BRILADONA 0.180 MG/0.035 MG + 0.215 MG/0.035 MG + 0.250 MG/0.035 MG Фильмированная таблетка

Содержание инструкции

1. Briladona Trifase 0.180 mg/0.035 mg film-coated tablets, 0.215 mg/0.035 mg film-coated tablets, 0.250 mg/0.035 mg film-coated tablets
   1. Cos'è BRILADONA TRIFASE e a cosa serve
2. BRILADONA TRIFASE is contraindicated in girls who have not yet reached puberty –
3. BRILADONA TRIFASE must be stopped immediately and a doctor consulted. If
   1. How to take BRILADONA TRIFASE
4. BRILADONA TRIFASE is contraindicated in girls who have not yet reached puberty –
   1. Possible side effects
   2. How to store BRILADONA TRIFASE
   3. Contents of the pack and other information

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

norgestimate/ethinylestradiol
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not 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 may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

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

1. Cos'è BRILADONA TRIFASE e a cosa serve

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

2. Cosa deve sapere prima di prendereBRILADONA TRIFASE
General information

Before starting to use BRILADONA TRIFASEyou must 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”).

Before starting to use BRILADONA TRIFASE, your doctor will ask you some questions about your personal

medical history and that of your close relatives. The doctor will also measure your blood

pressure, and, depending on your personal situation, may also perform other tests.

This leaflet describes several situations in which you must stop using BRILADONA

TRIFASE, or where the reliability of BRILADONA TRIFASEmay be reduced. In such situations,

you should not have sexual intercourse or you should take additional non-hormonal contraceptive precautions, for example use a condom or another barrier method. Do not use methods

like the rhythm or basal temperature. These methods may be unreliable because

BRILADONA TRIFASEalters the monthly changes in body temperature and cervical mucus

cervical.

BRILADONA TRIFASE, like other hormonal contraceptives, does not protect against HIV (AIDS) and other sexually transmitted diseases.
Do not take BRILADONA TRIFASE
Do not use BRILADONA TRIFASE if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. The doctor will discuss with you which other methods of
birth control may be more suitable for your case.

• if you have (or have ever had) a blood clot in a vessel in your legs ( deep vein thrombosis, DVT), lungs ( pulmonary embolism, PE) or other organs;
• if you know you have a disorderthat affects blood coagulation, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you need to undergo surgery or if you will be bedriddenfor 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 diseases that may increase the risk of clots forming in the arteries: severe diabeteswith damage to blood vessels, very high blood pressure, very high levels of fats(cholesterol or triglycerides) in the blood, or a disease known as hyperhomocysteinemia;
• if you have (or have ever had) the type of migraine called “migraine with aura ";
• if you have heart valve disorders that have caused complications;
• if you have (or have ever had) a liver diseaseand liver function has not yet returned to normal;
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) or suspect you have breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you had jaundice during a pregnancy caused by the bile duct or if you have had jaundice previously during the use of the pill;
• if you have an abnormal thickening of the uterine lining;
• if you are allergicto norgestimate or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) pancreatitis (inflammation of the pancreas) associated with severe hypertriglyceridemia;
• if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir / pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section Other medicines and BRILADONA TRIFASE).
• if you are pregnant or think you might be pregnant
• if you are a girl who has not yet reached puberty.

Warnings and precautions
When you need to be particularly careful with BRILADONA TRIFASE
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 clots"). For a description of the symptoms of these serious side effects, see the section “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.
Talk to your doctor or midwife before taking BRILADONA TRIFASE.
If this condition appears or worsens while you are using BRILADONA TRIFASE , you should
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 body's defense 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 fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you need to undergo surgery 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 delivery you can start taking BRILADONA TRIFASE;
• if you have inflammation of the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins.
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema .
• if you have otosclerosis (hearing loss)
• if you have or have ever had chloasma (a discoloration of the skin especially on the face or neck known as "pregnancy spots"). If so, avoid direct sunlight or ultraviolet light.
• if you have a blistering rash during pregnancy (herpes gestationis) that appears for the first time during pregnancy
• if you have (or have ever had) gallstones or inflammation of the gallbladder
• if you have a blood disease called porphyria (increased secretion of pigment in the blood)
• if you suffer from epilepsy
• if you have a nervous system disease that causes sudden movements of the body (Sydenham's chorea)
• if a close relative of yours has or has ever had breast cancer
• if you have depression
• some women using hormonal contraceptives including BRILADONA TRIFASE 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, contact your doctor as soon as possible for further medical advice.
• if you have a liver disease.

Blood clots
The use of a combined hormonal contraceptive like BRILADONA TRIFASE causes an increased
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, 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
BRILADONA TRIFASEis 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 suffer 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 can only be felt when standing or walking
• increased feeling of warmth in the affected leg
• change in skin color of the leg, such as paleness, reddishness or bluishness
• shortness of breath or unexplained rapid breathing;
• sudden cough with possible blood production;
• sharp chest pain that may increase when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are not sure, inform your doctor as some of these
symptoms such as cough or shortness of breath may be
mistaken for a milder condition such as a respiratory infection
(e.g. a “common cold”).
Pulmonary embolism
Symptoms that occur more frequently in one eye: Retinal vein thrombosis
(blood clot
in the eye)

• sudden loss of vision or
• painless blurred vision that may progress to vision loss
• pain, discomfort, feeling of pressure or heaviness in the chest Heart attack

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 you
take a combined hormonal contraceptive for the first time. 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 BRILADONA TRIFASE the risk of developing a blood
clot returns to normal levels within a few weeks.

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

• Out of 10,000 women who are not using any combined hormonal contraceptiveand 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 or norethisterone or norgestimate like BRILADONA TRIFASE, about 5-7 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 developing a blood clot”).

Riskofdevelopinga
blood clot in a year
Women who are not usinga pill/patch/ring
hormonal combined and who are not pregnant
About 2 women out of 10,000
Women who use a combined hormonal contraceptive
pill containing levonorgestrel, norethisterone or
norgestimate
About 5-7 women out of 10,000
Women who use BRILADONA TRIFASE About 5-7 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 BRILADONA TRIFASE 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 the leg, lung or another organ at a young age (e.g. 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 plaster. You may need to stop taking BRILADONA TRIFASE a few weeks before surgery or during the period when you are less mobile. If you need to stop taking BRILADONA TRIFASE, 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 more than 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 inform your doctorif any of these conditions apply to you,
even if you are not sure. Your doctor may decide to stop you from taking BRILADONA
TRIFASE.
If any of the above conditions change while you are using BRILADONA TRIFASE, 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 BRILADONA
TRIFASE is very low but can increase:

• with increasing age(over 35 years);
• if you smoke.When using a combined hormonal contraceptive like BRILADONA TRIFASE it is advisable to stop smoking. If you cannot stop 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 relativehas had a heart attackor a strokeat 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 fatsin the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have any problems with your heart(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 above conditions change while you are using BRILADONA TRIFASE, 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.

BRILADONA TRIFASEand cancer
The risk of breast cancer increases with age. The risk of breast cancer increases slightly with
oral contraceptives. Compared to the risk of breast cancer at a given point in life, the increase in
risk associated with the use of oral contraceptives is low. The excess risk of breast cancer
gradually decreases over 10 years after stopping the use of oral contraceptives. The
breast cancers diagnosed in women who used oral contraceptives were not as advanced as
in non-users. It is important that you check your breasts regularly and must see your doctor
if you feel any lumps.
In rare cases, benign liver tumors have been reported, and in even rarer cases malignant tumors of the
liver, in women who use the pill. Contact your doctor if you have unusually severe abdominal pain.
Cervical cancer has been reported in long-term users, but it is not clear whether it is also affected
by sexual behavior or other factors.

Bleeding between periods
During the first few months of taking BRILADONA TRIFASE you may have unexpected bleeding
(bleeding outside the week without tablets). If this bleeding lasts
for more than a few months, or if it starts after a few months, your doctor will need to investigate the cause.

What to do if you do not have bleeding during the pill-free days
If you have taken all the tablets correctly, you have not had severe vomiting or diarrhea and you have not taken any other
medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive times, it is possible that you are pregnant. See
your doctor immediately. Do not start the next blister until you are sure you are not
pregnant.
Folate levels in the blood may be lower in women who use oral contraceptives. This
may be important for women who become pregnant soon after stopping the use of
oral contraceptives.

Children and adolescents

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

before the menarche.

Other medicines and BRILADONA TRIFASE
Tell your doctor if you are taking, have recently taken or might take any other
medicine. Also tell your doctor or dentist, who prescribes you other medicines (or the pharmacist),
that you are taking BRILADONA TRIFASE tablets. They can tell you if you need to
use additional contraceptive precautions (for example condoms) and if so, for how long,
or if you need to change the use of other medicines.
Some medicines and herbal products

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

These include:

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

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

• medicines containing ciclosporin (an immunosuppressant that prevents rejection of the transplant after transplantation)
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat pain and/or muscle cramps).

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

Laboratory tests
If you are going to have a blood test, tell your doctor or the people working in the laboratory that you are
taking the pill, because oral contraceptives can affect the results of some tests.

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

Pregnancy, breastfeeding and fertility
Pregnancy
You must not take BRILADONA TRIFASE if you are pregnant. If you become pregnant during the use of

BRILADONA TRIFASE must be stopped immediately and a doctor consulted. If

you wish to become pregnant, you can stop taking BRILADONA TRIFASE at any time.
Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
Taking BRILADONA TRIFASE is generally not recommended when a woman is
breast-feeding.
If you want to take the pill while breast-feeding, you should consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Fertility
BRILADONA TRIFASE is indicated for preventing pregnancy.

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

BRILADONA TRIFASEcontains lactose and sodium.
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking
BRILADONA TRIFASE.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.
In addition, the film-coated tablets blue and azure contain aluminium tartrazine lake (E102) and
aluminium sunset yellow FCF lake (E 110). These may cause allergic reactions.

3. How to take BRILADONA TRIFASE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage
Take one tablet regularly each day strictly at the same time (at the time you are least
likely to forget) for 21 consecutive days with a 7-day interval without
tablets between two blisters.
On the first day of using the blister, apply the label* of the corresponding day of the
week and take tablet number 1. In the following days, take the tablets
approximately at the same time in chronological order, up to day 21.
Then do not take tablets for 7 days. During this interval, withdrawal bleeding should occur, usually on the 2nd-3rd day after taking the last tablet.
Start the next blister on day 8, even if the withdrawal bleeding continues. You must always
start the next blister on the same day of the week.
* Labels are available under the flap of the box.

Elderly
The use of this product is not indicated in women after menopause.

Paediatric population

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

before menarche.

How to administer
Oral use.
Take one tablet daily regularly at strictly the same time (at the time that is least
likely to be forgotten) with or without food, if necessary with a small amount of water and
without chewing it, for 21 consecutive days with a 7-day interval between two blisters. The effect
contraceptive starts as soon as the first tablet is taken.
After taking the 21 tablets from the blister, you have a 7-day interval without a pill. If you took
the last tablet of the first blister on Friday, you must take the first tablet of the blister
next on Saturday of the following week. Two or three days after taking the last tablet
from the blister, a withdrawal bleed usually occurs, similar to menstruation. This withdrawal
bleeding may not have ended when the next pack of tablets begins.
You do not need to use any other contraceptive method during this 7-day interval,
provided you have taken the tablets correctly and have started the next pack at the
right time.
Then, start the next blister.
Start a new blister after a 7-day interval without pills.
If you use BRILADONA TRIFASE in this way, you will be protected from pregnancy even during the 7 days in
which you do not take any tablets.

When you can start with the first blister

• Start of oral contraception: If you have not used a hormonal contraceptive in theprevious monthStart taking BRILADONA TRIFASE on the first day of your cycle (i.e. the first day of your period). If you start taking BRILADONA TRIFASE on the first day of your period, contraceptive protection starts immediately. You can also start between the second and fifth day of your cycle, but in this case you must use additional protective measures (for example, a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive, or from a combined vaginalcontraceptive ring or a patchYou can start BRILADONA TRIFASE preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but at the latest the day after the end of the pill-free days of the previous pill (or the day after the last placebo tablet, the last tablet without active ingredient of the previous pill). When switching from a combined vaginal contraceptive ring or a patch, follow your doctor's advice.
• Switching from a progestin-only method (progestin-only pill, injection,implant or a progestin-releasing intrauterine device- IUD).You can switch any day from the progestin-only pill (from an implant or IUD on the day of its removal, from an injectable when the next injection would have been due) but in all these cases you must use additional protective measures (for example, a condom) for the first 7 days of taking the tablet.
• After an abortion, spontaneous or inducedFollow your doctor's advice.
• After having a baby

You can start BRILADONA TRIFASE between 21 and 28 days after childbirth. If you start taking
it later than day 28, use a barrier contraceptive method (for example, a condom)
during the first seven days of taking BRILADONA TRIFASE.
If, after having a baby, you have had sexual intercourse before starting to take
BRILADONA TRIFASE (or restarting it), make sure you are not pregnant or wait until the
next menstrual cycle.

• If you are breastfeeding and want to start taking BRILADONA TRIFASE(or restarting it) afterhaving a babyRead the paragraph relating to “Breast-feeding”.

Ask your doctor what to do if you are not sure when to start.

Duration of treatment
According to your doctor's opinion.

If you take more BRILADONA TRIFASEthan you should
There are no reports of serious adverse effects due to taking too many tablets of
BRILADONA TRIFASE. If you take several tablets at the same time, you may have some symptoms
such as nausea or vomiting. Young girls may have vaginal bleeding.
If you have taken too many tablets of BRILADONA TRIFASE or discover that a child has taken
some, contact your doctor or pharmacist, a hospital or a poison control center immediately,
especially if accidentally taken by a child, in order to assess the risks and inform you about
what to do.

If you forget to take BRILADONA TRIFASE
If you are less than 12 hourslate in taking a tablet, contraceptive protection
is not reduced. Take the forgotten tablet as soon as possible and then continue taking the
tablets at the usual time.
If you are more than 12 hourslate in taking a tablet, the contraceptive effect may be
reduced; the longer the time since the last intake, the greater the risk of
becoming pregnant.
The risk of incomplete protection from pregnancy is greater if you forget to take a
tablet at the beginning or end of the blister. Therefore, you must follow the following rules (see also the
diagram below):

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

Contact your doctor.

• If you have forgotten a tablet between days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets
at the same time. Continue taking the tablets at the usual time and use additional precautions
for the next 7 days, for example, a condom. If you have had intercourse in the week before
forgetting to take the tablet, you may be pregnant. In this case, contact your
doctor.

• If you have forgotten a tablet between days 8-14 (second row)

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

• If you have forgotten a tablet between days 15-21 (third row) You can choose between two options:
• 1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets
  at the same time. Continue taking the tablets at the usual time. Instead of starting the pill-free interval, start the next blister. You are more likely to have a menstrual period at the end of the second blister, but you may have some light bleeding or spotting during the taking of the tablets in the second blister.
• 2. You can also stop taking the tablets in the blister and start the 7-day pill-free interval immediately (note the day you forgot thetablet). If you want to start a new blister on the day you usually do, reduce the pill-free interval to less than 7 days.

If you follow one of these two recommendations, you will continue to have contraceptive protection.
If you have forgotten any of the tablets in a blister, and you do not have any bleeding during the
first pill-free interval, it is possible that you are pregnant. You should consult your doctor before
starting the next blister.

What to do in case of severe vomiting 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 present in the pill have not been completely absorbed by the body. The
situation is almost the same as when you forget a tablet. After vomiting or diarrhea, you must
take another tablet from a reserve blister as soon as possible. If possible, take it within 12
hours of the usual time you take the pill. If this is not possible or if 12 hours have passed, you must
follow the advice given in the paragraph "If you forget to take BRILADONA TRIFASE”.

How to delay your period: what you need to know
Although not recommended, you can postpone your period by moving directly to
a new blister of BRILADONA TRIFASE, without starting or ending the pill-free period.
While taking the tablets from the second pack, you may experience some light
bleeding or spotting.
Then, start taking the tablets from the next blister after the usual 7-day pill-free period.

You can ask your doctor for advice before deciding to delay your period.
How to change the first day of your period: what you need to know
If you take the tablets as instructed, your period will start during the pill-free week.
If you want to change this day, reduce the number of pill-free days (but
never increase it – 7 is the maximum!). For example, if the pill-free interval usually starts on
Friday, and you want to change this to Tuesday (3 days earlier), you must start a new blister 3
days earlier than usual. If you reduce the pill-free interval too much (for example, 3 days or less)
you may not have any bleeding during those days. You may then have some light bleeding or spotting.
If you are unsure how to proceed, consult your doctor.

If you stop taking BRILADONA TRIFASE
You can stop taking BRILADONA TRIFASE whenever you want.
If you do not want to become pregnant, ask your doctor for advice on other reliable contraceptive methods.
If you want to become pregnant, stop taking BRILADONA TRIFASE and wait for a
menstrual period before planning a pregnancy.

If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your
health that you think might be due to BRILADONA TRIFASE, inform 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 who take combined hormonal
contraceptives. For more detailed information on the different risks associated with taking combined
hormonal contraceptives, see paragraph 2 “What you need to know before you take BRILADONA TRIFASE”.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the
face, tongue and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties (see also
paragraph When you need to pay particular attention withBRILADONA

TRIFASE).
Below is a list of side effects that have been associated with the use of BRILADONA TRIFASE.

Very common(may affect more than 1 in 10 people)

• Headache(if severe, unusual or prolonged, consult a doctor as soon as possible)
• Stomach problemssuch as nausea, vomiting and diarrhea
• Bleeding and spottingbetween periodsfor the first few months (even if this usually stops when the body adjusts to BRILADONA TRIFASE - see paragraph 2). Bleeding between periods should not last long.
• Painful or unusual periods.

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

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

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

• Breast problems, such as breast enlargement; nipple discharge
• Abnormal cellsof the cervix (identified by a smear test)
• Feeling of anxietyor weakness;
• Feeling of tinglingor numbness
• Changes in skin color
• Skin problemssuch as rednessand itchingor discoloration,
• Thinning of hair(alopecia), excessive hair growth
• Changes in appetite, weight loss
• Change in sexual desire
• Dry eyes
• Changes in vision
• Palpitations(feeling of heartbeat)
• Hot flashes
• Muscle pain
• Vaginal and vulvar dryness
• Ovarian cysts(may cause abdominal pain and swelling, changes in periods)
• High blood pressure
• Shortness of breathor breathlessness (subjective feeling of respiratory discomfort)

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

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

Frequency not known:cannot be estimated from the available data

• Reduced amount of breast milk (if breastfeeding)
• Contact lensesmay be uncomfortable
• Red, swollen and painful lumpson the legs
• Changes in blood fat levels(seen from blood tests)
• Night sweats
• Hepatic adenomas (liver tumors generally induced by hormones)
• Breast cancer
• Benign breast tumors
• Focal nodular hyperplasia (benign tumor)
• Fibroadenoma of the breast
• Stroke
• Abnormal violent and involuntary contraction or series of muscle contractions (convulsions)
• Heart attack
• Angioedema (swelling in the deep layers of the skin)

The following serious adverse reactions have been reported slightly more frequently in women using
birth control pills (see paragraph 2: When you need to pay particular attention with

BRILADONA TRIFASE)

• increased blood pressure
• liver tumors or breast cancer
• liver function disorders
• harmful blood clots in a vein or in an artery, for example: in a leg or foot (DVT) or in a lung (PE) or heart attack or stroke or mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA) or 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).

The following conditions may occur or worsen with combined oral contraceptives: Crohn's disease,
ulcerative colitis, epilepsy, uterine fibroids, porphyria (a metabolic disorder that causes abdominal pain
and mental disorders), lupus erythematosus systemic (a condition in which the body attacks and
damages its own organs and tissues), herpes in advanced pregnancy, Sydenham's chorea (rapid involuntary
or jerky movements), hemolytic uremic syndrome (a condition that occurs after diarrhea caused by E. coli),
liver problems that present with jaundice, gallbladder problems or formation of gallstones.

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

5. How to store BRILADONA TRIFASE

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

• The active ingredients are norethindrone and ethinylestradiol. The white film-coated tablets contain 0.180 mg of norethindrone and 0.035 mg of ethinylestradiol. The light blue film-coated tablets contain 0.215 mg of norethindrone and 0.035 mg of ethinylestradiol. The blue film-coated tablets contain 0.250 mg of norethindrone and 0.035 mg of ethinylestradiol.
• The other ingredients are: White film-coated tablets: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol. Light blue film-coated tablets: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, indigotine carmine cochineal aluminum lake (E132), brilliant blue FCF aluminum lake (E133) and tartrazine aluminum lake (E102). Blue film-coated tablets: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol, indigotine carmine cochineal aluminum lake (E132), brilliant blue FCF aluminum lake (E133) and sunset yellow FCF aluminum lake (E110).

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

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

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

• 24008- Navatejera, León Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy Briladona Trifase
France TRINARA, film-coated tablet