
If several tablets are taken at once, you may experience nausea, vomiting, and vaginal bleeding. Vaginal bleeding may also occur in girls before menarche if they accidentally take the medicine.
If children have taken Novadien, consult a doctor.
If you have taken too many Novadien tablets or discover that a child has taken any tablets, seek advice from your doctor or pharmacist.

If you forget to take Novadien
The green tablets are placebo tablets. If you forget to take one of these green tablets, this does not affect the reliability of this medicine. Discard the forgotten placebo tablet to avoid prolonging the placebo week, which could negatively affect the reliability of Novadien.

If you forget to take an active white tablet, follow these instructions:

If the delay is less than 12 hours, take the missed tablet as soon as you remember. You are still protected against pregnancy. Continue taking the following tablets at your usual time.
If the delay is more than 12 hours, protection against pregnancy may be reduced. The greater the number of missed tablets, the higher the risk of becoming pregnant.

The risk of pregnancy is higher if you forget to take tablets at the beginning or near the end of a pack. In such cases, follow these rules:
If you have missed more than one tablet
Seek advice from your doctor.

What to do if you miss a tablet in week 1
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. You must also use a barrier method, such as a condom, for the next 7 days. If you had sexual intercourse during the previous 7 days, consider the possibility of pregnancy. In this case, consult your doctor as soon as possible.

What to do if you miss a tablet in week 2
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Protection against pregnancy is not reduced, provided you took the tablets correctly in the 7 days before the missed tablet. However, if you missed more than one tablet, you must use additional contraceptive measures for the next 7 days.

What to do if you miss a tablet in week 3
The risk of pregnancy is particularly high if you miss active white tablets close to the green placebo tablet interval. The contraceptive effectiveness can be maintained by modifying the dosing schedule. Additional contraceptive measures are not necessary provided you took the tablets correctly in the 7 days before the first missed tablet and you follow one of the two options below:

Take the last missed white tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time until all the white tablets in the current pack are finished. Start taking the white tablets from the next pack immediately, without taking the green placebo tablets. Withdrawal bleeding is unlikely until you finish the active tablet section of this second pack; however, you may experience breakthrough bleeding or spotting.

You may immediately stop taking the white tablets from the current pack and begin the 7-day period with the green placebo tablets ( Note the day on which you missed the tablet ); then continue with the white tablets from the next pack. If you wish to start the new pack on your usual day of the week, take the green placebo tablets for a period shorter than 7 days.

If you have missed tablets and do not have withdrawal bleeding during the green placebo tablet period, consider the possibility of pregnancy. In this case, speak with your doctor before starting the next pack.

What to do if you vomit or have severe diarrhoea
If you vomit or have severe diarrhoea within 3–4 hours of taking an active white tablet, the active ingredients may not be completely absorbed by your body. This situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another active white tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the instructions in the section “If you forget to take Novadien”.

The last 7 green tablets in the pack are placebo tablets and do not contain active ingredients. If you vomit or have severe diarrhoea within 3–4 hours after taking a green tablet, the reliability of Novadien is maintained.

What to do if you wish to delay your period
Although not recommended, you may delay your monthly period by starting the next Novadien blister pack immediately after taking the last white tablet of the current pack, skipping the green placebo tablets of that pack. From this second pack, take tablets until you wish your period to begin. However, do not stop taking tablets later than when you finish this second pack. During use of the second pack, you may experience intermenstrual bleeding or spotting. Start the next pack after the usual 7-day interval with green placebo tablets.
Consult your doctor before deciding to delay your menstrual period.

What to do if you wish to change the day of the week on which your period starts
If you take Novadien correctly, your period will occur every 4 weeks on the same day of the week. If you wish to shift your period to another day of the week, you may shorten (but not lengthen) the next green placebo tablet interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday (i.e., three days earlier), you should start the next Novadien pack three days earlier than usual. If the green placebo interval is significantly shortened (e.g., 3 days or less), withdrawal bleeding may not occur during these days. You may then experience light bleeding.
If you are unsure what to do, consult your doctor.

If you wish to stop taking Novadien
You may stop taking Novadien at any time. If you do not wish to become pregnant, ask your doctor to recommend other reliable contraceptive methods.
If you wish to become pregnant, stop taking Novadien and wait for your menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
After stopping, it may take some time for your cycle to return to normal.

Additional information for special patient groups

Use in children and adolescents
Novadien may only be used after the first menstrual period (menarche).

Elderly patients
Novadien may only be used in women before menopause.

Patients with impaired liver function
Novadien must not be used in women with severe liver disorders (see section 2 "Do not use Novadien").

Patients with impaired kidney function
The use of Novadien in women with impaired kidney function has not been studied. Available data do not suggest any need to modify treatment in this patient group.

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

4. Possible side effects

Like all medicines, Novadien can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Novadien, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Novadien”.

Serious side effects
Serious reactions related to the use of the pill, as well as associated symptoms, are described in the following sections: "Blood clots" and "Novadien and cancer". Please read these sections carefully and consult your doctor immediately if necessary.
Contact a 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").

Other side effects
The following side effects have been observed in clinical studies with medicinal products containing 2 mg dienogest and 0.03 mg ethinylestradiol.

Common side effects (may affect up to 1 in 10 people):

Headache
Chest pain, including breast discomfort and tenderness

Uncommon side effects (may affect up to 1 in 100 people):

Inflammation of the vagina and/or external genitalia (vaginitis/vulvovaginitis), fungal infections of the vagina (candidiasis, vulvovaginal infections)
Increased appetite
Depressed mood
Migraine, dizziness (vertigo)
Low or high blood pressure
Abdominal pain (including bloating), nausea, vomiting, or diarrhoea
Acne, hair loss (alopecia), skin rash, itching
Irregular bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhoea), infrequent bleeding (oligomenorrhoea), and absence of bleeding (amenorrhoea)
Bleeding between periods, consisting of vaginal haemorrhage and irregular bleeding between menstrual cycles (metrorrhagia), menstrual pain (dysmenorrhoea)
Genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in internal genital organs, breast enlargement, breast swelling
Weakness, fatigue, and feeling unwell
Weight gain

Rare side effects (may affect up to 1 in 1,000 people):

Inflammation of the ovaries and fallopian tubes, urinary tract infections, bladder inflammation (cystitis), breast gland inflammation (mastitis), cervical inflammation (cervicitis), fungal infections (e.g. candida), viral infections (e.g. cold sores), fever (influenza), bronchitis, sinus infection (sinusitis), upper respiratory tract infections
Benign growths in the uterus (fibroids), benign fatty tissue growths in the breast (breast lipoma)
Decreased number of red blood cells (anaemia)
Allergic reactions
Masculinization (virilism)
Loss of appetite (anorexia)
Depression, psychiatric disorders, insomnia, sleep disorders, aggression
Circulatory disorders of the brain or heart, muscle disorders causing, for example, abnormal posture (dystonia)
Dry or irritated eyes, visual disturbances, blurred vision
Sudden hearing loss, sensation of ringing or other noises in the ears (tinnitus), dizziness, impaired hearing
Rapid heartbeat
Vein inflammation, increased diastolic blood pressure, dizziness or fainting when rising from a sitting or lying position (orthostatic dysregulation), hot flushes, varicose veins (varices), vein disorders or pain
Harmful blood clots in a vein or artery, for example:
- in a leg or foot (deep vein thrombosis, DVT)
- in a lung (pulmonary embolism, PE)
- heart attack
- stroke
- mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
- blood clots in the liver, stomach/intestine, 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).
Asthma, increased breathing rate (hyperventilation)
Inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis), stomach discomfort (dyspepsia)
Allergic skin inflammations (dermatitis), skin rash (e.g. neurodermatitis), skin disease with thickened red patches (psoriasis), excessive sweating (hyperhidrosis), changes or disorders in skin pigmentation (chloasma), overproduction of oil by sebaceous glands (seborrhoea), dandruff, skin lesions, orange-peel skin (cellulite), a central red spot with radiating red extensions resembling a spider’s web (spider nevus)
Back pain, bone, joint, and muscle pain (myalgia), pain in arms and legs
Abnormal cell growth on the surface of the cervix (cervical dysplasia), pain or fluid-filled structures in the fallopian tubes and ovaries, fluid-filled structures in the breasts, pain or spasms during sexual intercourse (dyspareunia), milk-like secretion from the mammary gland (galactorrhea), menstrual disorders
Chest pain, swelling of hands, ankles or feet (peripheral oedema), flu-like symptoms, inflammation, fever, irritability
Elevated levels of fat in the blood (increased triglyceride or cholesterol levels), weight loss or fluctuations
Congenital swelling of extra-mammary breast glands outside the breast area (accessory breast)

Other side effects observed in users of the pill, but whose exact frequency is unknown:
Mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, hives; skin and/or mucosal reactions with rash, nodules, blisters or tissue necrosis (erythema nodosum or multiforme); breast secretion, fluid accumulation in the body (oedema).

Tumours

The frequency of breast cancer diagnosis is slightly increased among users of combined oral contraceptives. Since breast cancer is rare in women under 40 years of age, the excess number is small in relation to the overall risk of breast cancer. For further information, see section "Novadien and cancer".
Liver tumours (benign and malignant)
Cervical cancer

Other conditions

Women with hypertriglyceridaemia (increased fat levels in the blood may increase the risk of pancreatitis during use of combined oral contraceptives)
Increased blood pressure
Onset or worsening of conditions whose association with combined oral hormonal contraceptives is not clear: jaundice and/or pruritus associated with cholestasis (impaired bile excretion), gallstone disease, a metabolic condition called porphyria, systemic lupus erythematosus (chronic autoimmune disease), haemolytic-uraemic syndrome (a disease caused by blood clot formation), a neurological condition called Sydenham’s chorea, gestational herpes (a type of skin disorder occurring during pregnancy), hearing loss due to otosclerosis
Liver dysfunction
Changes in glucose tolerance or peripheral insulin resistance
Crohn’s disease, ulcerative colitis
Chloasma

Interactions
Unexpected bleeding and/or contraceptive failure may result from interactions between other medicines and oral contraceptives (e.g. St John’s wort, medicines for epilepsy, tuberculosis, HIV infection, and other infections). See also “Other medicines and Novadien”.
Other serious side effects and related symptoms are described in the section “Warnings and precautions”.

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 Novadien

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack and the carton after Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. Store below 30°C.
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 Novadien contains
One blister of Novadien contains 21 white active tablets and 7 green placebo tablets.
White active tablets

The active substances are dienogest and ethinylestradiol. Each white active tablet contains: 2 mg of dienogest and 0.03 mg of ethinylestradiol.
Other components are:

The placebo tablets do not contain any active substances.
Other components are:

Tablet core: monohydrate lactose, microcrystalline cellulose, polacriline potassium salt, magnesium stearate.
Coating: hydroxypropylmethylcellulose, hydroxypropylcellulose, talc, stearic acid, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue (E133).
Description of the appearance of Novadien and package contents
The active tablets are white, round, biconvex, film-coated.
The placebo tablets are green, round, biconvex, film-coated.
Novadien 2 mg/0.03 mg film-coated tablets are packaged in PVC/PVDC/Aluminum blisters containing 28 tablets. Commercially available pack sizes contain one or three blisters of 28 tablets.
Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy
Manufacturer responsible for batch release
Helm Pharmaceuticals GmbH
Nordkanalstrasse 28,
20097 Hamburg (Germany)