Belara Gedeon daily contraceptives (1 blister x 21 tablets)

Dosage form Film bag tablets
Specifications Box of 1 blister x 21 tablets
Ingredient Ethinylestradiol, chlormadinone acetate

Ingredient

Thành phần cho 1 viên

Composition information	Content
Ethinylestradiol	0.03mg
Chlormadinone acetate	2mg

Uses

Indications

Belara are indicated for contraception.

Pharmacokological

Use Belara continuously for 21 days to inhibit the pituitary gland excretion FSH and LH and thus inhibit ovulation. The lining of the uterus increases and there is a change in excretion. The uniformity of the uterus is changed. This change prevents sperm from moving through the cervical tube and changes the mobility of sperm.

The lowest daily daily dose of chlormadinonononononononononon to fully inhibit ovulation is 1.7 mg. The completely endometrial change dose is 25 mg for each cycle.

Chlormadinon acetate is an anti -androgen -resistant progestogen. The effect of the drug is due to the ability to replace androgen on its receptors.

pharmacokinetic pharmacokinetics

chlormadinon acetate (CMA)

Absorption: After drinking, CMA is absorbed quickly and almost completely. CMA's full body bioavailability due to the drug does not pass through the first metabolism. The drug reaches the peak concentration in plasma after 1-2 hours.

Distribution: CMA in combination with human plasma proteins, mainly with albumin at a rate of over 95%. CMA has no affinity with SHBG or CBG. CMA is stored mainly in adipose tissue.

Metabolism: The reduction, oxidation and glucuronic and sulfate complexes produce many different metabolites. The main metabolites in human plasma are 3α- and 3ß-Hydroxy-CMA with biological disposal time not much different from the non-metabolic CMA. 3-hydroxy metabolites have an anti-androgenic activity similar to the activity of CMA. In urine, metabolites appear mainly in the form of combined. Under the effect of the enzyme, the main metabolite is 2-hydroxy-cma besides 3-hydroxy and dihydroxy metabolites.

Elimination: CMA is eliminated from plasma with the average selling time of about 34 hours (after single dose) and about 36 - 39 hours (after repeated dose). After drinking, CMA and metabolites are excreted through both the kidneys and feces in the same amount.

ethinylestradiol (EE)

Absorption: EE is absorbed quickly and almost completely after drinking and the average peak concentration in plasma is achieved after 1.5 hours. The absolute bioavailability of the drug is only about 40% when taking into account the form of combination before penetration into the general circulation and the first metabolic process in the liver and is considered to have a change between individuals (20 - 65%).

Distribution: The plasma EE concentration recorded in literature has a significant difference. About 98% EE binds to plasma proteins, mainly with albumin.

Metabolism: Similar to natural estrogen, EE is biological metabolism according to the aromatic hydroxy circles (via cytochrome P-450). The main metabolite is 2-hydroxy -e, which is continued to be metabolized and combined. EE experienced the complex before penetrating the general circulation both in the small intestinal and liver mucosa. In the urine, the drug is mainly found in the form of glucuronic complex, in bile and plasma mainly in the form of sulfate.

Elimination: The average selling time in the plasma of EE is about 12-14 hours. EE is excreted through the kidney and stool with a ratio of 2: 3. The sulphate EE is excreted through the bile after being hydrolyzed by the bacteria of the intestine, followed by the intestinal circulation.

Before taking Belara Gedeon daily contraceptives (1 blister x 21 tablets)

How to use

must take the drug daily at the same time (should be used in the evening) for 21 consecutive days, then stop for 7 days without using the drug; Vaginal bleeding is like menstruation usually appears in 2-4 days after taking the last tablet. After 7 days of stopping the medication, using the next belara blade, whether it is still out of menstruation.

Take the pill from the blister and swallow the whole pill, if needed with a little water. Take the medicine daily in the direction of the arrow.

Dosage

Previously not using hormonal contraceptives (in the last menstrual cycle):

should take the first tablet on the first day of the natural menstrual cycle, for example on the first day of the next menstrual cycle. If the drug is used on the first day of the menstrual cycle, the contraceptive effect starts on the first day of taking the drug and continues to maintain for 7 days of stopping the drug. In this case, it is necessary to use more mechanical contraception in the first 7 days of medication.

Conversion from another coordinated hormonal contraceptive: Should start using Belara on the next day after the time of not using other combined contraceptive hormonal drugs or after the use of placebo. Mechanical contraception must be used for the first 7 days of taking the drug. Mechanical contraception must be used in the first 7 days of medication.

It is possible to start using Belara immediately after miscarriage or abortion during the first triples of pregnancy, in this case, there is no additional method of other contraception.

Postpartum or after miscarriage or abortion in the middle of pregnancy:

After giving birth 21 - 28 days, the mother who is not breastfeeding can start taking the drug, in this case, there is no need to use other mechanical contraception. Start taking medicine.

Breastfeeding period:

Women who are breastfeeding should not use Belara.

After stopping using Belara:

After stopping Belara, the current cycle may be about 1 week late.

Non -frequent drug use:

If users forget to take a pill but have taken within 12 hours, it is not necessary to use other contraceptive methods. Users should continue taking the drug as usual. Control the use of drugs is guided in accordance with the following two principles: (1) Do not stop the drug for more than 7 days; (2) Requirement of 7 days of continuous medication to achieve the completely inhibited effect of the hypothalamus - pituitary - ovaries. The next pill should be used as usual. In addition, other mechanical contraceptives such as condoms are also used for the next 7 days. The possibility of pregnancy may occur if the drug is forgotten in the first week of the cycle and has sex within 7 days before forgetting the drug (including the period of stopping the drug). The higher the risk of pregnancy if the number of drugs is forgotten as much and closer to the normal stop time. Normal menstrual periods may not appear until the second blister is used; However, sometimes it is possible to see hemorrhage or bleeding outside the menstrual cycle, which may appear during the use of the drug. If you do not see bleeding at the end of the period after using the second blister, you should check the possibility of pregnancy.

Instructions in case of vomiting or diarrhea:

If vomiting within 4 hours after taking the drug or severe diarrhea progresses, the drug may not be completely absorbed and the contraceptive effect is no longer guaranteed. In this case, it is advisable to follow the instructions in the section "Non -regular use" (see above). Should continue using Belara.

How to delay menstruation:

To slow menstruation, after drinking all the drug, continue to use another belara blade, ignoring the stop phase. This case may last as long as the second blister ends. During this time may have hemorrhage or bleeding outside the menstrual cycle. After 7 days of stopping the drug as usual, using Belara again as usual. The shorter this time, the higher the risk of no menstruation and the woman will experience hemorrhage or bleeding outside the menstrual cycle while using the next drug blister (like when delayed for a while). Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? The following symptoms may occur: nausea, vomiting and especially in young girls, mild vaginal bleeding. There is no detoxifying antidote, only symptomatic treatment. Monitoring water, electrolytes and liver function may be necessary in very rare cases.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose?

Do not use double dose to compensate for missed dose.

Side Effects

Common, ADR> 1/100

Neurological: depressed, stressed, dizzy, migraine. Kinh.

The immune system: sensitivity, allergies. Body: Increased sweating, reducing libido.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindications

Do not use hormonal contraceptives in the following cases. Belara should be stopped immediately if one of the following events appears during the use of the drug:

Under control diabetes. (PE)). There are many risk factors.

is being or arterial thrombosis (ATE).

arterial thrombosis - are suffering from arterial thrombosis, arterial thrombosis (e.g. myocardial infarction) or warning signs (for example: angina). Blood and anti -phospholipid antibodies (using anti -cardilipin antibodies, anticoagulants); Severe hypertension; Severe blood lipoprotein disorders.

hepatitis, jaundice, liver dysfunction until the liver function returns to normal. taste, hypertrophy or abdominal bleeding symptoms.

pancreatitis or a history of pancreatitis, if there is a combination with hyperglyceride. ). Drugs.

Precautions when using

Warning

Smoking increases the risk of serious side effects on the heart of hormonal contraceptives. This risk increases with the age and smoking amount and is evident in women over 35 years old. Women over 35 years old smoking should use other contraceptive measures.

Using coordinated hormonal contraceptives is associated with increasing the risk of various serious diseases such as myocardial infarction, thrombosis, stroke or liver tumor. Other risk factors such as hypertension, hyperlipidemia, obesity and diabetes significantly increase the risk of disease and mortality.

If there is any of the following risk factors, should discuss with a woman about Belara's suitability before use.

In case of aggravation or for the first time these risk conditions or factors appear, women need advice to see a doctor to determine whether to stop the drug or not.

Tasiasis thrombosis and other vascular diseases:

Epidemiological research results show that there is a link between the use of hormonal contraceptives and increasing the risk of venous or arterial thrombosis such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. Rare these events. It is very rare for thrombosis to be reported on the user of hormonal contraceptives in other blood vessels, for example: arteries and liver veins, intestinal mesenteric, kidney or retina.

Risk of venous thrombosis (VTE):

The use of coordinated hormonal contraceptives increases the risk of venous thrombosis compared to unused. The drugs containing levonorgestrel, Norgestimat or Norethisteron are associated with the lowest risk of venous thrombosis. It is not known what the risk of venous thrombosis of Belara compared to this lower risk contraceptive is like.

The decision to use any other contraceptive drugs at the lowest risk of venous thrombosis should only be given after discussing with users of the drug to ensure they understand the risk of belara venous thrombosis, the effects of risk factors that users are currently on this risk, and the risk of venous thrombosis is the highest in the first year of use. There are also some evidence that this risk increases when the coordinated hormonal contraceptive is started to use after 4 weeks or longer.

Venous thrombosis:

The risk of venous thrombosis in users of hormonal contraceptives can increase in women with attached risk factors, especially when there are many risk factors at the same time (see Table 2).

Contraindicated to use Belara if a woman has many risk factors, increasing the risk of venous thrombosis. If a woman has more risk factors, it may increase the risk than the total of single risk factors - in this case, consider the overall thrombosis risk. If the risk of using drugs is higher than the benefits, it is not advisable to prescribe hormonal contraceptives.

Table 2. Venous thrombosis factors.

Risk factors

Evaluation

The risk of increasing significantly when the body mass index increases. Special consideration should be considered if there are other risk factors.

Note: The temporary immobilization includes traveling in air for more than 4 hours can also be a risk factor for venous thrombosis, especially in women with other risk factors.

In these cases, it is advisable to stop using the type of pills/pill/IUD (in the case of surgery under the program for at least 4 weeks earlier) and do not take the drug for at least 2 weeks after completely recovered. Other contraception should be used to prevent unwanted pregnancy. It may be necessary to consider the use of anti -thrombotic therapy if they are constantly using Belara before.

If you doubt genetic ability, you should consult a specialist before deciding to use hormonal contraceptives.

Cancer, systemic erythematosus lupus, urea soluble syndrome, chronic bowelitis (Crohn's disease or colon ulcer) and sickle cell disease.

Old

Especially women over 35 years old.

Pay attention to the risk of increased thrombosis in pregnant women, and especially during the 6 -week period around the birth time.

Symptoms of venous thrombosis (deep vein thrombosis and pulmonary embolism):

If the following symptoms are available, medical care should be taken immediately and notified to the doctor if they are taking hormonal contraceptives.

Symptoms of deep vein thrombosis may include: swelling on one side and/or feet or along the leg vein; Pain or stiffness in the legs can only feel when standing or walking; The affected legs feel warmer, the skin becomes red or discolored.

Symptoms of pulmonary embolism may include: Suddenly, unexplained, unexplained breathing; Suddenly coughing, can be tied with blood coughing; pain in the chest; dizziness, heavy dizziness; tachycardia or abnormalities.

Some of these symptoms (for example, "short breath", "cough") are not specific and may be misunderstood into common or non -serious manifestations (for example, respiratory infections).

Other signs of congestion may include: sudden pain, swelling and light blue. If congested in the eye, symptoms may change from painless blurred expressions, then may progress to loss of vision. Sometimes it can be blind immediately.

Aortic thrombosis (ATE):

Epidemiological studies show that there is a relationship between the use of hormonal contraceptives in combination with increased risk of arteriosclerosis or stroke (for example, transient ischemia, stroke). Arterial thrombosis can be fatal.

Aortic thrombosis factors:

The risk of arterial thrombosis (myocardial infarction) or a stroke in the user of hormonal contraceptives increases in women with risk factors (see Table 3). Contraindicated Belara if a woman has a serious risk factor or has many arterial thrombus risk factors because this has a high risk of arterial thrombosis. If a woman has more than one risk factor, the risk of arterial thrombosis will be more likely to increase than the sum of individual factors - in this case, it is necessary to consider the overall risk of that person. If the risk of using drugs is higher than the benefits, it is not advisable to use the hormonal contraceptive pills.

Table 3. Aortic thrombosis factors.

Risk factors

Evaluation

Old

Especially women over 35 years old.

Women should not smoke if they want to use combined contraceptive hormones. Women over 35 years old and smoking are definitely using other contraception.

Hypertension

The risk of increasing significantly when the body mass index increases. Special consideration should be considered if there are other risk factors.

If you doubt genetic ability, you should consult a specialist before deciding to use hormonal contraceptives.

Increase the week's week of migraine and intensity while taking hormonal drugs using combined contraceptives (maybe a warning sign of a brain vessel event) may be the reason for stopping the drug immediately.

Diabetes, Homocystein increased blood, valve and atrial fibrillation, blood lipoprotein disorders and systemic lupus erythematosus.

Symptoms of a stroke may include: Sudden numbness or muscle weakness on the face, arm or leg, especially on the same side of the body; Suddenly traveling difficult, dizzy, losing the ability to balance or coordinate movements; Suddenly confused, speaking or understanding; Suddenly looking difficult in one or both eyes; Sudden headache, severe or prolonged headache for unknown reasons; Loss of awareness or fainting or no epilepsy. annoying spread in the back, jaw, throat, arms and abdomen; The feeling of fullness, indigestion, suffocation; Sweating, nausea, vomiting or dizziness; intense fatigue, anxiety, short breath; tachycardia or abnormal heart. If there is a suspicion or affirmation of thrombosis, it is necessary to stop Belara immediately.

tumors:

Some epidemiological studies show that long -term use of endocrine contraceptives is a risk factor for the development of cervical cancer in women infected with HPV (Human Papilloma Virus). However, there are still controversy over these results affected by interference factors (such as the difference in the number of partners or the use of mechanical contraception).

In rare benign cases and in less than cases, malignant liver tumors have been reported during the use of hormonal contraceptives. In single cases, the tumor causes abdominal bleeding that threatens life. In the case of severe abdominal pain, the liver or the signs of abdominal bleeding must be considered for tumor ability in the liver and must stop using Belara.

Other pathologies:

Many women use hormonal contraceptives with mild hypertension; However, hypertension is clinically significant rarely occurs. The relationship between the use of hormonal contraceptives and hypertension manifested clinically has not been confirmed. If hypertension is clinically significant while taking Belara, it is necessary to stop taking the drug and treating hypertension. Can continue using Belara as soon as the blood pressure returns to normal while treating hypertension.

On women with a history of genital herpes, the disease may recur during the period of use of hormonal contraceptives.

In women with a history or a history of hyperglyceria, the risk of pancreatitis increases during the use of coordinated hormonal contraceptives. Acute or chronic liver dysfunction may need to stop using combined contraceptives until the liver function returns to normal. If there is a recurrence of jaundice, the cholestatic skin has appeared during pregnancy or when using the previous sex hormones, it is necessary to stop using hormonal contraceptives.

Coordinated hormonal contraceptives may affect peripheral insulin resistance or glucose tolerance. Therefore, patients with diabetes should be closely monitored while taking hormonal contraceptives.

rarely occurs skin pigmentation, especially in women with a history of pregnancy pigmentation. Women tend to have melasma should avoid exposure to the sun and ultraviolet rays during the use of endocrine contraceptives.

Patients with rare genetic diseases such as galactose intolerance, Lapp Lactase deficiency or Glucose - Galactose should not use this drug.

Precautions

Using estrogen or combining estrogen and progestogen may adversely affect some diseases and/or condition. Medical monitoring is especially necessary in the case:

epilepsy;

scattered sclerosis;

tetanus; blood;

autoimmune diseases; sex;

depression;

Clinical examination and advice

Before starting to use or start using Belara, you must consider the entire history of a woman's disease (including the history of the family) and eliminate the possibility of pregnancy. Blood pressure and clinical examination should be measured according to the instructions in the contraindications and the warning section. These checks should be repeated every year during the use of Belara.

Regular physical examination is also necessary due to contraindications (such as transient ischemic anemia) or risk factors (such as family history of arterial thrombosis or veins) may first appear or become clear when taking hormonal contraceptives. Clinical examination must include blood pressure measurement, breast, abdominal examination, internal genitalia and external genitalia, cervical spread, and necessary tests.

It is important to note that the woman with information about venous thrombosis and arterial thrombosis, including the risk of Belara compared to other coordinated hormonal contraceptives, symptoms of venous thrombosis and arterial thrombosis, known risk factors and what to do when suspected of having thrombosis.

Women need to be carefully read the user guide and follow the instructions in it. The frequency and content of the examination should be based on practical guidelines and applied on each woman.

Women need to be advised that the use of unprotected hormonal contraceptives from HIV infection (AIDS) or other sexually transmitted diseases.

Inadequate drugs: Forgetting the drug, vomiting or gastrointestinal disorders including diarrhea, simultaneous use of long -term with some drugs or cases of very rare metabolic disorders can reduce the effectiveness of contraception of the drug.

affect cycle control:

Hemorrhage or mid -term hemorrhage: All endocrine contraceptives can cause abnormal vaginal bleeding (hemorrhage or mid -term bleeding), especially in the first few cycles when taking the drug. Therefore, abnormal cycles should only be examined after going through the period of adjustment of about 3 cycles. If in the process of using Belara still has a long -term midtermic bleeding, or occurs when the previous cycle is normal, it is advisable to visit to eliminate the possibility of pregnancy or organic disorders. After eliminating these factors, Belara can be continued or transferred to another oral contraceptive. Bettery bleeding may be a sign of contraceptive reduction.

Do not see bleeding at the end of the period: After 21 days of drug use, usually the end of the period will see the end of the period. Sometimes, especially in the first few months of taking the drug, may not see bleeding at the end of the period. However, this phenomenon is not a sign of drug contraception. If there is no bleeding after a cycle of not forgetting the drug, the period of stopping the drug does not last for more than 7 days, no drug is used simultaneously and does not vomit or diarrhea, it is unable to conceive and can continue to use Belara. If Belara is not used according to the instructions before not seeing the first bleeding for the first time, the bleeding is not seen at the end of the period in two consecutive cycles, it is necessary to eliminate the possibility of pregnancy before continuing to use the drug. Do not use medications containing holy grass (Hypericum Perforatum) along with Belara.

The ability to drive and operate machinery

It is unknown whether the hormonal contraceptive pills have adversely affected the ability to drive and operate the machine.

Pregnancy

Belara is not recommended for use during pregnancy. Before starting to use the drug, you must eliminate the possibility of pregnancy. If pregnant during Belara, stop the drug immediately.

When starting to reuse Belara, it is important to pay attention to the risk of increased venous thrombosis during postpartum.

Breastfeeding period

Milk secretion can be affected by estrogen because drugs can change the number and composition of breast milk. A small amount of contraceptive steroids and/or its metabolites can be excreted into breast milk and therefore can affect breastfed babies. Therefore, Belara should therefore be used during breastfeeding.

Medicinal interaction

Ethinylelestradiol's drug interaction, Belara's estrogen component, with other drugs that can increase or decrease the concentration of ethinylestradiol in serum. If it is necessary to treat these medications for a long time, the methods of contraception should be used without hormonal use. Ethinylelestradiol levels in serum decrease can lead to an increase in the number of bleeding outside the menstrual cycle, cycle disorders and reduce the effectiveness of Belara's contraception. Ethinylelestradiol concentration in serum increases can lead to increased frequency of appearance and severity of unwanted effects.

The active ingredients below can reduce the concentration of ethinylelestradiol in serum:

Medications that increase gastric gastric motility (such as metoclopramid) or reduce absorption (activated carbon). Modafinil, Protease inhibitors (such as Ritonavir) and Holy John.

When used with these drugs/active ingredients for short -term treatment should use more mechanical contraception and Belara during treatment and for 7 days later. With active ingredients that reduce the concentration of serum ethinylestradiol due to microsom enzyme induction in the liver, additional mechanical contraceptives are used up to 28 days after stopping treatment.

If the drugs are still used in the same time when the contraceptive drug blister is over, they should use another blister without taking the drug.

The active ingredients below can increase the concentration of ethinylelestradiol in serum:

The active ingredients inhibit the Ethinyletradiol Ethinylestradiol processes in the small intestinal wall such as ascorbic acid or paracetamol; fluconazole), indinavir or troleandomycin.

Ethinylestradiol may affect the metabolism of other drugs:

Due to the inhibition of liver enzyme and the result increases the concentration of the active ingredients in the serum such as diazepam (and the metabolism of other benzodiazepin), ciclosporin, theophylin and prednisolon. Paracetamol, morphin, Lorazepam. This can also be applied to drugs in the nearest time.

Testing: The use of endocrine contraceptives can affect some test results, including biochemical indicators of liver, kidney, adrenal and thyroid function, plasma concentrations of carrier proteins (such as steroid globulin - SHBG, lipoprotein), carbohydrate metabolism parameters, blood clots and fibrin pepper. The nature and level of influence part of the nature and the dose of hormones are used.

Storage

Store in a dry place, at a temperature not exceeding 30 ° C.

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