BELARA 2 мг/0,03 мг Фильм-coated таблетки

Содержание инструкции

1. Belara 2 mg/0.03 mg film-coated tablets
   1. What is BELARA and what is it used for
   2. Cosa deve sapere prima di prendere Belara
   3. How to take Belara
   4. Possible side effects
   5. How to store Belara
   6. Contents of the pack and other information

Belara 2 mg/0.03 mg film-coated tablets

Clormadinone acetate, ethinylestradiol

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before you start taking 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.

Contents of this leaflet

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

1. What is BELARA and what is it used for

Belara is an oral hormonal contraceptive. These products containing two hormones,
such as Belara, are also called combined hormonal contraceptives (CHC). The 21 tablets in a
pack contain the same amount of the two hormones and therefore Belara is also called a “monophasic
pill”.
Other hormonal contraceptives like Belara do not protect you against AIDS (HIV infection) or other
sexually transmitted diseases. Only condoms can help protect you.

2. Cosa deve sapere prima di prendere Belara

Note generali
Before starting to use Belara, read the information on blood clots in paragraph 2. It is
particularly important that you read the symptoms of a blood clot (see paragraph 2
“Blood clots”).
Before taking Belara, your doctor will perform a general and gynecological examination, exclude a possible pregnancy and consider the contraindications and precautions and finally decide if Belara is suitable for you. This examination should be carried out every
year during the use of Belara.

Non prenda Belara
Do not take Belara 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 chlormadinone acetate or to any of the other ingredients of this medicine (listed in paragraph 6);
• if you have (or have ever had) a blood clot in a leg vessel (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you experience the first signs of a blood clot, inflammation of the veins or embolism, such as transient stabbing pain or chest tightness;
• 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 surgery or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you suffer from diabetes or if blood sugar levels fluctuate uncontrollably;
• if you have high blood pressure that is difficult to control or if it increases considerably (values higher than 90/140 mm Hg);
• 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, which may increase the risk of blood clots forming in the arteries: or severe diabetes with damage to blood vessels or very high blood pressure or very high levels of fats (cholesterol or triglycerides) in the blood or a disease known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer from liver inflammation (e.g. caused by a virus) or jaundice and liver function values have not yet returned to normal;
• if you suffer from widespread itching or biliary disorders, especially if these have occurred during a previous pregnancy or during a previous treatment with estrogens;
• if the bilirubin (a product of blood pigment degradation) in the blood is above normal values, for example due to congenital disorders of bile excretion, such as Dubin-Johnson syndrome or Rotor syndrome;
• If you have meningioma or have ever been diagnosed with meningioma (a generally benign tumor of the tissue layer between the brain and the skull).
• if you suffer from, or have suffered in the past, liver cancer;
• if you suffer from severe stomach pains, enlarged liver or show signs of abdominal bleeding;
• if porphyria (a disorder of blood pigment metabolism) occurs or you have had it in the past;
• if you have, or have had in the past or suspect a hormone-dependent malignant tumor, e.g. breast or uterine cancer;
• if you suffer from severe fat metabolism disorders;
• if pancreatitis occurs or you have suffered from it in the past and simultaneously suffer from a severe increase in blood fats (triglycerides);
• if you suffer from severe, frequent and prolonged headaches;
• if you have a sudden disturbance of perception (vision or hearing);
• if you experience a movement disorder (especially signs of paralysis);
• if your epilepsy attacks worsen;
• if you suffer from severe depression;
• if you suffer from a certain type of hearing loss (otosclerosis) that has worsened during previous pregnancies;
• if for unknown reasons you have not had menstruation;
• if you suffer from abnormal thickening of the uterine lining (endometrial hyperplasia);
• in case of vaginal bleeding of unknown origin.

Do not use Belara if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir (see also the section Other medicines and Belara).
If any of these conditions occur during the administration of BELARA, stop
immediately taking Belara.
You must not take Belara, or must stop it immediately if you have a serious risk or more
risk factors for blood clotting disorders.

Avvertenze e precauzioni
Talk to your doctor or pharmacist before taking Belara.
When should you see a doctor?
Seek urgent medical attention

• if you observe possible signs of a blood clot that may indicate that 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 the following paragraph "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, go to the paragraph “How

to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.

• If you are a smoker. Smoking increases the risk of serious side effects on the heart and blood vessels during the use of combined hormonal contraceptives. The risk increases with age and the number of cigarettes. This particularly applies to women over 35 years of age. Women who smoke over 35 years of age should use other methods of contraception.

If this condition occurs or worsens while you are using Belara, tell your doctor:

• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with potential breathing difficulties, contact your doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary or acquired angioedema.
• if you have high blood pressure, high levels of fats in the blood, if you are overweight or if you have diabetes (see also paragraph 2). In these cases, the risk of side effects (e.g. heart attack, embolism, stroke or liver tumors) is increased by the use of hormonal contraceptives.
• 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 are going to have surgery or if you will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after giving birth you can start taking Belara;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.

COAGULI SANGUIGNI
The use of a combined hormonal contraceptive like Belara 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 veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
§ in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or
TEA).
Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, these effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Belara
is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

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 blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of use of 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 Belara, 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 TEV and the type of combined hormonal contraceptive
you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with
Belara 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.
• It is not yet known how the risk of developing a blood clot with Belara compares to the risk associated with a combined hormonal contraceptive containing levonorgestrel.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of a blood clot forming”).

If you notice an increase in frequency or intensity of migraine attacks while taking
Belara (which may indicate a disturbance of blood flow to the brain) consult your doctor as
soon as possible. Your doctor may advise you to stop taking Belara immediately.

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Belara is low but some conditions cause
an increase. Your risk is greater:

• 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 plaster. It may be necessary to stop taking Belara a few weeks before surgery or during the period when you are less mobile. If you need to stop taking Belara, 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 (duration >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 doctor if any of these conditions apply to you, even if you are not sure. Your doctor may decide to stop you from taking Belara. If any of the above conditions change while you are using Belara, 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 Belara is
very low but can increase:

• as you get older (over 35 years);
• if you smoke.When using a combined hormonal contraceptive like Belara 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 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 migraines, especially migraines 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 severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Belara, 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.

CancerIt has been reported that, in women with cervical infection with particular sexually transmitted viruses (human papilloma virus) who use hormonal contraceptives for a long time, there may be a risk factor for developing cervical cancer. However, it is not clear how much this is due to other factors (e.g. differences in the number of sexual partners or the use of mechanical contraceptive methods).

Studies have shown that hormonal contraceptives can cause a modest increase in the
risk of breast cancer. During the 10 years following the cessation of COC use this
increased risk gradually returns to age-related risk levels. Because the risk of
breast cancer is rare in women under 40 years of age, the excess number of diagnoses of
breast cancer in women who have recently used or are using COCs is
small compared to the overall risk of breast cancer.
In rare cases, with the use of hormonal contraceptives, benign and even more rarely malignant
tumors of the liver have been found, which can cause internal bleeding. In the case of
severe stomach pain that does not resolve spontaneously, you should inform your doctor.
The use of chlormadinone acetate has been linked to the development of a generally
benign tumor of the tissue layer between the brain and the skull (meningioma). The risk increases
especially when it is used at high doses for a prolonged period (several years). If you are
diagnosed with a meningioma, your doctor will stop treatment with Belara (see
paragraph “Do not take Belara”). If you notice symptoms such as changes in vision (e.g. double or blurred vision), hearing loss or ringing in the ears, loss of smell, headache that
worsens over time, memory loss, seizures, weakness of the arms or
legs, inform your doctor immediately.

• Other disorders

Psychiatric disorders
Some women who use hormonal contraceptives including Belara have reported depression or
low 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.
Many women have a slight increase in blood pressure while taking
hormonal contraceptives. If the pressure increases a lot while you are using Belara, the doctor will
advise you to stop taking Belara and prescribe medicines to lower the pressure of
blood. When the pressure returns to normal, you can start taking Belara again.
If you have suffered from herpes during a previous pregnancy, this may recur with
the use of a hormonal contraceptive.
If you have an alteration of the values of fats in the blood (hypertriglyceridemia) or if your family suffers from it,
there is an increased risk of pancreatic disease. If you experience acute or
chronic disorders of liver function, your doctor may stop you from taking Belara until the
liver values return to normal. If you were to have a new episode of jaundice that
had already occurred during a previous pregnancy or with the use of other hormonal contraceptives
your doctor will advise you to stop using Belara.
If you are diabetic and blood sugar levels are under controland you are taking Belara, your doctor will
monitor you carefully throughout the time you take Belara. It may be necessary
to modify the antidiabetic treatment.
In rare cases, brown spots may appear on the skin (chloasma), especially if they have
already appeared during a previous pregnancy. If you are prone to these spots,
do not stay in the sun for long or expose yourself to ultraviolet rays while taking Belara.

• Disorders that may be negatively affected

Further medical supervision is also required:

• if you suffer from epilepsy;
• if you suffer from multiple sclerosis;
• if you suffer from severe muscle cramps (tetany);
• if you suffer from migraines (see also paragraph 2);
• if you suffer from asthma;
• if you suffer from heart or kidney problems (see also paragraph 2);
• if you suffer from St. Vitus' dance (minor chorea);
• if you are diabetic (see also paragraph 2);
• if you have a liver disease (see also paragraph 2);
• if you have disorders of fat metabolism (see also paragraph 2);
• if you suffer from an autoimmune disease (including lupus erythematosus);
• if you are significantly overweight;
• if you suffer from high blood pressure (see also paragraph 2);
• if you suffer from endometriosis (the tissue lining the uterine cavity, called the endometrium, is located outside this lining) (see also paragraph 2);
• if you have varicose veins or suffer from inflammation of the veins (see also paragraph 2);
• if you have blood clotting disorders (see also paragraph 2);
• if you suffer from breast disorders (mastopathy);
• if you have a benign tumor (fibroid) of the uterus;
• if you have suffered from blisters (gestational herpes) in a previous pregnancy;
• if you suffer from depression;
• if you suffer from inflammatory bowel disease (Crohn's disease, ulcerative colitis). Consult your doctor if you have, or have had in the past, any of the above disorders, or if one appears during treatment with Belara.

Effectiveness
If you have forgotten to take the tablets, have vomited or had diarrhea after taking the
tablet (see paragraph 3) or are taking other medicines (see paragraph 2), the effectiveness of
a hormonal contraceptive may be reduced. In very rare cases, metabolic disorders
can compromise the contraceptive effectiveness.
Even if you are taking the tablets correctly, a hormonal contraceptive cannot
guarantee complete birth control.

Irregular cycle
Particularly during the first few months of taking hormonal contraceptives, you may experience some
vaginal bleeding irregularities (breakthrough bleeding/spotting). If irregular bleeding continues for 3 months, or recurs in subsequent regular cycles, you should consult
your doctor.
Spotting can also be a symptom of a decrease in the contraceptive effect.
In some cases, after taking Belara for 21 days, withdrawal bleeding may be
absent. If you have taken the pills according to the instructions in paragraph 3, it is unlikely that
you are pregnant. If BELARA has not been taken as directed before the absence of
withdrawal bleeding, a pregnancy must be ruled out with certainty before
continuing use.

Children and adolescents
BELARA is only indicated after the first menstruation. The safety and efficacy of Belara in
adolescents under 16 years of age have not been established.

Elderly
BELARA is not indicated after menopause.

Other medicines and Belara
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not use Belara if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir or glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these medicines can cause increases in liver function test results (increased liver enzyme ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these
medicines.
Belara can be resumed about 2 weeks after completion of this treatment. See
paragraph “How to take Belara”.
Some medicines may have an influence on the levels of Belara in the blood and may make it

less effective in preventing pregnancy, or they may cause unexpected bleeding.
These include medications used for

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g. rifampicin, rifabutin),
• sleep disorders (modafinil),
• viruses causing HIV or hepatitis C infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• herbal preparations containing St John's Wort (Hypericum perforatum). If you wish to use herbal products containing St John's Wort while using Belara, you should consult your doctor first.

Medicines that stimulate intestinal peristalsis (e.g. metoclopramide) and activated charcoal
may reduce the absorption of the active ingredients of Belara and reduce its effects.
During treatment with these medicines, you should use a mechanical contraceptive method
(e.g. a condom). You should use a mechanical contraceptive method during the entire period
of concomitant pharmacological therapy and for 28 days after the end of treatment.
If the concomitant pharmacological therapy continues after the tablets of the
current COC pack have been finished, you should start the next pack immediately after the previous
one without the usual suspension interval.
If long-term treatment with the aforementioned active ingredients is necessary, you should use
non-hormonal contraceptive methods. Ask your doctor or pharmacist for advice.
Interactions between Belara and other medicines may increase or intensify the undesirable effects
of Belara. The following medicines may have adverse effects on the tolerability of Belara:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (which relieves pain and controls fever),
• atorvastatin (which reduces blood cholesterol),
• troleandomycin (an antibiotic),
• imidazole antifungals - e.g. fluconazole (for treating fungal infections),
• indinavir (a preparation for treating HIV infection).

Belara may influence the effect of other medicines. The efficacy or tolerability of the following
medicines may be reduced by Belara:

• some benzodiazepines, e.g. diazepam (for the treatment of sleep disorders),
• cyclosporine (a medicine that suppresses the immune system),
• theophylline (treatment of asthma symptoms),
• corticosteroids, e.g. prednisolone (known as steroids, anti-inflammatory medicines e.g. for lupus, arthritis, psoriasis),
• lamotrigine (for the treatment of epilepsy),
• clofibrate (which reduces high cholesterol levels),
• paracetamol (which relieves pain and controls fever),
• morphine (a potent specific analgesic - which relieves pain),
• lorazepam (used to treat anxiety disorders).

Read also the package leaflets of other prescribed preparations.
Inform your doctor if you are taking insulin or other medicines to lower blood glucose levels. The
dosage of these medicines may need to be adjusted.
Remember that this data also applies if you have taken one of these drugs shortly before
starting therapy with Belara.
The administration of Belara may alter some laboratory tests to check the
functionality of the liver, kidneys, adrenal glands and thyroid, some blood proteins, glucose metabolism and blood coagulation. The changes generally remain
within the normal laboratory range. Before having a blood test, inform your doctor
that you are taking Belara.

Pregnancy and breastfeeding
Belara is not indicated in pregnancy. If you become pregnant while taking Belara, you should stop the
therapy immediately. The use of Belara before a pregnancy does not justify an abortion.
If you are taking Belara while breastfeeding, remember that the amount of milk
may be reduced and be qualitatively altered. Small amounts of the active substances
pass into the milk. Hormonal contraceptives such as Belara should only be taken after
stopping breastfeeding.

Driving and operating machinery
No adverse effects of combined hormonal contraceptives on the ability to drive vehicles
or operate machinery are known.

Belara contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Belara

Take this medicine always exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.

Method of administration
Orally.

When and how should Belara be taken?
Take the first tablet choosing it from those marked with the corresponding day of the week
(e.g. Sun. for Sunday) and swallow it without chewing. Then take one
tablet every day following the direction of the arrow, if possible, at the same time of day,
preferably in the evening. If possible, the interval between two tablets should be 24 hours.
The indication of the days printed on the package will help you check that you have taken the
tablet on that specific day.
Take 1 tablet every day for 21 days. After that there will be a 7-day break.
Normally, 2-4 days after taking the last tablet, you will experience withdrawal bleeding
similar to menstruation. After a 7-day break, start taking the tablets
from the new pack of Belara without worrying if your period has not ended.

When can you start taking Belara?
If you were not taking hormonal contraception (during your last menstrual cycle)
Take the first tablet of Belara on the first day of your period. Contraception begins on
the first day of administration and continues even during the 7-day break.
If your period has already started, take the first tablet from the 2nd to the 5th day of
your period, even if the menstrual flow has not yet finished. In this case, however, you must
also use another method of contraception for the first 7 days (the 7-day rule).
If your period started more than 5 days ago, you must wait for your next period and then
start taking Belara.
If you were taking another combined hormonal contraceptive
Take all the tablets of the previous medicine as usual. You must start taking the
Belara tablet the day after the pill-free interval or the placebo tablets of your previous combined hormonal contraceptive.
If you were taking a progestin-only hormonal contraceptive (mini-pill)
If you are using a hormonal contraceptive that contains only progestin, you may not have a menstrual flow.
In this case, the first tablet of Belara must be taken the day after the last
“mini-pill”. However, you will also need to use another method of contraception for the first 7
days.
If you were using a hormonal injectable contraceptive or a contraceptive implant
Take the first tablet of Belara on the day the implant is removed or the day you
would have had your next injection. However, you will also need to use another method
of contraception for the first 7 days.
If you have had a curettage or an abortion in the first trimester of pregnancy
After a curettage or an abortion, you can start taking Belara immediately. In this
case, you do not need to use another method of contraception in addition.
After childbirth or after an abortion in the second trimester of pregnancy
If you are not breastfeeding, you can start taking Belara 21-28 days after delivery. You do not
need to use another method of contraception in addition.
If more than 28 days have passed since delivery, you will need to use another method of contraception
in addition for the first seven days.
If you have already had sexual intercourse, you should rule out pregnancy or wait for your
next period before starting to take Belara.
Remember that you cannot take Belara if you are breastfeeding (see section on pregnancy and
breastfeeding).

How long to take Belara?
You can take Belara for as long as you want, as long as taking it is not limited by risks
to your health (see section 2). After stopping Belara, your next
period may be delayed by about a week.

What to do if you vomit or have diarrhea while taking Belara?
If you experience vomiting or diarrhea within 4 hours of taking a tablet, it is possible
that the active substances contained in Belara are not completely absorbed. This situation
is similar to that of a forgotten tablet and therefore you should immediately take a new
tablet from a new pack. If possible, take the new tablet within 12 hours
of taking the last tablet and continue to take Belara at the usual time. If this is not
possible or more than 12 hours have passed, follow section 3 “If you forget to take Belara”
or contact your doctor.

If you take moreBelara than you should
There is no evidence of serious poisoning symptoms caused by ingesting many tablets in a single dose.
Nausea, vomiting and, in young girls, mild
bleeding may occur. In this case, consult a doctor who, if necessary, will check the electrolyte balance
and liver function.

Ifyou forget to take Belara
If you have forgotten to take a tablet at the usual time, you must take it, at the latest,
within the next 12 hours. In this case, you do not need to use additional contraceptive methods
and you can continue to take the other tablets as usual.
If the delay is more than 12 hours, the contraceptive effect of Belara is no longer guaranteed. In this
case, you must immediately take the forgotten tablet and continue to take Belara
as usual, even if this means taking two tablets in one day. However,
you will need to use another method of contraception (e.g. a condom) for
the next 7 days. If you finish the tablets contained in
the pack during these 7 days, immediately start using the tablets from the next pack of Belara,
without respecting the 7-day break (the 7-day rule). You will probably not experience the withdrawal
bleeding until the new pack is finished; however, you may experience an increase in breakthrough bleeding or spotting during the intake
of the tablets from the new pack.
The more tablets you have forgotten, the greater the risk that protection
from pregnancy is reduced. If you have forgotten one or more tablets in the first week and
have had intercourse in the week before the omission, you should consider the risk of
pregnancy. The same applies if you forget one or more tablets and if you do not have a bleed
during the break. In these cases, contact your doctor.

If you want to delay your period
Although not recommended, it is possible to delay your period (withdrawal bleeding) by going directly to a new pack of Belara instead of the break period, until the end of the second pack. During the use of the second pack
you may experience spotting (drops or stains of blood) or withdrawal bleeding. After the usual
7-day break, continue with the next pack. Before deciding to
delay your period, you should ask your doctor for advice.

If you want to move the first day of your period
If you take the tablets as instructed, your period/withdrawal bleeding
will start during the break. If you want to move this day, you can do so by shortening the
break period (but never lengthening it!). For example, if the break starts on
Friday, and you want to move it to Tuesday (3 days earlier) you must start a new pack 3
days earlier than usual. If you shorten the break period too much (e.g. to 3 days or
less) then you may not have any bleeding during this period of
break. Spotting (drops or stains of blood) or withdrawal bleeding may occur.
If you have any doubts about how to proceed, ask your doctor for advice.

If you stop taking Belara
When you stop taking Belara, your ovaries return to full activity quickly, and you may become
pregnant.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

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 Belara, inform your doctor.
Contact your 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 with potential
breathing difficulties (see also the section “Warnings and precautions”).
An increased 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 section 2 “What you need to
know before using Belara”.
The frequencies of reported side effects are defined as follows:

Very common:may affect more than 1 in 10 people
Nausea, vaginal discharge, menstrual pain, absence of menstruation.

Common: may affect up to 1 in 10 people
Depression, nervousness, irritability, dizziness, migraine (and/or worsening), visual disturbances,
vomiting, acne, feeling of heaviness, abdominal pain, fatigue, fluid retention,
weight gain, increased blood pressure.

Uncommon: may affect up to 1 in 100 people
Fungal infection of the vagina, benign changes in the connective tissue of the breasts, hypersensitivity to
the drug including allergic reaction, changes in blood fats including increased triglycerides,
decreased libido, stomach pain, intestinal rumbling, diarrhea, skin pigmentation problems,
brown spots on the face, hair loss, dry skin, tendency to sweat, back pain,
muscle problems, breast discharge.

Rare:may affect up to 1 in 1,000 people
Inflammation of the vagina, increased appetite, conjunctivitis, discomfort when wearing contact
lenses, hearing loss, tinnitus, high blood pressure, low blood pressure, circulatory collapse,
varicose veins, hives, eczema, inflamed skin, itching, worsening of
psoriasis, excessive hair growth on the body or face, breast enlargement, longer and/or
heavier periods, premenstrual syndrome (physical and emotional problems before the start of
menstruation).

• 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).

Very rare: may affect up to 1 in 10,000 people
Erythema nodosum.
In addition, the following adverse reactions associated with the
active ingredients, ethinylestradiol and chlormadinone acetate, have been reported post-marketing: weakness and allergic reactions including
swelling of the deeper layers of the skin (angioedema).
Combined hormonal contraceptives have also been associated with an increased risk of serious
diseases and side effects:

• risk of blockage of veins and arteries (see section 2)
• risk of bile duct disease (see section 2)
• risk of tumors (e.g. liver tumors, which in isolated cases have caused severe bleeding in the abdominal cavity, cervical and breast tumors; seesection 2)
• worsening of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see section 2). Read the information in section 2 carefully and, if necessary, consult your doctor immediately.

Reporting of side effects
If you get any side effects, even those 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 Belara

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the package and on the blister (therapy cycle) after EXP. The expiry date refers to the last day of that month.
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 Belara contains

• The active ingredients are ethinylestradiol and chlormadinone acetate. One film-coated tablet contains 0.030 mg of ethinylestradiol and 2.0 mg of chlormadinone acetate.
• The other ingredients are:

Tablet core: lactose monohydrate, corn starch, povidone K 30, magnesium stearate.
Coating: hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium
dioxide (E171), red iron oxide (E172).

Description of Belara and contents of the pack
Belara is available in packs of 21 round, slightly pinkish, film-coated tablets
for each blister (therapy cycle).
Packs: 1x21, 3x21, 6x21, 13x21 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
For any information regarding this medicinal product, contact the Marketing Authorisation
Holder.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Belara – Filmtabletten
Belgium Bellina 0.03 mg/2 mg – Filmomhulde tabletten
France Belara comprimés pelliculés
Germany Belara Filmtabletten
Italy Belara 2 mg/0.03 mg film-coated tablets
Luxembourg Bellina 0.03 mg/2 mg – Filmomhulde tabletten
Portugal Belara 2 mg + 0.03 mg comprimidos
Slovenia Belara 0.03 mg/2 mg filmsko obložene tablete
Spain Belara comprimidos recubiertos con película.