Briladona

Package leaflet: Information for the user

Briladona 0.25mg/0.035 mg tablets

Norgestimate / Ethinylestradiol
Equivalent medicinal product

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

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What BrILADONA is and what it is used for

Briladona is a combined hormonal oral contraceptive (“the Pill”). You take it to prevent
pregnancy.
This contraceptive contains two types of female sex hormones, an oestrogen and a progestogen. These hormones
prevent the ovaries from releasing an egg each month, so you cannot become pregnant. In addition, Briladona thickens
the fluid (mucus) in the cervix, making it more difficult for sperm to enter the uterus.
Briladona must be taken as directed to prevent pregnancy.

2. What you should know before taking Briladona

General information
Before starting Briladona, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before you start using Briladona, your doctor will ask you questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes various situations in which you must stop using Briladona, or when the reliability of Briladona may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use methods such as rhythm or basal body temperature, as these may be unreliable because Briladona alters the monthly changes in body temperature and cervical mucus.
Briladona, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

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

• if you have (or have ever had) a blood clot in a vein of the leg (deep venous thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section “Blood clots”);
• if you have, or have ever had, a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have one of the following conditions that could increase the risk of forming clots in the arteries:
  o severe diabetes with blood vessel damage or very high blood pressure or very high levels of fats (cholesterol or triglycerides) in the blood or a condition known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have a heart valve disorder that has caused complications;
• if you have (or have ever had) a liver disease and liver function has not yet returned to normal;
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had), or are suspected of having, breast cancer or a tumour of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you developed jaundice during pregnancy due to bile duct obstruction or if you previously developed jaundice while taking the pill;
• if you have abnormal thickening of the uterine lining;
• if you are allergic to norgestimate or ethinylestradiol, or to any of the other 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 (see also section “Other medicines and Briladona”).

When you must be especially careful with Briladona
When should you contact a doctor?
Contact a doctor urgently

• if you notice any possible signs of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots”).

For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Briladona, you must inform your doctor.

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or if you will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Briladona;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have otosclerosis (hearing loss);
• if you have or have ever had chloasma (skin discoloration, particularly on the face or neck, also known as "pregnancy mask"). If so, avoid direct sunlight or ultraviolet light;
• if you have a blistering skin rash during pregnancy (herpes gestationis) that first appeared during pregnancy;
• if you have (or have ever had) gallstones or inflammation of the gallbladder;
• if you have a blood disorder called porphyria;
• if you have a nervous system disorder causing sudden involuntary movements (Sydenham's chorea);
• if a close relative has or has ever had breast cancer;
  • if you have depression. Some women using hormonal contraceptives, including Briladona, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.
  • if you have a liver disease.

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

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

| Condition | Do you have any of these signs? | Likely? | |---------|-------------------------------|--------| | Swelling in one leg or along a vein in the leg or foot, especially if accompanied by: | | | | * pain or tenderness in the leg, felt only when standing or walking | Deep vein thrombosis | | | * increased warmth in the affected leg | | | | * change in skin colour of the leg, such as paleness, redness, or bluish discoloration | | | | * unexplained shortness of breath or sudden rapid breathing; | | | | * sudden cough without an obvious cause, possibly with coughing up of blood; | Pulmonary embolism | | | * sharp chest pain that may worsen when breathing deeply; | | | | * severe dizziness or vertigo; | | | | * rapid or irregular heartbeat; | | | | * severe stomach pain; | | |

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

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

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Briladona, the risk of developing a blood clot returns to normal levels within a few weeks.

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

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate such as Briladona, about 5–7 will develop a blood clot in one year.
• The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

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

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (for example, under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Briladona several weeks before surgery or during periods of reduced mobility. If you need to stop taking Briladona, 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.
Long-haul flights (over 4 hours) may temporarily increase the risk of blood clot formation, particularly if you have any of the other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Briladona.
If any of the above conditions change while you are using Briladona, for example if a close relative develops thrombosis without a known cause or if you gain significant weight, contact your doctor.

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

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

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Briladona, it is advisable to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if 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—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Briladona and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it is possible that more cancers are detected in women taking combined pills because they undergo medical check-ups more frequently.
The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important that you regularly examine your breasts and consult your doctor if you feel any lumps.
In rare cases, benign liver tumors, and even more rarely malignant liver tumors, have been reported in women using the pill. Contact your doctor if you experience unusually severe abdominal pain.

Intermenstrual bleeding
During the first few months of taking Briladona, you may experience unexpected bleeding (bleeding occurring outside the tablet-free week). If this bleeding lasts for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if withdrawal bleeding does not occur
If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Consult your doctor immediately. Do not start the next blister pack until you are certain you are not pregnant.

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

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

These include:

• medicines used to treat epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (for example, rifampicin), HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), fungal infections (e.g., griseofulvin), arthritis, osteoarthritis (etoricoxib), or medicines used to treat pulmonary arterial hypertension (bosentan); or the herbal remedy St. John’s wort.

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

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or cramps).

Do not use Briladona if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in blood test results indicating liver function abnormalities (elevated ALT transaminases).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Briladona may be restarted approximately 2 weeks after completing this treatment. See the section “Do not use Briladona”.

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

Briladona with food and drink
Briladona 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 if you are pregnant. If you become pregnant while using Briladona, you must stop taking it immediately and consult your doctor. If you wish to become pregnant, you may stop taking Briladona at any time.
Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
The use of Briladona is generally not recommended while breastfeeding. If you wish to take the pill while breastfeeding, you should consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No effects of Briladona on the ability to drive or use machines are known.

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

3. How to take Briladona

How to take it
Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Blister pack preparation
To help you keep track, each Briladona blister pack comes with 7 stickers, each showing the days of the week.
Choose the weekly sticker starting with the day you begin taking the tablets. For example, if you start on a Wednesday, use the sticker starting with "WED".
Attach the sticker to the top left corner of the pack, in the "Start" position. This will place a day of the week above each tablet, allowing you to see whether you have taken your pill. The arrows indicate the order in which you should take the tablets.

Take one tablet daily for 21 consecutive days. The tablets may be taken with or without food, and if necessary, with a small amount of water. Start a new blister pack after a 7-day tablet-free interval. During this interval, withdrawal bleeding (a menstrual period) usually occurs.

This withdrawal bleeding, which resembles a menstrual period, typically begins 2 to 3 days after taking the last tablet and may not have finished before starting the next blister pack.

If you take Briladona as instructed, you will be protected against pregnancy during the 7 tablet-free days as well.

When to start the first blister pack

• If you have not used a hormonal contraceptive in the previous month: Start taking Briladona on the first day of your cycle (i.e., the first day of your menstrual period). If you start Briladona on the first day of your period, contraceptive protection begins immediately. You may also start between day 2 and day 5 of your cycle, but in this case, you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive, vaginal ring, or patch: Start Briladona preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the end of the tablet-free interval of your previous pill (or the day after the last placebo tablet, i.e., the last inactive tablet of your previous pill). When switching from a combined hormonal contraceptive, vaginal ring, or patch, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen – IUD): You may switch on any day from the progestogen-only pill (from an implant or IUD on the day of removal, from an injectable when the next injection would have been due), but in all these cases, you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of tablet intake.
• After a spontaneous or induced abortion: Follow your doctor’s advice.
• After childbirth: You may start Briladona between 21 and 28 days after delivery. If you start later than day 28, use a barrier contraceptive method (e.g., a condom) during the first 7 days of taking Briladona. If you have had sexual intercourse after childbirth before starting (or restarting) Briladona, ensure you are not pregnant or wait until your next menstrual period.
• If you are breastfeeding and wish to start (or restart) taking Briladona after childbirth: Read the section on “Breast-feeding”.

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

If you take more Briladona than you should
There are no reports of serious harmful effects from taking too many Briladona tablets. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may have vaginal bleeding.
If you have taken too many Briladona tablets or discover that a child has taken some, consult your doctor or pharmacist.

If you forget to take Briladona

• If you are less than 12 hours late in taking a tablet, contraceptive protection is not reduced. Take the missed tablet as soon as possible and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, contraceptive effectiveness may be reduced. The greater the number of tablets you have missed, the higher the risk of pregnancy.

The risk of inadequate protection against pregnancy is higher if you miss a tablet at the beginning or end of the pack. Therefore, follow the rules below (see also the flowchart later):

• If you have missed more than one tablet in this pack: Contact your doctor.
• If you missed a tablet between days 1–7 (first row): Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions for the next 7 days, for example, a condom. If you had sexual intercourse in the week before missing the tablet, be aware that there is a risk of pregnancy. In this case, contact your doctor.
• If you missed a tablet between days 8–14 (second row): Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Contraceptive effectiveness is not reduced, and you do not need additional precautions.
• If you missed a tablet between days 15–21 (third row): You have two options:
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of starting the tablet-free interval, start the next blister pack immediately. You will most likely have a menstrual period at the end of the second pack, but you may experience light bleeding or breakthrough bleeding during the second pack.
  2. You may also stop taking tablets in the current pack and immediately start the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, shorten the tablet-free interval to less than 7 days.

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

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

More than 1 tablet
missed in 1 pack Ask your doctor
Yes
Did you have sexual intercourse in the week
before missing the tablet?
No
Take the missed tablet
Use a barrier method (condom) for the next 7
days, and finish the pack
Only 1 tablet
missed
Take the missed tablet
Finish the pack
(taken more than 12 hours late)
Take the missed tablet and
Finish the pack
Instead of the 7-day break
Start the next pack
or
Immediately stop the current pack
Start the 7-day break (not exceeding 7
days, including the missed tablet)
Then start the next pack

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

How to delay your menstrual period: what you need to know
Although not recommended, you can delay your menstrual period by moving directly to a new Briladona blister pack and completing it, instead of having the tablet-free interval. You may experience light bleeding or breakthrough bleeding while taking the tablets in this second pack. After the usual 7-day tablet-free interval, start the next blister pack.
You may consult your doctor before deciding to delay your menstrual period.

How to change the first day of your menstrual period: what you need to know
If you take the tablets as instructed, your menstrual period will begin during the tablet-free week. If you wish to change this day, reduce the number of tablet-free days (but never extend it – 7 days is the maximum!). For example, if your tablet-free interval usually starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If you shorten the tablet-free interval significantly (e.g., 3 days or fewer), you may not have any bleeding during these days. You may then experience light or breakthrough bleeding later.
If you are unsure how to proceed, consult your doctor.

If you stop taking Briladona
You may stop taking Briladona at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods. If you wish to become pregnant, stop taking Briladona and wait for a menstrual period before planning a pregnancy. This will make it easier to calculate the expected date of delivery.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Briladona, inform your doctor.

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Briladona”.

Below is a list of side effects that have been associated with the use of Briladona.

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

• Headache (if severe, unusual or prolonged, consult a doctor as soon as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and spotting between periods during the first few months (although this usually stops as the body adjusts to Briladona, see section 4.3). Bleeding between periods should not last long
• Painful or unusual menstrual cycles

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

• Urinary tract infections (pain when urinating)
• Vaginal infections such as thrush
• Depression, mood changes; feeling nervous
• Migraine (see a doctor as soon as possible if this is your first migraine or if it is worse than usual)
• Acne, rash
• Breast pain
• Chest pain
• Muscle spasms; pain in the legs, arms and back
• Absence of menstrual periods
• Weight gain
• Feeling of weakness
• Stomach ache and bloating; constipation, flatulence
• Swollen hands, ankles or feet
• Difficulty sleeping (insomnia)
• Hypersensitivity (anaphylactic reaction)

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

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

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

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

Frequency not known:

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

The following serious adverse reactions have been reported slightly more frequently in women using contraceptive pills (see section 2: What you need to know before taking Briladona?):

• increased blood pressure
• liver tumours or breast carcinoma
• disturbances in liver function
• harmful blood clots in a vein or 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 stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

The following conditions may occur or worsen with combined oral contraceptives: Crohn’s disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham’s chorea (rapid involuntary movements or jerky movements), haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli), liver problems associated with jaundice, gallbladder disorders or formation of gallstones.

In women with hereditary angioedema (sudden onset of swelling of the skin, mucous membranes, internal organs or brain), the oestrogens present in contraceptive pills may induce or worsen angioedema symptoms.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Briladona

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Keep the blister pack in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Briladona contains
The active substances are 250 micrograms of norgestimate and 35 micrograms of ethinylestradiol.
Briladona also contains the following excipients: maize starch, lactose, magnesium stearate and indigo carmine (E132).

Description of Briladona and contents of the pack
Each film-coated tablet is blue, round and biconvex, with a diameter of 6 (5.9–6.1) mm and a thickness of 2.5 (1.5–3.5) mm.
Briladona is available in blisters containing 21 tablets.
Pack sizes are 1 or 3 blisters, each blister containing 21 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Exeltis Healthcare S.L.
Av. Miralcampo 7 - Poligono Ind. Miralcampo
19200 Azuqueca de Henares – Guadalajara
Spain

Manufacturer
CYNDEA PHARMA S.L.
Poligono Industrial Emiliano Revilla
Sanz. Avenida de Agreda, Olvega
42110 Soria, Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:
Spain: Liberelle 0.25 mg/0.035 mg tablets EFG
France: Liberelle 0.035 mg/0.25 mg, comprimé
Poland: Liberelle
Denmark: Liberelle
Netherlands: Liberelle 0.25 mg/0.035 mg tabletten
Italy: Briladona