BRILLEVE 20 MICROGRAMS/75 MICROGRAMS Film-coated tablets

Содержание инструкции

1. BRILLEVE 20 micrograms / 75 micrograms coated tablets
   1. Cos’è BRILLEVE e a cosa serve
   2. Cosa deve sapere prima di prendere BRILLEVE
   3. How to take BRILLEVE
   4. Possible side effects
   5. How to store BRILLEVE
   6. Contents of the pack and other information
2. BRILLEVE 30 micrograms / 75 micrograms coated tablets
   1. Cos’è BRILLEVE e a cosa serve
   2. Cosa deve sapere prima di prendere BRILLEVE
   3. How to take BRILLEVE
   4. Possible side effects
   5. How to store BRILLEVE
   6. Contents of the pack and other information

BRILLEVE 20 micrograms / 75 micrograms coated tablets

Ethinylestradiol/gestodene
Generic medicine

Read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

• They are one of the most reliable reversible methods of contraception, if used correctly
• They slightly increase the risk of 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
• Pay attention and see your doctor if you think you have 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. Cos’è BRILLEVE e a cosa serve

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

2. Cosa deve sapere prima di prendere BRILLEVE

General information
Before starting to use BRILLEVE, read the information on blood clots in
section 2. It is particularly important that you read the symptoms of a blood clot
(see section 2 “Blood clots”).
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Before starting or restarting BRILLEVE, it is recommended to have a thorough
medical examination (including a family history). It is also advisable to have periodic
check-ups, at least once a year, during use of the product. The frequency and type of visit will be determined by the doctor and will focus in particular on monitoring blood
pressure, breast examination, abdominal and general gynecological examination, including a
Pap test, and relevant 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 for the initial visit, as described above, should be carried out.

BRILLEVE, like other hormonal contraceptives, does not protect against HIV (AIDS)
or other sexually transmitted diseases.
BRILLEVE is prescribed for personal use and should not be available to more
than one person at a time.

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. The doctor
will discuss other methods of birth control that may be more suitable
for you.
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 leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in 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 going to have surgery or will be bedridden for a long 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 that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
if you have one of the following conditions, which may increase the risk of blood clots forming
in the arteries:

• severe diabetes with damage to blood vessels;
• 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) a benign or malignant liver tumor; if you have (or have had) breast or genital cancer; if you are (or suspect you are) pregnant; if you have vaginal bleeding of unknown origin; if you are taking Ritonavir; if you have eye diseases of vascular origin.

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If any of these conditions occur for the first time during use of the
product, stop taking it immediately and consult your doctor. In the meantime
use non-hormonal methods of contraception. 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 particularly careful with BRILLEVE
Seek medical attention 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 clot (thrombosis)” below).

For a description of the symptoms of these serious side effects, see section “How
to recognize a blood clot”.
This leaflet describes various situations that require stopping BRILLEVE,
or in which the effectiveness may be reduced. In such situations, you should not have
sexual intercourse or should use additional precautions, other than hormonal
contraception, such as a condom or other barrier methods. Do not use methods based on the rhythm or
temperature, which may be unreliable because the pill alters the monthly variations in temperature and cervical mucus that occur during the menstrual
cycle.

Precautions
In the presence of any of the conditions listed below, the use of a combined pill
may require close monitoring by the doctor. Tell your doctor
about the presence of any of the conditions listed below before starting to
use BRILLEVE. The doctor may advise you to use a completely different method of contraception (non-hormonal).

Tell your doctor if any of the following conditions apply to you.
If this condition occurs or worsens while you are using BRILLEVE, tell your
doctor:

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects the immune system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of cholesterol and triglycerides (fats) in the blood (also in close relatives);

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• if you are going to have surgery or will be bedridden for a long period (see section 2 “Blood clots”);
• if you have just 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 the veins in 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 problems or heart rhythm disorders;
• if you have breast lumps;
• if you suffer from liver or gallbladder disease;
• if you suffer from or have suffered from mood changes and depression;
• if you have a history of thrombosis, heart attack or stroke (also in close relatives);
• if you suffer from or have suffered from migraine (headache on one side);
• if you suffer from or have suffered from epilepsy (seizures) (see “Other medicines and BRILLEVE”);
• if you have or have had:
• asthma,
• a family history of vascular disease,
• high blood pressure,
• heart, kidney or liver dysfunction, if you have a disease that first appeared during pregnancy or during previous use of sex hormones, for example, hearing loss from otosclerosis, porphyria (a blood disease), herpes gestationis (skin rashes during pregnancy), Sydenham's chorea (a nervous disease that causes sudden movements of the body); if you suffer from superficial phlebitis (vein inflammation); if you have (or have had) chloasma (brown-gold pigmented patches, especially on the face, typical of pregnancy). In this case, avoid direct exposure to sunlight or ultraviolet rays; if you suffer from some pathological 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 the onset of venous or arterial thrombosis; if you suffer from hereditary angioedema (severe allergic reaction), medicines containing estrogens may induce or worsen the symptoms. You should seek immediate medical attention if symptoms of angioedema appear, such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing or hives alone or with difficulty breathing.

If any of these conditions appear for the first time, recur, or worsen during
use of the pill, consult your doctor.
Do not take preparations based on Hypericum perforatum in combination with medicines
containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, phenytoin due to the risk of a decrease in plasma levels and a decrease in the effectiveness
therapeutic of oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital,
phenytoin (see “Other medicines and BRILLEVE”).
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Psychiatric disorders
Some women who use hormonal contraceptives including BRILLEVE have reported
depression or depressed mood. Depression can be severe and sometimes can lead to
suicidal thoughts. If you experience changes in mood and depressive symptoms, see your
doctor as soon as possible for further medical advice.

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

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Healing from blood clots is not always complete. Rarely, there may be long-term serious effects or, very rarely, such effects may 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
See a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to suffer from?
Swelling in one leg or along a vein in the leg or
foot, especially if accompanied by:
Deep vein
thrombosis

If you are unsure, tell your doctor as some of
these symptoms such as cough or shortness of breath
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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 linked to an increased risk of 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 in 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, the clot can form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
first using a combined hormonal contraceptive. The risk may also be higher if you restart a combined hormonal contraceptive (the
same medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 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.

• Out of 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing gestodene, like BRILLEVE, about 9-12 will develop a blood clot in a year.
• The risk of forming a blood clot depends on your medical history (see below “Factors that increase the risk of a blood clot”).

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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 some conditions increase it.
Your risk is higher:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to undergo surgery or if you need to be bedridden for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking BRILLEVE a few weeks before surgery or during the time you are less mobile. 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) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you are not sure. Your doctor may decide to stop you from taking
BRILLEVE.
If any of the conditions mentioned above change while you are using BRILLEVE, for
example if a close relative develops a thrombosis for no known reason or if you gain
a lot of 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 cause 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 can increase:

• with increasing age (over 35 years);

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• if you smoke.When using a combined hormonal contraceptive like BRILLEVE it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high 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 any heart problems (valve 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 mentioned above change while you are using BRILLEVE, for
example if you start smoking, if a close relative develops a thrombosis for no known
reason or if you gain a lot of weight, contact your doctor.

Tumors
Diagnoses of breast cancer are slightly more frequent in women who use the pill
compared to those of the same age who do not use it. The slight increase in the number of breast cancer diagnoses gradually disappears within 10 years of stopping
treatment. It is not known whether the difference is due to the pill. This could be
due to earlier diagnosis, as women are visited more frequently, to the biological effect of the pill or to both factors. Breast cancer diagnosed in
women who take or have recently taken a combined oral contraceptive tends
to be clinically less advanced than that diagnosed in women who do not
use it.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. These can cause internal bleeding
leading to severe abdominal pain. Contact your doctor if you experience unusual and severe abdominal pain.
Cervical cancer has been reported to be more frequent in women who
use the pill for a long time. This may not be due to the pill, but to sexual behavior and other factors occasionally implicated in the genesis of tumors in general.
The tumors mentioned above can be life-threatening or fatal.

When should you see a doctor
Seek immediate medical attention

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

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

Periodic checks
While using the pill, your doctor will ask you to attend periodic check-up visits, usually every year.

Consult your doctor as soon as possible

• if you notice any change in your health status, especially in relation to

“When to be particularly careful with BRILLEVE”. Do not forget the references
to close family members);

• if you feel a lump in your breast;
• if you need to use other medicines (see also “Other medicines and BRILLEVE”);
• if you become immobilized or need to undergo surgery (consult your doctor at least four weeks before);
• if you have heavy and unusual vaginal bleeding;
• if you have forgotten to take the tablets in the first week of use and have had sexual intercourse in the seven days before the missed dose;
• if you do not have your period for two consecutive cycles and if you suspect you are pregnant, do not start a new pack without your doctor's authorization.

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

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

The situations and symptoms above are illustrated and explained in more detail in other

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 impaired liver function (liver)
Do not take BRILLEVE if you suffer from liver disease. See section “Do not use BRILLEVE” and
“Warnings and Precautions”.

Patients with kidney damage (kidneys)
BRILLEVE has not been specifically studied in patients with reduced kidney function.
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Other medicines and BRILLEVE
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Some medicines may influence the levels of BRILLEVE in the blood and prevent
an effective action of the pill.
These include:

• some anti-HIV medicines and other medicines for the treatment of viral infections (ritonavir and nevirapine);
• medicines used for the treatment of epilepsy, such as barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate;
• griseofulvin (used for the treatment of other infections);
• azole antifungal medicines, such as itraconazole, voriconazole, fluconazole (used for the treatment of fungal infections);
• rifampicin, rifabutin (medicines for the treatment of tuberculosis);
• modafinil and flunarizine;
• calcium channel blockers such as verapamil and diltiazem (used for the treatment of some heart conditions and high blood pressure);
• macrolide antibiotics such as clarithromycin, erythromycin (used for the treatment of bacterial infections);
• etoricoxib (for treating arthritis and osteoarthritis);
• medicines containing ciclosporin;
• the anti-epileptic lamotrigine;
• melatonin (a hormone);
• midazolam (a sedative);
• theophylline (used to dilate the airways);
• tizanidine (used to dilate muscles);
• omeprazole.

St John's Wort (Hypericum perforatum) preparations should not be taken
simultaneously with oral contraceptives, as this could lead to a loss
of contraceptive efficacy. Unwanted pregnancies and resumption of the
menstrual cycle have been reported. This is due to the induction of enzymes responsible for the metabolism of
medicines by St John's Wort preparations.
The induction effect can persist for at least 2 weeks after stopping the
treatment with St John's Wort products (see paragraph “BRILLEVE with
foods and beverages”).
Always inform the doctor who prescribes the pill about the medicines you are already
taking, and also inform all other doctors or dentists who prescribe other
medicines that you are using BRILLEVE, so that they can establish whether and for
how long additional contraceptive methods are necessary.
The use of the pill may affect the results of some blood tests, but such variations
generally fall within the normal range. For this reason, it is advisable to inform the doctor who
requested the tests that you are taking the pill.
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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 test results (increased liver enzyme ALT). The 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 the paragraph “Do not use BRILLEVE”.

BRILLEVE with food and beverages
BRILLEVE should not be taken with grapefruit juice. While taking
oral contraceptives, do not take St John's Wort (Hypericum perforatum) preparations.
Simultaneous use may lead to a loss of contraceptive efficacy
(see “Other medicines and BRILLEVE”).

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

Driving and operating machinery
No effects on the ability to drive and use machines have been observed.

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

3. How to take BRILLEVE

Take one BRILLEVE tablet every day, without chewing if necessary with a little
water. You can 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. If, for example, you start on Wednesday, take the
tablet next to the writing “WED”. Follow the direction of the arrow on the blister pack until
you have taken the 21st tablet.
Then do not take tablets for 7 days. During these 7 days without tablets (also called the
pill-free week) your period (withdrawal bleeding) should appear. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day
of the pill-free week.
On the eighth day after the last BRILLEVE tablet (i.e. after the 7 days of the pill-free week), start the next blister pack, even if your period has not yet finished.
This same day of the week will represent the starting day of each subsequent
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pack. In this way, you will always start the new pack on the same day of the
week and the withdrawal bleeding will occur around the same days of the
week each month.
Combined oral contraceptives, when taken correctly, have a failure rate of 1% per year. The failure rate increases when the pills
are forgotten or not taken correctly.
Take this medicine exactly as your doctor has instructed. If you have
any doubts, consult your doctor or pharmacist.

When you can start the first blister

• IfyouhavenotusedahormonalcontraceptiveinthepreviousmonthStart taking BRILLEVE on the first day of your cycle (i.e. the first day of your period). If you start taking BRILLEVE on the first day of your period, you will be immediately protected from pregnancy. You can also start taking it between the 2nd and 5th day of your cycle, but in this case you should use additional contraceptive measures (e.g. a condom) for the first 7 days of taking the tablets in the first cycle.
• Switching from another combined hormonal contraceptive or from a combined vaginal ringcontraceptiveorfromatransdermalpatchTake the first BRILLEVE tablet the day after you have taken the last active tablet of the previous product (i.e. without observing any interval). If the previous contraceptive pack also contains inactive tablets, you can take BRILLEVE the day after the last activetablet (in case of doubt, ask your doctor). Alternatively, you can also take the first BRILLEVE tablet later but no later than the day after the end of the pill-free interval (or the day after the last inactive tablet) of the previous contraceptive. When switching to BRILLEVE from a vaginal ring or a transdermal patch, it is preferable to start on the day of removal, but in any case within the day for which the next application would have been scheduled. If you follow these instructions, you do not need to use an additional contraceptive method.
• Switchingfromaprogestin-onlypill(mini-pill)You can stop taking the mini-pill at any time and start taking BRILLEVE the next day, at the same time. However, for the first seven days of taking the tablets, use an additional contraceptive method (barrier method) when you have sexual intercourse.
• Switching from an injectable contraceptive, an implant or an intrauterine device releasing progestin (IUS)Start using BRILLEVE on the day you are due for your next injection or the day the implant is removed. However, for the first seven days of taking BRILLEVE tablets, use an additional contraceptive method (barrier method) when you have sexual intercourse.

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• After a spontaneous or induced abortion.Follow your doctor's advice.
• After childbirth.The start of the pill after childbirth must be established by your doctor. He/she will determine whether to start treatment between the 21st and 28th day, or later. If you start more than 28 days later, you should use a so-called barrier method (e.g. a condom) for the first 7 days of taking BRILLEVE. If you have had sexual intercourse after childbirth before starting (or restarting) to use BRILLEVE, you must first make sure you are not pregnant, otherwise you must wait until your next period. If you are unsure, ask your doctor for advice on when to start. If you are breastfeeding and wish to take BRILLEVE, talk to your doctor first (see “Pregnancy and breastfeeding”).

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

If you forget to take BRILLEVE
If the delay is less than 12 hoursin taking a tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and then
take the next tablet as scheduled.
If the delay is 12 hours or morein taking a tablet, the
contraceptive protection may be reduced. The more tablets
you have forgotten, the greater the risk that contraceptive protection is reduced.
The risk of pregnancy is greater if you have forgotten a tablet at the beginning or end of the
blister.
Follow the instructions below (see the diagram below):

• More than one tablet forgotten in the blisterContact your doctor
• One tablet forgotten in the first weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Take the next tablets as scheduled and use additional contraceptive measures for the next 7 days, such as a condom. If you have had sexual intercourse in the week before forgetting or if you have forgotten to start a new blister after the pill-free period,

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there is a risk of pregnancy. In this case, contact your
doctor.

One tablet forgotten in the second week
Take the forgotten tablet as soon as you remember, even if this means
taking 2 tablets at the same time. Take the next tablets as
scheduled. Contraceptive protection is not reduced and you do not need to take additional contraceptive measures.

Onetabletforgotteninthethirdweek
You can choose one of the following alternatives, without the need for additional contraceptive precautions:

• 1. Take the forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Take the next tablets as scheduled. Start the new pack as soon as you have finished the current one, without an interval between the two packs. You will most likely not experience a period (withdrawal bleeding) until the end of the second blister, but you may have some spotting or breakthrough bleeding during the second blister. or
• 2. Stop taking the tablets from the pack you are using, observe an interval of 7 days or less (including the day you forgot to take thetablet)and continue with a new pack .If you choose this alternative, you can start the new pack on the same day of the week as usual.

If you have forgotten any of the tablets in a blister and you do not have a period
during the first pill-free period, this may mean that you are pregnant. You should contact your
doctor before starting the next blister.
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What to do in case of gastrointestinal disorders (e.g. vomiting and/or diarrhea)
If you vomit within 3-4 hours of taking a tablet or if you have severe diarrhea, there is a
risk that the active ingredients of the tablet are not completely absorbed by your
body. The situation is comparable to that which occurs in case of forgetting
a tablet. Therefore, follow the instructions in case of forgotten tablets.

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

Ask your doctor for advice before deciding to delay your period.
Changing the start day of your period: what you should know
If you take the tablets according to the instructions, your periods will start around
the same day of the week. If you need to change that day, you can shorten (never
lengthen!) the normal break between two consecutive packs. For example, if your periods
usually start on Friday and you want them to start on Tuesday (3 days earlier), you will have to
start the next pack 3 days earlier. If you make the break between cycles too short (e.g. 3 days or less), you may not experience a period
during that interval. In this case, you may have breakthrough bleeding or spotting during the
next treatment cycle.

Contact your doctor if you have any doubts about how to proceed.
In case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods in the first few months of taking them. Irregular bleeding usually disappears once the body gets used to the pill (usually after about 3 cycles of
taking it).

Consult your doctor if such bleeding persists, becomes heavy or recurs at
intervals.
If your period does not occur
If all the tablets have been taken correctly, you have not experienced vomiting and have not
taken any other medications, it is very unlikely that you have become pregnant.
Continue using the product as usual. If your period does not
occur for two consecutive times, it is possible that you have become pregnant. Consult
your doctor immediately. Do not start the new pack until your doctor has ruled out
pregnancy.

If you stop taking BRILLEVE
You can stop taking BRILLEVE at any time. If you do not want to become pregnant,
consult your doctor about other methods of contraception.
If you want to stop taking 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 being regular before attempting to conceive.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to BRILLEVE, tell your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE))
or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all
women taking combined hormonal contraceptives. For more detailed information on the
various risks associated with taking combined hormonal contraceptives, see paragraph
2 “What you need to know before using BRILLEVE”.

Serious side effects
Serious adverse reactions associated with the use of the pill, and related symptoms, are described in
the paragraph “When to be particularly careful with BRILLEVE”. For more
information, read these paragraphs and consult your doctor immediately.

Other side effects
The following side effects have been reported in women using the pill:

• tension, pain and secretions of the breast;
• headache, migraine (unilateral headache);
• changes in sexual desire, depressed mood;
• intolerance to contact lenses;
• nausea, vomiting and feeling unwell;
• changes in vaginal secretions;
• skin reactions (of the skin);
• fluid retention;
• changes in body weight;
• hypersensitivity reactions;
• oligomenorrhea (increase in the time interval between one menstruation and the next), amenorrhea (absence of menstruation);
• intermenstrual bleeding;
• urticaria (uncommon);
• harmful blood clots in a vein or artery, for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility of developing a blood clot may be higher if you have any other condition that increases this risk (see paragraph 2 for more
information on conditions that increase the risk of blood clots and the symptoms of a
blood clot).
In women with hereditary angioedema (rare inherited disease characterized by
the appearance of swelling (edema) of the skin, mucous membranes and internal organs) exogenous estrogens
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(hormone replacement therapy) may induce or worsen the symptoms
of angioedema.
side effects.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store 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 blisters and the packaging
after “EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep the blister in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRILLEVE contains

• The active ingredients are ethinylestradiol and gestodene. Each tablet contains: 20 micrograms of ethinylestradiol and 75 micrograms of gestodene
• The other ingredients are: Tablet core: Disodium edetate, magnesium stearate, povidone 25, corn 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 contents of the pack
BRILLEVE coated tablets are white, biconvex, round, and shiny.
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.
Not all pack sizes may be marketed.

Marketing Authorisation 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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BRILLEVE 30 micrograms / 75 micrograms coated tablets

Ethinylestradiol/gestodene
Generic medicine

Read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

• They are one of the most reliable reversible methods of contraception, if used correctly
• They slightly increase the risk of 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
• Pay attention and see your doctor if you think you have 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. Cos’è BRILLEVE e a cosa serve

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

2. Cosa deve sapere prima di prendere BRILLEVE

General information
Before starting to use BRILLEVE, read the information on blood clots in
section 2. It is particularly important that you read the symptoms of a blood clot
(see section 2 “Blood clots”).
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Before starting or restarting BRILLEVE, it is recommended to have a thorough
medical examination (including family history). It is also advisable to have periodic
check-ups, at least once a year, during use of the product. The frequency and type of
visit will be established by the doctor and will focus in particular on monitoring blood
pressure, breast examination, abdominal examination and general gynaecological
examination, including a Pap smear, and related 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 for the initial visit, as described above, should be carried
out.

BRILLEVE, like other hormonal contraceptives, does not protect against HIV (AIDS)
or other sexually transmitted diseases. A condom is necessary to protect yourself
from these diseases.
BRILLEVE is prescribed for personal use and should not be available to more
than one person at a time.

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. The 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 leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have an operation or if you will be bedridden for a long 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 that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following conditions, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• 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 or genital cancer;
• if you are (or suspect you are) pregnant;
• if you have vaginal bleeding of unknown origin;
• if you are taking Ritonavir; 22/40
• if you have eye diseases of vascular origin.

If any of these conditions occur for the first time during use of the
product, stop taking it 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 particularly careful with BRILLEVE
When should you contact a doctor?
Contact your doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in your leg (deep vein thrombosis), a blood clot in your 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, see the section
“How to recognize a blood clot”.
stop taking the product or during which the effectiveness of the product may be reduced.
In such situations, do not have sexual intercourse or use additional non-hormonal
contraceptive precautions such as condoms or another barrier method. Do not use the
rhythm method and basal body temperature, which may be unreliable, as the pill alters
the normal variations in temperature and cervical mucus that occur during the menstrual
cycle.

Precautions
In the presence of any of the conditions listed below, use of a combined pill may require
close monitoring by the doctor. Tell your doctor about the presence of any of the
conditions below before starting to use BRILLEVE. The doctor may advise you to use a
completely different method of contraception (non-hormonal).

Tell your doctor if any of the following applies to you.
If this condition occurs or worsens while you are using BRILLEVE, tell your
doctor.

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects the immune system);

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• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of cholesterol and triglycerides (fats) in your blood (also in close relatives);
• if you are going to have an operation or if you will be bedridden for a long period (see section 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking BRILLEVE;
• if you have inflammation of the veins in 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 problems or heart rhythm disorders;
• if you have breast lumps;
• if you suffer from liver or gallbladder disease;
• if you suffer from or have suffered from mood changes and depression;
• if you have a history of thrombosis, heart attack or stroke (also in close relatives);
• if you suffer from or have suffered from epilepsy (seizures) (see “Other medicines and BRILLEVE”);
• if you suffer from or have suffered from migraine (headache);
• if you have or have had:
• asthma,
• a family history of vascular disease,
• high blood pressure,
• heart, kidney or liver dysfunction,
• a disease that appeared for the first time during pregnancy or during previous use of sex hormones, for example hearing loss due to otosclerosis, porphyria (a blood disease), herpes gestationis (skin rashes during pregnancy), Sydenham's chorea (a nervous disease that causes sudden movements of the body);
• if you suffer from superficial phlebitis (venous inflammation);
• if you have varicose veins;
• if you have (or have had) chloasma (brown-gold pigmented patches, especially on the face, typical of pregnancy). In this case, avoid direct exposure to sunlight or ultraviolet rays;
• if you suffer from some pathological 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 the onset of venous or arterial thrombosis;
• if you suffer from hereditary angioedema (severe allergic reaction), medicines containing estrogens may induce or worsen your symptoms. You should seek immediate medical attention if symptoms of angioedema such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing or urticaria alone or with difficulty breathing appear.

If any of these conditions occur for the first time, recur, or worsen during use of the pill, consult your doctor.
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Do not take preparations based on Hypericum perforatum in conjunction with medicines
containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, phenytoin
due to the risk of a decrease in plasma levels and a decrease in the therapeutic efficacy of
oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital,
phenytoin (see section “Other medicines and BRILLEVE”).

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

BLOOD CLOTS
The use of a combined hormonal contraceptive like BRILLEVE increases the risk
of developing a blood clot compared to not using it. In rare cases, a blood clot
can block blood vessels and cause serious problems.
Blood clots can develop:

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, such effects may 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
Contact your doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to be suffering from?
Swelling in one leg or along a vein in the leg or
foot, especially if accompanied by:

• pain or sensitivity in the leg that may be Deep vein thrombosis

felt only when standing or walking;

• increased feeling of warmth in the affected leg;
• change in skin color of the leg, such as paleness, redness or bluishness.
• sudden shortness of breath or rapid breathing Pulmonary embolism
• sudden cough without a clear cause, possibly with blood;
• sharp chest pain that may worsen when you 25/40

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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 linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
first using a combined hormonal contraceptive. The risk may also be higher if you restart a combined hormonal contraceptive (the
same medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 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.

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

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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 some conditions increase it.
The risk is greater:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to have surgery or if you need to be bedridden for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking BRILLEVE a few weeks before surgery or during the time you are less mobile. 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);
• 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) can temporarily increase the risk of a
blood clot forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you are not sure.
The doctor may decide to stop you from taking BRILLEVE.
If any of the above conditions change while you are using BRILLEVE, for
example if a close relative develops a thrombosis for no known reason or if you gain
a lot of 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 cause a heart attack or stroke.
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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 can increase:

• as you get older (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like BRILLEVE it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use 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 about 50 years). In this case you may also be at high 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 (valve 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 serious, the
risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using BRILLEVE, for
example if you start smoking, if a close relative develops a thrombosis for no known
reason or if you gain a lot of weight, contact your doctor.

Tumors
Diagnoses of breast cancer are slightly more frequent in women who use the pill
compared to those of the same age who do not use it. The slight increase in the number of breast cancer diagnoses gradually disappears within 10 years of stopping
treatment. It is not known whether the difference is due to the pill.
This may be due to earlier diagnosis, as women are visited more
frequently, the biological effect of the pill or both factors. Breast cancer
diagnosed in women who take or have recently taken a combined oral
contraceptive tends to be clinically less advanced than that diagnosed in
women who do not use it.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. These can cause internal bleeding
leading to severe abdominal pain.
Contact your doctor if you experience unusual and severe abdominal pain.
Cervical cancer has been reported to be more frequent in women who
use the pill for a long time. This may not be due to the pill, but to sexual behavior and other factors called in turn in the genesis of tumors in general.
The aforementioned tumors can be life-threatening or fatal.

When should you see a doctor
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Seek urgent medical attention

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or 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”.

Periodic checks
While using the pill, your doctor will ask you to attend periodic check-up visits, usually every year.

Consult your doctor as soon as possible

• if you notice any change in your state of health, especially

pay particular attention with BRILLEVE”. Do not forget the references to
close family members);

• if you feel a lump in your breast;
• if you need to use other medicines (see also “Other medicines and BRILLEVE”);
• if you are immobilized or need to undergo surgery (consult your doctor at least four weeks before);
• if you have heavy and unusual vaginal bleeding;
• if you forgot to take the tablets in the first week of use and had sexual intercourse in the seven days before the missed dose;
• if you have not had a period for two consecutive cycles and suspect you are pregnant, do not start a new pack without your doctor's permission.

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

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

The situations and symptoms above are illustrated and explained in more detail in other

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 impaired liver function (liver)
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Do not take BRILLEVE if you have liver disease. See section “Do not use BRILLEVE” and
“Warnings and Precautions”.

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

Other medicines and BRILLEVE
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Some medicines can affect the levels of BRILLEVE in the blood and prevent
an effective action of the pill.
These include:

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

Hypericum perforatum-based preparations should not be administered
concurrently with oral contraceptives, as this may lead to a loss
of contraceptive efficacy. Undesirable pregnancies and resumption of
the menstrual cycle have been reported following the induction of enzymes responsible for the metabolism of
medicines by Hypericum perforatum-based preparations. The induction effect may persist for at least 2 weeks after discontinuation of
treatment with Hypericum perforatum-based products (see section “BRILLEVE with
food and drinks”).
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Always inform the doctor who prescribes the pill about the medicines you are already
taking, and also inform all other doctors or dentists who prescribe other medicines that
you are using BRILLEVE, so that they can establish whether and for how long it is
necessary to use additional contraceptive methods.
The use of the pill can affect the results of some blood tests, but such variations
generally fall within the normal range. Therefore, it is appropriate to inform the doctor who
requested 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 the blood test results of liver function (increased liver enzyme ALT). The doctor will prescribe you another type of contraceptive before starting treatment with these
medicines. Brilleve can be resumed about 2 weeks after the end of this
treatment. See section “Do not use BRILLEVE”.

BRILLEVE with food and beverages
BRILLEVE should not be taken with grapefruit juice. While taking
oral contraceptives, do not take preparations containing St. John's wort (Hypericum perforatum).
Concurrent use may lead to a loss of contraceptive efficacy
(see section “Other medicines and BRILLEVE”).

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

Driving and operating machinery
No effects on the ability to drive and use machines have been observed.

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

3. How to take BRILLEVE

Take one BRILLEVE tablet every day, swallowing it without chewing, if necessary with a little
water. You can 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. If, for example, you start on Wednesday, take the
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tablet next to the “WED” marking. 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 days without tablets (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 blister pack, even if your period has not yet finished.
This same day of the week will be the starting day for each subsequent
pack. This way you will always start the new pack on the same day of the
week and the withdrawal bleeding will occur around the same days
of the week each month.
Combined oral contraceptives, when taken correctly, have a failure rate of 1% per year. The failure rate increases when the pills
are forgotten or not taken correctly.
Take this medicine exactly as your doctor has told you. If you
have any doubts, ask your doctor or pharmacist.

When you can start the first blister
Start taking BRILLEVE on the first day of your cycle (i.e. the first day of your
period). If you start using BRILLEVE on the first day of your period you will
be immediately protected from pregnancy. You can also start taking it 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 taking the tablets in the
first cycle.

• Switching from another combined hormonal contraceptive, vaginalcontraceptivering,orcontraceptivepatchTake the first BRILLEVE tablet the day after you have taken the last active tablet of the previous product (i.e. without observing any interval). If the previous contraceptive pack also contains inactive tablets, you can take BRILLEVE the day after the last activetablet (if in doubt, ask your doctor). Alternatively, you can also take the first BRILLEVE tablet later, but no later than the day after the end of the pill-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 in any case within the day on which the next application would have been scheduled. If you follow these instructions, you do not need to use an additional contraceptive method.
• Switchingfromaprogestin-onlypill(mini-pill)You can stop taking the mini-pill on any day and start taking BRILLEVE the day

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after, at the same time. However, for the first seven days of taking the tablets
use an additional contraceptive method (barrier method) during sexual intercourse.

• Switching from an injectable contraceptive, implant, or intrauterine device releasing progestin (IUS)Start using BRILLEVE on the day you are due to have your next injection or the day the implant is removed. However, for the first seven days of taking BRILLEVE tablets, use an additional contraceptive method (barrier method) during sexual intercourse.
• After a spontaneous or induced abortion.Follow your doctor’s advice.
• After childbirth.The timing of starting the pill after childbirth must be decided by your doctor. They will decide whether to start treatment between the 21st and 28th day, or later. If you start more than 28 days after delivery, you should use a barrier method (e.g. a condom) for the first 7 days of taking BRILLEVE. If you have had sexual intercourse after childbirth before starting (or restarting) to use BRILLEVE, you must first make sure you are not pregnant, otherwise you should wait until your next period.

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

If you forget to take BRILLEVE

• If the delay is less than 12 hoursin taking a tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and then take the next tablet as scheduled.
• If the delay is 12 hours or morein taking a tablet, contraceptive protection may be reduced. The more tablets you have forgotten, the greater the risk that contraceptive protection is reduced.

The risk of pregnancy is greater if you have forgotten a tablet at the beginning or end
of the blister pack. Follow these instructions (see the diagram below):

• More than one tablet forgotten in the blisterContact your doctor
• One tablet forgotten in the first weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Take the subsequent tablets as

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scheduled and use additional contraceptive measures for the next 7 days, for example a
condom. If you have had sexual intercourse in the week before the
forgetfulness or if you have forgotten to start a new blister pack after the pill-free period, there is a risk of pregnancy. In this case, contact your doctor.

• One tablet forgotten in the second weekTake the forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Take the subsequent tablets as scheduled. Contraceptive protection is not reduced and you do not need to use additional contraceptive measures.
• OnetabletforgotteninthethirdweekYou can choose one of the following alternatives, without the need for additional contraceptive precautions:
• 1. Take the forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Take the subsequent tablets as scheduled. Start the new pack as soon as you have finished the current one, without an intervalbetween the two packs. You are likely not to experience menstruation (withdrawal bleeding) until the end of the second blister pack, but you may experience spotting or breakthrough bleeding during the second blister pack. or
• 2. Stop taking the tablets from the current pack, observe a 7-day interval (including the day you forgot to take the tablet)and continue with a new pack .If you choose this alternative, you can start the new pack on the same day of the week as usual

If you have forgotten any of the tablets in a blister pack and do not have a menstruation
during the first pill-free period, this may mean that you are pregnant. Contact your
doctor before starting the next blister pack.
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What to do in case of gastrointestinal disorders (e.g. vomiting and/or diarrhea)
If you vomit within 3-4 hours of taking a tablet or if you have severe diarrhea, there is a
risk that the active ingredients of the tablet are not completely absorbed by your
body. The situation is comparable to that which occurs in case of forgetting
a tablet. Therefore, follow the instructions in case of forgotten tablets.

Delayed menstruation: what you need to know
Although not recommended, it is possible to delay your period by continuing with a
new pack of BRILLEVE without observing the 7-day interval. During the use of this
second pack, you may experience breakthrough bleeding or spotting. Continue
the next pack after the usual 7-day interval.

Ask your doctor for advice before deciding to delay your period.
Changing the day of the start of your period: what you need to know
If you take the tablets according to the instructions, your periods will start around
the same day of the week. If you need to change that day, you can shorten (never
lengthen) the normal break between two consecutive packs. For example, if your periods
usually start on Friday and you want them to start on Tuesday (3 days earlier), you must
start the next pack 3 days earlier. If you make the break between cycles 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.

Contact your doctor if you have any doubts about how to proceed.
In case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods in the first few months of taking them. Irregular bleeding usually disappears once the body has adjusted to the pill (usually after about 3 cycles of
taking). Consult your doctor if this bleeding persists, becomes heavy or
recurs at intervals.
If your period does not occur
If you have taken all the tablets correctly, you have not experienced vomiting and have not
taken any other medications, it is very unlikely that you are pregnant. Continue
using the product as usual. If your period does not occur for
two consecutive times, you may be pregnant. Consult
your doctor immediately. Do not start the new pack until your doctor has ruled out
pregnancy.

If you stop taking BRILLEVE
You can stop using BRILLEVE at any time. If you do not want to become pregnant,
consult your doctor about other methods of contraception.
If you want 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 normal before trying to conceive.
If you have any questions about using this medicine, ask your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think might be due to
BRILLEVE, tell your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE))
or blood clots in the arteries (arterial thromboembolism (ATE)) is present 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 you use 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 careful with BRILLEVE”. For more
information, read these sections and consult your doctor immediately.

Other side effects
The following side effects have been reported in women using the pill:

• tension, pain and secretions of the breast;
• headache, migraine (unilateral headache);
• changes in sexual desire, depressed mood;
• intolerance to contact lenses;
• nausea, vomiting and feeling unwell;
• changes in vaginal secretions;
• skin (cutaneous) reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions;
• oligomenorrhea (increase in the time interval between one menstruation and the next), amenorrhea (absence of menstruation);
• breakthrough bleeding;
• urticaria (uncommon);
• 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 symptoms similar to those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility 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 the symptoms of a
blood clot).
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In women with hereditary angioedema (rare hereditary disease characterized by
the appearance of swelling (edema) of the skin, mucous membranes and internal organs), exogenous estrogens (hormone replacement therapy) may induce or worsen the symptoms
of angioedema.
side effects.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store 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 blisters and the packaging
after “EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Keep the blister in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BRILLEVE contains

• The active ingredients are ethinylestradiol and gestodene. Each tablet contains: 30 micrograms of ethinylestradiol and 75 micrograms of gestodene
• The other ingredients are: Tablet core: Disodium edetate, magnesium stearate, povidone 25, corn 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 contents of the pack
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.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA) - Italy

Manufacturer responsible for batch release
Salutas Pharma Gmbh
Otto-von-Guericke-Allee 1

• 39179 - Barleben Germany

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