BRILADONA TRIFASE

Package leaflet: Information for the user

Briladona Trifase 0.180 mg/0.035 mg film-coated tablets, 0.215 mg/0.035 mg film-coated tablets, 0.250 mg/0.035 mg film-coated tablets

norgestimate/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 they have the same symptoms as you, 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 information 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 blood clots forming 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

1. What BRILADONA TRIFASE is and what it is used for
2. What you need to know before taking BRILADONA TRIFASE
3. How to take BRILADONA TRIFASE
4. Possible side effects
5. How to store BRILADONA TRIFASE
6. Contents of the pack and other information

1. What BRILADONA TRIFASE is and what it is used for

Pharmacotherapeutic category: progestogens and estrogens, sequential preparations, ATC code:
G03AB09.
This is a contraceptive and anti-acne medicinal product.
It prevents ovulation. It is recommended to prevent pregnancy in women with mild to
moderate acne. This contraceptive treatment does not replace specific acne treatment, if
necessary.
This contraceptive contains two types of female sex hormones, estrogen and progestogen.
These hormones act by preventing the release of the egg (ovulation) from the ovaries and thus prevent pregnancy. In addition, BRILADONA TRIFASE thickens the cervical fluid, making it more difficult for sperm to enter the uterus. The contraceptive effect begins when the first tablet is taken.

2. What you need to know before taking BRILADONA TRIFASE

General information

Before starting to use BRILADONA TRIFASE, you must read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood clots”).

Before starting to use BRILADONA TRIFASE, 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 perform other examinations.

This leaflet describes various situations in which you must stop using BRILADONA TRIFASE or when the reliability of BRILADONA TRIFASE may be reduced. In such situations, you must avoid sexual intercourse or take additional non-hormonal contraceptive precautions, for example use a condom or another barrier method. Do not use methods such as the rhythm method or basal body temperature. These methods may be unreliable because BRILADONA TRIFASE alters the monthly changes in body temperature and cervical mucus.

BRILADONA TRIFASE, like other hormonal contraceptives, does not protect against HIV (AIDS) and other sexually transmitted infections.

Do not take BRILADONA TRIFASE

Do not use BRILADONA TRIFASE 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 which other methods of birth control might be more suitable for your case.

• if you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), lungs (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 due to undergo surgery or if you 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 transient ischemic attack (TIA - temporary stroke-like symptoms);
• if you have any of the following conditions that could increase the risk of forming clots in the arteries:
  o severe diabetes with blood vessel damage,
  o very high blood pressure,
  o very high levels of fats (cholesterol or triglycerides) in the blood,
  o a condition known as hyperhomocysteinemia;
• if you have (or have ever had) the type of migraine called “migraine with aura”;
• if you have heart valve disorders that have caused complications;
• if you have (or have ever had) liver disease and liver function has not yet returned to normal;
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) or if it is suspected that you have breast cancer or a genital organ tumor;
• if you have any unexplained vaginal bleeding;
• if you have had jaundice during pregnancy caused by bile duct obstruction or if you previously developed jaundice while using the pill;
• if you have abnormal thickening of the uterine lining;
• if you are allergic to norgestimate or ethinylestradiol, or to any of the other components of this medicine (listed in section 6);
• if you have (or have ever had) pancreatitis (inflammation of the pancreas) associated with severe hypertriglyceridemia;
• if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and BRILADONA TRIFASE”);
• if you are pregnant or think you might be pregnant;
• if you are a girl who has not yet reached puberty.

Warnings and precautions

When to be particularly careful with BRILADONA TRIFASE

When should you contact a doctor?

Contact a doctor urgently if:

• you notice possible signs of a blood clot which may indicate you are suffering from 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 adverse effects, refer to the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
Talk to your doctor or midwife before taking BRILADONA TRIFASE.
If any of these conditions appear or worsen while you are using BRILADONA TRIFASE, you must 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 defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or if you 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 BRILADONA TRIFASE;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, possibly with breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you have otosclerosis (hearing loss);
• if you have or have ever had chloasma (skin discoloration, particularly on the face or neck, also known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light;
• if you have a blistering skin rash during pregnancy (herpes gestationis) that first appeared during pregnancy;
• if you have (or have ever had) gallstones or inflammation of the gallbladder;
• if you have a blood disorder called porphyria (increased pigment secretion in the blood);
• if you have epilepsy;
• if you have a nervous system disorder causing sudden involuntary movements (Sydenham’s chorea);
• if a close relative has or has ever had breast cancer;
• if you have depression;
• some women using hormonal contraceptives, including BRILADONA TRIFASE, have reported depression or low mood. Depression can be severe and sometimes may 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 liver disease.

Blood clots

The use of a combined hormonal contraceptive such as BRILADONA TRIFASE 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 BRILADONA TRIFASE 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 symptoms? 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
  • skin discoloration of the leg, such as paleness, redness, or bluish color
    → 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

• sudden loss of vision

• painless blurring of vision that may progress to loss of vision
  → Retinal vein thrombosis (blood clot in the eye)

• chest pain, discomfort, pressure, or heaviness
  → Heart attack

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”).

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, the 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 when you start taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking 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 if you were not using a combined hormonal contraceptive.
When you stop taking BRILADONA TRIFASE, 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 BRILADONA TRIFASE 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, such as BRILADONA TRIFASE, about 5–7 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 within one year
Women who do not use a combined hormonal pill, patch, or ring – and who are not pregnant: Approximately 2 out of 10,000
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate: Approximately 5–7 out of 10,000
Women using BRILADONA TRIFASE: Approximately 5–7 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 BRILADONA TRIFASE 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 had a blood clot in the leg, lung, or another organ at a young age (e.g., under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for 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 BRILADONA TRIFASE several weeks before surgery or during periods of reduced mobility. If you need to stop taking BRILADONA TRIFASE, ask your doctor when you can restart it.
• as you get older (especially over 35 years);
• 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 longer than 4 hours) may temporarily increase the risk of blood clot formation, especially if you have other risk factors listed above.

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 BRILADONA TRIFASE.
If any of the conditions listed above change while you are using BRILADONA TRIFASE—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 can 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 BRILADONA TRIFASE is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as BRILADONA TRIFASE, it is advisable to stop smoking. If you cannot stop smoking and you 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 elevated levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have a heart condition (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 conditions listed above change while you are using BRILADONA TRIFASE—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.

BRILADONA TRIFASE and cancer
Breast cancer risk increases with age. The risk of breast cancer slightly increases with oral contraceptives. Compared to the baseline risk of breast cancer at any given point in life, the additional risk associated with using oral contraceptives is low. The excess risk of breast cancer gradually decreases over 10 years after stopping oral contraceptives. Breast cancers diagnosed in women using oral contraceptives were not more advanced than in non-users. It is important that you regularly examine your breasts and consult your doctor if you detect any lumps.

In rare cases, benign liver tumors have been reported in women using oral contraceptives, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

Cervical cancer has been reported in long-term users, but it is unclear whether this is also influenced by sexual behavior or other factors.

Bleeding between menstrual cycles
During the first few months of taking BRILADONA TRIFASE, you may experience unexpected bleeding (bleeding outside the tablet-free week). If this bleeding lasts longer than a few months or starts after several months, your doctor should investigate the cause.

What to do if no withdrawal bleeding occurs
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack until you are certain you are not pregnant.

Folate levels in the blood may be lower in women using oral contraceptives. This may be important for women who become pregnant soon after stopping oral contraceptives.

Children and adolescents
BRILADONA TRIFASE is contraindicated in girls who have not yet reached puberty—before menarche.

Other medicines and BRILADONA TRIFASE
Inform your doctor if you are taking, have recently taken, or might take any other medicines. Also inform your doctor, dentist, or pharmacist who prescribes other medicines that you are taking BRILADONA TRIFASE tablets. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of other medicines.

Some medicines and herbal products:

• may affect the levels of BRILADONA TRIFASE in the blood;
• may make BRILADONA TRIFASE less effective in preventing pregnancy;
• may cause unexpected bleeding.

These include:

• medicines used to treat:
  o epilepsy (e.g., phenytoin, primidone, phenobarbital, carbamazepine, oxcarbazepine, topiramate, and felbamate)
  o tuberculosis (e.g., rifampicin)
  o HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz, atazanavir, indinavir, etravirine)
  o fungal infections (e.g., griseofulvin)
  o arthritis, osteoarthritis (etoricoxib)
  o pulmonary arterial hypertension (bosentan)
• the herbal remedy St. John’s wort (Hypericum perforatum).

BRILADONA TRIFASE may affect the effectiveness of other medicines, for example:

• medicines containing cyclosporine (an immunosuppressant used to prevent transplant rejection);
• the antiepileptic lamotrigine (this may lead to increased seizure frequency);
• theophylline (used to treat respiratory disorders);
• tizanidine (used to treat muscle pain and/or cramps).

Do not use BRILADONA TRIFASE if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these may cause increases in liver function blood tests (elevated ALT transaminases). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines. BRILADONA TRIFASE may be restarted approximately 2 weeks after completing this treatment. See section “Do not take BRILADONA TRIFASE *”.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as oral contraceptives may affect the results of certain tests.

BRILADONA TRIFASE with food and drink
BRILADONA TRIFASE may be taken with or without food, if necessary with a small amount of water.

Pregnancy, breastfeeding, and fertility
Pregnancy
You must not take BRILADONA TRIFASE if you are pregnant. If you become pregnant while using BRILADONA TRIFASE, stop taking it immediately and consult your doctor. If you wish to become pregnant, you may stop taking BRILADONA TRIFASE at any time.
Consult your doctor or pharmacist before taking any medicine.

Breastfeeding
Taking BRILADONA TRIFASE is generally not recommended while breastfeeding.
If you wish to take the pill while breastfeeding, consult your doctor.
Consult your doctor or pharmacist before taking any medicine.

Fertility
BRILADONA TRIFASE is indicated for the prevention of pregnancy.

Driving and using machines
No effects of BRILADONA TRIFASE on the ability to drive or operate machinery are known.

BRILADONA TRIFASE contains lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking BRILADONA TRIFASE.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
In addition, the blue and turquoise film-coated tablets contain tartrazine aluminium lake (E102) and sunset yellow FCF aluminium lake (E110). These may cause allergic reactions.

3. How to take BRILADONA TRIFASE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

Take one tablet daily at the same time each day (at the time least likely to be forgotten) for 21 consecutive days, followed by a 7-day tablet-free interval between two blisters.

On the first day of using the blister, apply the label* corresponding to the day of the week and take tablet number 1. On subsequent days, take the tablets at approximately the same time each day, in chronological order, until day 21.

Then, do not take any tablets for 7 days. During this interval, withdrawal bleeding usually occurs on the 2nd–3rd day after taking the last tablet.

Start the next blister on day 8, even if withdrawal bleeding is still ongoing. You must always start the next blister on the same day of the week.

* Labels are available under the flap of the box.

Elderly

This product is not indicated for use in postmenopausal women.

Paediatric population

BRILADONA TRIFASE is contraindicated in girls who have not yet reached puberty – before menarche.

Method of administration

Oral use.

Take one tablet daily at the same time each day (at the time least likely to be forgotten), with or without food, and if necessary with a small amount of water, without chewing, for 21 consecutive days, followed by a 7-day tablet-free interval between two blisters. The contraceptive effect begins as soon as the first tablet is taken.

After taking the 21 tablets from the blister, you have a 7-day tablet-free interval. If you took the last tablet of the first blister on Friday, you should take the first tablet of the next blister on Saturday of the following week. Withdrawal bleeding, similar to menstruation, usually occurs two or three days after taking the last tablet from the blister. This withdrawal bleeding may not have finished when you start the next pack of tablets.

You do not need to use any additional contraceptive method during this 7-day interval, provided you have taken the tablets correctly and started the next pack on time.

Then, start the next blister.

Begin a new blister after a 7-day tablet-free interval.

If you use BRILADONA TRIFASE in this way, you will be protected against pregnancy during the 7 days when you are not taking any tablets.

When to start the first blister

• Starting oral contraception: If you have not used a hormonal contraceptive in the previous month Start taking BRILADONA TRIFASE on the first day of your cycle (i.e. the first day of your menstrual period). If you start taking BRILADONA TRIFASE on the first day of your period, contraceptive protection begins immediately. You may also start between day 2 and day 5 of your cycle, but in this case you must use additional protective measures (e.g. a condom) for the first 7 days.

• Switching from another combined hormonal contraceptive, a combined contraceptive vaginal ring, or a contraceptive patch You may start BRILADONA TRIFASE the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the end of the tablet-free days of your previous pill (or the day after the last placebo tablet, the last inactive tablet of your previous pill). When switching from a combined contraceptive vaginal ring or a contraceptive patch, follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen - IUD) You may switch on any day from the progestogen-only pill (from an implant or IUD on the day of its removal, from an injectable when 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 Follow your doctor's advice.

• After giving birth

You may start BRILADONA TRIFASE between 21 and 28 days after delivery. If you start taking it later than day 28, use a barrier contraceptive method (e.g. a condom) during the first seven days of taking BRILADONA TRIFASE.

If, after giving birth, you have had sexual intercourse before starting BRILADONA TRIFASE (or restarting it), make sure you are not pregnant or wait until your next menstrual cycle.

• If you are breastfeeding and wish to start (or restart) taking BRILADONA TRIFASE after giving birth Refer to the section on “Breast-feeding”.

Ask your doctor what to do if you are unsure about when to start.

Duration of treatment

As advised by your doctor.

If you take more BRILADONA TRIFASE than you should

There have been no reports of serious adverse effects due to overdose of BRILADONA TRIFASE. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may experience vaginal bleeding.

If you have taken too many tablets of BRILADONA TRIFASE or discover that a child has taken some, contact your doctor or pharmacist, a hospital, or a poison control centre immediately, especially if taken accidentally by a child, so that risks can be assessed and advice given on what to do.

If you forget to take BRILADONA TRIFASE

If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at your usual time.

If you are more than 12 hours late in taking a tablet, the contraceptive effect may be reduced; the longer the time since the last tablet was taken, the greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greater if you forget a tablet at the beginning or end of the blister. Therefore, follow the rules below (see also the diagram below):

• If you have missed more than one tablet in this blister

Contact your doctor.

• If you missed a tablet between days 1–7 (first row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions for the next 7 days, e.g. a condom. If you had sexual intercourse during the week before you missed the tablet, you may be pregnant. In this case, contact your doctor.

• If you missed a tablet between days 8–14 (second row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. The contraceptive effect is not reduced and you do not need additional precautions.

• If you missed a tablet between days 15–21 (third row) You have two options:
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of starting the tablet-free interval, start the next blister immediately. You will most likely have a menstrual period at the end of the second blister, but you may experience light bleeding or spotting during the intake of the second blister tablets.
  2. You may also stop taking tablets in the blister and immediately start the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start a new blister on your usual starting day, reduce the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will continue to have contraceptive protection.

If you missed any tablet in a blister and do not have bleeding during the first tablet-free interval, you may be pregnant. You should consult your doctor before starting the next blister.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active substances in the tablet have not been completely absorbed by your body. The situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another tablet from a reserve blister as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given in the section "If you forget to take BRILADONA TRIFASE".

How to delay your menstrual period: what you need to know

Although not recommended, you may delay your menstrual period by immediately starting a new blister of BRILADONA TRIFASE without starting or completing the tablet-free interval.

While taking tablets from the second pack, you may experience light bleeding or spotting.

Then, start taking tablets from the next blister after the usual 7-day tablet-free interval.

You may consult your doctor before deciding to delay your menstrual period.

How to change the first day of your menstrual period: what you need to know

If you take the tablets as instructed, your menstrual period will begin during the tablet-free week. If you wish to change this day, shorten the number of tablet-free days (but never extend it – 7 days is the maximum!). For example, if your tablet-free interval usually starts on Friday and you wish to change it to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. If you shorten the tablet-free interval significantly (e.g. 3 days or less), you may not have any bleeding during these days. You may then experience light bleeding or menstruation-like bleeding.

If you are unsure how to proceed, consult your doctor.

If you stop treatment with BRILADONA TRIFASE

You may stop taking BRILADONA TRIFASE at any time.

If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods.

If you wish to become pregnant, stop taking BRILADONA TRIFASE and wait for a menstrual period before planning a pregnancy.

If you have any doubts 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 will experience 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 BRILADONA TRIFASE, inform your doctor.
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 need to know before taking BRILADONA TRIFASE”.
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 potentially with breathing difficulties (also see section When you must pay special attention with BRILADONA TRIFASE).
Below is a list of side effects that have been associated with the use of BRILADONA TRIFASE.
Very common (may affect more than 1 in 10 people)

• Headache (if severe, unusual or prolonged, consult a doctor as soon as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and spotting between periods during the first months (although this usually stops as the body adapts to BRILADONA TRIFASE – see section 2). Bleeding between periods should not last for long.
• Painful or unusual menstrual cycles

Common (may affect up to 1 in 10 women):

• Urinary tract infections (pain when urinating)
• Vaginal infections
• Depression, mood changes; feeling of nervousness
• Migraine (see a doctor as soon as possible if this is your first migraine or if it is worse than usual)
• Acne; rash
• Allergic reactions (hypersensitivity)
• Fluid retention
• Breast pain
• Chest pain
• Muscle spasms; pain in the legs, arms and back
• No menstrual period
• Weight gain
• Feeling of weakness
• Dizziness
• Stomach ache and bloating; constipation, flatulence
• Swollen hands, ankles or feet
• Difficulty sleeping (insomnia)

Uncommon (may affect up to 1 in 100 women):

• Breast problems, such as breast enlargement; nipple discharge
• Abnormal cells of the cervix (identified by a smear test)
• Feeling of anxiety or weakness
• Tingling or numbness sensation
• Changes in skin colour
• Skin problems such as redness and itching or discoloration
• Thinning of hair (alopecia), excessive hair growth
• Changes in appetite, weight loss
• Change in sexual desire
• Dry eyes
• Changes in vision
• Palpitations (awareness of heartbeat)
• Hot flushes
• Muscle pain
• Vaginal and vulvar dryness
• Ovarian cysts (may cause abdominal pain and swelling, changes in menstruation)
• High blood pressure
• Shortness of breath or breathlessness (subjective feeling of breathing discomfort)

Rare (may affect up to 1 in 1,000 women):

• Breast lumps
• Feeling confused
• Faster heartbeat
• Pancreatitis (inflammation of the pancreas, causing severe abdominal and back pain)
• Increased sweating
• Sensitivity to light
• Hepatitis (inflammation of the liver, causing severe abdominal and back pain)
• Vaginal discharge (change in vaginal fluid)

Frequency not known: cannot be estimated from the available data

• Reduced amount of breast milk (if breastfeeding)
• Contact lenses may cause discomfort
• Painful red swelling with lumps on the legs
• Changes in blood fat levels (seen in blood tests)
• Night sweats
• Hepatic adenomas (benign liver tumours generally hormone-induced)
• Breast cancer
• Benign breast tumours
• Focal nodular hyperplasia (benign tumour)
• Fibroadenoma of the breast
• Stroke (cerebrovascular accident)
• Sudden, violent, involuntary muscle contraction or series of contractions (convulsions)
• Heart attack
• Angioedema (swelling in the deep layers of the skin)

The following serious adverse reactions have been reported slightly more frequently in women using contraceptive pills (see section 2: When you must pay special attention with BRILADONA TRIFASE)

• increased blood pressure
• liver tumours or breast carcinoma
• disturbances in liver function
• harmful blood clots in a vein or artery, for example: in a leg or foot (DVT), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or 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).

The following conditions may occur or worsen with combined oral contraceptives: Crohn’s disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham’s chorea (involuntary rapid movements or jerking movements), haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli), liver problems presenting with jaundice, gallbladder disorders or gallstone formation.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at 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 BRILADONA TRIFASE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Keep the blister pack in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice any visible signs of deterioration.
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 BRILADONA TRIFASE contains

• The active substances are norgestimate and ethinylestradiol. The white film-coated tablets contain 0.180 mg of norgestimate and 0.035 mg of ethinylestradiol. The blue film-coated tablets contain 0.215 mg of norgestimate and 0.035 mg of ethinylestradiol. The dark blue film-coated tablets contain 0.250 mg of norgestimate and 0.035 mg of ethinylestradiol.
• The other components are:
  White film-coated tablets: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol.
  Blue film-coated tablets: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) and tartrazine aluminium lake (E102).
  Dark blue film-coated tablets: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, indigo carmine aluminium lake (E132), brilliant blue FCF aluminium lake (E133) and sunset yellow FCF aluminium lake (E110).

Description of the appearance of BRILADONA TRIFASE and package contents
The white, blue and dark blue tablets are round, film-coated tablets with a diameter of approximately 5 mm and a thickness of approximately 2.5 mm.
BRILADONA TRIFASE is available in blisters containing 21 film-coated tablets (7 white tablets, 7 blue tablets, 7 dark blue tablets). Packs contain 1, 3 or 6 blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/a
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Laboratorios León Farma S.A
Calle La Vallina s/n, Polígono Industrial Navatejera
24008 Navatejera, León
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Briladona Trifase
France: TRINARA, comprimé pelliculé