Brilleve

Patient Information Leaflet

BRILLEVE 20 micrograms / 75 micrograms film-coated tablets

Ethinylestradiol/gestodene
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 when used correctly.
• They slightly increase the risk of developing blood clots in the 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 may be experiencing symptoms of a blood clot (see section 2, “Blood clots”).

Contents of this leaflet

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

1. What BRILLEVE is and what it is used for

BRILLEVE is a low-dose combined oral contraceptive for women of reproductive age.
Low-dose combined oral contraceptives contain a small amount of two different female hormones: gestodene (a progestogen) and ethinylestradiol (an oestrogen).
BRILLEVE is used to prevent pregnancy.

2. What you should know before taking BRILLEVE

General notes
Before starting to use BRILLEVE, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
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Before starting or restarting BRILLEVE, a thorough medical examination (including family history) is recommended. Furthermore, periodic check-ups—at least once a year—should be carried out during treatment with this product. The frequency and type of examination will be determined by your doctor and should specifically include monitoring of blood pressure, breast and abdominal examination, general gynecological examination including a Pap test, and appropriate blood tests. The first follow-up visit should take place 3 months after starting the combined oral contraceptive. At each annual visit, the investigations required at the initial visit, described above, should be repeated.
BRILLEVE, like other hormonal contraceptives, does not protect against HIV (AIDS) infections or other sexually transmitted diseases.
BRILLEVE is prescribed for personal use only and should not be shared among multiple individuals.

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

• if you are allergic to ethinylestradiol or gestodene, or to any of the other components of this medicine (listed in section 6);

• 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 disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;

• if you are scheduled for 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 transient ischemic attack (TIA – temporary stroke-like symptoms);

• if you have any of the following conditions, which may increase the risk of arterial 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 hyperhomocysteinemia;
  • if you have (or have ever had) a type of migraine called “migraine with aura”;
  • if you have (or have ever had) jaundice (yellowing of the skin) or severe liver disease;
  • if you have (or have had) benign or malignant liver tumor;
  • if you have (or have had) breast or genital organ cancer;
  • if you are (or suspect you may be) pregnant;
  • if you have unexplained vaginal bleeding;
  • if you are taking Ritonavir;
  • if you have vascular eye diseases.

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If any of these conditions occur for the first time during use of the product, stop taking BRILLEVE immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods. See also “General notes”.
Do not use Brilleve if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Brilleve”).

Warnings and precautions
When to be especially careful with BRILLEVE
Seek urgent medical advice

• if you notice signs suggestive of a blood clot, which may indicate 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 clot (thrombosis)”).

For a description of the symptoms of these serious adverse effects, refer to the section “How to recognize a blood clot”.
This leaflet describes several situations that require discontinuation of BRILLEVE, or in which reduced effectiveness may occur. In such situations, you must avoid sexual intercourse or take additional precautions other than hormonal contraception, such as using a condom or other barrier methods. Do not use rhythm or temperature-based methods, which may be unreliable because the pill alters the monthly variations in body temperature and cervical mucus that occur during the menstrual cycle.

Precautions
If any of the following conditions apply, use of combined-type oral contraceptives may require close medical supervision. Inform your doctor if you have any of the conditions listed below before starting BRILLEVE. Your doctor may recommend a completely different (non-hormonal) method of contraception.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using BRILLEVE, 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 elevated levels of cholesterol and triglycerides (fats) in the blood (even in close relatives);

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• if you are scheduled for 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 BRILLEVE;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a family history of breast cancer;
• if you have diabetes;
• if you smoke;
• if you are overweight;
• if you have heart valve disorders or heart rhythm disturbances;
• if you have breast nodules;
• if you suffer from liver or gallbladder diseases;
• if you suffer or have suffered from mood changes and depression;
• if you have a personal or family history of thrombosis, heart attack, or stroke (even in close relatives);
• if you suffer or have suffered from migraine (one-sided headache);
• if you suffer or have suffered from epilepsy (seizures) (see “Other medicines and BRILLEVE”);
• if you have or have had:
  • asthma,
  • family history of vascular disease,
  • arterial hypertension,
  • cardiac, renal, or hepatic dysfunction;
• if you have a condition that first appeared during pregnancy or during previous use of sex hormones, such as hearing loss due to otosclerosis, porphyria (a blood disorder), gestational herpes (skin eruptions during pregnancy), Sydenham's chorea (a nerve disorder causing sudden body movements);
• if you suffer from superficial phlebitis (venous inflammation);
• if you have (or have had) chloasma (pigmented brown-golden patches, especially on the face, typical during pregnancy). In this case, avoid direct exposure to sunlight or ultraviolet rays;
• if you suffer from certain medical conditions characterized by resistance to Activated Protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibody syndrome (anticardiolipin antibodies, lupus anticoagulant), which predispose to venous or arterial thrombosis;
• if you have (or have had) hereditary angioedema (severe allergic reaction), medicines containing estrogens may trigger or worsen symptoms. You should seek immediate medical attention if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives alone or with breathing difficulties.

If any of the above conditions appear for the first time, recur, or worsen during use of the pill, consult your doctor.
Do not take preparations containing Hypericum perforatum (St. John’s wort) concomitantly with medicines containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, or phenytoin, due to the risk of decreased plasma levels and reduced therapeutic efficacy of oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, and phenytoin (see “Other medicines and BRILLEVE”).
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Psychiatric disorders
Some women using hormonal contraceptives, including BRILLEVE, 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.

BLOOD CLOTS
Using a combined hormonal contraceptive such as BRILLEVE 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, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with BRILLEVE is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

Do you have any of these signs? What are you likely 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, felt only when standing or walking
  • increased warmth in the affected leg
  • change in skin color of the leg, such as paleness, redness, or bluish discoloration → Deep vein thrombosis

• Sudden and unexplained shortness of breath;

• Sudden cough without an obvious cause, possibly with blood;

• Sharp chest pain that worsens 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
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may be mistaken for a milder condition such as a respiratory tract infection (e.g., a "common cold").
sudden loss of vision or painless blurring of vision in one eye, which may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, or heaviness – a crushing sensation or fullness in the chest, one arm, or under the breastbone; – a 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, arm, or leg, especially on one side of the body; – sudden confusion, difficulty speaking or understanding; – 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 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?
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• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it 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
in which 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 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 BRILLEVE, 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 on 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 BRILLEVE 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 gestodene, such as BRILLEVE, about 9–12 will develop a blood clot in one year.
• The risk 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 are not using a combined hormonal contraceptive pill, patch or vaginal ring and who are not pregnant	About 2 women in 10,000

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Women using a combined oral hormonal contraceptive containing levonorgestrel, norethisterone or norgestimate	About 5-7 women out of 10,000
Women using BRILLEVE	About 9-12 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 BRILLEVE 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 need to undergo surgery or must 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 BRILLEVE several weeks before surgery or during periods of reduced mobility. If you need to stop taking BRILLEVE, 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 some of the 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 have you stop taking BRILLEVE.
If any of the conditions listed above change while you are using BRILLEVE—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

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

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

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as BRILLEVE, 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 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 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 BRILLEVE—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.

Tumors
Breast cancer diagnoses are slightly more frequent in women using the pill compared to women of the same age who do not use it. This slight increase in breast cancer diagnoses gradually disappears over the 10 years following discontinuation of treatment. It is not known whether this difference is due to the pill. It could be due to earlier diagnosis, as women are examined more frequently, to the biological effect of the pill, or to both factors. Breast cancer diagnosed in women who are currently using or have recently used a combined oral contraceptive tends to be clinically less advanced than in women who do not use it.

Benign liver tumors have been reported rarely in women taking the pill, and malignant liver tumors even more rarely. These can cause internal bleeding leading to severe abdominal pain. Contact your doctor if you experience unusual and severe abdominal pain.

It has been reported that cervical cancer is more frequent in women who use the pill for a long time. This may not be due to the pill, but rather to sexual behavior and other factors involved in the development of cancers in general.

The tumors mentioned above can be life-threatening or fatal.

When to consult a doctor
Seek medical advice urgently:

• if you notice possible signs of a blood clot, which may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see section “BLOOD CLOTS” – Thrombosis).

For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.

Regular check-ups
While using the pill, your doctor will ask you to attend periodic check-ups, usually once a year.

Consult your doctor as soon as possible:

• if you notice any change in your health status, particularly related to what is described in this leaflet (see “Do not use BRILLEVE” and “When to be particularly cautious with BRILLEVE”). Do not forget to consider family history;
• if you detect a lump in your breast;
• if you need to take other medicines (also see “Other medicines and BRILLEVE”);
• if you are immobilized or need to undergo surgery (consult your doctor at least four weeks in advance);
• if you have heavy and unusual vaginal bleeding;
• if you missed taking tablets during the first week of use and had sexual intercourse in the seven days before the missed dose;
• if you miss your periods for two consecutive cycles and suspect pregnancy; do not start a new pack without your doctor’s approval.

Stop taking the tablets and consult your doctor immediately if you notice possible signs of thrombosis:

• sudden onset of cough;
• severe chest pain that may radiate to the left arm;
• sudden shortness of breath;
• unusual, severe, and prolonged headache or migraine attack;
• partial or total loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of the body;
• severe abdominal pain;
• severe pain or swelling in one leg.

The situations and symptoms listed above are described and explained in greater detail in other sections of this leaflet.

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

Patients with hepatic impairment (liver)
Do not take BRILLEVE if you have liver disease. See section “Do not use BRILLEVE” and “Warnings and Precautions”.

Patients with renal impairment (kidneys)
BRILLEVE has not been specifically studied in patients with reduced kidney function.

Other medicines and BRILLEVE
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 can affect BRILLEVE levels in the blood and prevent the pill from working effectively.

These include:

• certain anti-HIV drugs and other antiviral medications (ritonavir and nevirapine);
• medicines used to treat epilepsy, such as barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate;
• griseofulvin (used to treat other infections);
• azole antifungals, such as itraconazole, voriconazole, fluconazole (used to treat fungal infections);
• rifampicin, rifabutin (medicines used to treat tuberculosis);
• modafinil and flunarizine;
• calcium channel blockers such as verapamil and diltiazem (used to treat certain heart conditions and high blood pressure);
• macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections);
• etoricoxib (used to treat arthritis and osteoarthritis);
• medicines containing cyclosporine;
• the antiepileptic lamotrigine;
• melatonin (a hormone);
• midazolam (a sedative);
• theophylline (used to dilate the airways);
• tizanidine (used to relax muscles);
• omeprazole.

Preparations containing Hypericum perforatum (St. John's Wort) should not be taken simultaneously with oral contraceptives, as this may lead to loss of contraceptive effectiveness. Unintended pregnancies and resumption of menstrual bleeding have been reported. This is due to the induction of enzymes responsible for drug metabolism by Hypericum perforatum preparations.

The enzyme-inducing effect may persist for at least 2 weeks after discontinuation of Hypericum perforatum products (see section “BRILLEVE with food and drink”).

Always inform the doctor prescribing the pill about any other medicines you are taking, and also inform any other doctors or dentists prescribing other medicines that you are using BRILLEVE, so they can determine whether and for how long additional contraceptive methods are needed.

The use of the pill may affect the results of certain blood tests, but such changes generally remain within the normal range. Therefore, it is advisable to inform the doctor requesting the tests that you are taking the pill.

Do not use Brilleve if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in blood test results for liver function (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Brilleve can be resumed approximately 2 weeks after completion of this treatment. See section “Do not use BRILLEVE”.

BRILLEVE with food and drink
BRILLEVE should not be taken with grapefruit juice. During treatment with oral contraceptives, do not take preparations containing St. John's Wort (Hypericum perforatum). Concurrent use may lead to loss of contraceptive effectiveness (see “Other medicines and BRILLEVE”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take BRILLEVE during confirmed or suspected pregnancy.
BRILLEVE is not recommended for women who are breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

BRILLEVE contains lactose, sucrose, and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take BRILLEVE

Take one BRILLEVE tablet every day, without chewing, and if necessary, with a little water. You may take the tablets with or without food, but you must take them every day at approximately the same time.
The blister pack contains 21 tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, take the tablet next to the label “WED”. Follow the direction of the arrow on the blister pack until you have taken the 21st tablet.
Then, do not take any tablets for 7 days. During these 7 tablet-free days (also known as the "tablet-free interval"), you should experience menstruation (withdrawal bleeding). This so-called "withdrawal bleeding" usually begins on the 2nd or 3rd day of the tablet-free interval.
On the 8th day after taking the last BRILLEVE tablet (i.e., after the 7 days of the tablet-free interval), start the next blister pack, even if your menstruation has not yet finished. This same day of the week will then represent the starting day for each subsequent pack. By doing so, you will always start a new pack on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
Combined oral contraceptives, when taken correctly, have a failure rate of 1% per year. The failure rate increases if tablets are forgotten or not taken correctly.
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

When to start the first blister pack

• If you have not used a hormonal contraceptive in the previous month
  Start taking BRILLEVE on the first day of your cycle (i.e., the first day of menstruation). If you start taking BRILLEVE on the first day of your period, you will be immediately protected against pregnancy. Alternatively, you may start between the 2nd and 5th day of your cycle, but in this case, you must use additional contraceptive measures (e.g., a condom) for the first 7 days of tablet intake during the first cycle.

• Switching from another combined oral contraceptive, a combined vaginal contraceptive ring, or a contraceptive patch
  Take the first BRILLEVE tablet the day after taking the last active tablet of the previous product (i.e., without any interval). If the previous contraceptive pack also contains inactive tablets, you may start BRILLEVE the day after the last active tablet (in case of doubt, consult your doctor). Alternatively, you may start taking BRILLEVE later, but not later than the day after the end of the tablet-free interval (or the day after the last inactive tablet) of the previous contraceptive. When switching from a vaginal ring or a transdermal patch, it is preferable to start on the day of removal, but no later than the day the next application would have been due. If you follow these instructions, no additional contraceptive method is necessary.

• Switching from a progestogen-only pill (mini-pill)
  You may stop the mini-pill on any day and start taking BRILLEVE the next day at the same time. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) during sexual intercourse.

• Switching from an injectable contraceptive, an implant, or a progestogen-releasing intrauterine system (IUS)
  Start using BRILLEVE on the day the next injection is due or on the day the implant is removed. However, during the first seven days of BRILLEVE tablet intake, use an additional contraceptive method (barrier method) during sexual intercourse.

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• After spontaneous or induced abortion
  Follow your doctor’s advice.

• After childbirth
  The timing of starting the pill after childbirth must be determined by your doctor. He or she will decide whether to start treatment between days 21 and 28, or later. If you start later than day 28, you must use a so-called barrier method (e.g., a condom) for the first 7 days of BRILLEVE intake. If you have had sexual intercourse after childbirth before starting (or restarting) BRILLEVE, you must first ensure that you are not pregnant; otherwise, wait until your next menstruation. If you are unsure, consult your doctor about when to start. If you are breastfeeding and wish to take BRILLEVE, speak to your doctor first (see “Pregnancy and breastfeeding”).

If you take more BRILLEVE than you should
There are no reports of serious effects in cases of taking several tablets at once.
If you have taken several tablets at once, you may experience symptoms such as nausea or vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue. Young girls may experience vaginal bleeding. In case of accidental ingestion/overdose of BRILLEVE, contact your doctor immediately or go to the nearest hospital.
If you have taken too many BRILLEVE tablets or if you find that a child has ingested them, contact your doctor or pharmacist for advice. There are no specific antidotes, and further treatment for overdose should be symptomatic.

If you forget to take BRILLEVE
If the delay is less than 12 hours in taking a tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, then take the next tablet at your usual time.
If the delay is 12 hours or more in taking a tablet, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk that contraceptive protection is reduced.
The risk of pregnancy is higher if you miss a tablet at the beginning or end of the pack.
Follow the instructions below (see the diagram below):

• More than one tablet missed in the pack
  Contact your doctor.

• One tablet missed in the first week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets as scheduled and use additional contraceptive measures (e.g., a condom) for the next 7 days. If you had sexual intercourse in the week before the missed tablet or if you forgot to start a new pack after the tablet-free period, be aware that there is a risk of pregnancy. In this case, contact your doctor.

• One tablet missed in the second week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets as scheduled. Protection against pregnancy is not reduced, and no additional contraceptive measures are needed.

• One tablet missed in the third week
  You may choose one of the following alternatives, without needing additional contraceptive precautions:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets as scheduled. Start the next pack immediately after finishing the current one, without any interval between packs. Menstruation (withdrawal bleeding) will most likely not occur until the end of the second pack, but you may experience breakthrough bleeding or spotting during the second pack. or
2. Stop taking tablets from the current pack, observe a tablet-free interval of 7 days or less (including the day on which you missed the tablet), and then start a new pack. If you choose this option, you can always start the new pack on the same day of the week as you usually do.

If you have missed any tablet in a pack and do not have a period during the first tablet-free interval, this may indicate pregnancy. You must contact your doctor before starting the next pack.

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What to do in case of gastrointestinal disturbances (e.g., vomiting and/or diarrhoea)
If you vomit within 3–4 hours after taking a tablet or if you have severe diarrhoea, there is a risk that the active ingredients of the tablet are not completely absorbed by your body. This situation is similar to missing a tablet. Therefore, follow the instructions for missed tablets.

Delaying menstruation: what you should know
Although not recommended, it is possible to delay menstruation by starting a new pack of BRILLEVE without observing the 7-day interval. During the use of this second pack, breakthrough bleeding or spotting may occur. Then, continue with the next pack after the usual 7-day interval.
Consult your doctor before deciding to delay menstruation.

Changing the day of menstruation onset: what you should know
If you take the tablets as instructed, your periods will begin approximately on the same day of the week. If you wish to change this day, you may shorten ( never lengthen! ) the usual 7-day interval between two consecutive packs. For example, if your periods usually start on Friday and you wish them to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier. If the interval between two cycles is made too short (e.g., 3 days or less), menstruation may not occur during that interval. In such cases, you may experience breakthrough bleeding or spotting during the next treatment cycle.
Consult your doctor if you have any doubts about how to proceed.

In case of unexpected bleeding
With all oral contraceptives, irregular vaginal bleeding between periods may occur during the first few months of use. Usually, such irregular bleeding stops once your body has adjusted to the pill (typically after about 3 cycles of use).
Consult your doctor if such bleeding persists, becomes heavy, or recurs regularly.

In case of absence of menstruation
If all tablets have been taken correctly, without vomiting or use of other medications, it is very unlikely that you are pregnant. Continue using the product as usual. However, if you do not have a period for two consecutive cycles, pregnancy may have occurred. Consult your doctor immediately. Do not start a new pack until your doctor has ruled out pregnancy.

If you stop taking BRILLEVE
You may stop using BRILLEVE at any time. If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you wish to stop using BRILLEVE because you want to become pregnant, speak to your doctor. In general, it is advisable to wait until your periods return to regularity before trying to conceive.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to BRILLEVE, 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 various risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using BRILLEVE”.
Serious side effects
Serious adverse reactions associated with the use of the pill, and their related symptoms, are described in the section “When to be particularly cautious with BRILLEVE”. For further information, read these sections and consult your doctor immediately.
Other side effects
The following side effects have been reported in women using the pill:

• breast tenderness, pain, and discharge;
• headache, migraine (unilateral headache);
• changes in sexual desire, depressed mood;
• intolerance to contact lenses;
• nausea, vomiting, and feeling unwell;
• changes in vaginal discharge;
• skin reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions;
• oligomenorrhoea (increased interval between menstrual periods), amenorrhoea (absence of menstruation);
• intermenstrual bleeding;
• urticaria (not common);
• harmful blood clots in a vein or an artery, for example:
• in a leg or foot (DVT)
• in a lung (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).
In women with hereditary angioedema (a rare inherited disease characterized by the occurrence of swelling (oedema) of the skin, mucous membranes, and internal organs), exogenous estrogens (hormone replacement therapy) may induce or worsen angioedema symptoms.
Following the instructions contained in this leaflet reduces the risk of side effects.
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 the website
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 BRILLEVE

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 outer carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister in the original packaging to protect the medicine from light.
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 BRILLEVE contains

• The active substances are ethinylestradiol and gestodene. Each tablet contains: 20 micrograms of ethinylestradiol and 75 micrograms of gestodene.
• The other components are:
  Tablet core: Disodium edetate, magnesium stearate, povidone 25, maize starch, lactose monohydrate, purified water.
  Tablet coating: Povidone 90 F, macrogol 6000, talc, calcium carbonate, sucrose, lignite wax, purified water.

Description of the appearance of BRILLEVE and pack contents
BRILLEVE coated tablets are white, biconvex, round, and glossy.
The tablets are packaged in PVC/aluminum blisters – each blister contains 21 tablets. The blisters are supplied in cardboard boxes. Each box contains 1 blister.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA) - Italy
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Manufacturer responsible for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 - Barleben
Germany
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Package Leaflet: Information for the User

BRILLEVE 30 micrograms / 75 micrograms coated tablets

Ethinylestradiol/gestodene
Equivalent medicine
Please read this leaflet carefully before using this medicine as 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when 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 may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

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

1. What BRILLEVE is and what it is used for

BRILLEVE is a low-dose combined oral contraceptive for women of childbearing age.
Low-dose combined oral contraceptives contain small amounts of two different female hormones: gestodene (a progestogen) and ethinylestradiol (an oestrogen).
BRILLEVE is used to prevent pregnancy.

2. What you should know before taking BRILLEVE

General information
Before starting to use BRILLEVE, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
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Before starting or restarting BRILLEVE, a thorough medical examination (including family medical history) is recommended. In addition, periodic check-ups should be carried out at least once a year while using this product. The frequency and type of examination will be determined by your doctor and should specifically include monitoring of blood pressure, breast and abdominal examination, general gynecological examination including a Pap test, and appropriate blood tests. The first follow-up visit should occur three months after starting the combined oral contraceptive. At each annual visit, the investigations required at the initial visit, described above, should be repeated.
BRILLEVE, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections. A condom is necessary to protect against these diseases.
BRILLEVE is prescribed for personal use and should not be shared among multiple individuals.

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

• if you are allergic to ethinylestradiol or gestodene, or to any of the other ingredients of this medicine (listed in section 6);
• 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 disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for 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 transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of developing arterial 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 hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer from jaundice (yellowing of the skin) or severe liver disease;
• if you have (or have had) a benign or malignant liver tumor;
• if you have (or have had) breast cancer or cancer of the genital organs;
• if you are (or suspect you may be) pregnant;
• if you have vaginal bleeding of unknown origin;
• if you are taking Ritonavir; 22/40
• if you have vascular eye diseases.

If any of these conditions occurs for the first time while using the product, stop taking BRILLEVE immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods. See also “General information”.
Do not use Brilleve if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Brilleve”).

Warnings and precautions
When to be especially careful with BRILLEVE
When should you contact a doctor?
Seek urgent medical advice

• 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 clot (thrombosis)”).

For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.
This patient information leaflet describes certain situations in which you must stop taking the product or in which its effectiveness may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions such as condoms or other barrier methods. Do not use rhythm or basal body temperature methods, which may be unreliable because the pill alters the normal fluctuations in temperature and cervical mucus that occur during the menstrual cycle.

Precautions
If you have any of the following conditions, the use of a combined oral contraceptive may require close monitoring by your doctor. Inform your doctor if you have any of the conditions listed below before starting BRILLEVE. Your doctor may recommend a completely different (non-hormonal) method of contraception.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are using BRILLEVE, 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);

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• 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 cholesterol and triglycerides (fats) in the blood (even in close family members);
• if you are scheduled for 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 BRILLEVE;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a family history of breast cancer;
• if you have diabetes;
• if you smoke;
• if you are overweight;
• if you have heart valve disorders or heart rhythm problems;
• if you have breast nodules;
• if you have liver or gallbladder disease;
• if you suffer or have suffered from mood changes or depression;
• if you have a personal or family history (even in close relatives) of thrombosis, heart attack, or stroke;
• if you suffer or have suffered from epilepsy (seizures) (see “Other medicines and BRILLEVE”);
• if you suffer or have suffered from migraine (one-sided headache);
• if you have or have had:
• asthma,
• family history of vascular disease,
• high blood pressure,
• cardiac, renal, or hepatic dysfunction,
• if you have a condition that first appeared during pregnancy or during a previous use of sex hormones, for example hearing loss due to otosclerosis, porphyria (a blood disorder), herpes gestationis (skin rashes during pregnancy), Sydenham's chorea (a nerve disorder causing sudden body movements);
• if you suffer from superficial phlebitis (vein inflammation);
• if you have varicose veins;
• if you have (or have had) chloasma (pigmented brown-golden patches, especially on the face, typical during pregnancy). In this case, avoid direct exposure to sunlight or ultraviolet rays;
• if you suffer from certain medical conditions characterized by resistance to Activated Protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid syndrome (anticardiolipin antibodies, lupus anticoagulant), which predispose to venous or arterial thrombosis;
• if you have hereditary angioedema (severe allergic reaction), estrogen-containing medicines may trigger or worsen symptoms. You should contact your doctor immediately if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives alone or with difficulty breathing.

If any of the above conditions appears for the first time, recurs, or worsens during use of the pill, consult your doctor.
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Do not take preparations containing Hypericum perforatum (St. John's wort) concomitantly with medicines containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, or phenytoin due to the risk of decreased plasma levels and reduced therapeutic efficacy of oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, and phenytoin (see section “Other medicines and BRILLEVE”).

Psychiatric disorders
Some women using hormonal contraceptives, including BRILLEVE, 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.

BLOOD CLOTS
Using a combined hormonal contraceptive such as BRILLEVE 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, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with BRILLEVE is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention 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:
Deep vein thrombosis

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

Sudden and unexplained shortness of breath or rapid breathing;
Pulmonary embolism

Sudden cough without an obvious cause, possibly with coughing up blood;
Sudden, sharp chest pain that may worsen when breathing 25/40

take a deep breath; severe dizziness or vertigo; rapid or irregular heartbeat; severe stomach pain. 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 like a respiratory 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)
pain, discomfort, pressure or heaviness in the chest; -crushing sensation or fullness in the chest, in one arm or under the sternum; -feeling of fullness, indigestion or suffocation; -discomfort in the upper body spreading to the back, jaw, throat, arms and 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 trouble 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

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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 the 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 breaks loose from the leg and travels to 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
when taking a combined hormonal contraceptive for the first time. The risk may also
be higher when restarting a combined hormonal contraceptive (the same or a different
product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking BRILLEVE, 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 BRILLEVE 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 gestodene, such as BRILLEVE, about 9–12 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”).

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	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 in 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 in 10,000 women
Women who use BRILLEVE	About 9-12 in 10,000 women

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with BRILLEVE is low, but certain conditions can increase it. The 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 may have an inherited blood clotting disorder;
• if you need to undergo surgery or must remain bedridden for a long period due to injury or illness, or if you have a leg in a cast. You may need to stop taking BRILLEVE several weeks before surgery or during periods of reduced mobility. If you need to stop taking BRILLEVE, ask your doctor when you can start taking it again;
• as you get older (especially over the age of 35);
• if you gave 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 some of the 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 BRILLEVE.
If any of the conditions listed above change while you are using BRILLEVE—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 BRILLEVE is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as BRILLEVE, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative 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 fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if any 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 BRILLEVE—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.

Tumours
Breast cancer diagnoses are slightly more frequent in women using the pill compared to women of the same age who do not use it. This slight increase in breast cancer diagnoses gradually disappears within 10 years after stopping treatment. It is not known whether this difference is due to the pill.
This could be due to earlier diagnosis, as women are examined more frequently, to the biological effect of the pill, or to both factors. Breast cancer diagnosed in women currently or recently using a combined oral contraceptive tends to be clinically less advanced than in women who do not use it.
Benign liver tumours have been reported rarely in women taking the pill, and malignant liver tumours even more rarely. These may cause internal bleeding leading to severe abdominal pain.
Contact your doctor if you experience unusual and severe abdominal pain.
An increased incidence of cervical cancer has been reported in women who use the pill for a long time. This may not be due to the pill itself, but rather to sexual behaviour and other factors that are sometimes implicated in the development of tumours in general.
The tumours mentioned above can be life-threatening or fatal.

When to contact a doctor
Contact a doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see section “BLOOD CLOTS” – Thrombosis).

For a description of the symptoms of these serious side effects, see the section “How to recognize a blood clot”.

Regular check-ups
While using the pill, your doctor will ask you to attend periodic check-ups, usually once a year.

Contact your doctor as soon as possible

• if you notice any change in your health status, particularly related to what is described in this leaflet (see “Do not use BRILLEVE” and “When to be particularly careful with BRILLEVE”). Do not forget to consider information regarding close relatives;
• if you detect a lump in your breast;
• if you need to take other medicines (also see “Other medicines and BRILLEVE”);
• if you are immobilized or need to undergo surgery (consult your doctor at least four weeks beforehand);
• if you have unusually heavy vaginal bleeding;
• if you missed taking tablets during the first week of use and had sexual intercourse in the seven days before the missed dose;
• if you miss your periods for two consecutive cycles and suspect pregnancy; do not start a new pack without your doctor’s approval.

Stop taking the tablets and contact your doctor immediately if you notice possible signs of thrombosis:

• sudden onset of coughing;
• severe chest pain that may radiate to the left arm;
• sudden shortness of breath;
• unusual, severe, and prolonged headache or migraine attack;
• partial or complete loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of the body;
• severe abdominal pain;
• severe pain or swelling in one leg.

The situations and symptoms listed above are described and explained in greater detail in other sections of this leaflet.

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

Patients with hepatic impairment (liver)
Do not take BRILLEVE if you have liver disease. See section “Do not use BRILLEVE” and “Warnings and Precautions”.

Patients with renal impairment (kidneys)
BRILLEVE has not been specifically studied in patients with reduced kidney function.

Other medicines and BRILLEVE
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 can affect BRILLEVE levels in the blood and reduce the effectiveness of the pill.
These include:

• certain anti-HIV drugs and other antiviral agents (ritonavir and nevirapine);
• medicines used to treat epilepsy such as barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate;
• griseofulvin (used to treat other infections);
• azole antifungals such as itraconazole, voriconazole, fluconazole (used to treat fungal infections);
• macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections);
• rifampicin, rifabutin (medicines used to treat tuberculosis);
• modafinil and flunarizine;
• calcium channel blockers such as verapamil and diltiazem (used to treat certain heart conditions and high blood pressure);
• etoricoxib (used to treat arthritis and osteoarthritis);
• medicines containing cyclosporine;
• the antiepileptic lamotrigine;
• melatonin (a hormone);
• midazolam (a sedative);
• theophylline (used to dilate the airways);
• tizanidine (used to relax muscles);
• omeprazole.

Preparations containing Hypericum perforatum (St. John’s wort) should not be taken at the same time as oral contraceptives, as they may reduce contraceptive effectiveness. Unintended pregnancies and resumption of menstruation have been reported due to enzyme induction affecting drug metabolism caused by Hypericum perforatum preparations.
The enzyme-inducing effect may persist for at least 2 weeks after stopping Hypericum perforatum treatment (see section “BRILLEVE with food and drink”).
Always inform the doctor prescribing the pill about any other medicines you are taking, and also inform any other doctors or dentists prescribing other medications that you are using BRILLEVE, so they can determine whether and for how long additional contraceptive methods are needed.
Using the pill may affect the results of certain blood tests, but these changes generally remain within the normal reference range. Therefore, it is important to inform the doctor who ordered the tests that you are taking the pill.
Do not use Brilleve if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver function blood test results (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Brilleve can be restarted approximately 2 weeks after completing this treatment. See section “Do not use BRILLEVE”.

BRILLEVE with food and drink
BRILLEVE should not be taken with grapefruit juice. During treatment with oral contraceptives, do not take Hypericum perforatum (St. John’s wort) preparations. Taking them together may reduce contraceptive effectiveness (see section “Other medicines and BRILLEVE”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist.
Do not take BRILLEVE if you are pregnant or suspect pregnancy. BRILLEVE is not recommended during breastfeeding.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

BRILLEVE contains lactose, sucrose, and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take BRILLEVE

Take one BRILLEVE tablet every day, without chewing, and if necessary, with a little water. You may take the tablets with or without food, but you must take them every day at approximately the same time.
The blister pack contains 21 tablets. Next to each tablet is printed the day of the week on which it should be taken. For example, if you start on Wednesday, take the tablet next to the word “WED”. Follow the direction of the arrow on the blister pack until you take the 21st tablet.
Then, do not take any tablets for 7 days. During these 7 tablet-free days (also called the hormone-free interval), you should experience menstruation (withdrawal bleeding). This so-called "withdrawal bleeding" usually starts on the 2nd or 3rd day of the hormone-free interval.
On the eighth day after the last BRILLEVE tablet (i.e., after the 7 days of the hormone-free interval), start the next pack, even if your period has not yet finished. This same day of the week will then become the starting day for each subsequent pack. By doing this, you will always start a new pack on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
Combined oral contraceptives, when taken correctly, have a failure rate of 1% per year. The failure rate increases if tablets are missed or not taken correctly.
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

When to start the first pack

• If you have not used a hormonal contraceptive in the previous month
  Start taking BRILLEVE on the first day of your cycle (i.e., the first day of menstruation). If you start BRILLEVE on the first day of your period, you will be immediately protected against pregnancy. You may also start between the 2nd and 5th day of your cycle, but in this case, you must use additional contraceptive measures (e.g., a condom) for the first 7 days of tablet intake in the first cycle.

• Switching from another combined oral contraceptive, a combined vaginal ring, or a contraceptive patch
  Take the first BRILLEVE tablet the day after taking the last active tablet of the previous product (i.e., without any interval). If the previous contraceptive pack contains inactive tablets, you may take BRILLEVE the day after the last active tablet (in case of doubt, consult your doctor). Alternatively, you may start BRILLEVE later, but not later than the day after the end of the tablet-free interval (or the day after the last inactive tablet) of the previous contraceptive. When switching from a vaginal ring or transdermal patch, it is preferable to start on the day of removal, but no later than the day the next application would have been due. If you follow these instructions, no additional contraceptive method is required.

• Switching from a progestogen-only pill (mini-pill)
  You may stop the mini-pill on any day and start taking BRILLEVE the next day at the same time. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.

• Switching from an injectable, implant, or intrauterine system releasing progestogen (IUS)
  Start taking BRILLEVE on the day the next injection is due or on the day the implant is removed. However, during the first seven days of BRILLEVE intake, use an additional contraceptive method (barrier method) when having sexual intercourse.

• After spontaneous or induced abortion
  Follow your doctor’s advice.

• After childbirth
  The timing of starting the pill after childbirth must be determined by your doctor. He or she will decide whether to start treatment between days 21 and 28, or later. If you start later than day 28, you must use a so-called barrier method (e.g., a condom) for the first 7 days of BRILLEVE intake. If you have had sexual intercourse after childbirth before starting (or restarting) BRILLEVE, you must first ensure you are not pregnant; otherwise, wait until your next menstruation.

If you take more BRILLEVE than you should
There are no reports of serious effects in case of taking several tablets at once.
If you have taken several tablets at once, you may experience symptoms such as nausea or vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue. Young girls may experience vaginal bleeding. In case of accidental ingestion/overdose of BRILLEVE, contact your doctor immediately or go to the nearest hospital.

If you forget to take BRILLEVE

• If the delay is less than 12 hours in taking a tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then take the next tablet at your usual time.

• If the delay is 12 hours or more in taking a tablet, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of reduced contraceptive protection.

The risk of pregnancy is higher if you missed a tablet at the beginning or end of the pack. Follow the instructions below (see the diagram below):

• More than one tablet missed in the pack
  Contact your doctor.

• One tablet missed in the first week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at the usual time and use additional contraceptive measures for the next 7 days (e.g., a condom). If you had sexual intercourse in the week before the missed tablet or if you forgot to start a new pack after the tablet-free interval, be aware that there is a risk of pregnancy. In this case, contact your doctor.

• One tablet missed in the second week
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at the usual time. Protection against pregnancy is not reduced, and no additional contraceptive measures are needed.

• One tablet missed in the third week
  You may choose one of the following options, without needing additional contraceptive precautions:

  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at the usual time. Start the next pack immediately after finishing the current one, without any interval. You will most likely not have a menstrual period (withdrawal bleeding) until the end of the second pack, but you may experience spotting or breakthrough bleeding during the second pack. or
  2. Stop taking tablets from the current pack, observe a 7-day interval (including the day you forgot to take the tablet), and then start a new pack. If you choose this option, you can start the new pack on the same day of the week as your usual starting day.

If you missed any tablet in a pack and do not have a period during the first tablet-free interval, this may indicate pregnancy. You must contact your doctor before starting the next pack.

What to do in case of gastrointestinal disturbances (e.g., vomiting and/or diarrhea)
If you vomit within 3–4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients are not completely absorbed by your body. This situation is comparable to missing a tablet. Therefore, follow the instructions for missed tablets.

Delaying menstruation: what you should know
Although not recommended, it is possible to delay menstruation by starting a new pack of BRILLEVE without observing the 7-day interval. During the second pack, you may experience breakthrough bleeding or spotting. Continue with the next pack after the usual 7-day interval.
Consult your doctor before deciding to delay your period.

Changing the day of menstruation onset: what you should know
If you take the tablets as instructed, your periods will start approximately on the same day of the week. If you wish to change this day, you may shorten ( never lengthen ) the normal interval between two consecutive packs. For example, if your periods usually start on Friday and you wish them to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier. If the interval between two cycles is made too short (e.g., 3 days or less), you may not have a period during that interval. In this case, you may experience breakthrough bleeding or spotting during the next treatment cycle.
Consult your doctor if you have any doubts about how to proceed.

In case of unexpected bleeding
With all oral contraceptives, vaginal bleeding between periods (breakthrough bleeding) may occur during the first few months of use. Irregular bleeding usually disappears once your body has adjusted to the pill (typically after about 3 cycles). Consult your doctor if such bleeding persists, becomes heavy, or recurs regularly.

In case of absence of menstruation
If all tablets have been taken correctly, there has been no vomiting, and no other medications have been taken, it is very unlikely that you are pregnant. Continue using the product as usual. If you miss two consecutive periods, pregnancy may have occurred. Consult your doctor immediately. Do not start a new pack until your doctor has ruled out pregnancy.

If you stop taking BRILLEVE
You may stop using BRILLEVE at any time. If you do not wish to become pregnant, consult your doctor about other methods of contraception.
If you wish to stop using BRILLEVE because you want to become pregnant, talk to your doctor. In this case, it is generally advisable to wait until your periods return to regularity before trying to conceive.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to BRILLEVE, 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 various risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before using BRILLEVE”.
Serious side effects
Serious adverse reactions associated with the use of the pill, and their related symptoms, are described in the section “When to be particularly cautious with BRILLEVE”. For further information, read these sections and consult your doctor immediately.
Other side effects
The following side effects have been reported in women taking the pill:

• breast tenderness, pain, and discharge;
• headache, migraine (unilateral headache);
• changes in sexual desire, depressed mood;
• intolerance to contact lenses;
• nausea, vomiting, and feeling unwell;
• changes in vaginal discharge;
• skin reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions;
• oligomenorrhoea (increased interval between one menstruation and the next), amenorrhoea (absence of menstruation);
• intermenstrual bleeding;
• urticaria (not common);
• harmful blood clots in a vein or an artery, for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys, or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
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In women with hereditary angioedema (a rare inherited disease characterised by the occurrence of swellings (oedema) of the skin, mucous membranes, and internal organs), exogenous estrogens (hormone replacement therapy) may induce or worsen angioedema symptoms.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website
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 BRILLEVE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister in the original packaging to protect the medicine from light.
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 BRILLEVE contains

• The active substances are ethinylestradiol and gestodene. Each tablet contains: 30 micrograms of ethinylestradiol and 75 micrograms of gestodene.
• The other components are: Tablet core: Disodium edetate, magnesium stearate, povidone 25, maize starch, lactose monohydrate, purified water. Tablet coating: Povidone 90 F, macrogol 6000, talc, calcium carbonate, sucrose, lignite wax, purified water.

Description of the appearance of BRILLEVE and package contents
BRILLEVE coated tablets are white, biconvex, round, and glossy.
The tablets are packed in PVC/aluminum blisters – each blister contains 21 tablets. The blisters are supplied in cardboard boxes. Each box contains 1 blister.
It is possible that not all pack sizes are marketed.
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Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA) - Italy
Responsible manufacturer for batch release
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 - Barleben
Germany
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