Active ingredients: Ethinylestradiol, Chlormadinone acetate
BELARA 0.03 mg / 2 mg film-coated tablets
Why is Belara used? What is it for?
Important things to know about combined hormonal contraceptives (COCs):
- They are one of the most reliable reversible methods of contraception when used correctly
- They slightly increase the risk of having blood clots in the veins and arteries, especially during the first year of taking or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
- Take care and see your doctor if you think you have symptoms of a blood clot (see section "Blood clots")
BELARA is an oral hormonal contraceptive. These products that contain two hormones, such as BELARA, are also called combined hormonal contraceptives (COCs). The 21 tablets of a blister pack contain the same amount of the two hormones and therefore BELARA is also called the "monophasic pill".
Other hormonal contraceptives such as BELARA do not protect you from AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can help protect you.
Contraindications When Belara should not be used
General notes
Before you start using BELARA you should read the information on blood clots in section 2. It is especially important that you read the symptoms of a blood clot (see section "Blood clots").
Before taking BELARA, your doctor will undergo a thorough general and gynecological examination, rule out pregnancy, consider contraindications and precautions, and finally decide if BELARA is suitable for you. This visit must be made every year while taking BELARA.
Do not take BELARA
Do not take BELARA if you have any of the conditions listed below. If you have any of the conditions listed below, please contact your doctor. Your doctor will discuss with you other birth control methods that may be more suitable for you.
- if you are allergic to ethinyl estradiol or chlormadinone acetate or any of the other ingredients of this medicine
- if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE) or other organs;
- if you feel the first signs of a blood clot, inflammation of the veins or embolism, such as transient stabbing pain or tightness in the chest;
- 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 due to have an "operation or if you are going to lie down for a long time (see section" Blood clots ");
- if you have diabetes or if your blood sugar levels are uncontrollable;
- if you have high blood pressure that is difficult to control or increases significantly (values above 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 transient ischemic attack (TIA - temporary stroke symptoms);
- if you have any of the following diseases, which could increase the risk of blood clots in the arteries:
- severe diabetes with blood vessel injury
- very high blood pressure
- very high level of fat (cholesterol or triglycerides) in the blood
- a disease known as hyperhomocysteinemia
- if you have (or have ever had) a type of migraine called 'migraine with aura';
- if you have liver inflammation (e.g. caused by a virus) or jaundice and your liver function values have not yet returned to normal;
- if you suffer from widespread itching or biliary disorders, particularly if these occurred during a previous pregnancy or during previous estrogen treatment;
- if the bilirubin (a product of the breakdown of blood pigmentation) in the blood is above normal values, for example due to congenital disorders of biliary excretion, such as Dubin-Johnson Syndrome or Rotor Syndrome;
- if you have, or have had in the past, liver cancer;
- if you suffer from severe stomach pain, enlarged liver or have signs of abdominal bleeding;
- if you develop or have new episodes of porphyria (blood pigment metabolism disorder);
- if you have, or have had in the past or suspected a hormone-dependent malignancy, eg. breast or uterus cancer;
- if you suffer from severe fat metabolism disorders;
- if you have inflammation of the pancreas or have suffered from it in the past and at the same time suffer from a severe increase in blood fats (triglycerides);
- if you suffer from a severe, frequent and long-lasting headache;
- if you have a sudden disturbance of perception (sight or hearing);
- if you experience a movement disorder (especially signs of paralysis);
- if you notice a worsening of your epilepsy attacks;
- if you suffer from severe depression;
- if you suffer from some type of deafness (otosclerosis) which has worsened during previous pregnancies;
- if for unknown reasons you have not had your period;
- if you suffer from abnormal thickening of the lining of the womb (hyperplasia of the endometrium);
- in case of vaginal bleeding of unknown origin.
If any of these conditions occur while taking BELARA, stop taking BELARA immediately.
You must not take BELARA, or you must stop it immediately if you have a serious risk or multiple risk factors for blood clotting disorders (see section 2).
Precautions for use What you need to know before taking Belara
Talk to your doctor or pharmacist before taking Belara.
When should you see a doctor?
Contact a doctor urgently
- if you notice possible signs of a blood clot which may indicate that you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see section below " Blood clot (thrombosis) ").
For a description of the symptoms of these serious side effects go to the section "How to recognize a blood clot".
Tell your doctor if any of the following apply to you.
- If you are a smoker. Smoking increases the risk of serious side effects on the heart and blood vessels when using combined hormonal contraceptives. The risk increases with age and with the number of cigarettes. This particularly applies to women over the age of 35. Smoking women over the age of 35 should use other methods of contraception.
If this condition appears or worsens while you are using BELARA you should tell your doctor:
- If you have high blood pressure, high levels of fat in the blood, if you are excess weight or if you are diabetic. In these cases the risk of side effects (eg heart attack, embolism, stroke or liver cancer) 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 affecting the natural defense system);
- if you have haemolytic uremic syndrome (HUS - a blood clotting disorder causing kidney failure);
- if you have sickle cell anemia (an inherited disease of the red blood cells);
- if you have high levels of fat in the blood (hypertriglyceridaemia) or a "positive family history of this condition." Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
- if you are due to have an "operation or if you are going to lie down for a long time (see section" Blood clots ");
- if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how soon after having a baby you can start taking BELARA;
- if you have "inflammation of the veins under the skin (superficial thrombophlebitis);
- if you have varicose veins.
BLOOD CLOTS
Using a combined hormonal contraceptive such as BELARA increases your risk of developing a blood clot compared with not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
- in veins (called "venous thrombosis", "venous thromboembolism" or VTE)
- in the arteries (referred to as 'arterial thrombosis', 'arterial thromboembolism' or ATE).
Recovery from blood clots is not always complete. Rarely, long-lasting severe effects can occur or, very rarely, they can 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
See a doctor immediately if you notice any of the following signs or symptoms.
- swelling of one leg or along a vein in the leg or foot, especially when accompanied by:
- pain or tenderness in the leg which may only be felt when standing or walking
- increased sensation of heat in the affected leg
- change in color of the skin on the leg, such as turning pale, red or blue
- sudden and unexplained shortness of breath or rapid breathing;
- sudden cough with no obvious cause, possibly causing blood to be emitted;
- sharp chest pain which may increase with deep breathing;
- severe light headedness or dizziness;
- rapid or irregular heartbeat;
- severe pain in the stomach
- immediate loss of vision or
- painless blurring of vision which can progress to loss of vision
- chest pain, discomfort, feeling of pressure or heaviness
- sensation of squeezing or fullness in the chest, arm or below the breastbone;
- feeling of fullness, indigestion or choking;
- upper body discomfort radiating to the back, jaw, throat, arms and stomach;
- sweating, nausea, vomiting or dizziness;
- extreme weakness, anxiety, or shortness of breath;
- rapid or irregular heartbeats
- sudden numbness or weakness of the face, arm or leg, especially on one side of the body;
- sudden confusion, difficulty speaking or understanding;
- sudden difficulty seeing in one or both eyes;
- sudden difficulty walking, dizziness, loss of balance or coordination;
- sudden, severe or prolonged migraine with no known cause;
- loss of consciousness or fainting with or without seizures.
- swelling and pale blue discoloration of one extremity;
- severe stomach pain (acute abdomen)
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 forming 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 a deep vein thrombosis (DVT).
- If a blood clot travels from the leg and lodges in the lung, it can cause a "pulmonary embolism."
- Very rarely, a clot can form in another organ such as the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may be even higher if you restart taking a combined hormonal contraceptive (the same drug or a different drug) after a break of 4 or more weeks.
After the first year, the risk is reduced but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking BELARA, your risk of developing a blood clot returns to normal 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 BELARA is low.
- Out of 10,000 women who are not using 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 are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone 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 [invented name] compares with the risk associated with a combined hormonal contraceptive containing levonorgestrel.
- The risk of a blood clot forming depends on your medical history (see under "Factors that increase the risk of a blood clot forming").
If you notice an increase in the frequency or intensity of migraine attacks while taking BELARA (which may indicate a disturbance in the blood supply to the brain), consult your doctor as soon as possible. Your doctor may advise you to stop 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 it to increase. Its risk is greater:
- if you are severely overweight (body mass index or BMI above 30 kg / m2);
- if a member of your immediate family has had a blood clot in the leg, lung or other organ at a young age (less than about 50 years). In this case you could have an inherited blood clotting disorder;
- if you are going to have an operation or if you have to lie down for a long time because of an injury or illness or if you have a leg in a cast. You may need to stop taking BELARA a few weeks before the surgery or during the period in which you are less mobile. If you have to stop taking BELARA ask your doctor when you can start taking it again;
- as you get older (especially over the age of 35);
- if you gave birth less than a few weeks ago
The risk of developing a blood clot increases the more conditions you have of this type.
Air travel (lasting> 4 hours) may temporarily increase the risk of a blood clot, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these apply to you, even if you are not sure. Your doctor may decide that BELARA needs to be stopped.
If any of the above conditions change while you are using BELARA, for example if a close relative has 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:
- with increasing age (over 35 years);
- if you smoke. When using a combined hormonal contraceptive such as BELARA you are advised to stop smoking. If you are unable to stop smoking and are over the age of 35, your doctor may advise you to use a different type of contraceptive;
- if you are overweight;
- if you have high blood pressure;
- if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at high risk of having a heart attack or stroke;
- if you or a close relative have a high level of fat in the blood (cholesterol or triglycerides);
- if you suffer from migraines, especially migraines with aura;
- if you have any heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
- if you have diabetes.
If you have more than one of these conditions or if any of them are 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 has a thrombosis for no known reason or if you gain a lot of weight, contact your doctor.
- Tumor
It has been reported that in women with cervical infection from 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 (eg differences in the number of sexual partners or the use of mechanical means of contraception).
Studies have shown that hormonal contraceptives can cause a modest increase in the risk of breast cancer. During the 10 years following 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 the age of 40, the excess number of breast cancer diagnoses in women who have recently used or are using COCs is small compared to the overall risk of breast cancer. In rare cases, benign, and even more rarely malignant, tumors of the liver have been found with the use of hormonal contraceptives, which can cause internal bleeding. In the case of intense stomach pain that does not resolve spontaneously, the doctor should be informed.
- Other ailments
Many women experience a slight increase in blood pressure while taking hormonal contraceptives. If your blood pressure rises a lot while you are using BELARA, your doctor will advise you to stop taking BELARA and prescribe medicines to lower your blood pressure. When your blood pressure has returned to normal, you can start taking BELARA again.
If you have suffered from herpes in a previous pregnancy, this may recur when taking a hormonal contraceptive.
If you have an abnormal blood fat level (hypertriglyceridaemia) or if your family members suffer from it, there is an increased risk of pancreatic disease. If you experience acute or chronic liver function disorders, your doctor may have you stop taking it. taking BELARA until liver values have returned to normal. If you 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 your blood sugar level is under control and you are taking BELARA, your doctor will monitor you closely for as long as you are taking BELARA. The antidiabetic treatment may need to be changed.
In rare cases, brown spots may appear on the skin (chloasma), especially if they have already appeared during a previous pregnancy. If you have a tendency to have these spots, do not stay in the sun for a long time or expose yourself to ultraviolet rays while taking BELARA.
- Disorders that can be negatively affected
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
- if you suffer from asthma;
- if you suffer from heart or kidney problems
- if you suffer from St. Vitus's dance (minor chorea);
- if you are diabetic
- if you have liver disease
- if you have fat metabolism disorders
- if you have an immune system disease (including lupus erythematosus)
- if you are significantly overweight;
- if you have high blood pressure
- if you have endometriosis (the tissue that lines the cavity of the uterus, called the endometrium, is outside this lining)
- if you have varicose veins or suffer from inflammation of the veins
- if you have blood clotting disorders
- if you suffer from breast problems (mastopathy);
- if you have a benign tumor (myoma) of the uterus;
- if you have suffered from blisters (gestational herpes) in a previous pregnancy;
- if you suffer from depression
- if you suffer from chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).
Consult your doctor if you have, or have had in the past, any of the above conditions, or if you develop one being treated with BELARA.
Effectiveness
If you have forgotten to take tablets, have vomiting or diarrhea after taking the tablet or are taking other medicines, the effectiveness of a hormonal contraceptive may be reduced. In very rare cases, metabolic disorders can impair contraceptive efficacy. 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, irregular bleeding from the vagina (intermenstrual bleeding / discharge) may occur. If irregular bleeding continues for 3 months, or reappears in subsequent regular cycles, you should see your doctor.
Leaking may also be a symptom of a decreased contraceptive effect.
In some cases, after taking BELARA for 21 days, there may be no withdrawal bleeding. If you have taken the pills according to the instructions in section 3, it is unlikely that you are pregnant. If BELARA has not been taken according to the instructions. instructions before the absence of withdrawal bleeding, pregnancy must be safely ruled out before continuing use.
What drugs or foods can modify the effect of?
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The contraceptive effect of BELARA may be changed if you are taking other medicines at the same time.
These include epilepsy medicines (eg phenytoin, carbamazepine and topiramate), medicines for the treatment of tuberculosis (eg rifampicin, rifabutin), some antibiotics such as ampicillin, tetracyclines and griseofulvin, barbiturates, primidone, barbesaclone, modafinil, some medicines to treat HIV infection (eg ritonavir) and products containing St. John's wort (hypericum perforatum). Medicines that stimulate intestinal peristalsis (eg metoclopramide) and activated charcoal can reduce the absorption of the active ingredients of BELARA.
You should not take herbal medicines containing St. John's Wort together with BELARA.
If you are taking a medicine that contains any of these substances (except St. John's Wort) or starting treatment, you can continue to take BELARA but, while taking these medicines, you must also use a mechanical method of contraception ( eg condoms). If you take these medicines, you must use mechanical contraception for at least 7 days or up to 28 days after the end of treatment. If long-term treatment with the above active substances is necessary, you must use methods non-hormonal contraceptives Ask your doctor or pharmacist for advice.
If concomitant drug administration continues after the tablets from the COC blister pack are finished, the next pack should be started without the usual withdrawal interval.
Tell your doctor if you are taking insulin or other medicines to lower your blood sugar level. The dosage of these medicines may need to be changed.
When using a hormonal contraceptive, the excretion of diazepam, cyclosporine, theophylline or prednisolone may be reduced, with the result that the effect of these substances will be greater and last longer. The effect of preparations containing clofibrate, paracetamol, morphine or lorazepam may be reduced if they are used concomitantly with BELARA.
Remember that these data are valid even if you have taken one of these drugs shortly before starting BELARA therapy.
Certain laboratory tests to check the function of the liver, adrenal and thyroid glands, certain blood proteins, carbohydrate metabolism and blood clotting may be changed when taking BELARA. So before having a blood test tell your doctor that you are taking BELARA.
Warnings It is important to know that:
Pregnancy and breastfeeding
BELARA is not indicated during pregnancy. If you become pregnant while taking BELARA, you must stop the therapy immediately. The use of BELARA before pregnancy does not justify abortion. If you are taking BELARA while breastfeeding, you should remember that the amount of milk may be reduced and its quality changed. Small quantities of the active substances pass into the milk. Hormonal contraceptives such as BELARA should only be taken after breastfeeding is stopped.
Driving and using machines
There are no known negative effects of combined hormonal contraceptives on the ability to drive or use machines
BELARA contains lactose monohydrate
BELARA contains lactose monohydrate. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking BELARA.
Dosage and method of use How to use Belara: Dosage
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Method of recruitment
Orally.
When and how should BELARA be taken?
Take the first tablet from those marked with the corresponding day of the week (eg Sun for Sunday) and swallow it without chewing. Then take one tablet every day in the direction of the arrow, if possible at the same time of the day, preferably in the evening. If possible, the interval between two tablets should be 24 hours. The indication of the days printed on the pack will help you to 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, a menstruation-like withdrawal bleed will begin. After a 7-day break, resume taking the tablets from the new BELARA pack without worrying if your period has not finished.
When can I start taking BELARA?
If you were not taking a hormonal contraceptive (during your last menstrual cycle)
Take the first BELARA tablet on the first day of your period.Contraception begins on the first day of administration and continues during the 7-day break.
If your period has already started, take the first tablet from day 2 to day 5 of your period, even if your period has not yet finished. In this case, however, you must also use another contraceptive system for the first 7 days (7-day rule).
If your period has started for more than 5 days, you must wait for the next period and then start taking BELARA.
If you were taking another combined hormonal contraceptive
Take all the tablets of the previous drug as usual. You must start taking your BELARA tablet on the day following the stop or placebo tablet interval of your previous combined hormonal contraceptive.
If you were taking a progestogen-only hormonal contraceptive (minipill)
If you are using a hormonal contraceptive that contains only progestins, you may not have a period. In this case, the first BELARA tablet should be taken the day after the "last" minipill. However, another contraceptive method will also need to be used for the first 7 days.
If you were using an injectable hormonal contraceptive or an implant contraceptive
Take the first BELARA tablet on the day the implant is removed or the day you should have given the new injection. However, you will also need to use another method of birth control for the first 7 days.
If you have had a curettage or miscarriage in the first trimester of pregnancy
After a curettage or miscarriage, you can start taking BELARA immediately. In this case it is not necessary to use another contraceptive method 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 having a baby. It is not necessary to use another contraceptive method in addition.
If more than 28 days have passed since the birth, you will need to use another method of birth control in addition for the first seven days.
If you have already had sexual intercourse, you need to rule out pregnancy or wait for your next menstrual flow before you start taking BELARA.
Remember that you cannot take BELARA if you are breastfeeding (see pregnancy and breastfeeding section).
How long to take BELARA?
You can take BELARA for as long as you like, as long as the intake is not limited by any health risks. After you stop taking BELARA, your next period may be delayed for about a week. What to do in case of vomiting or diarrhea during BELARA therapy? If you have episodes of 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 the forgotten tablet and therefore you must immediately take a new tablet from one tablet. If possible, take the new tablet within 12 hours of taking the last tablet and continue taking BELARA at the usual time. If this is not possible or it has already been more than 12 hours follow section 3 "If you forget to take BELARA "or contact your doctor.
Overdose What to do if you have taken too much Belara
If you take more BELARA than you should
There is no evidence of severe intoxication symptoms caused by the ingestion of several tablets in a single dose at one time. Nausea, vomiting, and, in young girls, mild blood loss may occur. In this case, consult a doctor who, if necessary, will check the water and electrolyte balance and liver function.
If you forget to take BELARA
If you have forgotten to take a tablet at the usual time, you must take it within the next 12 hours at the latest. In this case you do not need to use any other contraceptive methods in addition and you can continue taking the other tablets as usual.
If the delay is greater than 12 hours, the contraceptive effect of BELARA is no longer guaranteed. In this case, you must take the forgotten tablet immediately and continue taking BELARA as usual, even if this means that you have to take two tablets in one day. However, you will also need to use another method of contraception (eg a condom) for the next 7 days. If you run out of tablets in the pack during these 7 days, start using the tablets from the next pack of BELARA immediately. , without respecting the 7-day break (7-day rule). The withdrawal flow will probably not occur until the new pack is finished; however, accentuation of intermenstrual bleeding or discharge may occur while taking the tablets. new packaging.
The more tablets you have forgotten, the greater the risk that the protection against pregnancy is reduced. If you have forgotten one or more tablets in the first week and had intercourse in the week before the forgetting, you should consider the risk of becoming pregnant. The same applies if you forget one or more tablets and if you do not have a "bleeding in the withdrawal interval". In such cases, contact your doctor.
If you want to delay your period
Although it is not recommended, it is possible to delay the menstrual cycle (withdrawal bleeding) by switching directly to a new pack of BELARA instead of the withdrawal period, until the second pack is finished. You may experience discharge (drops or blood spots) or withdrawal bleeding while using the second pack. After the usual 7-day withdrawal period, continue with the next pack. Before deciding to delay your period you should ask your doctor for advice. doctor. If you want to move the first day of your period If you take the tablets according to the instructions, your period / withdrawal bleed will start in the withdrawal period. If you want to move this day, you can do so by shortening the withdrawal period (but never lengthening it! For example, if the withdrawal period starts on a 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 withdrawal period too much (for example, to 3 days or not) then you may not have any bleeding during this withdrawal period. suspension lamp.
If you are not sure how to proceed, ask your doctor for advice.
If you stop taking BELARA
When you stop taking BELARA, your ovaries quickly return to full activity, and you can get pregnant. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Belara
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, especially if they are severe or persistent, or if there is any change in your health that you think might be due to BELARA, please tell your doctor.
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 taking combined hormonal contraceptives. For more detailed information on the different risks of "taking combined hormonal contraceptives, see section" What you need to know before you use BELARA ".
Frequencies of reported undesirable effects are defined as follows:
Very common: may affect more than 1 in 10 people Nausea, vaginal discharge, menstrual pain, no menstruation, withdrawal bleeding, discharge, headache, sinus pain
Common: may affect up to 1 in 10 people Depression, irritability, nervousness, dizziness, migraine (and / or their worsening), visual disturbances, vomiting, acne, belly pain, tiredness, feeling of heaviness in the legs, accumulation of water, weight gain, increased blood pressure Uncommon: may affect up to 1 in 100 people Stomach pain, drug hypersensitivity including allergic reaction, rumbling of the intestines, diarrhea, pigmentation problems, brown spots on the face, hair loss, dry skin, muscle problems, discharge from the breasts, benign changes in the connective tissue of the breasts, fungal infection of the vagina, decreased libido, tendency to sweat, changes in blood fats including increased triglycerides
Rare: may affect up to 1 in 1,000 people Conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, varicose veins,
Harmful blood clots in a vein or artery, for example:
- in a leg or foot (DVT)
- in one lung (PE)
- heart attack
- stroke
- mini-stroke or temporary stroke-like symptoms, known as a transient ischemic attack (TIA)
- blood clots in the liver, stomach / intestines, kidneys or eye.
The chance of developing a blood clot may be higher if you have any other conditions that increase this risk (see section for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).
Hives, eczema, inflamed skin, itching, worsening of psoriasis, excess body or facial hair, enlarged breasts, inflammation of the vagina, longer and / or more intense menstruation, premenstrual syndrome (physical and emotional problems before the onset of of menstruation), increased appetite.
Very rare: may affect up to 1 in 10,000 people
Erythema nodosum
Combined hormonal contraceptives have also been linked to increased risk of serious illness and side effects:
- Risk of blockage of veins and arteries
- Risk of biliary tract disease
- Risk of tumors (eg liver tumors, which in isolated cases have caused severe and fatal haemorrhage in the abdominal cavity, cervical and breast cancers;
- Worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Read the information in section 2 carefully and consult your doctor immediately if necessary.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 safety. of this medicine.
Expiry and Retention
Do not store above 30 ° C. 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 carton and blister (course of therapy) after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What BELARA contains
- The active ingredients are ethinyl estradiol and chlormadinone acetate. One film-coated tablet containing 0.030 mg ethinylestradiol and 2.0 mg chlormadinone acetate
- The other ingredients are:
Tablet core: lactose monohydrate, maize starch, povidone K 30, magnesium stearate
Coating: hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E171), red iron oxide (E172)
Description of what BELARA looks like and contents of the pack
BELARA is available in packs of 21 round, slightly pink, film-coated tablets for each blister (course of therapy).
Pack sizes: 1x21, 3x21, 6x21, 13x21 film-coated tablets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BELARA
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains: 2 mg chlormadinone acetate, 0.030 mg ethinyl estradiol
For excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
Round, slightly pinkish film-coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Hormonal contraception.
04.2 Posology and method of administration
Administration of the tablets
Each tablet should be taken at the same time each day (preferably in the evening) for 21 consecutive days. Administration must be suspended for the next 7 days; menstrual-like bleeding should begin two to four days after taking the last tablet. Administration should resume after 7 days of suspension, using a new blister of BELARA, whether the bleeding has stopped or continues.
The tablets must be removed from the blister and swallowed whole, if necessary with a little water, choosing the one marked with the corresponding day of the week. The tablets should be taken daily in the direction of the arrow.
Start of therapy
When no other hormonal contraceptive has been taken (during the last menstrual cycle)
The first tablet should be taken on the first day of your period. If the first tablet is taken on the first day of menstruation, the contraceptive efficacy begins from the first day of therapy and continues even during the 7 days off.
The first tablet can also be taken from day 2 to day 5 of the menstrual period whether the bleeding has stopped or not. In this case, additional contraceptive measures will need to be taken for the first 7 days of administration.
If your period has started for more than 5 days, you must wait for the next menstrual period to start therapy with BELARA.
Switching to BELARA from another hormonal contraceptive
Changing from a hormonal contraceptive to 22 days or 21 days: all your previous contraceptive tablets should be taken as usual. The first BELARA tablet should be taken the next day. In this case there is no interval between the two treatments and you do not have to wait for the next menstrual period to start therapy with BELARA. No other contraceptive measures are necessary.
Changing from a hormonal contraceptive in packs of 28 tablets: BELARA must be started after finishing the "last" active "tablet in the pack (ie after taking the 21st or 22nd tablet). The first BELARA tablet must be taken the next day. There must be no gap between the two. treatments and you do not have to wait until your next menstrual period to start therapy with BELARA No other contraceptive measures are necessary.
Changing from a progestogen-only contraceptive (mini pill): the first tablet of BELARA should be taken the day after stopping the progestogen contraceptive. Other contraceptive measures should be used for the first seven days.
Changing from an injectable or implant hormonal contraceptive: You can start with BELARA on the day of implant removal or the day the next injection was scheduled. Additional contraceptive measures must be taken for the first 7 days.
After a first trimester curettage or abortion
Following curettage or abortion in the first trimester, administration of BELARA can be started immediately. No other contraceptive measures are necessary.
After childbirth or after curettage or abortion in the second trimester
After delivery, administration to non-breastfeeding mothers can be started 21-28 days after delivery; in this case no other contraceptive measure is necessary.
If administration begins more than 28 days after delivery, additional contraceptive measures are required for the first 7 days of treatment with BELARA. If the patient has had intercourse in the meantime, a possible pregnancy should be ruled out before starting therapy or waiting for the next menstrual period.
Breastfeeding (see 4.6)
BELARA should not be used in women who are breastfeeding.
After the discontinuation of BELARA
After stopping BELARA therapy, the first menstrual cycle may be delayed by approximately 1 week.
Incorrect assumption
If you have forgotten to take a tablet, but still take it within 12 hours, no additional contraceptive measures are necessary.
Subsequent tablets should be taken as normal.
If more than 12 hours have passed since the forgetting, the contraceptive effect is reduced. The forgotten tablet should be taken immediately. Subsequent tablets should be taken at the usual time. In addition, additional mechanical contraceptive measures, such as condoms, must be taken for the next 7 days. If these 7 days go beyond the end of the pack in use, the next pack of BELARA should be started immediately after finishing the previous one, i.e. without any interruption (7 day rule). Menstrual flow will likely not occur until after the second pack is finished. However, intermenstrual bleeding or "spotting" may occur while taking the tablets. If the flow fails after the second pack is finished, a pregnancy test should be performed.
Instructions in case of vomiting
If vomiting occurs within 3-4 hours after taking the tablet or if severe diarrhea occurs, absorption may be incomplete and "adequate contraception is not ensured. In this case, the instructions given in the paragraph above must be followed." Incorrect assumption ".
Taking BELARA should be continued. However, additional mechanical contraceptive measures should be taken for the remainder of the cycle.
04.3 Contraindications
COCs should not be used under the conditions listed below. Furthermore, the use of BELARA must be stopped immediately in the event of one of these situations:
• Previous or current venous or arterial thrombosis (eg deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke)
• prodrome or first signs of thrombosis, thrombophlebitis or embolic symptoms, for example transient ischemic attack, angina pectoris
• scheduled surgery (at least 4 weeks before the surgery) and for periods of immobility, for example after accidents (eg. Plaster casts after an accident)
• diabetes mellitus with vascular distress
• uncontrolled diabetes
• uncontrolled hypertension or significant increase in blood pressure (values consistently above 140/90 mm Hg)
• hepatitis, jaundice, impaired liver function until liver function values have returned to normal
• generalized itching, cholestasis, especially during a previous pregnancy or estrogen therapy
• Dubin-Johnson syndrome, Rotor syndrome, bile flow disorders
• history of previous or current liver cancer
• severe epigastric pain, liver enlargement or symptoms of intra-abdominal bleeding (see section 4.8)
• onset or relapse of porphyria (all 3 forms, in particular acquired porphyria)
• presence or history of hormone-sensitive malignant tumors eg. breast or uterus
• severe alterations in lipid metabolism
• pancreatitis or a history of pancreatitis if associated with severe hypertriglyceridaemia
• appearance of migraines or more frequent attacks of headache of unusual intensity
• history of migraine with focal neurological symptoms (accompanied migraine)
• sensory disturbances with acute onset, eg. impaired vision or hearing
• motor disorders (in particular paresis)
• increase in the frequency of epileptic seizures
• severe depression
• otosclerosis aggravated during previous pregnancies
• amenorrhea of unknown cause
• endometrial hyperplasia
• genital bleeding of an unknown cause
• hypersensitivity to chlormadinone acetate, ethinyl estradiol or excipients
The presence of a serious risk factor or multiple risk factors for venous or arterial thrombosis may constitute a contraindication (see section 4.4).
04.4 Special warnings and appropriate precautions for use
Warnings
Smoking increases the risk of severe cardiovascular side effects when associated with the use of combined oral contraceptives (COCs). The risk increases with age and with the number of cigarettes and is very pronounced in women over 35 years of age. Smoking patients over the age of 35 must use other methods of contraception.
Administration of COCs carries an increased risk of severe diseases, such as myocardial infarction, thromboembolism, stroke or liver cancer.
Other risk factors such as hypertension, hyperlipidemia, obesity and diabetes distinctly increase the risk of morbidity and mortality.
In the presence of any of the following conditions or risk factors, the benefit of administering BELARA should be weighed against the risks and discussed with the patient before starting therapy. If worsening of any of these diseases or risk factors is observed during treatment, the patient should contact her doctor. The doctor will then have to decide whether the treatment should be stopped.
Thromboembolism and other vascular disorders
The results of epidemiological studies indicate a correlation between the use of oral contraceptives and the increased risk of venous and arterial thrombosis and thromboembolism such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These events are rare.
The use of combined oral contraceptives (COCs) carries an increased risk of venous thromboembolism (VTE) compared to those who do not use them. The risk of VTE is greater during the first year of using a combined oral contraceptive. This increased risk VTE is less than that associated with pregnancy which is estimated in 60 cases per 100,000 pregnancies. The outcome of VTE is fatal in 1-2% of cases.
It is not known whether BELARA affects the occurrence of these events in comparison with other COCs.
Venous thromboembolic risk is increased by the following factors:
• age
• positive family history (eg venous or arterial thrombosis in siblings, or parents at a relatively young age). If a hereditary predisposition is suspected, it is preferable to request a specialist examination before deciding on the use of COC.
• prolonged immobilization (see section 4.3)
• obesity (body mass index> 30 Kg / m2).
The risk of arterial thromboembolism increases with:
• age
• smoke
• dyslipoproteinemia
• obesity (body mass index> 30 kg / m2)
• hypertension
• heart valve dysfunction
• atrial fibrillation
• family history of arterial thromboembolism in siblings or parents at a relatively young age. If hereditary predisposition is suspected, it is preferable to request a specialist examination before deciding on the use of COC.
Other medical conditions related to blood circulation are: diabetes mellitus, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis), sickle cell anemia.
In consideration of the benefit / risk ratio, it must be borne in mind that adequate treatment of the above diseases can reduce the risk of thrombosis.
Biochemical factors, which indicate a hereditary or acquired predisposition to venous or arterial thrombosis, are: resistance to APC (activated protein C), hyperhomocystinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, anti-phospholipid antibodies (antibodies anti-cardiolipin, lupus anticoagulants).
The increased thromboembolic risk during the puerperium must be considered.
There is no shared opinion on the possible relationship between superficial thrombophlebitis and / or varicose veins and the etiology of venous thromboembolism.
Symptoms of a venous or arterial thrombosis could be:
• pain and / or swelling in one leg
• sudden and severe chest pain with or without irradiation to the left arm
• sudden wheezing, sudden coughing attack of unknown cause
• unexpected intense and persistent headache
• sudden partial or total loss of vision, diplopia, dysarthria or aphasia
• dizziness, loss of consciousness which in some cases may include a focal epilepsy attack
• sudden weakness or numbness of one side of the body or part of it
• motor disturbances
• acute abdominal pain.
Women taking COCs should be advised that they should consult their physician in the event of possible symptoms of thrombosis. BELARA should be discontinued if thrombosis is suspected or confirmed.
The increased frequency and intensity of migraine attacks while taking BELARA (which may be a prodromal sign of cerebrovascular accident) may be a reason for immediate discontinuation of COC use.
Tumors
Epidemiological studies have shown an increased risk of cervical cancer in relation to the prolonged use of oral contraceptives in patients with human papillomavirus infections, but the role of other factors in this occurrence is discussed, (eg. The number of partners or "use of mechanical contraceptives) (see also" Medical Checkups ").
A meta-analysis of 54 epidemiological studies found that, with the use of oral contraceptives, there is a slight increase in the risk of breast cancer (RR = 1.24). The increase in risk is transient and gradually decreases within 10 years after stopping the drug. treatment. These studies give no indication of the causes. The increased risk observed may be attributed to the early detection of breast cancer in patients taking COCs, the biological effects of COCs, or both.
In rare cases, benign liver tumors and, in even rarer cases, malignant tumors have been found in patients taking oral contraceptives. In isolated cases, these tumors have caused severe intra-abdominal haemorrhages. In the event of severe abdominal pain which does not subside spontaneously, of hepatomegaly or signs of intra-abdominal haemorrhage the possibility of hepatic cancer should be considered and BELARA should be discontinued.
Other conditions
Modest increases in blood pressure have been observed in many patients taking oral contraceptives but clinically significant increases are rare. The correlation between oral contraceptive use and clinically manifest hypertension has not been confirmed so far. If during treatment with BELARA the increase in blood pressure is clinically relevant, the doctor will have to stop BELARA and start anti-hypertensive therapy. norm.
In patients with a history of gestational herpes there may be recurrence when taking COCs. In patients with hypertriglyceridaemia or with a family history of hypertriglyceridaemia the risk of pancreatitis being treated with CHC is increased. Acute or chronic liver disorders may require discontinuation of COC treatment until liver function values have normalized. treatment with COC.
Oral contraceptives can change peripheral insulin resistance or glucose tolerance. Therefore, diabetic patients using oral contraceptives should be monitored closely.
In rare cases, chloasma may occur, particularly in women with a history of chloasma gravidarum. Patients with a tendency to chloasma should avoid exposure to the sun and ultraviolet rays while using oral contraceptives.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Precautions
The administration of estrogen or COCs can have negative effects on some conditions or diseases.
A "careful medical observation is necessary in these cases:
• epilepsy
• multiple sclerosis
• tetany
• migraine (see section 4.3)
• asthma
• heart or kidney failure
• chorea minor
• diabetes mellitus (see section 4.3)
• liver disease (see section 4.3)
• alterations in lipid metabolism (see section 4.3)
• auto immune diseases (including systemic lupus erythematosus)
• obesity
• hypertension (see section 4.3)
• endometriosis
• varices
• phlebitis (see section 4.3)
• bleeding disorders (see section 4.3)
• mastopathy
• uterine myomas
• gestational herpes
• depression (see section 4.3)
chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, see section 4.3)
Medical checks
Before prescribing oral contraceptives, a complete personal and family medical history should be taken, taking into account contraindications (see section 4.3) and risk factors (see section 4.4) and a medical examination should be performed. The control must be repeated at least once a year during the use of BELARA. Periodic monitoring of the general state of health is also important as some contraindications (e.g. transient ischemic attacks) or certain risk factors (e.g. family history of venous or arterial thrombosis) may appear for the first time during contraceptive therapy oral. The visit should include blood pressure control, breast and abdomen examination, gynecological examination, vaginal smear, as well as appropriate laboratory tests. Patients should be advised that oral contraceptives, including BELARA, do not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Reduction of effectiveness
Missing a tablet (see "Incorrect intake"), vomiting or intestinal diseases leading to diarrhea, prolonged administration of certain drugs (see section 4.5) or, rarely, metabolic disturbances can reduce contraceptive efficacy.
Alterations of the cycle
Intermenstrual spotting or bleeding
All oral contraceptives can cause irregular bleeding (spotting or intermenstrual bleeding), particularly during the first months of use. Therefore, a medical assessment of cycle irregularity should be made after a settling period of approximately three cycles. If intermenstrual bleeding persists or occurs after previous regular cycles during administration of BELARA, a medical check-up should be performed to rule out pregnancy or organic disease. After the exclusion of pregnancy or organic disease, the administration of BELARA can be continued or it is possible to switch to the use of another product. Intermenstrual bleeding may indicate "insufficient contraceptive efficacy" (see "Incorrect use", "Instructions in case of vomiting" and section 4.5).
Absence of menstrual flow
After 21 days of taking, a "withdrawal bleed" usually occurs. Occasionally, particularly in the first months of therapy, the flow may not occur; this phenomenon should not be interpreted as reduced contraceptive efficacy. If the flow does not occur after a cycle in which no tablets have been forgotten, the 7-day interval has not been extended, no other medications have been taken and no vomiting or diarrhea has occurred, conception is not likely and BELARA can be continued. If BELARA has not been taken according to the instructions prior to the missed withdrawal bleeding or if the withdrawal bleeding does not occur for two consecutive cycles, pregnancy must be ruled out before continuing administration. Herbal products containing St. John's Wort (Hypericum perforatum) should not be used concomitantly with BELARA therapy (see section 4.5).
04.5 Interactions with other medicinal products and other forms of interaction
Interaction of ethinylestradiol, the estrogen component of BELARA, with other drugs may increase or decrease plasma concentrations of ethinylestradiol. If long-term therapy with these active substances is required, non-hormonal contraceptive methods should be used. Reduced concentrations plasma concentrations of ethinylestradiol may increase intermenstrual bleeding and cycle disturbances and reduce the contraceptive efficacy of BELARA; elevated plasma levels of ethinylestradiol may increase the incidence and severity of side effects.
The following medicinal products or active substances may reduce the plasma concentration of ethinylestradiol:
• all drugs that increase gastrointestinal motility (eg metoclopramide) or reduce absorption (eg activated charcoal)
• active substances that induce liver microsomal enzymes, such as rifampicin, rifabutin, barbiturates, antiepileptics (such as carbamazepine, phenytoin and topiramate), griseofulvin, barbexaclone, primidone, modafinil, some protease inhibitors (eg ritonavir) and Hypericum perforatum (see Hypericum perforatum) 4.4).
• some antibiotics (eg ampicillin, tetracycline) in some patients, possibly due to estrogen's reduced enteropathic circulation.
In the case of concomitant treatment with these drugs or active substances and BELARA additional mechanical contraceptive methods should be used during the treatment period and for seven days thereafter.With active substances that reduce the plasma concentration of ethinylestradiol by induction of hepatic microsomal enzymes, additional mechanical contraceptive methods should be used up to 28 days after the end of treatment.
The following medicinal products or active substances may increase the plasma concentration of ethinylestradiol:
• active substances that inhibit the sulfation of ethinyl estradiol in the intestinal wall (eg. Ascorbic acid or paracetamol)
• atorvastatin (increases the AUC of ethinylestradiol by 20%)
• active substances that inhibit liver microsomal enzymes, such as imidazole, antifungals (eg fuconazole), indinavir or troleandomycin.
Ethinylestradiol can modify the metabolism of other active substances:
• inhibiting liver microsomal enzymes and consequently increasing the plasma concentration of active substances such as diazepam (and other benzodiazepines metabolized by hydroxylation), cyclosporine, theophylline and prednisolone
• by inducing hepatic glucuroconjugation and consequently reducing the plasma concentration of clofibrate, paracetamol, morphine and lorazepam.
The need for insulin or oral antidiabetics may change as a result of the effect on glucose tolerance (see section 4.4).
This can also be the case for recently taken medications.
The SmPC of the prescribed drug should be read carefully for possible interaction with BELARA.
Lab test
During COC administration the results of some laboratory tests may be altered, including liver, adrenal and thyroid function tests, plasma levels of carrier proteins (e.g. SHBG, lipoproteins) and parameters of carbohydrate metabolism, hemocoagulation and fibrinolysis. The nature and extent of these changes are in part dependent on the nature and dose of the hormone used.
04.6 Pregnancy and lactation
BELARA is not indicated during pregnancy. Pregnancy must be excluded before starting administration of the medicinal product. Should the onset of pregnancy occur during therapy with BELARA, the drug should be discontinued immediately. Most epidemiological studies conducted to date have excluded clinical evidence of teratogenic or foetotoxic effects when estrogens, in combination with other progestogens, are accidentally taken during pregnancy in dosages similar to those contained in BELARA. Although animal studies have shown evidence of reproductive toxicity (see section 5.3), clinical data on more than 330 human pregnancies exposed to chlormadinone acetate, have shown no effects embryotoxic.
Breastfeeding can be influenced by estrogen as it can change the quantity and composition of breast milk. Small amounts of contraceptive steroids and / or their metabolites may be excreted in breast milk and affect the baby. Therefore BELARA should not be taken during breastfeeding.
04.7 Effects on ability to drive and use machines
Hormonal contraceptives have not been shown to adversely affect the ability to drive or operate machinery.
04.8 Undesirable effects
Clinical studies with BELARA have shown that the most frequent side effects (> 20%) are intermenstrual bleeding (intermenstrual bleeding and spotting), headache and breast tenderness.
The following undesirable effects were reported after administration of BELARA in a clinical study involving 1629 women.
Their frequency is defined as follows:
- very common (≥1 / 10)
- common (≥1 / 100,
- uncommon (≥1 / 1000,
- rare (≥1 / 10,000,
- very rare (
Psychiatric disorders
Common: depressive state, irritability, nervousness.
Alterations of the nervous system
Common: dizziness, migraine (and / or worsening of migraine).
Eye disorders
Common: visual disturbances.
Rare: conjunctivitis, discomfort in wearing contact lenses.
Alterations of the auditory and vestibular apparatus
Rare: sudden hearing loss, tinnitus.
Alterations of the vascular system
Rare: hypertension, hypotension, cardiovascular collapse, varices.
Alterations of the gastrointestinal system
Very common: nausea.
Common: vomiting.
Uncommon: abdominal pain, abdominal swelling, diarrhea.
Alterations of the skin and subcutaneous tissue
Common: acne.
Uncommon: pigmentation abnormalities, chloasma, hair loss, dry skin.
Rare: urticaria, allergic reactions, eczema, erythema, pruritus, worsening of psoriasis, hirsutism.
Very rare: erythema nodosum.
Alterations of the musculoskeletal system, connective tissue and bone
Uncommon: low back pain, muscle disorders.
Disorders of the reproductive system and breast
Very common: vaginal discharge, dysmenorrhea, amenorrhea.
Common: pelvic pain.
Uncommon: galactorrhea, fibrocystic mastopathy, genital candidiasis, ovarian cyst.
Rare: breast enlargement, vulvovaginitis, menorrhagia, premenstrual syndrome.
General unrest
Common: fatigue, heaviness in the legs, water retention, weight gain.
Uncommon: decreased libido, sweating.
Rare: increased appetite.
Control exams
Common: increased blood pressure.
Uncommon: blood lipid changes, including hypertriglyceridaemia.
The following side effects have also been observed during the administration of COCs:
• the administration of combined oral contraceptives is associated, as known, with an increased risk of venous and arterial thrombo-embolism (venous thrombosis, pulmonary embolism, stroke, myocardial infarction). This risk may be aggravated by other associated factors (see section 4.4)
• an increased risk of biliary tract disease has been reported in some studies on long-term administration of COCs. The possibility of gallstone formation during treatment with estrogen-containing products is controversial.
• in rare cases benign, and more rarely malignant, hepatic tumors have been observed after administration of hormonal contraceptives, in isolated cases these tumors have caused severe, life-threatening intra-abdominal haemorrhage (see section 4.4).
• worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, see also section 4.4).
For other serious side effects, such as cervical or breast cancer, see section 4.4.
04.9 Overdose
There is no information on serious toxic effects in case of overdose. The following symptoms may occur: nausea, vomiting and, especially in early adolescence, modest vaginal bleeding. There are no antidotes; treatment is symptomatic. In rare cases, monitoring of the electrolyte balance and liver function may be necessary.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: systemic hormonal contraceptives, monophasic preparations with
With continued use of BELARA for 21 days, there is inhibition of the pituitary secretion of FSH and LH and therefore suppression of ovulation. The endometrium proliferates with subsequent secretory transformation. The consistency of the cervical mucus is changed. This prevents sperm migration through the cervical canal and changes sperm motility.
The lowest daily chlormadinone acetate dosage for complete inhibition of ovulation is 1.7 mg. The overall dose for complete endometrial transformation is 25 mg per cycle.
Chlormadinone acetate is an anti-androgen progestin. Its effect is based on its ability to displace androgen hormones from their receptors.
Clinical efficacy
In clinical studies investigating the administration of BELARA for up to 2 years of therapy in 1655 women, comprising more than 22,000 menstrual cycles, 12 pregnancies occurred. In 7 women during the period of conception there were errors of intake, onset of diseases that caused nausea or vomiting, concomitant administration of drugs known to reduce the contraceptive efficacy of hormonal contraceptives.
05.2 Pharmacokinetic properties
Chlormadinone acetate (CMA)
Absorption
After oral administration CMA is rapidly and almost completely absorbed. The systemic bioavailability of CMA is high since it is not subject to hepatic first pass metabolism. Peak plasma levels are reached after 1-2 hours.
Distribution
The fraction of CMA bound to plasma proteins, mainly albumin, is greater than 95%. However, CMA has no binding affinity for SHBG or CBG. In the organism CMA is deposited mainly in the adipose tissue.
Metabolism
Several reduction and oxidation processes and glucuronide and sulfate conjugation result in a number of metabolites. The major metabolites in human plasma are 3α and 3β-hydroxy-CMA, the half-life of which does not differ essentially from that of unmetabolized CMA. The 3α-hydroxide metabolites show to possess an "antiandrogenic activity similar to that of CMA. In the urine the metabolites of CMA are predominantly conjugated. After enzymatic cleavage, the main metabolite is 2α-hydroxy-CMA in addition to the 3-hydroxy metabolites. and dihydroxy metabolites.
Elimination
CMA is cleared from plasma with a half-life of approximately 34 hours after single dose and approximately 36-39 hours after repeated doses. CMA and its metabolites, after oral administration, are excreted by both the renal and faecal routes in a similar percentage.
Ethinylestradiol (EE)
Absorption
EE is rapidly and almost completely absorbed after oral administration; the average plasma peak is reached in about 1.5 hours. Due to presystemic conjugation and hepatic first pass metabolism, absolute bioavailability is approximately 40% and subject to considerable interindividual variation (20-65%).
Distribution
The plasma concentration of EE reported in the literature is characterized by a marked variability. About 98% of EE is bound to plasma proteins, almost exclusively to albumin.
Metabolism
Like natural estrogens, EE is biotransformed through cytochrome P-450 by hydroxylation of the aromatic ring. The main metabolite is 2-hydroxy-EE which is further metabolized into conjugated metabolites. EE undergoes presystemic conjugation both in the intestinal mucosa. small intestine than in the liver. Glucuronides are mainly present in the urine, while sulphates are present in the bile and plasma.
Elimination
EE is eliminated from plasma with a half-life of approximately 12-14 hours. EE is excreted via the kidney and faeces in a urine / faeces ratio of 2: 3. EE sulfate excreted in bile after hydrolysis by intestinal bacteria is subject to the enterohepatic circle.
05.3 Preclinical safety data
Acute estrogen toxicity is low. Taking into account the considerable difference between animal species and in relation to humans, the results of studies with estrogen on animals have only a limited predictive value for use in humans. Ethinyleastradiol, a synthetic estrogen frequently used in oral contraceptives, has an embryolethal effect in laboratory animals even at relatively low doses; abnormalities of the urogenital tract and feminization of male fetuses have been observed. These effects are considered species-specific. Chlormadinone. acetate showed embryolethal and teratogenic effects in rabbits, rats and mice. Furthermore, the teratogenic effect was observed in rabbits at embryotoxic doses and also in mice at the lowest doses tested (1 mg / kg / day). The significance of these data in relation to human administration is unclear. The preclinical data derived from conventional studies of chronic toxicity, genotoxicity and carcinogenic potential, did not show particular risks for humans, apart from those described in the other sections of this CPR.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate, corn starch, povidone K30, magnesium stearate, hypromellose, macrogol 6000, propylene glycol, talc, titanium dioxide (E171), red iron oxide (E172).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
No special instructions.
06.5 Nature of the immediate packaging and contents of the package
PVC / PVDC / Al or PP / Al blisters
Packs with 1 x 21 film-coated tablets
06.6 Instructions for use and handling
Store at a temperature not exceeding 30 ° C.
07.0 MARKETING AUTHORIZATION HOLDER
FORMENTI S.r.l. products - Via R. Koch, 1/2 - 20152 Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 036875019 / M - 1 x 21 film-coated tablets in PVC / PVDC / Al blister
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: May 2005
10.0 DATE OF REVISION OF THE TEXT
September 2010
11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY
12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL
CHECKLIST FOR PRESCRIPTORS - COMBINED HORMONAL CONTRACEPTIVES
Please use this checklist together with the Summary of Product Characteristics during any consultation on Combined Hormonal Contraceptives (COCs).
• The thromboembolism (eg deep vein thrombosis, pulmonary embolism, heart attack and stroke) represents an important risk associated with the use of COCs.
• The risk of thromboembolism with a CHC is higher:
- during the first year d "employment;
- when you leave resume use after a break in intake of 4 or more weeks.
• COCs containing ethinylestradiol in combination with levonorgestrel, norgestimate or norethisterone have the lower risk to cause venous troembolism (VTE).
• The risk for a woman also depends on her baseline risk of thromboembolism. The decision to use a COC must therefore take into account the contraindications and individual risk factors, particularly those relating to thromboembolism - see the boxes below and the relevant Summary of Product Characteristics.
• The decision to use any CHC rather than one with the lowest risk of venous thromboembolism (VTE) should only be made after an interview with the woman to ensure she understands:
- the risk thromboembolism associated with its COC;
- the effect of any risk factor inherent in his risk of thrombosis;
- which must pay particular attention to signs and symptoms of a thrombosis.
Remember that a woman's risk factors can vary over time. It is therefore important to use this checklist at every consultation.
• You need surgery;
• It is necessary that you undergo a prolonged period of immobilization (as in the case of an accident or illness, or for a "cast in a lower limb).
→ In these cases it would be better to reconsider whether or not to use a non-hormonal contraceptive until the risk returns to normal..
• Travel for an extended period (> 4 hours);
• Develop any of the contraindications or risk factors for combined contraceptives;
• She has given birth in the last few weeks.
→ In such situations, your patient should pay particular attention to catch any signs and symptoms of thromboembolism.
Please strongly encourage women to read the Package Insert that accompanies each COC pack, including the symptoms of thrombosis which they should carefully watch out for.
Please report any suspected adverse reactions from COC to the territorially competent Pharmacovigilance Offices or to the AIFA as required by current legislation
IMPORTANT INFORMATION ABOUT COMBINED ORAL CONTRACEPTIVES (COCS) AND THE RISK OF BLOOD CLOTS
All combined contraceptives increase the risk of having a blood clot. The overall risk of a blood clot from taking a combined hormonal contraceptive (COC) is small., but clots can represent a serious condition and in very rare cases even fatal.
It is very important that you recognize when you may be at a higher risk for a blood clot, what signs and symptoms to watch out for and what actions you need to take.
In which situations is the risk of a blood clot higher?
- during the first year of use of a COC (including when resuming use after an interval of 4 or more weeks)
- if you are overweight
- if you are over 35 years of age
- if you have a family member who has had a blood clot at a relatively young age (i.e. under 50)
- if you have given birth in the last few weeks
Self smokes and over 35 years of age, she is strongly advised to stop smoking or to use a non-hormonal method of contraception.
See a doctor immediately if you experience any of the following symptoms:
• Severe pain or swelling in one of the legs which may be accompanied by flaccidity, warmth or changes in the color of the skin such as the appearance of paleness, redness or bluish color. He could have deep vein thrombosis.
• The sudden and unexplained shortness of breath or onset of rapid breathing; severe chest pain which may increase with deep breathing; a sudden cough with no obvious cause (which can produce blood). It could be a serious complication of deep vein thrombosis called pulmonary embolism. This occurs if the blood clot migrates from the leg to the lung.
• A pain in the chest, often sharp, but which sometimes occurs such as malaise, a sense of pressure, weight, upper body discomfort radiating to the back, jaw, throat, arm with a feeling of fullness associated with indigestion or choking, sweating, nausea, vomiting or dizziness . It could be a heart attack.
• A numbness or a sense of weakness in the face, arm or leg, especially on one side of the body; a difficulty in speaking or understanding; a "sudden confusion of mind, a sudden loss of vision or blurred vision; a headache / migraine intense and worse than usual. This could be a stroke.
Look out for symptoms of a blood clot, especially if:
• has just had surgery
• you have been immobilized for a long time (such as due to an accident or illness, or because you have had your leg in a cast)
• has traveled a long way (for more than 4 hours)
Remember to tell your doctor, nurse or surgeon that you are taking a combined hormonal contraceptive if:
• You have had or are due to have surgery
• There is any situation where a healthcare professional asks you what medications you are taking
For more information, please read carefully the Package Leaflet accompanying the drug and immediately report any undesirable effects associated with the use of the combined hormonal contraceptive to your doctor or pharmacist.
